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Analysis of The Socio-Economic Impacts of A Harmonised Classification of Carcinogen Category 2 For Titanium Dioxide (Tio)

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107 views324 pages

Analysis of The Socio-Economic Impacts of A Harmonised Classification of Carcinogen Category 2 For Titanium Dioxide (Tio)

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Dyala Ashraf

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Analysis of the socio-economic

impacts of a harmonised classification

of Carcinogen Category 2
for titanium dioxide (TiO2)

Updated Final Report

prepared for

Titanium Dioxide Industry Consortium

27 November 2017
Analysis of the socio-economic impacts of a
harmonised classification of Carcinogen Category 2
for titanium dioxide (TiO2)

November 2017

Updated Final Report

Quality Assurance

Project reference / title J918 / TDMA

Report status Updated Final Report

Panos Zarogiannis
Author(s) Linda-Jean Cockcroft
Rebecca Halliday

Approved for issue by Meg Postle

Date of issue 27 November 2017

Table of contents
Executive Summary...................................................................................................................... 1

1 Introduction to the analysis .................................................................................................. 7

1.1 Background to this report ............................................................................................................... 7
1.2 Consultation activities..................................................................................................................... 8

2 Properties of titanium dioxide .............................................................................................. 9

3 Supply chain overview ........................................................................................................ 11

3.1 Titanium dioxide feedstock and production ................................................................................. 11
3.1.1 Titanium dioxide feedstocks ......................................................................................... 11
3.1.2 Titanium dioxide production processes ........................................................................ 11
3.2 Titanium dioxide pigment production .......................................................................................... 13
3.2.1 Types and forms of titanium dioxide pigment .............................................................. 13
3.2.2 Titanium dioxide production capacity and locations .................................................... 14
3.3 Consumption of titanium dioxide pigments ................................................................................. 17
3.4 Applications for titanium dioxide.................................................................................................. 18
3.4.1 Overview ....................................................................................................................... 18
3.4.2 Paints and industrial coatings ....................................................................................... 21
3.4.3 Plastics........................................................................................................................... 24
3.4.4 Paper ............................................................................................................................. 27
3.4.5 Inks ................................................................................................................................ 29
3.4.6 Construction products .................................................................................................. 31
3.4.7 Fibre applications .......................................................................................................... 32
3.4.8 Catalysts ........................................................................................................................ 34
3.4.9 Food and feed additives and food contact materials ................................................... 34
3.4.10 Pharmaceuticals ............................................................................................................ 37
3.4.11 Cosmetics ...................................................................................................................... 39
3.4.12 Elastomers..................................................................................................................... 42
3.4.13 Pigment and pigment preparation manufacture .......................................................... 43
3.4.14 Ceramics ........................................................................................................................ 45
3.4.15 Glass .............................................................................................................................. 47
3.4.16 Medical devices ............................................................................................................. 48
3.4.17 Detergents..................................................................................................................... 49
3.4.18 Biocides ......................................................................................................................... 50
3.4.19 Other minor applications .............................................................................................. 50
4 Impact analysis ................................................................................................................... 51
4.1 Introduction .................................................................................................................................. 51
4.2 Drivers behind the impacts from the proposed classification of titanium dioxide ...................... 51
4.2.1 Impact driver 1: Existing regulatory requirements ...................................................... 51
4.2.2 Impact driver 2: Availability of alternatives ................................................................. 71
4.2.3 Impact driver 3: Market developments ....................................................................... 72
4.2.4 Impact driver 4: Industrial/professional user and consumer perceptions .................. 72
4.2.5 Other impacts ............................................................................................................... 73
4.3 Specific impacts on downstream users of mass applications of titanium dioxide ....................... 73
4.3.1 Paints and coatings ....................................................................................................... 73
4.3.2 Plastics........................................................................................................................... 95
4.3.3 Paper ........................................................................................................................... 108
4.3.4 Inks, toners, recreation colours and stationery products ........................................... 114
4.3.5 Construction products and coatings ........................................................................... 124
4.4 Specific impacts on downstream users of specialty applications of titanium dioxide ............... 131
4.4.1 Fibre applications ........................................................................................................ 131
4.4.2 Catalysts ...................................................................................................................... 141
4.4.3 Food and feed additives and food contact materials ................................................. 142
4.4.4 Pharmaceuticals .......................................................................................................... 149
4.4.5 Cosmetics .................................................................................................................... 154
4.4.6 Elastomers................................................................................................................... 159
4.4.7 Pigment and pigment preparation manufacture ........................................................ 160
4.4.8 Ceramics ...................................................................................................................... 164
4.4.9 Glass ............................................................................................................................ 169
4.4.10 Medical devices ........................................................................................................... 171
4.4.11 Detergents................................................................................................................... 174
4.4.12 Biocides ....................................................................................................................... 175
4.5 Summary of impacts on downstream uses of titanium dioxide ................................................. 175
4.5.1 Key market metrics for downstream industry sectors and estimate of overall
downstream sector impacts ....................................................................................................... 175
4.5.2 Estimation of the impacts on EEA-based demand for titanium dioxide ..................... 178
4.6 Impacts on producers of titanium dioxide .................................................................................. 187
4.6.1 Key market parameters for titanium dioxide.............................................................. 187
4.6.2 Value of titanium dioxide market and profitability of EEA-based operations ............ 188
4.6.3 Analysis of economic impacts on titanium dioxide manufacturers ............................ 190
4.6.4 Employment impacts .................................................................................................. 200
4.7 Impacts on upstream suppliers ................................................................................................... 200
4.7.1 Ore mining and slag production in the EEA ................................................................ 200
4.7.2 Impacts on suppliers of feedstock, raw materials and utilities .................................. 201
4.8 Impacts outside the titanium dioxide supply chains .................................................................. 204
4.8.1 Impacts on industrial minerals that contain titanium dioxide impurities .................. 204
4.8.2 Impacts on manufacturers and users of other poorly soluble powders..................... 213
4.9 Impacts on the environment ...................................................................................................... 214

5 Conclusions ...................................................................................................................... 221

5.1 Why and how the proposed classification would impact the EEA ............................................. 221
5.2 Impacts on the manufacture and supply of titanium dioxide in the EEA ................................... 222
5.3 Impacts on the supply of feedstock and raw materials and energy to titanium dioxide
manufacture in the EEA ...................................................................................................................... 224
5.4 Impacts on downstream users of titanium dioxide in the EEA ................................................... 224
5.4.1 Costs arising from compliance with horizontal legislation ......................................... 224
5.4.2 Market losses due to regulatory and voluntary restrictions on the use of titanium
dioxide 225
5.4.3 Market losses due to negative market and consumer perceptions of the safety of
titanium dioxide .......................................................................................................................... 227
5.4.4 Feasibility and cost of substituting titanium dioxide .................................................. 228
5.4.5 Increases to operating costs and associated loss of competitiveness and competition
229
5.4.6 Conclusion on economic impacts................................................................................ 230
5.4.7 Impacts on employment ............................................................................................. 230
5.5 Impacts on actors outside the titanium dioxide supply chains .................................................. 230
5.6 Impacts on consumers ................................................................................................................ 231
5.7 Impacts on the environment ...................................................................................................... 232
5.8 Potential benefits to health from the proposed classification for titanium dioxide .................. 233

6 References ....................................................................................................................... 235

7 Annex 1: Legislation of relevance to hazard classifications under consideration................. 247

7.1 EEA-wide legislative requirements ............................................................................................. 247
7.1.1 Classification and labelling .......................................................................................... 247
7.1.2 Carcinogens at work.................................................................................................... 250
7.1.3 Waste .......................................................................................................................... 251
7.1.4 Industrial Emissions .................................................................................................... 253
7.1.5 REACH Regulation ....................................................................................................... 254
7.1.6 Cosmetics .................................................................................................................... 259
7.1.7 Toy Safety .................................................................................................................... 262
7.1.8 Food contact materials ............................................................................................... 264
7.1.9 Food and feed additives .............................................................................................. 268
7.1.10 Colouring matters for medicinal products .................................................................. 271
7.1.11 Medical devices ........................................................................................................... 274
7.1.12 Construction products ................................................................................................ 275
7.1.13 Biocides ....................................................................................................................... 277
7.1.14 Electrical and electronic equipment ........................................................................... 279
7.1.15 Tobacco products ........................................................................................................ 280
7.1.16 Summary and conclusions .......................................................................................... 281
7.2 Other regulatory provisions ........................................................................................................ 286
7.2.1 National Health and Safety at Work and Consumer Safety Legislation...................... 286
7.2.2 Food contact materials ............................................................................................... 286
7.2.3 CEPE Code of Practice for coated articles where the food contact layer is a coating 290
7.2.4 EuPIA Exclusion Policy for printing inks and related products ................................... 291
7.2.5 Global Automotive Declarable Substance List ............................................................ 292
7.2.6 CE marking .................................................................................................................. 293
7.2.7 Ecolabelling schemes .................................................................................................. 293
7.2.8 OEKO-TEX® Standard .................................................................................................. 294
7.2.9 Other provisions.......................................................................................................... 295

8 Annex 2: Alternatives for titanium dioxide ....................................................................... 297

8.1 Technical feasibility of alternatives............................................................................................. 297
8.2 Hazard profile of alternatives ..................................................................................................... 304
8.3 Availability of alternatives .......................................................................................................... 305
8.4 Information from consultation ................................................................................................... 307
Executive Summary
Introduction

Titanium dioxide (TiO2) is by far the highest volume and most versatile globally-used white pigment
which is also widely used as a brightener for colours other than white. No other pigment comes
close to matching its exceptionally high opacity (a result of TiO2 having the highest refractive index
among all known white pigments), bright whiteness and UV absorbing, protective properties. It is
manufactured in 18 plants in the European Economic Area (EEA) with an annual production volume
of ca. 1,100 ktonnes and an estimated market value of ca. €3 billion. Most TiO2 is used in paints and
coatings (architectural: 36%; industrial: 17%; inks: 4%), followed by plastics (25%), paper (12%) and
specialty applications (6%) (based on Cefic data for 2013). Approximately 1-2% of all TiO2 is made in
non-pigmentary forms for use in many high-value-added applications including cosmetic sunscreens
and clean air environmental technologies.

The French authorities proposed the classification of TiO2 as a Carcinogen Category 1B substance in
May 2016. Whilst ECHA’s Risk Assessment Committee (RAC) has concluded that a Carc Cat 1B
classification cannot be scientifically justified, it has also asserted in its opinion dated 14 September
2017 that TiO2 meets the criteria to be classified as suspected of causing cancer (Carcinogen
Category 2) specifically through the inhalation route. Although, a Carc Cat 2 harmonised
classification is less severe than that proposed by the French authorities, this classification would still
have severe adverse consequences as a result of (a) the absence of technically feasible alternatives
for TiO2; (b) the triggering of a series of changes in how the marketing and use of TiO2 is treated
under a variety of chemical safety regimes in the EEA; and (c) the negative perceptions that would
develop among users and consumers over the safety of the substance. These changes would
disregard the importance of the TiO2 exposure pathway specified by RAC in their opinion: in a
mixture or matrix of any form, there can be no or extremely low levels of human exposure by
inhalation; nevertheless, regulatory changes would simply apply the classification as a carcinogen in
all cases, so irrespective of the specificity of the inhalation route, and negative perceptions would
develop due to consumers being largely oblivious to this critical parameter.

Impacts on downstream users of titanium dioxide

The Carc Cat 2 harmonised classification would impact upon a multitude of downstream user sectors
with a combined Gross Added Value of hundreds of billions of Euros; paints and plastics alone, the
most important uses for TiO2, account for over €120 billion per annum. Downstream users might
consider the reformulation of their products, however, in the vast majority of cases this could not be
successful due to the lack of alternative pigments that match TiO2’s performance in technical and
economic terms; in any case, substitution of TiO2 would be costly (example estimates: €0.05-60
million per company), take considerable time (2-20 years) and invariably be a case of regrettable
substitution. Additional workplace safety measures could have an investment cost of up to €0.1
million, if not more, per plant, while waste regulations would impact upon the recycling and reuse of
waste that contains over 1.0% TiO2 and might impose an additional cost ranging from a few
thousand Euros to millions of Euros per site for the disposal of packaging and manufacturing waste
classified that would be newly classified as hazardous.

The Carc Cat 2 harmonised classification could lead to the removal from the market of a multitude of
consumer formulations and products such as toys, cosmetics, foodstuff, food contact materials,
pharmaceuticals, tobacco products and ecolabelled products (including textiles); in some cases
exemptions could be secured following an evaluation of risks by relevant scientific bodies, however,

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the cost of obtaining them could be high (possibly up to millions of Euros to demonstrate low
bioavailability).

Importantly, the labelling of TiO2-containing mixtures as suspected carcinogens (CLP requires the
label to read “suspected of causing cancer”) and the stigmatisation of the substance would drive
negative consumer and industrial/professional user perceptions thus leading to market losses for
manufacturers of TiO2-containing products and their downstream supply chains.

Impacts on titanium dioxide manufacturers and their suppliers

It is estimated that a Carc Cat 2 classification would lead to 10-15% of current demand for TiO2 being
lost due to adverse effects on the downstream uses of the substance. This would in turn lead to the
shrinking of EEA’s TiO2 manufacturing base and the likely shutdown of an uncertain number of
production lines. The consequence of this would be a significant knock-on effect on the
manufacture of titanium chemicals and iron-based co-products, the sales of which underpin the
profitability of TiO2 manufacturing plants. Adverse impacts would not be limited to those driven by
effects on downstream users; the Carc Cat 2 harmonised classification would impact upon the sales
of co-products (iron filter salts) that contain TiO2 impurities at concentrations above 0.1% and would
also have the potential to precipitate severe repercussions on the waste management of large
volumes of manufacturing waste (neutralisation solids and red gypsum) which (a) could require
disposal as hazardous materials and (b) would prevent sale of such materials for reuse in a range of
industry sectors. Loss of sales and severely increased waste management costs could lead to the
ultimate collapse of EEA’s TiO2 manufacturing base.

Looking only at TiO2 manufacture, in the context of an EEA market value of ca. €3 billion, its Gross
Added Value to the EEA economy is estimated at ca. €560 million per annum, excluding other socio-
economically important co-products and by-products; the industry employs ca. 8,150 workers and is
responsible for the creation of a further 22,800 directly related support jobs. The adverse impacts
from the Carc Cat 2 harmonised classification could result in the loss of thousands of jobs across the
EEA. Decimation of EEA’s TiO2 manufacturing base would impact upon both EEA-based and non-EEA
supply chains as exports account for one-third of EEA manufacture while some TiO2 grades are only
produced by European plants.

Finally, a Carc Cat 2 harmonised classification would also cause market losses for two Norwegian
feedstock manufacturers and would affect the trade of ca. 4 million tonnes of raw materials used in
the manufacture of TiO2.

Impacts on EEA competitiveness

EEA businesses would become less competitive both domestically and overseas and, over time,
some parts of the value chains might consider relocating outside the EEA, unless a similar hazard
classification was also adopted by non-EEA jurisdictions. For TiO2 manufacture, production of the
pigment outside the EEA would likely significantly increase in order to supply global demand.
Downstream SMEs in the EEA would be particularly vulnerable to the loss of a critical raw material or
articles that depend on it.

Impacts on EEA workers

TiO2 formulations and articles are used by millions of workers; by way of example, 1 million workers
apply paints/coatings and 4.5 million workers are involved in the use of plastics. Even if the Carc Cat
2 harmonised classification caused the loss of jobs for only a modest percentage of this workforce,
the total number of jobs lost across all EEA would be significantly high. Impacts would not be limited

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to industries that use TiO2 as a raw material; the re-classification of TiO2-containing products such as
coatings would also affect employment in downstream industries that use these products.

Impacts on the marketing and use of other minerals

The handling, processing and use of minerals that contain TiO2 impurities at up to 4% by weight (e.g.
kaolin, a mineral often referred to as a potential partial replacement for TiO2, bentonite, mica, ball
clays and refractory materials) would be affected. Combined, these minerals are used in the EEA in a
volume of over 20 million tonnes per year and have a market value of over €3.3 billion. The volumes
and market value of downstream products of these minerals are even larger.

In its September 2017 opinion, RAC acknowledges that the carcinogenicity profile described for TiO2
is not exclusively characteristic of TiO2 but applies to a group of chemicals with similar toxicity profile
addressed as “poorly soluble low toxicity particles”. Thus, adoption of this proposed Carc Cat 2
harmonised classification could open the pathway for the classification of other poorly soluble
powders, including many minerals that might be considered potential (partial) substitutes for TiO2.

Impacts on consumers

Consumers would face a reduction in product availability and choice, increased market prices,
significantly increased costs for redecoration and maintenance tasks if these can as a result of the
classification only be undertaken by professionals (thus impacting, in particular, consumers on low
incomes), loss of performance, poorer aesthetics and also loss of a safe, effective UV filter in
sunscreens and other cosmetics if use of TiO2 was banned. More broadly, the hazard classification of
a substance used so widely (including in food and medicines) for suspected carcinogenicity arising
through an improbable, if not impossible, exposure pathway (inhalation) for the products
concerned, could cause uncertainty and confusion which could damage the confidence consumers
have in health protection rules and government decision-making and damage consumer confidence
in the reliability and accuracy of label information. Paints, coatings, adhesives, sealants and
generally consumer mixtures which typically contain TiO2 in excess of 1.0% by weight (NB. detergent
formulations may not) will be required to be labelled with “suspected of causing cancer (through
inhalation)”, but the meaning of this to a consumer would be unclear. It is not explicit, nor can it be
made explicit on the label under CLP, that this refers to inhalation of TiO2 dust particles and not to
inhalation of the paint/coating/mixture more generally.

Conclusion

This high-level impact analysis demonstrates that the Carc Cat 2 harmonised classification for TiO2
proposed by the RAC, similar to the original French proposal for a more severe Carc Cat 1B
classification, would result in severe social and economic cost impacts, firstly for the manufacturers
of the substance, secondly for the multitude of downstream users of TiO2 in a diverse range of
industry sectors, thirdly on the marketing and use of a vast array of industrial, professional and
consumer products and finally on the employment of a very significant number of workers. Whilst
quantification of these impacts has generally not been possible (due to, among other reasons, the
impacts partly being driven by negative user and consumer perceptions; studies show that
consumers read labels and do not understand them. There has been no research into how
consumers, or indeed retailers, would respond to a label which says: “suspected of causing cancer
via inhalation” which would be the required label wording under the CLP Regulation), the sheer
volume and range of uses and products that would be affected points to a very significant adverse
effect on EEA society as a whole.

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This report gives particular emphasis on impacts arising from the labelling of mixtures that contain
TiO2, potential restrictions arising for the marketing and use of the substance in products such as
toys, cosmetics, food contact materials, foodstuff and pharmaceuticals as well as products that are
currently awarded an ecolabel. It also highlights the waste management impacts of a Carc Cat 2
classification of TiO2. While some regulatory impacts of a Cat 2 harmonised classification could be
considered less severe than a Cat 1B classification, this is not true for waste and its management in
the EEA. Waste management impacts for both manufacturers and downstream users are considered
in detail in this report and available information indicates significant cost increases for the
management of waste which would be classified as hazardous if it contains above 1.0% TiO2. Whilst
Cefic has estimated that the price for treatment of waste classified as hazardous can be 2 to 3 times
the price for the same material classified as non-hazardous, information from consultation would
suggest a much higher price differential of 10-30 times (by way of example, the UK landfill tax for
one tonne of hazardous waste is ca. 31 times higher than the respective tax rate for non-hazardous
waste).

Impacts on waste management need to be seen in a wider policy context. One of the current major
policy issues of the EU is the Circular Economy, where two of the objectives are: to reduce use of the
earth’s natural resources (which are by definition limited) and to encourage recovery from
articles/products already in use via, for example, recycling, reuse, remake and energy recovery.
Waste legislation and waste management are currently in the spotlight as their role in contributing
to Circular Economy objectives is critical. In any event, objectives clearly aim to reduce landfill and
incineration as ways of dealing with waste. In the context of the Circular Economy, the concepts
underlying the current debates include the objectives to: (a) encourage and increase the volume of
waste recovery (with multiple initiatives to do so including significant investment in relevant
innovation research) and thereby reduce the volume of wastes that are incinerated and (b) aim to
ensure that waste streams available for recycling and reuse do not contain hazardous waste and by
extension, thereby reduce the amount of non-hazardous waste incinerated. The implications of a
Carc Cat 2 harmonised classification would be three-fold:

• Many applications of TiO2 generate waste streams which will or could become classified as
hazardous waste under the Waste Framework Directive. Given the very wide spread of
applications of TiO2 in industrial and consumer products, the sheer volume of waste potentially
reclassified as hazardous could in itself have a significant impact on waste management;

• Classification of several TiO2-containing waste streams as hazardous would have a very

detrimental effect on their recycling and reuse. An important example in this regard is plastic
packaging waste where the value chain would be severely impacted by any adverse effect on
recycling activities; and

• TiO2-containing waste classified as hazardous would require specialist disposal. If incineration is

selected as the appropriate waste management option, such waste would have to be shipped to
special incineration plants. It is reported that there are currently insufficient hazardous waste
incineration plants in the EU to deal with increasing volumes of waste classified as hazardous
and that in some cases it is difficult to get planning permission to build them.

In conclusion, the classification of TiO2 as Carc Cat 2 would have significant impacts in terms of non-
industrial waste management and negative impacts on the EU’s Circular Economy objectives.

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3 Supply chain overview

3.1 Titanium dioxide feedstock and production

3.1.1 Titanium dioxide feedstocks
The mineral sands2 industry is the main supplier of titanium raw materials for the production of TiO2
feedstocks. TiO2 is produced from ilmenite, rutile or titanium slag. According to the US Geological
Survey (USGS, 2017), the global mine production of ilmenite in 2016 was estimated at being 5.9
million tonnes, while mine production for rutile was estimated at 0.74 million tonnes. Major
producers of ilmenite include China, Australia, Vietnam, Mozambique, Kenya and Norway, while for
rutile major producers include Australia, Sierra Leone, Ukraine, Kenya and South Africa (USGS, 2017).
Overall, the largest producers of titanium dioxide feedstock are China (18%), Australia (17%), South
Africa (15%) and Canada (11%) (Iluka, 2015).

There is no mining operation in the EU, but Titania AS (owned by Kronos) operates a mine in Tellnes,
Norway. The ilmenite ore deposit was discovered in 1954 and is one of the world's largest3.
Another facility, also in Norway, operated by TiZir Titanium & Iron produces titanium slag from
ilmenite imported from Senegal. Production in Tyssedal, Norway started in 19864.

3.1.2 Titanium dioxide production processes

The overall process of manufacture is to take an impure TiO2 feedstock and to convert this into the
pure white TiO2 pigment. In essence, the process sounds very simple but to achieve this it is
necessary to chemically convert the impure TiO2 into another chemical, separate out the impurities
then to convert back to pure TiO2 — in effect a chemical purification (McNulty, 2012). Pure TiO2 is
produced by two processes, the sulphate process and the chloride process, presented in Figure 3–1.
The following table highlights some key technical differences between them.

Table 3–1: Comparison of the processes used to produce TiO2

Sulphate process Chloride process
Older process – used since 1920s Newer process – used since 1950s
Lower grade feedstock used Higher grade feedstock used
Can produce both rutile and anatase Produces only rutile
Dominates in China, significant capacity in Europe Dominates in North America and more widespread
than sulphate in Rest of World
In Europe, 55% TiO2 is produced via the sulphate In Europe, 45% of TiO2 is produced via the chloride
route route

2
Mineral sands are old beach sands that contain concentrations of the important minerals, rutile, ilmenite,
zircon and monazite. These minerals are heavy and are also called 'heavy minerals'. The relative density of
common sand minerals such as quartz is around 2.65.

3
Information available at http://kronostio2.com/en/manufacturing-facilities/hauge-norway (accessed on 25
October 2016).

4
Information available at http://www.tizir.co.uk/projects-operations/tyssedal-tio2/ (accessed on 2
November 2016).

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Micronising

Figure 3–1: Chloride and sulphate TiO2 production processes

Source: Chemours (2015)

The overall chemistry of the sulphate process can be represented as (McNulty, 2012):

FeTiO3 + 2H2SO4  TiOSO4 + FeSO4 + H2O

TiOSO4 + H2O  TiO2n.H2O + H2SO4
TiO2n.H2O  TiO2 + n.H2O

The sulphate process is more complicated in terms of the number of unit operations involved. On
the other hand, the overall chemistry of the chloride process can be represented as (McNulty, 2012):

TiO2 + C + 2Cl2  TiCl4 + CO + CO2

TiCl4 +O2  TiO2 + 2Cl2

In general, higher-grade (% TiO2) feedstocks are used for the chloride process than for the sulphate
process (McNulty, 2012). Australia produces mainly chloride feedstocks; South Africa predominantly
produces sulphate ilmenite, which is upgraded to chloride slag with ilmenite also produced in other
African countries, including Madagascar and Mozambique. Canada produces sulphate slag and
upgraded slag, while China mines mainly sulphate ilmenite from hard rock deposits, which is sold
directly or upgraded to sulphate slag (Iluka, 2015).

It is reported that 90% of global TiO2 feedstocks is used in the manufacture of pigment. The rest is
used for the production of welding rods (for example, in steel construction and the ship building
industry), or titanium metal (via sponge) for a variety of high-tech aerospace and military
applications, medical and sporting equipment (Iluka, 2015).

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3.2 Titanium dioxide pigment production
3.2.1 Types and forms of titanium dioxide pigment
Differentiation by crystal form

TiO2 is a polymorphous and simple inorganic compound, existing in three fundamental crystal forms.
All three forms, anatase, rutile and brookite, occur naturally but the latter is rare, and although it has
been prepared in the laboratory, it is of no commercial interest (Gázquez, et al., 2014). The chloride
production process allows the production of only rutile TiO2 and is primarily suited for large volume
production of standard TiO2 grades. The sulphate production process is capable of producing both
the rutile and anatase grade of TiO2 (Rockwood, 2012). The key differences between the two
commercial crystal forms are shown below.

Table 3–2: Comparison of the two commercial crystal forms of TiO2

Parameter Rutile Anatase
Stability More stable Less stable
Lattice structure Titanium is surrounded octahedrally Titanium is surrounded octahedrally
by six oxygen ions. Each octahedron by six oxygen ions. Each octahedron
shares two of its twelve edges shares four of its twelve edges
Density 4.2 g/cm3 3.9 g/cm3
Refractive index, opacity It has the highest refractive index of Delivers sufficient opacity, not as
any white mineral and so it can high refractive index
confer very high opacity
Dispersion Good dispersion Better dispersion
Production process Made with both sulphate and Made only by sulphate plants
chloride processes
Global market share More widely used Less widely used
Main use sectors: paints, Main area of use May be used
coatings, plastics, paper, inks
Minor use sectors: fibres, Typically, not used in food, Used in food, pharmaceuticals,
food, cosmetics, pharmaceuticals, fibre applications. fibres. Not preferred where UV
pharmaceuticals Preferred in cosmetics where UV absorbance is important
absorbance is important
Source: Kronos (1968); Rockwood (2012)

Differentiation by particle size

There are two grades of TiO2 with respect to particle size: pigmentary TiO2 and nano-scale TiO2.

Pigment grade TiO2 has primary particles mainly in the size range of 200–350 nm (TEM5) as this is the
optimum for scattering visible light; the surface area is typically from 6 to 60 m2/g (coated and
uncoated). Pigmentary TiO2 is used due to its excellent light-scattering properties, white opacity and
brightness and absorbance of UV light. When TiO2 is incorporated into a polymer, it minimises the
degradation of the system (embrittlement, fading and cracking) (TDMA, 2013).

On the other hand, nano-scale (also known as ultrafine) TiO2 is engineered to have primary particles
of a size less than 100 nm with a surface area varying typically from 50 to 200 m2/g (coated and
uncoated).

5
Transmission Electron Microscopy.

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This is a product used when different properties such as transparency, semi-conductive properties
and maximum UV light absorption are required.

Applications of nano-scale TiO2 include (Rockwood, 2012; IHS, 2015; StatNano, 2014; TiPMC, 2015;
TDMA, undated; Gázquez, et al., 2014):

• Cosmetic sunscreens (for UV ray absorbance);

• Generation of innovative colour variations for paints and coatings (“frost effect”);
• Photocatalysis applications such as surface self-cleaning and wood protection;
• Arsenic removal in wastewater treatment;
• Catalysts supports in the automotive industry to remove harmful exhaust gas emissions, and in
power stations to remove nitrous oxides (NOx);
• Precursors for electronics and energy storage materials; and
• Colour pigment precursors and intermediates for special (electro) ceramics, including dye-
sensitised solar cells (“DSSC”).

Nano-scale TiO2 represents only a small proportion of total TiO2 pigment production. In 2010, it was
estimated that the volume of nano-scale TiO2 would increase at the global scale from ca. 50,000 t/y
(representing only 0.7% of the market) to over 200,000 t/y (Research and Markets, 2011). This
increase has not yet materialised; instead it has been indeed estimated to be limited to between ca.
1% of the TiO2 market (TiPMC, 2015) and 2% (TDMA, undated)

3.2.2 Titanium dioxide production capacity and locations

Global producers of titanium dioxide

The first commercial TiO2 pigment manufacturing plant was set up in 1918 by Titan Co A/S,
forerunner of Kronos Titan (Chemours, 2015). According to the US Geological Survey, global TiO2
production capacity in 2016 was 7.4 million tonnes with largest players being China (ca. 2.9 million
tonnes), United States (ca. 1.3 million tonnes), Germany (ca. 0.46 million tonnes), Japan (ca. 0.31
million tonnes) and the United Kingdom (0.3 million tonnes). As of 2015, the most prominent global
producers of TiO2 (i.e. those holding at least 5% of the global market) included, in descending order:

• The Chemours Company;

• Huntsman Pigments;
• Cristal;
• Henan Billions + Lomon;
• Kronos Worldwide; and
• Tronox LLC.

It is important to note two recent developments in the TiO2 manufacturing industry. Firstly, in late
February 2017, it was announced that Cristal had signed a definitive agreement for the acquisition of
its TiO2 business, by Tronox LLC. The transaction would create the largest TiO2 company in the world,
based on titanium chemical sales and nameplate capacity6. The transaction was expected to close
before the first quarter of 2018. Secondly, in January 2017 Huntsman Corporation announced that it

6
Information available at http://www.cristal.com/news-
room/news/Pages/Cristal%20and%20Tronox%20Sign%20Transaction%20Agreement.aspx (accessed on 21
August 2017).

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would spin off its Pigments and Additives business under a new name, Venator Materials
Corporation7.

EEA producers of titanium dioxide

Focusing on the EEA, the main TiO2 producing countries are shown in Figure 3–2. Germany, the
United Kingdom, and Finland combined represent over 60% of EEA production capacity. The figure
takes into account recent closures of capacity in France (ICIS, 2016; ICIS, 2007b). Overall capacity is
at ca. 1,500 ktonnes.

Belgium

7% Czech Republic, Poland,

21% 10% Slovenia
Finland

9% France
5%
2% Germany

2% 6% Italy

6% Netherlands
32%
Norway

Spain

Figure 3–2: Main TiO2 producing countries in the EEA (shares based on nameplate production capacities)
Source: USGS (http://minerals.usgs.gov/minerals/pubs/commodity/titanium/mcs-2016-titan.pdf) and data
from TDMA members

Table 3–3 (overleaf) presents all eighteen EEA TiO2 production plants. EEA accounts for almost 20%
of the total worldwide production. It is further known that some TiO2 production also occurs in
Ukraine (by two companies, Krymsky Titan and Sumykhimprom).

7
Information available at
http://www.huntsman.com/corporate/Applications/itemrenderer?p_rendertitle=no&p_renderdate=no&p
_renderteaser=no&p_item_id=998540193&p_item_caid=1123 (accessed on 21 August 2017).

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Table 3–3: TiO2 production facilities in the EEA

# Country Company Location Process

1 Belgium Kronos Langerbrugge Chloride
2 Czech Republic Precheza Prerov Sulphate
3 Finland Venator Materials Pori Sulphate
4 France Venator Materials Calais (finishing only) Sulphate
5 France Cristal Thann Sulphate
6 Germany Evonik Hanau “Chloride”
7 Germany Venator Materials Duisburg-Homberg Sulphate
8 Germany Venator Materials Krefeld-Uerdingen Sulphate
9 Germany Kronos Leverkusen (2 plants) Both
10 Germany Kronos Nordenham Sulphate
11 Italy Venator Materials Scarlino Sulphate
12 Netherlands Tronox LLC Rotterdam-Botlek Chloride
13 Norway Kronos Fredrikstad Sulphate
14 Poland Grupa Azoty Zakłady Chemiczne "Police" SA Police Sulphate
15 Slovenia Cinkarna Celje Sulphate
16 Spain Venator Materials Huelva Sulphate
17 UK Venator Materials Greatham Works Chloride
18 UK Cristal Stallingborough Chloride
Source: based on AEA Energy and Environment (2007) and information from TDMA members

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The following EU companies are full members of the Titanium Dioxide Manufacturers Association at
Cefic:

• Cinkarna Celje d.d.;

• Cristal;
• Evonik Resource Efficiency GmbH;
• Grupa Azoty Zaklady Chemiczne “Police” S.A.;
• Kronos;
• Precheza AS;
• Tronox LLC; and
• Venator Materials.

Associate members include The Chemours Company, Tayca and Loman Billions.

Finally, with regard to the production of nano-scale TiO2, the global production capacity is only a
fraction of total TiO2 production and amounts to an estimated 80,000 t/y (TiPMC, 2015).

3.3 Consumption of titanium dioxide pigments

There are several sources of information regarding the consumption of TiO2 in the EEA and its origin.
Having considered electronic sources and information available to TDMA members, the following
key figures are established as relevant to this analysis:

• The demand (consumption) of TiO2 in the EEA was ca. 1,100 ktonnes in 2015 compared to a
global demand of just below 6 million tonnes, thus EEA demand accounts for ca. 20% of global
demand for TiO2;
• EEA demand comprises 67-68% EEA-produced TiO2 and 32-33% TiO2 imported from outside the
EEA, the majority coming from the USA, Mexico and China8; and
• EEA exports of TiO2 amounted to 360 ktonnes in 2015.

This breakdown is presented in Figure 3–3. To put these figures into further perspective, TiO2 is one
of the most consumed pigments globally alongside widely used substances such as calcium
carbonate, kaolin and carbon black.

8
An analysis prepared by the European Commission in 2014 on the basis of 2012 data had found that 31% of
EEA consumption was being imported into the EU and of this, the largest share (14%) came from North
America, 7% came from the Asia-Pacific Region, 5% was imported from Latin America, 5% was imported
from other European countries and 1% was imported from Africa and the Middle East. The EEA exported
399 ktonnes and imported 342 ktonnes TiO2 in 2012. Except for the NAFTA region, the EEA was a net
exporter vis-à-vis every other world region (European Commission, 2014).

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Figure 3–3: Demand and origin of EEA consumption of TiO2 (2015) – All figures in million tonnes per year
Source: information from TDMA members

There are several drivers behind future demand for TiO2 pigments, as shown in Figure 3–4.
Location-wise, the real driver to growth is China, where the coatings and plastics industries continue
to expand at high rates (IHS, 2015). Per capita consumption of TiO2 in China is about 1 kilogram per
year, compared with 2.7 kilograms for Western Europe and the USA (IHS, 2015).

Figure 3–4: Key drivers behind demand for TiO2 pigments (2014)
Source: Chemours (2015)

3.4 Applications for titanium dioxide

3.4.1 Overview
Table 3–4 summarises publicly available information on the breakdown of the global consumption of
TiO2 pigment for the years 20139. Other sources are available with somewhat variable percentages
for specific market segments over the years.

9
Note that more recent figures may be available; this is currently under investigation.

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Table 3–4: Global TiO2 pigments consumption breakdown by end-use sector
End-use sector Year: 2013
Paint 53% (assumed architectural 36% and industrial 17%)
Plastic 25%
Paper Laminates: 10%; Paper: 2%
Inks 4%
Specialty Food, Pharma, etc.: 1%; Catalysts: 1%; Other (e.g. cosmetics): 4%
Source: Cefic, aggregates of TDMA members’ data

The table identifies four key market segments: paints (incorporating functional coatings and
construction products), plastics, paper and inks. These account for over 90% of total TiO2 pigment
consumption in the world. These are described below as “mass applications” of TiO2 with the
remainder grouped under “specialty applications”. An overview of the applications that are
discussed below is given in Figure 3–5.

Figure 3–5: Overview of applications of TiO2 pigments

Table 3–5 overleaf summarises the key technical performance characteristics and advantages of TiO2
in its different application areas. These are expanded upon later in the document when each
application is considered in turn.

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Table 3–5: Overview of key technical performance characteristics and advantages of TiO2 use in its different applications
Properties

Pharmaceuticals

Medical devices
Construction

Detergents
Elastomers
Paints and

Cosmetics

Pigments

Ceramics
Catalysts
products
coatings

Biocides
Plastics

Fibres
Paper

Glass
Food
Inks
Good hiding power/opacity             
Ability to lighten coloured media      
Base for colour development       
Whiteness and brightness            
Stability to heat, light and weathering          
Thermal stability and flame retardancy   
Light reflection   
UV absorbance         
Offers support for catalysts 
Photocatalytic activity  
Approved for use in specific areas    
High efficiency          
Easy dispersion and particle distribution and
         
processability
Inertness in the presence of other components       
Purity       
Other         

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3.4.2 Paints and industrial coatings
Range of applications

As a white pigment, TiO2 is by far the most important raw material for paints and coatings. Paint and
coating applications for TiO2 are numerous and diverse and can generally be distinguished between
architectural and industrial.

Architectural paints such as interior coatings (“wall paints”), façade coatings and wood and “trim”
coatings, are used extensively in both DIY and professional applications. Examples include
emulsions, lacquers, primers, sun protection (black-out) coatings, trim, floor (polyurethane, epoxies),
woodcare varnishes and stains, garden paints and roof coatings, to name a few. These coatings are
applied on both the interior and exterior of residential and commercial buildings and are applied to a
variety of substrates.

Figure 3–6: White paint and industrial coatings, the major use of TiO2 pigment
Source: Brilliant White (http://brilliantwhite.life/), Cristal

Industrial coatings provide aesthetics and functionality in a wide range of applications in a broad
range of environments. Based on consultation with downstream users and literature, the key
market segments include (Huntsman, 2016b; Chemours, 2016; VCI, 2016)10:

• Automotive and aerospace coatings;

• Marine coatings (yacht, etc.);
• Coil coatings;
• Can coatings;
• Anti-corrosion coatings;
• Powder coatings;
• Natural paints;
• UV-resistant coatings;
• Durable and non-durable powder coatings; and
• Road marking paints.

10
It should be noted that following the spin-off of Venator Materials from Huntsman, web links to the old
Huntsman Pigments and Additives web pages are no longer functional.

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Under the industrial coatings heading, a very diverse range of less common coatings may be found.
Examples include:

• Flooring and other functional coatings: here TiO2 is used primarily for its white colour but also
as a performance additive (conferring, for instance, UV resistance and fire retardancy). Example
applications include:

− Sports flooring coatings;

− Floor coverings for heavy duty industrial floors;
− Surface protection systems for concrete components;
− Functional coatings in cars to e.g. eliminate squeaking as windows move up and down;
− Functional coatings on wind turbines to aid movement; and
− Ablatives and fire-resistant coatings and intumescents;

• Photoactive coatings (construction and air cleaning materials): many new applications are
based on the photo-activity of TiO2, including:

− Coatings on building materials (e.g. glass, concrete, stone, plaster, paints, plastics)
where outdoor photocatalysis (under UV light) decomposes pollutants such as nitrogen
oxides and carbon monoxide and coatings for the protection of facades, roofs, other
building components and PV modules against algae and mould can be found;

− Self-cleaning materials for outdoor use, for example in anti-fogging coatings and self-
cleaning windows (ICIS, 2007) but also textiles (Montazer & Pakdel, 2011). When used
as a photocatalytically active concrete additive to eliminate NOx, exposure of the
concrete surface to light causes the photocatalytic reaction to occur while, at the same
time, the reaction of TiO2 with the light also generates a superhydrophilic surface.
Particles of dirt soot and organic substances are undermined by the water and flushed
off by the next rainfall. This special cement can be used in concrete block paving,
concrete road surfaces, noise barriers, roof tiles and facades, for example, to create
durable photocatalytic active surfaces; and

− Dispersions for indoor use; TiO2 pigments can also be used behind glass, with standard
light bulbs and energy-saving lamps, in twilight, in scattered light and in the presence of
UV radiation. They can effectively remove undesirable odours, degrade organic stains
on surfaces, protect surfaces against germs and mould, and eliminate numerous
pollutants, such as nicotine and tar; ammonia and amines; aldehydes and alcohols (e.g.
formaldehyde, acetaldehyde, methanol); phenols and other aromatic compounds (e.g.
benzene, p-chlorophenol, PCBs) (Kronos Worldwide, 2012; Calderone, 2015):

Such TiO2 photocatalysts have been found to be less susceptible to attack by various algae, fungi
and bacteria (Kronos Worldwide, 2012) making them suitable for applications such as medical
devices, food preparation surfaces, air conditioning filters and sanitary ware surfaces (ICIS, 2007)
as well as textiles (Montazer, et al., 2011); and

• Other functional applications: these include castings for electrical and decorative applications
where TiO2 is used as a white pigment.

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Typical concentrations of titanium dioxide

Typical concentrations of TiO2 in paints are given in Table 3–6.

Table 3–6: Concentration of TiO2 in paints and industrial coatings

Application Typical TiO2 concentration (by weight)
Professional and DIY paints From 0.1% (varnishes) to 50% (and up to 70% for filling compounds)
General industrial coatings up to 30%
Anti-corrosion coatings up to 20%
Automotive refinishing coatings 25%
Eco-friendly natural paints up to 40%
Wood paints up to 20%
Road markings 0.2-15%
Source: data from consultation and VCI (2016)

Technical characteristics and advantages

TiO2 is the most widely used pigment for white colours and white is the reference colour in domestic
appliances and in most products used for buildings. TiO2 offers an unrivalled array of beneficial
effects, as shown in Table 3–7.

Table 3–7: Advantages of TiO2 use in the manufacture of paints

Properties Relevant key Notes, comments and sources
advantages
Good hiding  Allows the manufacture of fully opaque coating systems
power/opacity
Ability to lighten 
coloured media
Base for colour  The colour can be engineered to provide users with a broad range
development of pigments to choose from (Huntsman, 2016). TiO2 is not only
used in white shades, but in other shades as well. It is the only
white raw material that makes it possible to produce colours
according to relevant standards (RAL, NCS) in a controlled way
Whiteness and  High brightness level, delivering whites which meet the
brightness expectations of end users (for example, high brightness makes road
markings clearly visible to the road user at all times, including day
and night time and inclement weather conditions)
Stability to heat, light  TiO2 displays humidity and light resistance and thermal stability
and weathering
Thermal stability and  It is thermally stable, not combustible and nearly insoluble in
flame retardancy water. Thus, it shows retardancy performance; no other additive in
combination with intumescent additives gives the same level of fire
performance.
TiO2 is stable at the high temperature needed for production and
application of adhesives (curing may take place at 400 °C and few
pigments will withstand such temperature) where the colour of the
glue line is relevant and prevents the yellowing of the pigment
Light reflection 
UV absorbance  TiO2 protects the polymer matrix from effects of UV radiation by
absorbing UV rays that would degrade the organic binder but also
offers protection of the substrate on which paint is applied

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Table 3–7: Advantages of TiO2 use in the manufacture of paints
Properties Relevant key Notes, comments and sources
advantages
Photocatalytic activity  Two types of photochemical reaction occur on the surface of TiO2
when appropriately irradiated: one is the photo-induced redox
reaction of adsorbed substances, and the other is the photo-
induced hydrophilic conversion of the TiO2 itself. The combination
of these two functions is the basis of numerous novel
photocatalytic application
High efficiency  TiO2, having by far the greatest light scattering power of all white
pigments, is the only white pigment showing sufficient hiding
properties at relatively low dosage as a result of high tinting
strength without a strong, undesirable viscosity increase
Easy dispersion and  Due to its good wettability and dispersion, the formation of a large
particle distribution amount of sediment is prevented.
and processability TiO2 is relatively easy to process and does not generally require the
use of specialised milling equipment
Inertness in the  Thickening which is caused by reactions with the vehicle remains
presence of other excluded due to the chemical inertness of TiO2. No impairment in
components the technical properties of the surface coating occurs, even if the
container is repeatedly opened for the withdrawal of small portions
(Kronos, 1968).
It is compatible with most polymer systems within the paint
industry. It also has a low oil absorption value, which allows paints
to maintain good flow and levelling properties even when used at
high levels as well as the formulation of high gloss finishes which
retain their gloss for longer
Purity 
Other  Advantageous application properties: flow, levelling, printing and
transfer of coatings and desirable film build character (it allows
increased film thickness to be applied).
Low coefficient of friction / reduced abrasion: this is important for
numerous functional coatings

3.4.3 Plastics
Range of applications

According to the European Plastics Converters (EuPC), TiO2 finds wide use in the plastic conversion
industry. The plastics converting area covers a variety of sectors where TiO2 may be used such as
packaging, building and construction, automotive, electric and electronic equipment, medical,
household, leisure, footwear, clothes, toys and advertising. The main sectors are packaging, building
(flooring, wallcovering, furniture, playground and sports surfaces), construction (window profiles,
thermal cladding, rainwater and drainage, wood replacement articles, roof, wall, ceiling and flooring
coatings, heat reflective panels, water tanks), transport (automotive panels, automotive protective
film, caravans, motorhomes, trucks, trains, tarpaulins, road markings), marine (motor boats, yachts,
small craft, corrosion resistant coatings, off-shore wind turbines), clothing and sporting goods (EuPC
and WSL (2016)).

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Table 3–8: Advantages of TiO2 use in the manufacture of plastics
Properties Relevant key Notes, comments and sources
advantages
Good hiding 
power/opacity
Ability to lighten 
coloured media
Base for colour  Desirable colour whiteness and tone (bluish versus yellowish)
development
Whiteness and 
brightness
Stability to heat, light  Light stabilisation and weatherability, particularly for products such
and weathering as window profiles
Thermal stability and 
flame retardancy
Light reflection 
UV absorbance  Resistance to outdoor conditions and UV light and reflection of
incident light. The ability to protect the polymer from the natural
elements and degradation via UV attack allows long-term colour
stability and, more importantly, the retention of physical
performance, preventing the polymer becoming brittle, cracked or
easily damaged. TiO2 is the only white pigment that is stable for
outdoor applications. It offers a desirable absorption profile of
light wavelengths, preventing certain wavelengths from passing
through and affecting materials’ properties or the properties of the
contents (food, medicines, etc.)
Approved for use in  See above on food contact materials and pharmaceutical packaging
specific areas
High efficiency 
Easy dispersion and 
particle distribution
and processability
Inertness in the  Optimal surface chemical treatment that enhances effectiveness
presence of other and compatibility with a wide range of polymeric carriers to
components minimise the impact on mechanical/technical properties of the
polymeric matrix used.
Neutral effect on nucleation of semi-crystalline polymers
Other  Due to their high dielectric constant and their low loss angle, TiO2
pigments open up the possibility of increasing the dielectric
constants of plastics without considerably changing other
properties (e.g. specific resistance) (Kronos, 1968)

3.4.4 Paper
Range of applications

TiO2 is mostly used as an opacifier and less frequently for its whitening, brightness and surface
finishing properties in:

• Décor paper for laminate flooring and furniture;

• Packaging, including board;
• Printing and writing;
• Wallpapers; and
• Paper filling.

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In paper laminates, several layers of paper are laminated together using melamine resin under high
temperature and pressure. The top layer of paper contains TiO2 and plastic resin and is the layer
that is printed with decorative patterns (e.g. wood effects). Paper laminates are used to replace
materials such as wood and tile in counter tops, furniture and wallboard (Kronos Worldwide, 2016).
Here, a high opacity is required to stop the substrate underneath the printed material showing
through following lamination. The TiO2 is modified to provide excellent colour stability in the
laminated article, which enables longer life for the final product.

In packaging, papers that contain TiO2 are used in food packaging where they are waxed prior to use
in packing fatty or greasy foods; to prevent the paper becoming translucent during this process, the
paper needs to have a high opacity. TiO2 is also used in labels, for instance, C1S (e.g. Coated One
Side) label papers where one side of the paper is coated for good printability and outlook whereas
the reverse side is not (as it is typically attached to a surface (bottle, can, other packaging, etc.) by
means of an adhesive). In cartons (board), coatings that contain TiO2 improve the surface
smoothness and gloss which are required to achieve high quality printing.

LWC (Lightweight Coated), Ultra Lightweight Coated (ULWC) and super-calendered low grammage
papers are used when printing telephone directories, encyclopaedias, bibles, diaries or patient
information sheets for inclusion in pharmaceutical products. TiO2 can be used to enhance the
opacity of such extremely thin, lightweight papers so they can be printed on both sides without the
printing showing through (Huntsman, 2016d).

TiO2 pigments ensure that wallpapers are light

(the superior opacity of TiO2 means that the
wallpaper can be thinner and still be opaque)
and have a brilliant wet opacity. Ideally,
wallpapers can be manually coated or printed
using common printing processes. TiO2
pigments give the paper all these properties
and high lightfastness (Huntsman, 2016d).
Without the opacity and surface
texture/smoothness provided to the
wallcovering base material by TiO2, printing
would be practically impossible for most
printing methods. For many specialty papers, Figure 3–9: TiO2-containing paper
such as décor papers, TiO2 is essential as no Source: Cristal
dull fibre type can be produced without it.

Typical concentrations of titanium dioxide

TiO2 levels can typically be in the 20-40% range of the décor paper. In wallpapers, TiO2 may be
found in concentrations in the range of 1-10%.

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Technical characteristics and advantages

Use of TiO2 in paper is accompanied by significant technical advantages as shown in Table 3–9.

Table 3–9: Advantages of TiO2 use in the manufacture of paper

Properties Relevant key Notes, comments and sources
advantages
Good hiding  It ensures that paper and board maintain high opacity during and
power/opacity after the conversion process (calendering, waxing, impregnation)
Whiteness and 
brightness
Stability to heat, light  It assists in preventing the paper material from fading or changing
and weathering colour after prolonged exposure to sunlight and other weathering
agents (Kronos Worldwide, 2016)
High efficiency  TiO2 has good S (light scattering coefficient) and K (light absorption
coefficient) values – a high light scattering is desirable since the
paper then becomes more opaque and whiter. Other pigments,
such as calcium carbonate and calcinated clay, may have only one
good value, either S or K value. Thus, although TiO2 is not the
cheapest opacifier in terms of cost per kilogram, it is cost-effective
and helps maintain important paper/board properties at low
dosage.
Due to their high tinting strength and hiding power, it is possible to
prepare very good white and opaque printing papers even from
cheap raw materials by means of a quite thin coating of pigment
(Kronos, 1968)
Easy dispersion and  TiO2 adheres well to the paper fibre
particle distribution
and processability

3.4.5 Inks
Range of applications

TiO2 has been used for several decades in toners, inks, backings for inkjet printing substrates, coated
layers on specialty foils, and incorporated into PET for some applications (I&P Europe, 2016).
Notable applications include (Huntsman, 2016e):

• Inks for packaging: in flexible packaging (such as plastic or aluminium films), white is usually
printed as a full layer either as first ink layer (surface print) or as last lacer (reverse and
lamination). There key function is to produce maximum opacity in order to hide the packed
good. The white ink should deliver excellent hiding power to allow high quality colour printing.
This is also crucial for the function of most barcode scanners, which need a perfect contrast
between the barcode and the background. If the packed material is shining through then the
barcodes are difficult to read. For a typical flexible packaging printer, the consumed white inks
count for 40-60% of his total ink volume. Moreover, TiO2 pigments offer a broad performance
spectrum: high gloss, low abrasion, performance consistency, sparkling effects where desired,
and are suitable for use in solvent, water and oil-based inks as well as in UV curable inks. They
perform well in flexo, gravure and screen printing with gravure inks, pad printing, inkjet or sheet
fed offset applications and are suitable for flexible, paper and card or metal packaging. Because
of the high opacity of TiO2, the white layer reduces the metallic effect in laminates containing
alu-foil or metallised plastic film;

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• Labels: UV curable printing inks for the narrow to mid–web may contain TiO2 and are used in
self-adhesive labels, wrap around labels, lidding, shrink sleeve, in-mould labelling, etc. TiO2 is
used to produce high opacity white printing inks to allow the conversion of clear/metallic
materials;

• Toner: TiO2 pigment offers free flow and charge control;

• Writing materials and children’s modelling materials: these include coloured pencils, crayons,
finger paints, school tempera paints, lacquers and modelling clays (NB. TiO2 is present in almost
all plastic parts of pens and related products); and

• Inks for textiles and leather: TiO2 pigments can support the delivery of a strong opaque colour
that helps printed textiles stand out.

Typical concentrations of titanium dioxide

Typical concentrations of TiO2 in inks and related products are given in Table 3–10.

Table 3–10: Concentration of TiO2 in inks and related products

Application Typical TiO2 concentration
White printing inks Up to 50-60%, even 70% in dispersions
Printing pastes White concentrate: 80%
Ready-to-use compound: 20-30%
Shaded inks 5-10%
Pencils and similar products 3-35%
Correction fluids Up to 50%
Artists’ and recreation colours 0.1-100%
Toner 1-5%
Erasers ca. 1%
Source: data from consultation

Technical characteristics and advantages

TiO2 offers the following technical advantages to inks and ink-related products.

Table 3–11: Advantages of TiO2 use in the manufacture of inks

Properties Relevant key Notes, comments and sources
advantages
Good hiding  In graphic arts (printing), ink is usually applied in a much thinner
power/opacity film than a normal coating (a few microns)*. Ink correction fluid
for paper relies on TiO2 to hide errors. Inks for concealed writing
(scratch-off lottery tickets) likewise use TiO2 because of its
superior hiding power (Gázquez, et al., 2014)
Ability to lighten 
coloured media
Base for colour  TiO2 is used as white pigment, but also for colouration support in
development allowing (a) the dyes of the formula to be fixed; and (b) the
development of a wide range of colours to create pastel shades
and increase the colour gamut of the available pigment range
Whiteness and 
brightness
Stability to heat, light 
and weathering

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Table 3–11: Advantages of TiO2 use in the manufacture of inks
Properties Relevant key Notes, comments and sources
advantages
UV absorbance  TiO2 protects inorganic pigments from light through UV
absorbance
High efficiency 
Easy dispersion and  TiO2 can be readily dispersed, achieve rapid wetting at low
particle distribution and viscosities. TiO2 allows inks to achieve very high print quality
processability (excellent gloss) while not interfering with the technical
requirements of printing machinery, including low abrasion, high
printing speed and high temperatures (Kronos Worldwide, 2016)
Purity  TiO2 is accompanied by high purity and high definition of particle
size
* By way of example, in UV inkjet technology, the thickness of a full white ink layer (non-opaque, consisting of
ca. 20% TiO2) varies between 20 and 30 µm. If the layer is meant to be opaque (diffusion white layer) then the
thickness may be as low as 5 to 10 µm

3.4.6 Construction products

Range of applications

“Construction products” is a very diverse term which covers a great variety of articles and mixtures.
For example, plastic window frames are a type of construction product as they have one important
characteristic that distinguishes them from all other plastic products: they have a long lifecycle of
between 30 and (technically) 100 years. There are several other construction products, typically in a
coating form, which may contain TiO2 and can be used alongside architectural paints. These include
applications might be considered to be affiliated to either paints or plastics. In these, historically,
TiO2 has replaced other white pigments like “white lead” (lead carbonate) the use of which has been
restricted (VCI, 2016). Examples of relevant applications include:

• Construction products: a wide variety of construction products may contain TiO2 as a colouring
pigment. These include:

− Plasters (synthetic plasters, emulsion bound, mineral plasters);

− Fillers (such as wood and wall fillers);
− Caulks;
− Pigmented mortars (e.g. jointing grouts); and
− Synthetic resin screeds;

• Adhesives, for example:

− Liquid polyaddition, polycondensation and polymerisation adhesives like polyurethanes,

epoxides, silane modified polymers, acrylates and anaerobically curing adhesives and
adhesive films;
− EVA- and PE-based thermoplastic hot melts;
− Outside the construction sector, natural water-based gelatine adhesive for the paper
and cardboard industry. These glues are generally yellow, brown or beige. TiO2 is used
to whiten the adhesive without changing other technical properties like other fillers
would do. The whitened adhesives are used, for instance, in the back lining of books;

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− Water-based PVA dispersion glue. TiO2 is
used to whiten the dispersion so it can
be used as a master batch and colour can
be added by a downstream user. The
customer then uses this adhesive to glue
textile fibres to paper to make wallpaper.
TiO2 gives a whitening aspect no other
product can provide. All produced
products are in liquid form;
− Pigmentation of black-out foils and films;
and
− Flock adhesives; and Figure 3–10: TiO2 can be found in adhesives
Source: royalty-free photo

• Sealants: TiO2 is used as a white pigment in roles similar to those for adhesives. One such
example includes silicone sealants.

As a constituent of adhesive formulations, not only is TiO2 used in the construction sector but also in
the paper and packaging industries, the construction of motorcars, railway vehicles, ships and
airplanes, in electrical and electronic applications, the dental sector and other industries. TiO2 may
also be found in coloured adhesives (e.g. light green adhesive to glue artificial lawn or red adhesive
to glue tartan tracks) which are first brightened with TiO2 and then coloured with the desired colour.
Often, the use of TiO2 enables the use of coloured natural resins. Without pigment, application
would not be possible with a visible bond seam (VCI, 2016).

Typical concentrations of titanium dioxide

Based on consultation findings and literature (VCI, 2016), typical concentrations of TiO2 in
construction products include:

• Concrete, mortars, grout, plaster: 0.1-10%; and

• Sealants and adhesives: 1-15%.

Technical characteristics and advantages

The technical advantages TiO2 offers to construction products are largely those described earlier for
paints and industrial coatings.

3.4.7 Fibre applications

Range of applications

Textile and leather applications

Anatase grades may be used for delustering man-made fibres. Delustering plays a leading role in the
complex production of man-made fibres such as polyester, polyamide, acrylic, viscose, rayon, but
also cellulose acetate fibres. A melt-conditioning process helps to provide the fibre producer with
greater flexibility in changing between various degrees of delustration (i.e., between lustrous, semi-
matte and full-dull grades) (Huntsman, 2016g).

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Fibres of variable dullness (depending on the proportion of TiO2 used11) may be used in consumer
textiles, including high-class, high-fashion textile products of the most well-known and prestigious
fashion brands where dull lustre and handfeel is sought after.

When TiO2 is used as white pigment, it may act as (VCI, 2016):

• A component of a coating applied on commercial textiles such as those for sun protection (black-
out, dim-out) / roller and vertical blinds / decorative textile ceilings;
• A component of printing inks (e.g. inkjet, digital print) and in printing pastes for pigment print;
• A carrier material for biocides; and
• A component for the pigmentation of leather (i.e. pigment dispersions in polymer matrices that
are sprayed onto leather to produce pigmented leathers).

Another textiles-related but not fibre-based application for TiO2 is the pigmentation of
thermotransfer coatings used on textiles.

Non-textile applications

TiO2 may also be used in the delustering (matting) of man-made fibres, e.g. for white pigmentation
of glass fibre nonwovens or cigarette filter tow, where cellulose acetate fibre is used.

Typical concentrations of titanium dioxide

TiO2 is used in delustering within the range of 0.1-1.5% with the level depending on the lustre
required by end users (CIRFS, 2016).

Technical characteristics and advantages

The key technical advantages of TiO2 in its fibre applications are shown in Table 3–12.

Table 3–12: Advantages of TiO2 use in the manufacture of fibres

Properties Relevant key Notes, comments and sources
advantages
Good hiding  Originally, transparent man-made fibres are delustered to
power/opacity differing degrees using TiO2, thus losing their transparency. The
delustering process makes use of anatase pigments’ scattering
power, which causes the fibre to appear optically whiter,
opaquer, more matte and duller
Stability to heat, light  TiO2 special surface treated grades ensure good adherence to the
and weathering substrate and high light-fastness and non-colour fading
performance (i.e. UV resilience), which is paramount for man-
made fibres designed for outdoor applications. Pigments for
textile fabrics are also sweat-fast
UV absorbance  See above
Easy dispersion and  Anatase pigments reduce reflection in screen printing processes,
particle distribution and permitting much more reliable and faster thread guidance and
processability weaving behaviour, and thus enhancing productivity (Huntsman,
2016f) and have an effect on colour impression

11
In the field of synthetics fibres, a physical parameter named “ahine” is often used, defined as the amount
of reflected light. This is controlled by the amount of TiO2 added in the manufacturing process or
polymerisation; bright contains 0.06% TiO2; semi-opaque, 0.3% TiO2; and opaque, 2% TiO2 (Gázquez, et al.,
2014).

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Table 3–12: Advantages of TiO2 use in the manufacture of fibres
Properties Relevant key Notes, comments and sources
advantages
Inertness in the  TiO2 is chemically inert thus it does not react in processing; the
presence of other TiO2 grades used are practically free of any coarse fraction and
components show minimal abrasion, which ensures good filter-pack lives at
the spinnerets and decreased amounts of filament breakage
during production
Other  Anatase pigments, which have a lower Mohs hardness than their
rutile counterparts and are always used for applications in which
lower abrasiveness is desired, are selected for this purpose. Their
addition impacts on the touch of the articles

3.4.8 Catalysts
TiO2 is used as a catalyst support (up to 35% of the green body preparation) in Selective Catalytic
Reduction (SCR) processes for the reduction of oxides of nitrogen in exhaust gases, not only in
mobile applications such as road, rail and marine engines, but also in stationary installations such as
power generating and other industrial plants.

TiO2 is the catalyst of choice for the

desulphurisation of crude oil (the Claus
process, where TiO2 has the technical
advantage that it is a sulphur-resistant carrier
material), for the oxidative synthesis of
organic compounds, and in a large range of
other chemical processes (Huntsman, 2016k).
TiO2 is used both as a carrier material and as
an acidic catalytically active material for the
selective conversion of feedstocks into the
desired end products (e.g., phthalic
Figure 3–11: TiO2-based catalysts anhydride). Its use as an ingredient of the
Source: Cristal catalyst in the process reduces raw material
cost (e.g., o-xylene, naphthalene) for customers, reduces by-product formation (generation of
waste), reduces emissions in the process (e.g. lower COx), ensures long catalyst lifetimes, and thus
means lower costs for customers and reduction of waste from spent catalyst.

3.4.9 Food and feed additives and food contact materials

Range of applications

Titanium dioxide as a food component

In the EU, TiO2 (E171) is listed in Annex I of Directive 94/36/EEC as a permitted colour in foodstuff
and it is presumed as safe. E171 is accompanied by specific purity criteria (Commission Regulation
(EU) No 231/2012) and its use is authorised by Regulation (EC) No 1333/2008 on food additives. It
can be found at quantum satis (i.e. as much as needed) in many foods, for instance:

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• Dairy analogues, including beverage whiteners;
• Edible ices – TiO2 is a key ingredient in a range of pearlescent
colourants that are used to colour ice cream coatings and
chocolate/confectionary pieces that are used to decorate ice cream
products;
• Confectionery including breath refreshening microsweets (where it is
often used to provide a barrier between different colours);
• Chewing gum and lollipops;
• Decorations, coatings and fillings, except fruit based fillings;
• Fine bakery wares;
• Casings, coatings and decorations for meat (except edible external
coating of pasturmas);
• Soups and broths;
• Cottage and mozzarella cheeses, where it is used to increase opacity
(EUFIC, 2016);
• Sauces - including pickles, relishes, chutney, horseradish sauce and
piccalilli – excluding tomato-based sauces;
• Salad and savoury based sandwich spreads;
• Flavoured drinks - excluding chocolate milk and malt products, to
increase rich texture and turbidity (European Commission, 2014);
• Processed nuts; and
• Desserts.

TiO2 is also used as a dyestuff/pigment in dyes for egg shell decoration.

It is also present as an approved colourant feed additive in Annex I of Figure 3–12: Examples of
TiO2 use in foodstuff
Regulation 1831/2003/EC. In pet foods, it is used to obtain uniformity of
Source: Brilliant White
colour and appearance (Kronos Worldwide, 2016; Huntsman, 2016i;
(http://brilliantwhite.life/)
TDMA, 2013). and royalty-free photos

Titanium dioxide as a component of food contact materials

Beyond its use as an additive within food, TiO2 can be found in food contact materials. TiO2’s entries
in the Union List of Additives for Food Contact Materials (European Regulation (EU) 10/2011)12 are
shown in Table 3–13. It is accompanied by a high SML (specific migration limit) of 60 mg/kg from
plastic materials and articles intended to come into contact with food.

12
It is worth noting that coated and printed plastic food contact materials and articles are covered by the
scope of European Regulation (EU) 10/2011. Plastics held together by adhesives are also covered by its
scope. However, substances used only in printing inks, adhesives and coatings are not included in the
Union list because these layers are not subject to the compositional requirements of the Plastics
Regulation. The only exceptions are substances used in coatings which form gaskets in closures and in caps.
The requirements for printing inks, adhesives and coatings are intended to be set out in separate specific
Union measures. Until such measures are adopted, they are covered by national law. If a substance used
in a coating, a printing ink or an adhesive is listed in the European Union list, the final material or article has
to comply with the migration limit of this substance, even if the substance is used in the coating, printing
ink or adhesive only. Even though colourants fall under the definition of additives, they are not covered by
the Union list of substances. Colourants used in plastics are covered by national measures and are subject
to risk assessment in line with Article 19 of the European Union List Regulation.

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Table 3–13: Food Contact Material Union list entries for TiO2
Entry Chemical name Use Restrictions
610 Titanium dioxide Additive or polymer
production aid
805 Titanium dioxide, coated with a Additive or polymer The content of the surface treatment
copolymer of n- production aid copolymer of the coated titanium
octyltrichlorosilane and dioxide is less than 1% w/w
[aminotris(methylenephosphonic
acid), penta sodium salt]
873 Titanium dioxide reacted with Additive or polymer Reaction product of titanium dioxide
octyltriethoxysilane production aid with up to 2% w/w surface treatment
substance octyltriethoxysilane,
processed at high temperatures

As discussed elsewhere in this report, the presence of TiO2 can be established in:

• Food packaging: TiO2 can be found in plastic and paper as a whitening pigment, food-contact
coatings, food-packaging adhesives, food-contact polymers, paper/paperboard in contact with
aqueous/fatty foods, filler in food-contact rubber articles for repeated use, food-contact
textiles/fibres;

• Food homeware/containers: TiO2 may be found in white and pastel ceramic articles and as a
pigment in enamels applied on flatware, cookware, hollowware (both decorated and non-
decorated) and eventually also other white kitchenware (see discussion in Section 3.4.14); and

• Printing inks for food packaging: TiO2 is used as a pigment for inks applied on food contact
materials.

Technical characteristics and advantages

TiO2 (E171) is the most widely used white food colour because of the key advantages shown in Table
3–14.

Table 3–14: Advantages of TiO2 use in foodstuff

Properties Relevant key Notes, comments and sources
advantages
Good hiding 
power/opacity
Ability to lighten 
coloured media
Base for colour  In conjunction with E555 (Potassium aluminium silicate - mica)
development TiO2 has a unique use to produce 'glitter' powders which are
widely used as decorations for fine bakery wares
Whiteness and 
brightness
Stability to heat, light 
and weathering
UV absorbance  TiO2 can prevent premature spoilage in foods that react with UV
light

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Table 3–14: Advantages of TiO2 use in foodstuff
Properties Relevant key Notes, comments and sources
advantages
Approved for use in  As noted above, TiO2 is considered safe by oral ingestion and is
specific areas authorised under the EU Additives Regulation (EC) No 1333/2008
at Annex II as a Group II food colour, which may be used in most
foods at quantum satis. A recent EFSA opinion on the re-
evaluation of its safety for use as a food additive published on 14
September 2016 concluded that available data on TiO2 in food do
not indicate health concerns for consumers13
High efficiency 
Easy dispersion and
particle distribution and
processability
Inertness in the  TiO2 is chemically very stable and inert with very low
presence of other bioavailability. It does not react with other substances present in
components foods (for example, food acids) and it will withstand
cooking/baking processes unchanged
Purity 

3.4.10 Pharmaceuticals
Range of applications

TiO2 is presented in Ph Eur monograph 015014. TiO2’s chemical purity meets the requirements of
important official pharmaceuticals standards, such as the European pharmacopoeia (Ph. Eur/EP), the
Japanese pharmacopoeia (JP) and the US pharmacopoeia (USP) (Huntsman, 2016j). In addition, TiO2
is the only opacifying agent for materials used for containers that is named in the European
Pharmacopoeia’s Section 3.1.

Similar to food applications, TiO2 applications in pharmaceuticals can be both as an additive to

medication and as an additive to packaging:

• Medicine component:

− Excipient (colourant): ultra-high purity TiO2 as per Ph Eur is used in many medicinal
products as an excipient, mainly as the colourant E171. Its toxicological safety for
dermal or oral applications makes TiO2 an ideal and safe excipient. It can be found in
liquid medicines where it provides uniformity of colour. The use of TiO2 along with
other colourants enables pharmaceuticals manufacturers to produce products with a
great variety of colours. Such colour variety is extremely important to avoid medication
errors. Without TiO2, the available colour palette would be much more limited;

− Film coating: TiO2 is used in the film-coating of tablets and (gelatine) capsules (both
pharmaceuticals and nutraceuticals). The pigment is added because this adheres to and
covers the tablet core best. Without the use of TiO2 the colour is not as smooth and the
colour, spots or different coloured powder particles would come through and the
surface would not be smooth and homogeneous;

13
Available at http://www.efsa.europa.eu/en/efsajournal/pub/4545 (accessed on 24 October 2016).

14
See http://www.drugfuture.com/Pharmacopoeia/EP7/DATA/0150E.PDF (accessed on 20 June 2016).

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Figure 3–13: Nutraceutical tablets and pharmaceutical capsules that contain TiO2
Source: royalty-free photos

• Packaging: TiO2 is used in the manufacture of glass containers, opaque child-resistant pharma
blister packages and medical container closures as it offers a guarantee of chemical inertness for
pharmaceutical applications. TiO2 achieves the colour and spectral characteristics required by
the current regulations and physicochemical characteristics required by current standards for
pharmaceutical vessels. It also offers protection from UV radiation in certain bandwidth, which
is important when protecting medication in its container from the damaging effects of light,
helping extend product shelf life (Kronos Worldwide, 2016; Huntsman, 2016j). According to
MedPharmPlast (2016), there are currently at least 275 light-sensitive oral prescription drugs
(King, 2009) and over 300 light-sensitive injectable medicinal products (University of Illinois at
Chicago College of Pharmacy, 2014). These drugs thus require pharmaceutical packaging that is
able to prevent the passage of light, particularly in the spectrum 290 to 450nm to prevent
degradation of the pharmaceuticals. This requirement is defined in US Pharmacopeia <671> and
is critical for obtaining marketing authorisation for light-sensitive pharmaceuticals. To reduce
transmission, colours that filter (e.g. amber) need to be added. In the case of transparent
packaging or in other cases an opacifying agent needs to be added to the polymer.

Typical concentrations of titanium dioxide

Typically, TiO2 is present at concentrations of up to 3%.

Technical characteristics and advantages

Table 3–15 summarises the technical advantages of TiO2 in pharmaceutical applications.

Table 3–15: Advantages of TiO2 use in pharmaceuticals

Properties Relevant key Notes, comments and sources
advantages
Good hiding 
power/opacity
Base for colour 
development
Whiteness and 
brightness
UV absorbance  Offers protection to the active pharmaceutical ingredients (APIs)
of medicinal products

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Table 3–15: Advantages of TiO2 use in pharmaceuticals
Properties Relevant key Notes, comments and sources
advantages
Approved for use in  Established to be safe (being recognised as the E171 food
specific areas additive)
High efficiency 
Purity 

3.4.11 Cosmetics
Range of applications

TiO2 is currently listed in Annex IV of the Cosmetics Regulation EC 1223/2009 (list of colorants
allowed in cosmetic products); and Annex VI (list of UV filters allowed in cosmetic products), as
shown in Table 3–16.

Table 3–16: Cosmetics Regulation entries for TiO2

Annex Entry No. Notes
IV List of colorants allowed in cosmetic 143 The use if TiO2 (CI 77891) is allowed in all
products cosmetic products. Purity criteria as set out in
Commission Directive 95/45/EC (E 171) and its
amendments
VI List of UV filters allowed in cosmetic 27 Maximum concentration in ready for use
products preparation: 25%15
VI List of UV filters allowed in cosmetic 27a Titanium Dioxide (nano): Maximum
products concentration in ready for use preparation:
25%16

More specifically, TiO2’s colour, opacity and UV absorbance qualities mean that it can find many
applications in cosmetics (at variable concentrations), including:

• Sunscreens: TiO2 (INCI name Titanium Dioxide and Titanium Dioxide (nano)) at the non-nano and
nano-scale is an effective inorganic UV-filter and, in the case of the nano-scale TiO2, colourless.
This UV-filter has been recognised as safe by the European scientific body (SCCS) up to a
maximum concentration of 25% in cosmetics, when applied on healthy, intact or sunburnt skin.
TiO2 is one of the very few globally approved UV filters/sunscreen actives that are of relevance
for global formulations (Cosmetics Europe, 2016). Only two mineral UV-filters are allowed in
cosmetics, TiO2 and ZnO;

• Colour cosmetics (make-up) and skin care products: TiO2 as a colorant can confer satiny effects,
lustre effects and interference colours. It can be found in products such as foundation and face
powder. Due to its light diffusing qualities, its pearlescent effects find use in lipstick, eye-
shadow and blushers. For these applications, no concentration limit has been established;

15
It is understood that in other jurisdictions (e.g. Japan) no upper limit has been established.

16
Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only
nanomaterials meeting the characteristics set out in the Regulation are allowed. In case of combined use of
Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed 25%.

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Figure 3–14: Example of a TiO2 use in cosmetics – Sunscreens and face creams
Source: Brilliant White (http://brilliantwhite.life/) and royalty-free photo

• Soaps (liquid and solid), shampoos and shower gels and depilatory products and other
products: TiO2 acts as a pearlescent colourant and has opacifier effects due to its high refractive
index;

• Toothpaste: TiO2 can be used both as a white pigment and an abrasive;

• Hair colour formulations: TiO2 is used as an opacifier;

• Nail polishes: TiO2 is used as a colourant and opacifier in UV-curing nail polishes and gels that
are sold on the professional and retail cosmetics markets. It may also be present in nail
(anaerobic) adhesives; and

• Other: TiO2 can also be used as filler in cosmetic products (Huntsman, 2016h).

Typical concentrations of titanium dioxide

Concentrations of TiO2 in cosmetic formulations vary considerably across the wide range of cosmetic
products that contain the substance. There is insufficient information that would allow us to provide
typical concentrations across the cosmetics sector, although some individual consultees have
provided example concentration ranges for a small number of products (e.g. toothpaste and nail
polish). TiO2 as colorant is approved for all cosmetic products and has no restriction in the use level.
With specific reference to sunscreens, as shown above, the concentration of TiO2 in formulations is
up to 25%.

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Technical characteristics and advantages

The wide use of TiO2 in cosmetics derives from key properties of the pigment, as shown below.

Table 3–17: Advantages of TiO2 use in the manufacture of cosmetics

Properties Relevant key Notes, comments and sources
advantages
Good hiding  When the pigment size becomes bigger, visible light is blocked by
power/opacity TiO2 and skin appears white. This is particularly useful in decorative
cosmetics, such as make-up sticks and powders, where the consumer
may want to hide skin problems or simply improve his/her
appearance and confidence. In oxidative hair colourants (which
represent a fragile, reactive chemical environment), small amounts
(0.1%) of TiO2 boost opacity of the mass, thus increasing mass
visibility on hair. This allows stylists or consumers to apply the
correct amount of product (i.e. avoids overdosing). In addition to
this technical performance and efficacy, TiO2 does not adversely
affect the stability of the colour tint, an undesirable effect which may
occur with other (less efficient) opacifiers
Whiteness and  The whitening and opacifying characteristics of TiO2 can be used to
brightness improve the appearance and consumer appeal of cosmetics
Light reflection  TiO2 provides a very good SPF performance (protection against UVB
UV absorbance  radiations) and a significant UVA protection. The particles form a
protective film on the uppermost skin layer and scatter and absorb
the UV rays of the sun. In this manner, the skin is protected against
UV radiation and its harmful effects to health (sunburn, DNA
damage, skin aging, etc.). Particularly good sunscreen effects can be
achieved through the combination with other filter substances.
Ultrafine TiO2 in sunscreen products is invisible to the human eye and
leaves no whitish film on the skin, which motivates consumers to use
more generous applications that are absolutely essential to achieve
sun protection (VCI, 2016)
Approved for use in  Approved as a UV filter in sunscreens.
specific areas Included in the list of colorants allowed in cosmetic products
Easy dispersion and 
particle distribution
and processability
Inertness in the  TiO2 shows good compatibilities with several organic filters to allow a
presence of other broad coverage of the whole UV-range and ensure true broad-
components spectrum protection from the sun’s damaging rays. TiO2 is one of the
very few globally approved UV filters / sunscreen actives relevant for
global formulations. TiO2 is the UV filter of choice for SPF15 or higher
products whilst providing a non-greasy feel, a preferable attribute for
e.g. secondary sunscreen products (face creams with UV benefit). It
can also demonstrate good stability and processability in formulation
processes
Purity 
Other  Skin tolerance: another outstanding feature of TiO2 is its optimal
skin tolerance; intolerances or allergic reactions to TiO2 are
practically unknown (VCI, 2016)

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3.4.12 Elastomers
Range of applications

TiO2 is used as a filler and pigment in rubber-based applications including:

• Tyres: TiO2 is used as a white pigment in tyres to produce white sidewalls (thanks to its excellent
tinting strength which allows the use of very small quantities);

• General rubber goods: TiO2 is used in the manufacture of general rubber goods (GRG), including
food contact materials, construction materials, and other industrial products;

• Rubber-to-substrate parts: TiO2 is used in elastomer bonding agents as a pigment, UV protector

and filler required at the vulcanisation step to produce a matrix in which the functional
crosslinkers are dispensed. TiO2 is heat resistant, insoluble in water and resistant to aggressive
rubber chemicals. End uses include rubber-to-substrate parts such as mounts, stators, bushings,
brake pads, etc. Rubber-metal parts with essential functionality in the automotive industry
include airbag absorbers, anti-vibration elements, damping sleeves, chassis parts, steering parts,
engine bearings and several others;

• Pastes: TiO2 is used for heat stabilisation in (pastes for) silicone rubber; and

• Fluorinated rubber: TiO2 is used in fluorinated rubber and rubber thread.

Figure 3–15: Illustration of an automobile front axle. Parts such as damper bearing, steering link bearing or
suspension subframe mount those highlighted in the picture are parts made with TiO2 elastomer bonding
agents
Source: GOTEC Gorschlüter Gmbh (available at http://gotec-gmbh.de/user-
data/downloads/gotec_IB_ENG.pdf, accessed on 14 December 2016)

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Typical concentrations of titanium dioxide

Typical concentrations of TiO2 in the above products include:

• Colour pastes for silicone rubbers: 30-55%;

• Silicone: 1-5%;
• General rubber goods (GRG): 0.5-20% (depending on the application); and
• Wide sidewall tyres: <1%.

Technical characteristics and advantages

TiO2 offers the following technical advantages to rubber products.

Table 3–18: Advantages of TiO2 use in the manufacture of elastomers

Properties Relevant key Notes, comments and sources
advantages
Whiteness and 
brightness
Stability to heat, light 
and weathering
Easy dispersion and  TiO2 is not soluble in water and can be dispersed in a solvent
particle distribution and system
processability
Inertness in the  TiO2 does not impair the weather resistance and light fastness of
presence of other the rubber articles. It is resistant to aggressive rubber chemicals.
components It has no noticeable effect on the mechanical and vulcanisation
properties of the rubber

3.4.13 Pigment and pigment preparation manufacture

Range of applications

Overview

TiO2 is by far the most prominent raw material for the manufacture of pigments and pigment
preparations. Pigments and pigment preparations containing TiO2 are initially used in industrial (e.g.
high-quality coatings, paintings, printings inks, plastics, paper, ceramics) and professional (dispersion
paints and varnishes) applications and, secondly, in the field of private consumer applications (e.g.
cosmetics, pharmaceuticals, ceramics and glass) (Eurocolour, 2016; VdMi, 2016).

It is worth pointing out that TiO2 is a raw material that is used extensively by SMEs, e.g.
manufacturers of complex inorganic pigments, frits and pigment preparations, in quantities up to
several hundred thousand tonnes per year each (ANFFECC, 2016; VdMi, 2016b).

Titanium dioxide as a consumed raw material in pigment manufacture

TiO2 is used as starting material for the synthesis of important inorganic coloured pigments (e.g. with
rutile type structure), see Table 3–19. Here, TiO2 is fully converted during the manufacturing
process. As a structure-giving component, TiO2 is the indispensable basis for the manufacture of
these colour pigments (ANFFECC, 2016). The key functionality of TiO2 is the creation of a crystalline
structure that is very stable at high temperatures and all kind of atmospheres. This stability prevents
defects in the end product.

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Table 3–19: Complex Inorganic Pigments based on TiO2
EC No. CAS No. Name Formula Structure
269-052-1 68186-90-3 Chrome antimony titanium buff rutile (Ti,Cr,Sb)O2 Cassiterite-Rutile
269-054-2 68186-92-5 Chrome tungsten titanium buff rutile (Ti,Cr,W)O2 Cassiterite-Rutile
232-353-3 8007-18-9 Antimony nickel titanium oxide yellow (Ti,Ni,Sb)O2 Cassiterite-Rutile
270-185-2 68412-38-4 Manganese antimony titanium buff rutile (Ti,Mn,Sb)O2 Cassiterite-Rutile
269-047-4 68186-85-6 Cobalt titanite green spinel CoTi2O4 Spinel
269-054-2 68187-05-3 Spinels, cobalt tin grey CoSn2O4 Spinel
603-450-1 1310-39-0 Pseudobrookite Fe2TiO5 Pseudobrookite

These highly durable exterior and temperature-resistant pigments require not only the purely
colouring properties of the pigments, but also additional physical and chemical functions, such as
chemical resistance, high resistance to UV light and effective reflection of infrared radiation
(Huntsman, 2016m). These certain grades of orange/yellow/brown complex inorganic pigments are
used mainly in the ceramic sector and also in other surface applications such as plastics and coatings.

Planar structures based, inter alia, on white and also transparent TiO2 particles coated with various
inorganic coloured pigments form the basis for complex inorganic pigments. These “particle
sandwiches” are able to combine the outstanding chemical and physical properties of TiO2 with
virtually boundless colour highlights in the finished coating system (Huntsman, 2016m).

Notably, these pigments have been registered under the REACH Regulation according to the
paradigm that these represent toxicologically inert substances because of their crystalline (largely
rutile or spinel) structures (IP Consortium, 2016).

Other pigments

TiO2 is used as the most important white pigment, for example in pigment formulations such as (VCI,
2016; VdMi, 2016; VdMi, 2016b):

• Organic and inorganic pigments (including effect pigments/pearlescent pigments) as a

constituent and for finishing and coating;
• Iron oxides and ferrites, as a set-up agent for colorimetric properties;
• Pigment preparations (powder, liquid, paste);
• Masterbatches for subsequent colouring of polymers; and
• Artists’ and recreation (school) colours.

These products are discussed separately later in this section of the document.

Because of its excellent brightening capacity vis-à-vis coloured media, TiO2 is also used as filler (VCI,
2016; VdMi, 2016; VdMi, 2016b).

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Typical concentrations of titanium dioxide

The presence of TiO2 in pigment preparations ranges between 1% and nearly 100%. Typical
concentrations of TiO2 are given in Table 3–20.

Table 3–20: Concentration of TiO2 in pigments and pigment preparations

Application Typical TiO2 concentration
Complex Inorganic (rutile) pigments Nil
Pearlescent pigments 10 - 100 % (and ultimately 2-25/50% in the final product)
Iron oxides and ferrites <5%
Ceramic decorating colours 5-60%
Ceramic glass colours 5-25%;
White organic colours 30-60%
Pigments preparations Up to 100%
Blended pigments depends on the application
Source: data from consultation (VdMi, 2016b) and VCI (2016)

Technical characteristics and advantages

The following table summarises the key technical advantages of TiO2 in this application area.

Table 3–21: Advantages of TiO2 use in the manufacture of pigments

Properties Relevant key Notes, comments and sources
advantages
Good hiding power/opacity 
Ability to lighten coloured media  (ANFFECC, 2016)
Base for colour development 
Stability to heat, light and weathering  Exceptional light-fastness (ANFFECC, 2016)
Easy dispersion and particle distribution  Optimal particle size distribution in the range
of 0.2 - 0.35 µm

3.4.14 Ceramics
Range of applications

Ceramics is a broad term that encompasses a range of applications and is interconnected with
applications presented elsewhere, namely pigment manufacture and glass manufacture. In addition
to optical performance properties, the main focus of TiO2 applications is on chemical purity,
reactivity and sintering properties. Under ceramics, the use of TiO2 may include:

• Pigments: as shown in Section 3.4.13, TiO2 is a key raw material in the manufacture of Complex
Inorganic Pigments that find applications in ceramics (but also in plastics and coatings). Complex
Inorganic Pigments are largely used for yellow and brown colours in the ceramic tile industry.
This industry is still of great importance to some Italian and Spanish regions. There are also
more innovative applications such as the use of the substance as an additive to the body
composition of ceramic tiles to generate yellow pigmentation by means of digital printing. Also,
TiO2 is used as an additive to generate a yellow colour of facing bricks (mainly in Belgium and
The Netherlands);

• Frits, glazes and enamels: a frit is a ceramic composition that has been fused in a special fusing
oven, quenched to form a glass, and granulated. The purpose of this pre-fusion is to render any
soluble and/or toxic components insoluble by causing them to combine with silica and other

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added oxides. Put simply, a frit is the result of the chemical reaction between a mixture of
inorganic raw materials (usually metal oxides, e.g. TiO2). Frits may then be used in the
manufacture of glazes and enamels. TiO2 is mainly used as an opacifier in the production
process. TiO2 is essential in order to obtain very opaque white frits for the production of
porcelain enamels (enamels used to coat metallic surfaces) at low temperature (500-800 °C). It
is also necessary to obtain no watermark opaque engobes and slips, used in the production of
ceramic products. Key products include:

− White and pastel flatware, cookware, hollowware (both decorated and non-decorated)
and eventually also other white kitchenware. At least some of these or similar articles
can be found in almost every home, restaurant, hotel, school and hospital kitchen;
− Sanitaryware enamels;
− Hot water tanks;
− Silos;
− Ovens and cooktops;
− Architecture; and
− Rooftiles;

• Electroceramics: high-purity pigment grades are used in the production of ceramic materials for
electronic components as well as high-quality electroceramics, such as capacitors, PTC resistors,
and piezoceramic elements. Examples are barium titanate (BT), lead zirconate titanate (PZT),
strontium titanate, magnesium titanate, bismuth titanate and many others. TiO2 may be used in
vitreous enamels for electrodes as well as to act as a stabiliser in the electric arc in the coating of
welding electrodes (Huntsman, 2016l);

• Technical ceramics: there are many applications of TiO2 in technical ceramics, e.g. medical
components (hip or knee replacement) and protection against abrasion (components for textile
industry, automotive applications);

• Abrasives: TiO2 is present as impurity in abrasive grains which are essential raw materials for
the production of different types of abrasive products (inorganic bonded abrasives, organic
bonded abrasives and coated abrasives)17. Abrasive products are essentially required in Europe
by various industries such as automotive, aeronautic, turbine industry, mechanics, medical,
stone and construction, etc.; and

• Other: rutile is added to ceramic materials such as Al2O3 and ZrO2 to improve mechanical and/or
thermal properties. In addition, TiO2 is, at the same time, an important input material in the
production of titanium carbides, titanium-tungsten carbides and titanium borides.

Typical concentrations of titanium dioxide

Typical concentration ranges include:

• Frits: 3-20% depending on the application (ANFFECC, 2016);

• Porcelain enamels: 5-25%;
• Ceramic pigments: 5-60% (VCI, 2016; VdMi, 2016; VdMi, 2016b); and
• Complex Inorganic Pigments: no TiO2 present.

17
To completely remove TiO2 totally would be (a) extremely expensive and in addition, (b) the changed
product would be likely to have different properties (e.g. reduced robustness) which is crucial for abrasives
products.

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Technical characteristics and advantages

TiO2 offers the following technical advantages to ceramic products.

Table 3–22: Advantages of TiO2 use in the manufacture of ceramics

Properties Relevant key Notes, comments and sources
advantages
Good hiding 
power/opacity
Whiteness and  Porcelain and sanitaryware enamels need to be white. TiO2
brightness crystallises out of the oversaturated enamel frit during the firing
of the enamel coating on the metal substrate to give the enamel
its brilliant white colour
UV absorbance TiO2 increases UV absorption in glass and improves the
mechanical, thermal and electrical properties of glass fibres
High efficiency  Due to the thinness of the layer, the bending and impact strength
of the enamel is noticeably increased (Kronos, 1968)
Easy dispersion and  TiO2 is well dispersed and also easily soluble in the glaze melt or,
particle distribution and if occasion arises, in the frit batch (Kronos, 1968). It can be
processability readily fused in vitreous enamels (and glass)
Other  The susceptibility of glazes to crazing is reduced by an addition of
TiO2 and the gloss of transparent glazes is improved (Kronos,
1968). TiO2 enhances mechanical and thermal resistance in
ceramic glazes.
In porcelain enamels, without TiO2, the chemical resistance
against acids is lower. It is important that cookware enamel has
very good resistance against citric acid and acetic acid, while for
enamels used in industrial applications (for example heat
exchangers, architectural panels, chemical vessels) good
resistance against sulphuric and hydrochloric acids is required

3.4.15 Glass
Range of applications

TiO2 applications in glass include:

• Glass with enhanced hardness and higher resistance to abrasion;

• Glass with sun protection properties, good light, anti-reflection and energy performance for
window glass in buildings and in cars (TiO2 is used as a coating, it is not used as a raw material to
produce the glass sheet);
• Glass with self-cleaning properties in buildings (TiO2 is used as a coating, it is not used as a raw
material to produce the glass sheet; see photocatalysts, above);
• Radiation protection in the UV range for the pharmaceuticals industry (containers etc.);
• Glass for ophthalmic and optic applications;
• Glass-to-metal-seals for lithium batteries used in medical implantable devices such as
pacemakers, heart defibrillators, and neuro-stimulators; and
• Paints and decorating inks used to produce white-colour glass.

These uses are necessary for medical/public health protection, drug safety (inertness of medical
drug containers), eye protection and visual correction, and high-end medical applications that save
lives.

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Typical presence of titanium dioxide in raw materials for glass manufacture

During the chemical reaction to form glass, TiO2 is transformed into a non-crystalline vitreous new
substance (glass). In glass, Ti is incorporated via strong new chemical bonds and becomes an
integral part of the glass’ three-dimensional structure. The physicochemical properties of the new
substance glass (chemical resistance, mechanical resistance, transmittance, colour, etc.) are a
function of the composition and the network formed.

The share of TiO2 in the raw materials used for the manufacture of glass typically is:

• Ceramic glass colours: 4-20%; and

• Special glass: 1-30%.

Technical characteristics and advantages

Technical characteristics and advantages afforded by the use of TiO2 in the synthesis of glass cannot
be achieved by other means. These advantages can be summarised as follows.

Table 3–23: Advantages of TiO2 use in the manufacture of glass

Properties Relevant key Notes, comments and sources
advantages
Good hiding 
power/opacity
Base for colour 
development
UV absorbance  Reduces transmission of UV light, viscosity of the glass melt and
coefficient of expansion
Photocatalytic activity  Self-cleaning properties when used as coating in window glass
Other  A high refractive index leads to a reduction of the thickness of the
glass in optical application.
It increases hardness and abrasion resistance as well as resistance
to acids.
It acts as a crystallisation initiator or crystallisation accelerator

3.4.16 Medical devices

Range of applications

Various medical devices contain TiO2 as a pigment in bound form, e.g. as dental impression or dental
filling or dental temporary or dental lab materials and luting cements. Products include:

• Dental impression materials: these are used by dentists to perform impressions on teeth;
• Dental filling materials: these are used by dentists to fill cavities (instead of silver-mercury
amalgam);
• Dental luting cements: these are used by dentists to lute indirect restorations (crowns, bridges,
inlays, onlays) to the tooth structure;
• Dental temporary materials (cements, crown and bridge materials) and crown and bridge
materials (non-metallic): these are used by dentists to prepare temporary crowns or bridges or
to lute such temporary restorations to the tooth; and
• Dental lab materials: these are used by dental technicians for a variety of uses.

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Furthermore, TiO2 is present in various plastic parts in
medical equipment/medical devices where it provides
two main benefits: firstly, its light resistance provides
UV-protection which, in turn, improves the stability of
the product; and secondly the white colouration
enables dirt and other soiling to be instantly seen,
which is beneficial in terms of hygiene (German
Medicines Manufacturers Association, 2016). TiO2 may
also be used in surgical medical tapes, wound dressings
Figure 3–16: Example of dental impression
and bandages. In addition, as noted earlier, TiO2 is
materials that contain TiO2 extensively used in the medical plastics industry to
Source: royalty-free photo protect light sensitive pharmaceutical compounds from
photolysis.

TiO2 has been used for decades in medicinal products and medical devices, as well as in other
applications and there are no known examples of adverse reactions caused by the substance
(German Medicines Manufacturers Association, 2016).

Typical concentrations of titanium dioxide

The following information is available for TiO2 in dental formulations:

• Dental impression materials: 0.01 to <1%;

• Dental filling materials: 0.1-4%;
• Dental luting cements: 0.01-0.5%;
• Dental temporary materials: 0.01-0.1%; and
• Dental lab materials: 0.01-0.8%.

Technical characteristics and advantages

These TiO2-based products have the following advantages:

• Highly improved readability of impressions by dentists. Only materials containing TiO2 can be
well read by optical scanners used in digital dentistry; and

• TiO2 is the white pigment giving best results in obtaining aesthetic colours for dental materials.
With the lowest pigment concentration possible, the most aesthetically pleasing dental products
can be achieved.

3.4.17 Detergents
TiO2 is present in certain detergent products at levels below 1% (with the vast majority being <0.1%).
It is used in the following detergent applications:

• Laundry and cleaning products: TiO2 is used as a colourant (whitening) for granular enzymes. It
also gives important stability functionalities for the enzymes. Granular enzymes are key cleaning
agents in granular detergents and automatic dishwashing products. TiO2 can also be found in
curtain/fabric whiteners; and

• Toilet solid rim blocks: TiO2 is a white colourant and a process aid (for the extrusion of the
blocks).

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3.4.18 Biocides
Consultation with downstream users of the substance indicates that TiO2 is used as a carrier and
light stabiliser of special biocidal active substances based on silver (AgCl on TiO2). These are used as
in-can preservatives, additives for hygienic paints, additives to extend shelf life (e.g. paints), co-
biocides, etc. The substance is currently listed as “under review” in the form of “reaction mass of
titanium dioxide and silver chloride” for seven product types. The product types covered are:

1 – Human hygiene;

2 – Disinfectants and algaecides not intended for direct application to humans or animals;

6 – Preservatives for products during storage;

7 – Film preservatives;

9 – Fibre, leather, rubber and polymerised materials preservatives;

10 – Construction material preservatives; and

11 – Preservatives for liquid-cooling and processing systems.

3.4.19 Other minor applications

Several less widespread applications of TiO2 exist. Some that have been identified in the course of
preparing the present report include:

• Liquid chromatography;
• Growth promoter pigment for horticulture (greenhouse applications); and
• Lubricants.

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4 Impact analysis

4.1 Introduction
This is the main section of the impact assessment presented in this document. The section starts
with a discussion of the key drivers behind the socio-economic impacts that would arise from a Carc
Cat 2 harmonised classification for TiO2 and thereafter discusses the relevant impacts for each
downstream use sector taking into account the analysis of the regulatory framework presented in
Annex 1 (Section 7) of this document. Having discussed the impacts on the marketing and use of the
substance and its mixtures and articles, an analysis of upstream impacts (on TiO2 manufacturers and
their suppliers is provided). Lastly, a discussion on potential impacts outside the TiO2 supply chains
is provided and the Section concludes with an overview on potential impacts on the environment.

4.2 Drivers behind the impacts from the proposed classification of

titanium dioxide
4.2.1 Impact driver 1: Existing regulatory requirements
Framework of analysis

There is a wide range of legislative instruments at EU level that link to the CLP Regulation and which
therefore would come into play if a harmonised classification of Carc Cat 2 for TiO2 were to be
adopted. Annex 1 (Section 7) includes a series of tables that summarise the relevant legislation
(with a focus on EU-wide regulation and initiatives) and provides information on:

• The key provisions of each piece of legislation in relation to both Carc Cat 1B and Carc Cat 2
substances, in order for a quick comparison between the two harmonised classification
categories to be made;

• Whether each legislation applies to a single industrial sector/area of application (e.g. cosmetics)
or several (e.g. REACH);

• Whether the legislation and its implementation have implications primarily for industrial users
(I), professional users (P) or consumers, i.e. the general public (C);

• Importantly, whether the magnitude of the impact that legislative provisions would have on the
current applications of TiO2 would be defined by hazard profile alone (i.e. the new hazard
classification) or would take into account the risk of release and exposure (including exposure
pathway), and in many situations the availability of alternatives for TiO2 as well;

• A description of the process that would need to be followed before the new hazard classification
translates into some sort of restriction on the use of TiO2 in specific applications; and

• A final comparison of the severity of regulatory requirements between the two harmonised
classification categories.

The tables confirm that a wide variety of legislative instruments would be of relevance. Some of it is
cross-sectoral, such as the CLP Regulation itself, which will require changes to labelling of mixtures

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and their packaging; while other legislation focuses on specific areas of application of TiO2, for
example, pharmaceuticals, cosmetics, food safety and food contact materials. There is also
legislation that, whilst having a specific focus, may transcend market sectors and applications; for
example, biocides containing TiO2 may find applications in several end-user sectors (e.g. cosmetics,
paints, coatings). The following paragraphs firstly focus on legislation that would have an impact
across the manufacture, placing on the market and use of TiO2 and then discuss impacts specifically
relevant to downstream uses of the substance.

Supply chain-wide impacts arising under the CLP Regulation

New labelling requirements

Following the classification of the substance, there would be a need for replacing existing labels on
TiO2 and mixtures that contain the substance in concentrations exceeding 1.0% by weight to reflect
its new harmonised classification. This would have direct cost implications:

• Part of the existing stocks of labels and packaging (i.e. those intended for use within the EEA)
would need to be disposed of (or recycled, where possible);

• New labels and packaging would need to be designed, produced and supplied to interested
parties (NB. Article 35 of the CLP Regulation imposes safety requirements for the packaging of
substances and mixtures classified as hazardous – this might affect the packaging specifications
of some mixtures of TiO2); and

• Logistic complexities would arise from the new labels and packaging being selectively used when
trading within the EEA.

Estimates for the direct cost of new labelling following the proposed classification of TiO2 are not
available, although some figures can easily be retrieved online from other cases of (re-)classification
of substances and products18. Realistically, the cost per company may not be prohibitive depending
on the type and volume of packaging19; however, when aggregated across the numerous uses of the
substance, the overall cost would be very substantial. Moreover, given that inhalation is the only
exposure route of theoretical concern but the probability for such exposure (and at relevant
exposure levels) is extremely low in most cases, the expense for new labels would appear
disproportionate and unjustified.

It is useful to juxtapose the labelling requirements for Carc Cat 1B and Carc Cat 2 as prescribed under
the CLP Regulation, see Figure 4–1 (overleaf).

The differences, particularly to someone not conversant with the meaning of key terms (“Danger”,
“Warning”, “May cause cancer”, “Suspected of causing cancer”), are arguably subtle. The
pictograms are the same and the precautionary statements are the same (NB. the hazard statement
would indicate exposure route (i.e. inhalation) only if there is conclusive proof that no other routes

18
For instance, small changes to the hazard labelling of aerosols would cost £0.14-0.2 million per aerosol
manufacturer in the UK, or ca. £150-200 per production line (BIS, 2014). In another case, the cost of
changing the labelling/packaging of cement bags was estimated at €0.7-7 per 1,000 kraft paper bags
(depending on whether the entire bag or only part of it changes) and a total cost of €1.4-4 million per year
for the whole of Europe (Cerame-Unie, 2013).

19
It must also be remembered that proposed classification would also affect the use of TiO2 in labels and inks
that would need to be used in the new packaging.

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of exposure cause the hazard). A tactile warning of danger (raised triangle) would also accompany
mixtures containing more than 1.0% TiO2.

Figure 4–1: Label elements for carcinogenicity according to the CLP Regulation 1272/2008

Furthermore, a number of precautionary statements would also apply with respect to prevention,
response, storage and disposal with a maximum of six to be used. In order of importance, these
include:

• P281: Use personal protective equipment as required (highly recommended to be used for all
market sectors);
• P501: Dispose of contents/container to … (mandatory for products sold to the general public);
• P405: Store locked up (highly recommended for products sold to the general public, optional for
others);
• P201: Obtain special instructions before use & P308/P313: If exposed or concerned: Get
medical advice/attention (recommended); and
• P202: Do not handle until all safety precautions have been read and understood (optional).

Labelling creates perception and perception often transcends the scientific basis of the classification
and the label itself. Labelling could indeed prove problematic as it would apply to important TiO2-
based mixtures that are placed on the EEA consumer market, such as DIY paints that generally
contain TiO2 concentrations much higher than 1.0%. Importantly, labelling would be required even
where exposure by inhalation would be impossible to occur. Thus, consumers would not be able to
ascertain the ‘real’ risk from using a DIY paint or other formulation (e.g. adhesives, sealants, etc.)
and could grow reluctant to use products that contain a carcinogen, often at relatively high
concentrations. It should be noted that companies are not free to choose what they include in the

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labels affixed to their products and may only label according to the CLP Regulation with any
transgression potentially leading authorities’ demands for product withdrawal.

Poison Centre Notifications

According to the newly introduced Annex VIII to the CLP Regulation, before placing mixtures on the
market, submitters (i.e. importers and downstream users placing on the market mixtures for
consumer/professional/industrial use) shall provide information (product identification, hazard
identification, composition information and toxicological information) relating to mixtures classified
as hazardous on the basis of their health or physical effects to their national Poison Centres. A
universal submission format shall be used across the EU. Importers and downstream users placing
on the market mixtures for consumer, professional and industrial use shall comply from 1 January
2020, 1 January 2021 and 1 January 2024 respectively. If relevant information has already been
submitted, the obligation for submission of data to Poison Centres is deferred to 1 January 2025.
Thus, importers and downstream users of mixtures that are currently not classified as hazardous but
contain TiO2 in concentrations above 1.0% will become obliged to provide information to Poison
Centres over the period 2020-2024, depending on whether those mixtures are used by consumers,
professional users or industrial users. This new obligation will generate an additional administrative
burden and cost.

Supply chain-wide impacts under the Waste Framework Directive

Waste management implications of a Carc Cat 2 harmonised classification

A Carc Cat 2 classification would generate new requirements for the management of TiO2-containing
waste by resulting in the classification of several types of waste as hazardous. According to Annex III
(and Table 6 thereof) of Directive 2008/98/EC (the Waste Framework Directive), waste that contains
a Carc Cat 2 substance in concentrations above 1.0% would be classified as hazardous with a HP 7
classification. There are clearly many formulations (e.g. paints, inks, adhesives, sealants, etc.) and
products (e.g. plastics, elastomers, ceramics, etc.) in which the concentration of TiO2 significantly
exceeds the 1.0% level (by weight) and thus, in principle, associated waste streams might run the
risk of being classified as hazardous. The approach to the classification of TiO2-containing wastes as
hazardous is based on the provisions of the Waste Framework Directive and on Decision
2000/532/EC (as revised by EU Decision 2014/955/EU) which established the European List of
Wastes (LoW) can be described in Figure 4–2.

The LoW is divided into 20 chapters (labelled with 2 digits) based on the key process (source) that
generates the waste or specific waste types (e.g. Digit 20 for Municipal Wastes (Household waste
and similar commercial, industrial and institutional wastes – Including separately collected
fractions)). The waste categories are further divided into sub-chapters labelled with 4-digit codes
based on processes and/or input materials used in the process. Finally, each specific waste entry
under each sub-chapter is given a specific six-digit code and description (Wahlström, et al., 2016).

The wastes in the LoW are labelled in three different ways depending on their hazard classification
(Wahlström, et al., 2016):

• ‘Absolute hazardous’ entry: the code is marked with an asterisk (*) and the waste is classified as
hazardous waste (no further assessment needed). The producer of the waste does not need to
consider what chemicals are in the waste to find out if it is hazardous or not (still the producer
needs to establish what hazardous properties the waste displays to ensure appropriate
management of it). Even if that waste has no hazardous properties, the absolute hazardous
entry still applies;

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Figure 4–2: Flow chart for determination of applicable LoW entries (BiPRO, 2015)

• ‘Mirror’ entry: the mirror entries are typically a pair of two (sometimes more) entries (6-digit
codes) one hazardous and the other non-hazardous. The hazardous entry refers to the presence
of hazardous substances (general or specific) while the non-hazardous entry applies where the
hazardous components are absent and cross-refers to (mirrors) the hazardous entry digit code.
However, there are also cases where the mirror entries are unpaired i.e. there is no cross
reference from the non-hazardous entry to the hazardous entry. Both for the paired and
unpaired mirror entries, the waste producer must show that the waste does not exhibit
hazardous properties related to the presence of hazardous substances prior to assigning a non-
hazardous waste code. For a mirror pair where the hazardous entry has a specific reference to a
hazardous substance (for example, coal tar), the hazardous entry is chosen only if the waste
contains the particular hazardous substance (in this case coal tar) at or above levels that make it
hazardous. In short, a “mirror” entry waste is a potentially hazardous or non-hazardous waste
depending on the presence of specific or generic hazardous substances and thus an assessment
must be made whether any given waste is hazardous or not; and

• ‘Absolute non-hazardous’ entry: the waste is classified as non-hazardous (no further

assessment needed). The producer of the waste does not need to consider what chemicals are
in the waste to find out if it is hazardous or not. By way of example, “02 01 04 waste plastics
(except packaging)” under the general waste category “WASTES FROM AGRICULTURE,
HORTICULTURE, AQUACULTURE, FORESTRY, HUNTING AND FISHING, FOOD PREPARATION AND
PROCESSING” is an “absolute non-hazardous” entry and therefore waste products such as
agricultural plastic films would not be classified as hazardous after the adoption of the Carc Cat 2
classification that is being considered by the RAC even if they do contain TiO2 in concentrations
above 1.0% by weight.

A 2015 study reports that of the 842 entries in the LoW, 228 are ‘absolute hazardous’, 236 are
‘absolute non-hazardous’, 180 are ‘mirror hazardous’ and 198 are ‘mirror non-hazardous’ (BiPRO,
2015).

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Following from the above, it may be concluded that:

• A new harmonised classification for TiO2 would not affect the management of any ‘absolute
hazardous’ waste that contains the substance. These wastes are currently classified as
hazardous and will continue to be even after the introduction of the Carc Cat 2 harmonised
classification and can therefore be disregarded in this impact assessment;

• A new harmonised classification for TiO2 would have an impact on the management of waste
that currently falls under ‘mirror non-hazardous’ entries and contains more than 1% TiO2. Such
waste would need to be allocated to the respective ‘mirror hazardous’ entry that makes a
generic reference to “hazardous substances” (for instance, 08 01 16 aqueous sludges containing
paint or varnish other than those mentioned in 08 01 15 would be replaced by 08 01 15* -
aqueous sludges containing paint or varnish containing organic solvents or other hazardous
substances). It might be perceived that wastes already classified as hazardous under a ‘mirror
hazardous’ entry due to the presence of other hazardous substances would not substantially be
affected by the Carc Cat 2 harmonised classification for TiO2; however, information collected
during the preparation of this report indicates that whilst the hazard classification of the waste
might not change, the cost of its management might increase, as will be explained later in this
document); and

• The management of ‘absolute non-hazardous’ waste might also be impacted. In principle, if a

waste is allocated to an ‘absolute non-hazardous’ entry, in most cases it is non-hazardous
without any further assessment of its composition. However, there are notable exceptions
where these ‘absolute non-hazardous’ entries are linked to other entries in the LoW and the
other entries may need to be considered to determine if they are more appropriate to the
waste. A good example is empty TiO2 packaging waste that contains over 1.0% TiO2 residues.
Paper waste of this type (i.e. empty paper bags) is currently classified as 15 01 01 paper and
cardboard packaging but once TiO2 becomes a Carc Cat 2 substance, the appropriate entry will
be 15 01 10* packaging containing residues of or contaminated by hazardous substances (this is
discussed further below).

Where a waste is classified as hazardous, a number of specific obligations apply under the Waste
Framework Directive, e.g.

• Labelling and packaging obligations (Article 19);

• The obligation to provide evidence for the tracking of the waste according to the system put by
the relevant Member State (Article 17); and
• A mixing ban (Article 18).

Hazardous waste is also required to meet the waste hierarchy prescribed in the Directive and should
be minimised, reused or recycled before disposal occurs. Hazardous waste must be classified and is
required to be treated before it can be disposed of, in order to prevent or reduce possible harm to
human health and the environment. If hazardous waste cannot meet the upper levels of the waste
hierarchy then it should either be incinerated or disposed of in a hazardous waste landfill.

According to Cefic, the price for treatment of waste classified as hazardous can be 2 to 3 times the
price for the same material classified as non-hazardous20. Information from some consultees

20
Suggestion of Cefic to the European Commission, dated 6 April 2017, available at
https://ec.europa.eu/info/law/better-regulation/lighten-load/suggestions/S19535_en (accessed on 1
September 2017).

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suggests that an even higher cost increase might be possible. For instance, the EUWID Recycling and
Waste Management, a publication-source of information for the international waste management
and secondary raw materials sector, has been suggested to indicate price differences for the
management of hazardous and non-hazardous waste in the range of 10-30 times21.

Management of waste packaging with titanium dioxide residues

Handling of waste packaging that contained TiO2 or TiO2-containing mixtures would also be affected
by the harmonised classification of the substance. This packaging may now become classified as
hazardous and would need to be treated accordingly, depending on the level of residue / waste
retained in the packaging. Chapter 15 of the LoW contains the following codes for waste packaging
classified as non-hazardous under 15 01 Packaging (including separately collected municipal
packaging waste) (NB. all are ‘absolute non-hazardous entries’):

• 15 01 01 paper and cardboard packaging;

• 15 01 02 plastic packaging;
• 15 01 03 wooden packaging;
• 15 01 04 metallic packaging;
• 15 01 05 composite packaging;
• 15 01 06 mixed packaging;
• 15 01 07 glass packaging; and
• 15 01 09 textile packaging.

Chapter 15 of the LoW also contains the following codes for waste packaging classified as hazardous:

• 15 01 10* packaging containing residues of or contaminated by hazardous substances; and

• 15 01 11* metallic packaging containing a hazardous solid porous matrix (for example asbestos),
including empty pressure containers.

Recent guidance issued in the UK (by industry in association with the Environment Agency) is
summarised in Figure 4–3.

21
It was suggested in consultation that this significant difference in waste management costs was
demonstrated in the recent case of Hexabromocyclododecane (HBCDD)-containing insulation waste in
Germany. The German Federal Government revised the German Waste Catalogue Ordinance in March
2016 (the German List of Waste). This ordinance classifies non-hazardous and hazardous wastes.
Following the revision, insulation waste, typically expanded polystyrene waste which contains HBCDD
above the threshold of 0.1% by weight, had to be classified as hazardous from October 2016. According to
waste operators, both utilising energy-from-waste as well as recyclers, this resulted to a state of
emergency in Germany. The change in legislation largely brought a hitherto smoothly running and safe
disposal route to a standstill. The classification increased the requirements for site logistics and disposal
with transport, storage and plant permits becoming necessary. The ban on mixing hazardous waste did not
only increase the disposal costs, especially for so-called monocharges, but also led to capacity problems in
the waste treatment plants and thus to the unintended waste disposal bottleneck for polystyrene
insulation boards in Germany (see details here: http://www.agehda.de/cms/wp-
content/uploads/2017/04/Positionspapier_AGEHDA-final.pdf, accessed on 13 November 2017). As a
consequence, the German Government issued a memorandum of exemption in December 2016 and in
collaboration with industry eventually revised the German Waste Catalogue Ordinance again, which is now
effective from August 2017.

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Figure 4–3: Flow chart for assessing whether packaging to be taken offsite is waste or not – UK (IPA,
2017)

The following points are important for the interpretation of the flowchart (IPA, 2017):

• Indicators that packaging may be waste include a package that: (a) is not reusable; (b) requires
treatment other than simple rinsing to remove chemical residues; (c) is not ‘effectively empty’;
or(d) is damaged and requires repair before it can be re-used;

• ‘Effectively empty’ means that the packaging has been treated in such a way that all reasonable
efforts have been made to remove any left-over contents from the packaging, by applying
normal industrial standards or processes, or, if the packaging is sealed, has been designed in
such a way so that the residue when the packaging has been emptied is minimal. Regarding
powders, the use of bag shakers/massagers to remove the powder from FIBCs (flexible
intermediate bulk containers) or tipping and shaking of smaller bags would constitute ‘all

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reasonable efforts’ and the package would be considered ‘effectively empty’. Additionally, for
the packaging to be considered ‘effectively empty’, any contamination on the outside of the
packaging must be minimal; and

• If either the residue inside, or any contamination on the outside, of an ‘effectively empty’
container possesses a hazardous property, then it can be classified as hazardous waste
packaging without any further assessment using the LoW code 15 01 10*.

Thus, packaging containing residues of or contaminated by TiO2 containing more than 1.0% of the
substance (by weight), would be classified under 15 01 10* as hazardous waste. Such waste might
include 25kg bags, big bags, bulk bags (FIBCs) and potentially containers for slurries (NB. there is still
some uncertainty with regard to whether slurries will be classified HP7 hazardous or not or not, as
the TiO2 contained within slurries does not strictly go through a dry powder phase).

A particular separate mention is required for plastic packaging waste. LoW code 15 01 10* for
plastic packaging waste may become relevant not only as a result of the presence of TiO2-containing
residues in the packaging waste, but it can be also relevant when the packaging waste contains the
substance as an ingredient, i.e. an additive. This interpretation with respect to plastics and possibly
other chemical raw materials can be derived from the EU Commission’s “Guidance document on the
definition and classification of hazardous waste” drafted by JRC in June 201522. According to section
A.5.9 Plastics, “A specific plastic waste can be hazardous either because of the additives it contains or
because the waste is contaminated with hazardous substances e.g. oils or solvents”.

Role of exposure pathway and bioavailability in hazardous waste classification

The harmonised classification that is being considered by the RAC is expected to specify the
inhalation exposure route as the only one of relevance. Generally, inhalation exposure to TiO2 from
end-products and their waste forms is very unlikely, if not impossible, to arise as the pigment is
embedded into a matrix (a paint, a coating, a plastic, etc.), and migration is (nearly) zero. Even if
some activities would generate some dust (e.g. removal of paints from painted surfaces may
generate dust), such activities are generally infrequent and generate dust levels that, with
appropriate respiratory protection, are generally low.

On this basis, it would be reasonable to assume that many types of wastes that contain over 1.0%
TiO2 but cannot be inhaled (e.g. there are in the form of a viscous liquid or dust-free solid) would not
warrant a hazardous classification. To investigate whether this avoidance of a hazardous
classification based on low/no bioavailability (and therefore low/no risk of exposure) would be a
possibility, we need to look into waste management practices on the national (and possible also
regional) level, since the implementation of the Waste Framework Directive into national waste
legislation varies across the EU.

For reasons of time availability, it has not been possible to look into all Member States; instead, a
group of six Member States have been selected as case studies: France, Germany, Italy, Poland,
Sweden and the United Kingdom. In general, the disposal options available vary depending on the
EU State in which it has been produced. Taxes and licencing fees also vary depending on the country
and this will have an impact on the cost of disposal. Shipments of hazardous waste are controlled
and different EU states have slightly different rules on what wastes can be transported across their
borders for disposal. The following paragraphs discuss the regulatory framework in the selected

22
Available at http://ec.europa.eu/environment/waste/pdf/consult/Draft guidance document_09062015.pdf
(accessed on 7 November 2017).

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Member States and, information permitting, explain the realism and possibilities for taking the
exposure pathway into account when classifying TiO2-containing waste as hazardous (or not) and
national provisions for the treatment if such waste.

Box 4.1: Review of waste management requirements in selected Member States and possibilities for
exemptions based on exposure route for a H351 classified substance

France: according to a factsheet for TiO2 drawn up by the French Institute of Scientific Research (INRS), it is
already recommended that waste TiO2 be considered ‘hazardous waste’, packaged in closed air-tight
containers and labelled before being disposed of23. Waste producers locate their own waste disposal service
providers (who they can contact for a quote24) but are responsible for ensuring that these service providers
are compliant with regulation25. The quote is based on the type and amount of waste to be disposed of, the
form of disposal and transport costs.

The French Environment Code (Article R541-50) stipulates that companies are to file a declaration with the
prefect for the area (département) where their head office is based or, failing that, where the domicile of the
declarant is based, when a quantity greater than 0.1 tonnes of hazardous waste or 0.5 tonnes of non-
hazardous waste is collected or transported for disposal.

Producers are responsible for their waste from the moment that it is created until its final stage of disposal has
been completed (e.g. treatment or placed in landfill)26. For hazardous waste, the waste producer is obliged to
issue a hazardous waste tracking slip (un bordereau de suivi des déchets – BSD), which is then completed by
the carrier and the treatment facility/facilities receiving the waste. Once the waste has been disposed of, the
BSD is returned to the producer27. Waste producers are also obliged to keep a register monitoring their waste
disposal activities28.

23
INRS (2013): Fiche toxicologique – Dioxyde de titane, accessed on 30 August 2017 at:
http://www.inrs.fr/dms/ficheTox/FicheFicheTox/FICHETOX_291-2/FicheTox_291.pdf.

24
Veolia website: Déchets dangereux : des professionnels à votre service 24h/24, 7j/7, available at
http://recyclage.veolia.fr/entreprises/solutions-matieres/dechets-dangereux.html (accessed on 30 August
2017).

25
Legifrance website: Article L541-2 of the French Environment Code, available at
https://www.legifrance.gouv.fr/affichCode.do;jsessionid=81A4563FB6861C4317C754D1D72A6334.tpdila09
v_1?idSectionTA=LEGISCTA000024357401&cidTexte=LEGITEXT000006074220&dateTexte=20170830
(accessed on 30 August 2017).

26
Legifrance website: Article L541-2 of the French Environment Code, available at
https://www.legifrance.gouv.fr/affichCode.do;jsessionid=81A4563FB6861C4317C754D1D72A6334.tpdila09
v_1?idSectionTA=LEGISCTA000024357401&cidTexte=LEGITEXT000006074220&dateTexte=20170830
(accessed on 30 August 2017).

27
Legifrance website: Article R541-45 of the French Environment Code, available at
https://www.legifrance.gouv.fr/affichCode.do;jsessionid=9B5286EBFA0D549DB07EDFA51A65893D.tpdila0
7v_1?idSectionTA=LEGISCTA000024357355&cidTexte=LEGITEXT000006074220&dateTexte=20170831
(accessed on 30 August 2017).

28
Legifrance website: Article R541-46 of the French Environment Code, available at
https://www.legifrance.gouv.fr/affichCode.do;jsessionid=9B5286EBFA0D549DB07EDFA51A65893D.tpdila0
7v_1?idSectionTA=LEGISCTA000024357355&cidTexte=LEGITEXT000006074220&dateTexte=20170831
(accessed on 30 August 2017).

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Disposal of hazardous waste is organised at a regional level within the regional waste prevention and
management plans (plans régionaux de prévention et de gestion des déchets)29.

No information has been identified that would lead us to assume that exposure routes (in essence, levels of
risk) are taken into account in classifying a waste as hazardous or not. As such, a waste containing over 1%
TiO2 could be classified as hazardous even if exposure by inhalation could be impossible or very low.

Germany30: waste management in Germany is the responsibility of the competent Federal State authorities,
who impose delivery and handover obligations for hazardous waste. The waste producer is required to notify
the local authority of the type, quantity and composition of the waste, as well as the envisaged disposal
facility. The local authority will then assign the waste to a suitable facility. Supervision of hazardous waste
disposal is managed through documents such as the Waste Recovery and Disposal Record
(Entsorgungsnachweis), Transport Form (Begleitschein) and the Transfer Receipt (Übernahmeschein). Consent
by the competent authority can be forgone if the waste is disposed of by a company that is certified in
accordance with the Ordinance on Specialised Waste Management Companies. Commercial collection of
hazardous wastes from households is prohibited as a permit is required for hazardous waste disposal. There is
no separate permit for waste producers, it is contained within the relevant building or Emission Control Act
permits. The waste producer must show that they are trying to minimise their waste generation but there is
no licencing fee. An entity that is to transfer waste must make a number of notifications, such as those to road
traffic authorities, and obtain a Section 45 Close Cycle Management Act licence31. Transfer and disposal is
carried out by private companies commissioned by the waste producer, rather than the local authority.

The cost of hazardous waste disposal is based on the type and quantity of the waste to be disposed of and the
costs associated with transport. There is no landfill tax in Germany as there are restrictions on what can be
sent to landfill based on physical and chemical properties. Fees will vary depending on the type of treatment,
i.e. incineration or landfill.

As for France, no information has been identified that would lead us to assume that exposure routes (in
essence, levels of risk) are taken into account in classifying a waste as hazardous or not. As such, a waste
containing over 1% TiO2 could be classified as hazardous even if exposure by inhalation could be impossible or
very low.

Italy: a waste stream containing TiO2 classified as Carc Cat 2 will be classified as hazardous in the Italy. There
does not appear to be any differentiation between exposure pathways and treatment options. It appears that
where hazardous waste cannot be reused or recycled, it is mostly sent to a hazardous waste landfill. Waste for
incineration tends to be shipped to other countries. Costs of disposal are defined on a case by case basis,
depending on the type and amount of hazardous waste to be disposed of. The type and amount of waste
informs the form of disposal container that is required (drums, canisters etc.) and their size, which affects the
cost.

Waste management plans vary between municipality and the cost of disposal can be influenced by whether or
not there is an overarching contractor for waste collection, transport and disposal or whether there are

29
AdCF website: Les plans régionaux déchets (PRPGD) engagés dans plusieurs régions, available at
http://www.environnement-magazine.fr/article/47735-plan-regional-de-prevention-et-de-gestion-des-
dechets-ce-qu-il-faut-savoir/ (accessed on 30 August 2017).

30
Umweltbundesamt website: Hazardous waste, available at
http://www.umweltbundesamt.de/en/topics/waste-resources/waste-management/waste-
types/hazardous-waste (accessed on 30 August 2017).

31
Thomson Reuters Practical law website: Environmental law and practice in Germany: overview, available at
https://uk.practicallaw.thomsonreuters.com/4-503-
0486?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1 (accessed on 30 August
2017).

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intermediaries. A landfill tax is also incorporated in the cost of disposal. Transporters of hazardous waste are
subject to a licence but it is unclear whether premises that produce hazardous waste must be licenced or
registered.

Poland: the responsibility for waste management is held by the waste producer, although this may be
transferred to the entity that has been authorised for collection or treatment of such waste (this is not the
waste carrier). Waste carriers must be authorised by the sub-regional authority (Starosta) and are required to
be registered in a nationwide database. The transport permit indicates the codes of waste that the carrier is
authorised to transport32.

In order for hazardous waste to be incinerated there must be a detailed description of the waste (including
laboratory analysis), protection and precautionary measures and information on which substances the waste
must not be mixed with provided33. The cost of hazardous waste disposal is unclear but it appears that it is a
similar situation to that of the other EU States, whereby it is based on a quotation from the waste carrier.

As for France and Germany, no information has been identified that would lead us to assume that exposure
routes (in essence, levels of risk) are taken into account in classifying a waste as hazardous or not. As such, a
waste containing over 1% TiO2 could be classified as hazardous even if exposure by inhalation could be
impossible or very low.

Sweden34: a waste stream containing TiO2 classified as Carc Cat 2 will be classified as hazardous in Sweden.
There does not appear to be any differentiation between exposure pathways and treatment options. There is
no standard cost for disposal of hazardous waste as it is dependent on the type and amount of waste to be
disposed of and the treatment option. A permit is required for incineration operations, which is likely,
incorporated into costs for disposal. The tax on incineration depends on the fossil material in the waste and
whether the facility produces electricity. The landfill tax in Sweden is €55 per tonne and the average net fee
for landfilling is €50-75 per tonne, making the total fee payable approximately €120-170 per tonne, although it
is not clear if this is applicable for hazardous waste landfills.

Local authorities are responsible for the collection, transport and treatment of hazardous household waste,
with the most common collection system being at manned municipal recycling centres. There is no licence fee
for hazardous waste producers but depending on the waste fraction (i.e. WEEE, batteries and medicines),
there is producer responsibility, which means that the producers pay a fee to a producer responsibility
organisation who arrange the national collection system and treatment. The producer of hazardous waste
must ensure that the waste is managed according to the terms of the company’s environmental business
permit and Sweden’s environmental laws.

Hazardous waste producers can choose whether to have their waste collected and treated by either a private
company or a municipal waste company as long as the company chosen has the correct environmental
business permit. Hazardous household wastes are collected and managed by the Swedish municipalities. The

32
Improvement of hazardous waste management in the Republic of Serbia website: Waste management of
hazardous waste in Poland, available at http://hazardouswaste-
serbia.info/fileadmin/inhalte/haz_waste/pdf/Fact_sheets/02_Poland_fact_sheet_presentation.pdf
(accessed on 30 August 2017).

33
Improvement of hazardous waste management in the Republic of Serbia website: Waste management of
hazardous waste in Poland, available at http://hazardouswaste-
serbia.info/fileadmin/inhalte/haz_waste/pdf/Fact_sheets/02_Poland_fact_sheet_presentation.pdf
(accessed on 30 August 2017).

34
Avfall Sverige website: Swedish waste management 2016, available at
http://www.avfallsverige.se/fileadmin/uploads/Arbete/Remissvar/swm_2016.pdf (accessed on 30 August
2017).

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cost of disposal may vary depending on whether the same company is used as that which collects and
transports the waste.

United Kingdom35,36: a waste stream containing TiO2 classified as Carc Cat 2 will be classified as hazardous in
the UK. There does not appear to be any differentiation between exposure pathways and treatment options.
There are two forms of disposal of hazardous waste which cannot be reused or recycled: incineration or
hazardous waste landfill. The Environment Agency (EA) has produced decision trees to help waste producers
decide which point on the waste hierarchy they should be following to prevent the over use of landfill.

It used to be the case that the producer of hazardous waste would need to register their site at a cost, but this
is no longer required. Anyone who transports hazardous waste is required to have a waste carrier licence
which costs £234 (+VAT) (ca. €250 + VAT) for a new licence and £154 (+VAT) (ca. €170 + VAT) if the licence is
being renewed.

There is no direct fee payable by a waste producer to a disposal facility. The producer tends to enlist the
services of a waste disposal company to which they will pay a fee. This fee is dependent on the type and
amount of waste being disposed of as different wastes require different carrying methods (2- or 5-litre drums
etc.). Not only are different wastes liable to different costs, different types of waste within a waste stream are
liable to different costs, for example paints can be charged differently depending on their content. Transport
costs and the landfill tax payable by the disposal site operator are also included in the cost (NB. the landfill tax
for hazardous waste in the tax year 2017-18 is £86.10 / tonne).

The waste producer is required to classify and test their waste prior to requesting a quotation from the waste
disposal company. A material safety data sheet is required so that the technical team at the waste disposal
company can determine what risk management they will need to employ when transporting and disposing of
the waste.

Certain companies will not take certain wastes, although this tends to be nuclear or explosive wastes and is
unlikely to impact wastes containing TiO2.

The above analysis suggests that the classification is based on hazard alone and the level of risk (i.e.
route of exposure) is unlikely to be taken into account when classifying waste as hazardous or not.
As such, if the new harmonised classification would be specifically relevant to the inhalation
exposure route it would not mitigate the impact of the harmonised classification on the waste
management obligations of producers of waste that contains over 1.0% of TiO2.

Of interest is the analysis presented in a 2015 report commissioned by the European Commission
which looked into the scope of exemptions from classification as hazardous for types of plastic and
rubber waste. That report by BiPRO investigated how bioavailability of the components that render
a plastic or rubber waste hazardous could be taken into account in classifying such wastes as non-
hazardous (BiPRO, 2015b). The report notes that Article 12(b) of the CLP Regulations prescribes that
“conclusive scientific experimental data show that the substance or mixture is not biologically
available and those data have been ascertained to be adequate and reliable” should be taken into
account when classifying substances or mixtures as hazardous. Although the CLP Regulation defines
the term “biological availability”, a definition or interpretation of the term “not biologically
available” is not provided in the CLP Regulation or in available guidance; a concept of “non-biological

35
UK Government website: Hazardous waste, available at https://www.gov.uk/dispose-hazardous-waste
(accessed on 30 August 2017).

36
Personal communication.

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availability” is required in order to enable a sound evaluation of the biological availability.
Moreover, there appears to be no direct link between Article 12 of the CLP Regulation and the
Waste Framework Directive. Thus, although a low bioavailability of TiO2 in the vast majority of its
wastes (matrices) can be logically assumed, there appears to be no regulatory framework or
guidance on reliably demonstrating “non-biological availability” and using this as justification for
classifying a relevant waste stream as non-hazardous.

Deviations from entries in the LoW and possibilities for exemptions

Variability in approaches to applying the LoW: discussions with experts in the field have revealed
that the approach taken to assigning a LoW code to a specific waste and to its classification as
hazardous or not may vary. The approach described above assumes that first, a LoW code is
assigned based on the nature/origin/generation process of the waste and then the assigned LoW
code dictates whether the waste is hazardous, non-hazardous or it requires evaluation or testing as
to its hazardous properties. If an ‘absolute non-hazardous’ entry is found to be the most relevant,
there is no need to consider the presence or not of TiO2, as a suspected carcinogen, in
concentrations above 1.0% by weight.

However, another approach is possible and may be taken. The producer of waste might first
establish whether the waste is hazardous (for instance, whether it contains more than 1.0% TiO2)
and then seek to identify an appropriate LoW code which best describes the waste and its hazardous
(or not) classification. If the waste is found to be hazardous but would normally be assigned to an
‘absolute non-hazardous’ entry, its producer would need to seek an alternative entry that reflects
the established hazardous properties of the specific waste. Decision 2014/955/EU explains that the
appropriate entry needs to be sought within Chapters 01 to 12 or 17 to 20. If no appropriate waste
code can be found, the Chapters 13, 14 and 15 must be examined to identify the waste. If none of
these waste codes apply, the waste must be identified according to Chapter 16 and if the waste is
not in Chapter 16 either, the 99 code (wastes not otherwise specified) must be used in the section of
the LoW corresponding to the activity identified in step one.

Therefore, for the same waste, depending on circumstances and the approach taken, it may or may
not be classified as hazardous.

Selection between ‘mirror’ entries: it was concluded above that the focus of this impact
assessment needs to be on the ‘mirror entry’ wastes which may be classified as hazardous following
the introduction of the Carc Cat 2 harmonised classification for TiO2. Following discussions with
industry experts, it would appear that the producer of the waste may opt for the non-hazardous
‘mirror entry’ if they hold information to support such classification, including test results. A recent
report by BiPRO notes, “Please note that testing to determine carcinogenicity is neither envisaged for
waste nor for mixtures in the CLP Regulation. Mutagenicity tests (…) are considered in many cases to
be a suitable indicator of potential carcinogenicity” (BiPRO, 2015). Part B of the Annex to the Test
Methods Regulation (COUNCIL REGULATION (EC) No 440/2008) provides the following in-vitro test
methods which may be regarded in the assessment of HP 11 ‘Mutagenic’:

• B.10. Mutagenicity –In Vitro Mammalian Chromosome Aberration Test;

• B.13/14. Mutagenicity: Reverse Mutation Test Using Bacteria;
• B.15. Mutagenicity Testing and Screening for Carcinogenicity Gene Mutation – Saccharomyces
Cerevisiae; and
• B.17. Mutagenicity –In Vitro Mammalian Cell Gene Mutation Test.

It has not been possible to identify any tests relevant to demonstrating that a constituent of waste
can or cannot be inhaled (the critical route of exposure for TiO2). As such, it has not been possible to

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conclude what information producers of waste would need to generate to justify a non-hazardous
classification for a waste containing over 1.0% TiO2 (due to the lack of inhalation exposure to the
substance).

In other words, although the vast majority of TiO2-containing ‘mirror entry’ wastes cannot result in
inhalation exposure to the substance and thus should not be classified as hazardous, formally
demonstrating this might require tests which would increase companies’ costs and administrative
burden.

Possibilities for exemptions from the LoW: derogations from ‘absolute’ entries in the LoW are
possible. A waste assigned with an ‘absolute non-hazardous’ entry is classified as non-hazardous,
without any further assessment of its hazardous properties, i.e. even if it contains TiO2 at a
concentration above 1.0% after the substance received a harmonised classification of Carc Cat 2.
The only exception to this principle is described in Article 7(2) of the Waste Framework Directive,
whereby if the competent authority of the Member State concerned considers that, based on
adequate evidence, a given waste to which an ‘absolute non-hazardous’ code is attributed, is in
reality to be classified as hazardous, the waste in question will be classified as hazardous. This
should be communicated to the European Commission with a view to possible future amendments
of the LoW (BiPRO, 2015). Realistically, given the above discussion on a general lack of risk of
exposure by inhalation, the probability of Article 7(2) being acted upon would be low.

On the other hand, under Article 7(3) of the Waste Framework Directive, where a Member State has
evidence to show that specific waste that appears on the LoW as hazardous waste does not display
any of the properties listed in Annex III of the Directive, it may consider that waste as non-
hazardous. The Member State shall notify the European Commission of any such cases without
delay and shall provide the Commission with the necessary evidence. In the light of notifications
received, the LoW shall be reviewed in order to decide on its adaptation. Therefore, in theory,
industry might petition Member States to invoke Article 7(3) of the Waste Framework Directive and
thus classify such waste as non-hazardous.

However, in practice, little evidence can be found on whether any Member State has followed the
Article 7(3) route. A 2015 report for the European Commission which looked into the
implementation of the Waste Framework Directive over the period 2010-2012 reported the
contributions of 22 Member States of which none had taken the alternate classification option
allowed for by Article 7(3) (Eunomia Research and Consulting et al, 2015). Information on more
recent developments is not available so it cannot be precluded that some Member States have
notified any derogations to the LoW. A recent submission by Cefic to the European Commission37
suggests business operators may indeed approach their national authorities to request derogations
but often these are not accepted by the receiving authorities. Overall, the probability of derogation
under Article 7(3) of the Waste Framework Directive would appear to be low.

Process for periodic review of the LoW: there appears not to be any systematic, established
process for amending the LoW to adapt it to ‘technical progress’. At present, the approach is
dynamic and comes into when the classification of a substance changes under the CLP Regulation
and the presence of the substance in a waste automatically affects the classification of that waste
(see discussion above). Beyond the action that Member States can take under Article 7(2) and 7(3)
(see above), no provision is known to exist that would instigate periodic changes to the LoW.

37
Suggestion of Cefic to the European Commission, dated 6 April 2017, available at
https://ec.europa.eu/info/law/better-regulation/lighten-load/suggestions/S19535_en (accessed on 1
September 2017).

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Transboundary movement of wastes

With a Carc Cat 2 harmonised classification complications over the transboundary movement of
wastes containing TiO2 might be less severe compared to a Carc Cat 1B classification. The Basel
Convention includes waste streams potentially relevant to TiO2:

• Y2-Wastes from the production and preparation of pharmaceutical products;

• Y3-Waste pharmaceuticals, drugs and medicines;
• Y4-Wastes from the production, formulation and use of biocides and phytopharmaceuticals;
• Y12-Wastes from production, formulation and use of inks, dyes, pigments, paints, lacquers,
varnish;
• Y13-Wastes from production, formulation and use of resins, latex, plasticisers, glues/adhesives),

However, relevant wastes may not cause exposure as TiO2 may not be possible to inhale and thus
such wastes might not be subject to the provisions of the Convention. In addition, a Carc Cat 2
classification would not lead to the addition of TiO2 to Annex I of Regulation (EU) No 649/2012 on
export and import of hazardous chemicals (such addition would be a possibility with a Carc Cat 1B
classification). As such, transboundary movement of the substance and its wastes would be unlikely
to be significantly affected.

Supply chain-wide impacts from changes to existing controls on worker exposure to titanium
dioxide

In a previous version of this analysis, the focus had been on the Carc Cat 1B harmonised
classification that was proposed by the French authorities and it had been explained that such a
harmonised classification would trigger compliance requirements under the Carcinogens and
Mutagens Directive. This would have meant that employers would first need to investigate the
possibility of replacing TiO2. If substitution was not possible, measures should be taken to minimise
worker exposure to the substance.

Consultation that had been undertaken at the time had collected valuable information from a wide
range of consultees on the likely cost of implementing different worker exposure control measures;
such measures would range from a simple increase in the frequency of monitoring to the
implementation of completely closed systems for the handling and use of TiO2. The cost of such
measures had been found to range from ca. €1,000 to up to €20 million per company. For
reference, an overview of responses received at the time is provided here as Figure 4–4.

It has also been found that for applications where TiO2 can be used in the form of a slurry to
eliminate exposure to powders and thus eliminate the need for additional measures for certain parts
of the production lines, a higher raw material price would be payable as the price of slurry is €200-
250/tonne higher compared to powder (NB. the previous version of this analysis had provided an
order of magnitude of the change in raw material costs, if slurry could replace 10% of the volume of
TiO2 currently used in Europe – the cost increase across markets would be larger than €200 ×
1,107,000 × 10% = €22 million per year).

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If subject to the same regime as for example SrCrO4, then large investments to come to “zero” exposure… 20000
Complete closed handling of TiO2 15000
LEV, PPE, separate production areas, closed process 5000
Closed storage systems, transport and handling, LEV, PPE, facilities' enclosure 2500
Closed handling of dry TiO2 powder 1000
Closed systems, masks, worker training, new health protocols and monitoring, new specific insurance 1000
Closed system by installing an exhaust system 1000
Local enclosure and exhaust ventilation 750
Installation of special exhaust system to keep workplace clean from TiO2 dust 700
Closed storage systems, transport and handling, LEV, PPE, facilities' enclosure 500
Air extraction and purification 500
LEV, use of closed system, PPE, monitoring, improved waste management 400
Refurbishing existing ventilation system and local exhausts, installing dust filters/equipment 350
Regular monitoring, new ventilation systems, better PPE 300
Industrial filters, positive air pressure, protective masks, dosing through closed system 200
Dedicated dispensing system with a dedicated and filtered extract 150
Dust respirators and extraction; mixing under closed system, addition through powder feed system 130
Ventilation system, personal protection, special storage areas 100
Occupational monitoring, worker training, LEV, filter systems to control air emissions 50
LEV extraction, dust and face masks, PPE 50
Special dust extraction, ventilation, improved storage conditions, worker training 50
Protective clothing or specialised fume hoods 50
Combination of collective protection measures and PPE plus demacation of risk areas, adequate warning and… 50
Inhalation prevention, protective clothes, segregated production flow 40
Additional respiratory protection measures and medical monitoring 35
Dust collection filter 30
Extraction system and personal respiratory protection with P3 filters 25
Review SOP to ensure engineering controls are adequate and implement changes, if required 20
Switch from TIO2 powder to resin dispersions 20
Adjustment of existing local dust collection system, appropriate dust protection masks 17.5
Masks, exhaustion apparatus 15
An automated system for unpacking bags of TiO2 and integrating the substance into the mixture 10
LEV systems and PPE 5
Workstation LEV, mandatory use of masks, worker monitoring 4.5
Additional PPE at the early stages of the manufacturing process 1
Additional monitoring 1
0.001 0.01 0.1 1 10 100 1000 10000 100000
Thousands of Euros

Figure 4–4: TiO2 users’ estimates on the cost of implementing existing worker protection legislation on carcinogens (thousands of Euros)
Source: consultation

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However, under a Carc Cat 2 harmonised classification, the substance would fall outside the scope of
the Carcinogens and Mutagens Directive. Nevertheless, it is understood that TiO2 registrants are in
the process of updating their REACH registration Chemical Safety Report. If this results in lower
Derived No Effect Level (DNEL) values for downstream uses of the substance, the exposure scenarios
in the Safety Data Sheet (SDS) will be updated to reflect those and users of the substance would
need to comply. This might entail the strengthening of worker exposure controls. As shown in
Figure 4–4, replacement/installation of an LEV system, worker training and additional monitoring
might cost between €1,000 and €100,000 per company in Year 1 plus increased operating costs
thereafter. However, such costs would be linked to but could not be attributed to the introduction
of a Carc Cat 2 harmonised classification for TiO2. Irrespective of the developments with the
updating of the REACH registration dossier, some employers might voluntarily wish to further
minimise exposures to TiO2 powder after its classification as a suspected carcinogen.

In addition, the new harmonised classification might result in a tightening of existing Occupational
Exposure Limits (OELs) in EEA Member States (see some examples in Table 4–1). It is understood
that the Scientific Committee on Occupational Exposure Limits (SCOEL) has looked into an OEL for
TiO2 and had reached a preliminary opinion that an OEL of 1–2 mg/m3 would be warranted (based
on the minutes of the 86th SCOEL meeting); this is lower than all national OEL examples shown in the
table. Again, such action would be linked to the harmonised classification for the substance but
could not be assumed to be a direct consequence of it.

Table 4–1: Example national Occupational Exposure Limits for titanium dioxide in Europe
Country Occupational Exposure Limit in mg/m³ Notes
Belgium 10
Denmark 6 Total dust
France 11 Inhalable aerosol
Germany 1.25 Respirable fraction
Ireland 10 Inhalable fraction
Limit is 4 mg/m³ for respirable fraction
Latvia 10
Poland 10
Portugal 10
Spain 10 Inhalable aerosol
Sweden 5 Inhalable aerosol
Switzerland 3 Respirable aerosol
United Kingdom 10 Inhalable fraction
Limit is 4 mg/m³ for respirable fraction
Source: GESTIS (available at http://limitvalue.ifa.dguv.de/, accessed on 18 September 2017) and consultation

Supply chain-wide impacts arising from requirements of the REACH Regulation

A Carc Cat 2 classification would certainly result in a lower regulatory burden under the REACH
Regulation compared to a Carc Cat 1B. The substance would not meet the requirements for being
nominated as a Substance of Very High Concern (and ultimately being subject to REACH
Authorisation, if subsequently prioritised) and the probabilities of a proposal being submitted for a
restriction on its marketing and use would be significantly lower. Yet, Article 31 of the REACH
Regulation on the provision of Safety Data Sheets (SDS) would equally apply.

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Under said article, SDS are to be provided for any substance or mixture that is classified as hazardous
under the CLP Regulation and such SDS are to be provided free of charge (upon request), if a
mixture contains ≥ 0.1% TiO2, although provision of an SDS is not required if the economic operator
offers or sells dangerous substances or mixtures to the general public and provides sufficient
information to enable users to take the necessary measures as regards safety and the protection of
human health and the environment. There is the likelihood that, for mixtures which are currently
not classified as hazardous, the Carc Cat 2 harmonised classification could create an additional
administrative burden and cost in order to prepare the large number of exposure scenarios that
would be needed to cover the multiple applications of TiO2.

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a. Such poorly soluble powders could potentially be subject to a similar proposal for a
harmonised carcinogenicity classification with consequent adverse effects on their
supply chains; and

b. Potential albeit significantly less efficient alternatives to TiO2 are mainly poorly soluble
powders; if they were to be used as substitutes for TiO2 they would not reduce any
(theoretical) risk to human health from the use of TiO2. As such, they would be
unsuitable as substitutes for TiO2 from a risk reduction perspective.

A more extensive analysis of the feasibility and availability of potential alternatives is provided in
Annex 2 (Section 8) to this report.

4.2.3 Impact driver 3: Market developments

A third driver behind the impacts arising from the proposed classification is market developments,
which generally are difficult to predict. An increase of the regulatory burden associated with the use
of TiO2 and, in the case of some downstream applications, the potential restriction on the use of TiO2
under sectoral legislation could prompt many companies to review their product portfolios when
planning for the future. Relocating manufacturing operations outside the EEA where the
carcinogenicity classification for TiO2 would not apply would not become particularly attractive,
especially if TiO2-products would attract the same labelling requirements when placed on the EEA
market irrespective of their country of origin. Whilst a Carc Cat 2 harmonised classification would
disadvantage EEA-based operators vis-à-vis their non-EEA competitors, by comparison to a Carc Cat
1B classification, such adverse effects would be of modest magnitude.

4.2.4 Impact driver 4: Industrial/professional user and consumer

perceptions
A fourth driver would be professional/industrial user and consumer perceptions of the actual
exposure and risk thereof arising from the use of TiO2. As the existing legislation invariably is hazard-
based and does not account for the route of potential exposure or the level of risk, there could be
scope for misinterpretation of the new harmonised classification of the substance:

• Firstly, the link between the classification of TiO2 as a suspected carcinogen and the details of its
scientific basis would be lost. Industrial and professional users who have not followed the
process of the harmonised classification of the substance and certainly the vast majority of
consumers would be unaware of (a) the importance of the exposure route, (b) the fact that the
rat lung tumours only developed under inhalation exposure conditions associated with marked
particle loading of macrophages and (c) TiO2 epidemiology studies which consistently show no
association between occupational exposure to TiO2 and lung cancer mortality;

• Secondly, in the mind of consumers (and probably of many industrial and professional users) the
classification of TiO2 as a suspected carcinogen and the new labelling for carcinogenicity on
widely available consumer products (e.g. DIY paints) would likely be dissociated from the
severity of the hazard classification category (2 vs. 1B) and the importance of the route of
exposure attached to the classification itself. As such, the substance and many products that
contain it would be tarnished as carcinogenic irrespective of whether inhalation is actually
possible across their different applications. Lack of understanding of the refuted scientific basis
of the proposed classification combined with lack of appreciation of the differences between
hazard and risk (and how the latter is influenced by the route of potential exposure) would make

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consumers vulnerable to having their buying decisions influenced by poor science which
overstates the hazard, ignores the risk and potentially relies on generalisations over the
feasibility and suitability of potential alternatives; and

• Thirdly, if the use of TiO2 continued as a result of derogations and exemptions for applications
such as pharmaceuticals, food, cosmetics, etc., consumers would find it perverse that a
substance formally classified as a carcinogen could be present in such products. Again, as a
result of the likely oversimplification of the substance’s hazard profile, consumers might decide
to avoid consuming or using products that contain TiO2 irrespective of the lack of actual
exposure to the substance by inhalation. This uncertainty and confusion might damage the
confidence that both users and consumers have in health protection measures and government
decision-making.

4.2.5 Other impacts

The classification of TiO2 would pave the way to the potential classification of other poorly soluble
particles that could be considered to cause marked loading of alveolar macrophages. Such
classification would lead to another set of indirect impacts which are discussed in Section 0.

4.3 Specific impacts on downstream users of mass applications of

titanium dioxide
4.3.1 Paints and coatings
Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the The majority of paints/shades are of relevance to TiO2’s classification;

application only dark blue and black would not be impacted. All of the
applications for TiO2 have a socio-economic value, as the
paints/coatings/inks industry is essential for the continued activity in
virtually every downstream industry, from wall paints in construction
and public buildings, through corrosion-preventing coatings for metal
(aerospace, cars, bridges, heavy machinery), to high tech coatings for
electronics (mobile phones, laptops) and printing inks for food
packaging and magazines. Thus, if the harmonised classification
were to impact on the use of TiO2, this would affect everyday life for
everyone.

Estimated TiO2 tonnage Based on available information, paints, coatings and inks represent
used ca. 57% of total demand for TiO2. Based on past data on market
shares, we will assume that the split between architectural paints
and coatings, industrial coatings and inks is: 36% : 17% : 4%. This
would translate into a total of ca. 630 ktonnes of TiO2 consumed
which an assumed 400 ktonnes used in architectural paints and
construction products, ca. 190 ktonnes in industrial and functional
coatings and ca. 40 ktonnes in inks.

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Estimated tonnage of Application EEA production
products that contain TiO2 Architectural coatings 3.3 million tonnes/y
Industrial coatings for automotive, aerospace, 2.4 million tonnes/y
marine, etc. uses including coil coatings, can
coatings, road marking paints, flooring coatings
and functional coatings
Construction materials (plasters, caulks, fillers, 0.3 million tonnes/y
mortars)

Estimated value of markets Application EEA market value

Architectural coatings €6.2 billion/y
Industrial coatings €8.2 billion/y
Construction materials €0.55 billion/y

The value of painted/coated/printed/bonded end products equal

many times the actual value of the paint; for instance, for a new car
the paint represents an estimated 2% of the manufacturing costs.
The value of the end industries that depend on paints and coatings is
a high multiple of the value of the paints/coatings (e.g. the value of
the printed material would easily be a 100-fold of the printing ink
value). In the UK for instance, the British Coatings Federation has
estimated that £180 billion of the UK’s GDP (produced by 300,000
employees) is directly dependent on the UK coatings, inks and
wallcoverings industry which itself has a turnover of £3 billion.
Therefore, with a paints/coatings/inks value of ca. €15 billion, the
value of downstream markets could well exceed €750 billion.

Estimates of Gross Value The Gross Value Added for paints, varnishes and printing inks across
Added EU-28 is €5 billion/y.

Number of users of TiO2 The main EU trade association is CEPE. CEPE represents about 800
paint producers (plus 75 ink producers and 20 artist colour producers
across Europe).

Presence of SMEs Significant. It can be estimated that among CEPE’s membership of

paint and ink manufacturers more than 85% are SMEs38.

Number of stakeholders that Several associations and individual companies had submitted
participated in consultation completed questionnaires when the impacts from a Carc cat 1B
classification were being assessed (25-50 companies with a combined
production of ca. 0.6 million tonnes of paints, coatings, inks,
recreation and artists’ colours and stationery products (e.g.
correction fluids) and a combined associated turnover of over €1.1
billion). Through CEPE’s questionnaire response (plus several from
national associations-members of CEPE), the vast majority of the EEA
paints and coatings market has been captured. 7 responses were
received to the questionnaire on Carc Cat 2-related waste issues.

38
This may vary by sub-sector. For coil coatings, for instance, SMEs may represent 33% of members of the
relevant trade association ECCA (European Coil Coating Association).

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Locations of stakeholders Large paint/ink manufacturers are scattered across the EEA but the
that participated in following countries are particularly important: Germany, UK, France,
consultation Italy, Spain, Poland, Finland, Norway, the Netherlands (NB. the last
three countries host specific dominant manufacturers who are key
players across the whole of the EEA).

Employment in the sector 110,000 workers are employed by paint, coating and ink
manufacturers in the EEA. An estimated 15-20% of these would have
regular (daily/weekly) contact with TiO2 and/or TiO2-containing
products. An estimated 1,000,000 workers are involved in the
application of paints/coatings/inks and 30,000 workers39 are
employed in the DIY retail trade.

Relevant legislation

Table 4–2 (overleaf) summarises the relevance of different legislative instruments to the use of TiO2
in paints and coatings after the adoption of a Carc Cat 2 harmonised classification. Additional detail
is available in Annex 1.

Impacts on the marketing and use of titanium dioxide-containing products

Scale of adverse implications of a harmonised carcinogenicity classification

Trade associations and individual companies have estimated that a very large percentage of paints
manufactured in the EEA contain TiO2 in concentrations that typically well exceed 1.0% by weight
and thus would be affected by the proposed classification. More specifically, it is estimated that a
harmonised carcinogenicity classification would affect 80-90% of the product range of EEA-based
paint and coating manufacturers.

Reformulation of paint products so that the concentration of TiO2 could be kept below 1.0% by
weight would not be possible. The substance needs to be present in formulations at much higher
concentrations to deliver its desired functionality. A well-known paint manufacturer has asserted
that when less than about 15-20% TiO2 is present in the formulation, only translucent
paintings/coatings can be formulated.

Replacement of TiO2 by alternative pigments is not possible in the vast majority of products. Other
raw materials (e.g. calcium carbonate, zinc oxide and zinc sulphide, which are widely known white
pigments) typically cannot match TiO2’s performance in terms of stability and opacity, brightness,
gloss and abrasion resistance. Often, replacement substances raise concerns in ecological and
toxicological terms, especially if they contain heavy metals, e.g. lead carbonate. As the carcinogenic
effect in animal testing is not substance-specific but characteristic of dusts and as dust exposure can
be expected also in the processing of potential replacement substances, a substitution of substances
would not change the given situation (VCI, 2016). Annex 2 to this report provides an extensive
analysis of available alternative white pigments and the issues surrounding their technical
performance compared to TiO2.

39
This is an estimate by CEPE but may be an underestimate. For instance, in Greece alone, the Hellenic
Coatings Association estimates that ca. 9,000 workers are employed in the paints retail trade.

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Table 4–2: Relevance of different regulatory instruments and voluntary initiatives to paints and coatings applications of TiO2 following a harmonised classification of Carc
Cat 2 by inhalation
Relevant legislation Type Number Relevant to paints and coatings
CLP Regulation 1272/2008/EC Yes
Carcinogens and Directive 1989/391/EEC No
Mutagens at Work Directive 2004/37/EC
Waste Framework Directive 2008/98/EC Potentially
Regulation 1357/2014
Decision 2000/532/EC
Industrial Emissions Directive 2010/75/EC Potentially
REACH Regulation Annex XVII 1907/2006/EC No
Regulation Annex XIV 1907/2006/EC No
Regulation Article 31 1907/2006/EC Yes
Cosmetics Regulation 1223/2009/EC No
Toy Safety Directive 2009/48/EC Potentially
European Standard EN71-3:2013
Food Contact Materials Regulation 1935/2004 Yes.
Regulation EU/10/2011 For can coatings there is no specific EU wide legislation but reference is made to the Plastics
Plastics in Materials Regulation and CEPE’s Code of Practice
and Articles
Regulation 282/2008/EC
Recycled Plastic
Materials and Articles
Regulation (EC) No 450/2009
Food Additives Regulation 1333/2008/EC No
Directive 94/36/EEC
Regulation 231/2102
Regulation 1831/2003/EC

SEA for TiO2

Economic impacts for manufacturers of paints and coatings

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
paint manufacturers to use TiO2 and place on the market TiO2-containing formulations:

• Hazard labelling and perceptions: under the CLP Regulation, TiO2-based paints would be
accompanied by appropriate hazard labelling including a pictogram, a signal word, a hazard
statement and several precautionary statements. This would alter perceptions of users and
would damage the reputation of TiO2-based paints in terms of their safety, irrespective of the
relevance or not of the hazard classification to the inhalation exposure route. As previously
explained, the labelling requirements for Carc Cat 2 would be very similar to the non-expert
consumer eye to those of Carc Cat 1B. In any case, a GHS 08 pictogram of an ‘exploding person’,
and the terms “Warning” and “Suspected of causing cancer”, even if the inhalation exposure
route was to be specified, would cause alarm among users, particularly among DIY users who
would encounter such labelling on the shelves of their local DIY stores. This would be after
several years of becoming used to purchasing paint products with no hazard labelling following
the movement away from solvent- to water-based formulations. In certain countries in
particular, e.g. France, there is a ban on self-service in DIY stores for potentially carcinogenic
formulations, which could physically prevent consumer access to these products. Clearly, such a
ban would affect paints placed on the French market irrespective of the location of
manufacture.

Even for professional and industrial users, the presence of such labelling could cause
unwillingness to handle and (potentially) be exposed to the pigment and its formulations and
could encourage employers to seek alternative pigments or further improve exposure controls.
The entire DIY market for TiO2-containing paints, worth €3.5 billion per year, would come under
strain while pressure would also develop on the professional and industrial markets, worth an
additional €11.5 billion per year;

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• Ecolabel schemes: TiO2 could no longer be used in paints that hold an ecolabel. Known
ecolabelling schemes, such as the EU Ecolabel, the German Blue Angel and the Nordic Swan, list
CMR properties under their exclusion criteria. A harmonised classification of Carc Cat 2 would
mean that TiO2-containing paints and varnishes would no longer qualify for any of the relevant
ecolabels. By way of an indication of the scale of the impacts, as of September 2016, 4,423
indoor and outdoor paint and varnish products held the EU Ecolabel under 93 licences
(European Commission, 2017) while in January 2017, 350 indoor wall paints and 337 emulsion
paints held the Blue Angel award (Blue Angel, 2017). Companies that have invested in securing
an eco-label of their products would witness a loss of value for those investments;

• Toys: Carc Cat 2 substances are not permitted to be used in toys placed on the EEA market, but
possibilities for exemptions exist based on (a) concentration, (b) (in)accessibility of the
substance. The SCCS would review the use of the substance and would conclude as to whether
it might be appropriate to list it in Appendix A of the Toy Safety Directive (List of CMR substances
and their permitted uses). Notably, for a Carc Cat 2 substance, it will not be necessary to
demonstrate that there are no suitable alternative substances or mixtures available. Therefore,
there is a realistic likelihood that use of TiO2-based paints in toys could be allowed to continue.
However, the continued presence of the substance in toys could cause reputational damage to
the toy manufacturers and thus they may put pressure on paint manufacturers to attempt to
reformulate their products to substitute TiO2;

• Food contact materials: TiO2 appears in List 1 of approved additives under Council of Europe
(CoE) Resolution ResAP(2004)1 on coatings. It is understood however that a Draft CoE/EDQM
General Resolution is in preparation which will (once approved) stay above all existing
Coe/EDQM resolutions and guides; it is expected that this General Resolution would require that
all CMR additives demonstrate zero transfer into foodstuff. It would therefore appear that a
harmonised Carc Cat 2 classification might generate the need to demonstrate zero migration
from coatings so that the use of TiO2 in food contact material coatings could be approved under
national legislation which implements the CoE Resolution. This could ultimately result in the
listing (approval) of TiO2 being reviewed. TiO2 is also present in Annex III (Incomplete List of
Additives) of the CEPE Code of Practice without any limitation on migration or other use
condition; the harmonised classification of TiO2 would not have any immediate impact under the
CEPE Code of Practice, unless EFSA took the decision to review/revoke the authorisation of the
substance. Such a development would them be mirrored under the CEPE Code of Practice. It is
worth noting that some industry consultees have expressed the view that a Carc Cat 2
classification by inhalation would be unlikely to result in an adverse impact on the continued use
of the substance in coatings for food contact materials;

• Global Automotive Declarable Substance List (GADSL): under the GADSL a Carc Car 2 substance
would not be “Prohibited” but would be “Declarable” thus making it less appealing for
automotive manufacturers and less marketable by paint manufacturers; and

• Setting precedence and an example for action by other jurisdictions: similar regulatory action
in other global regions could follow. This would further impact upon exports of EEA-made
products.

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Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification that could increase the
manufacturing costs and thus impact the profitability of EEA-based paint manufacturers, including:

• Cost of paint reformulation to eliminate TiO2: as noted above, reformulation of paint products
so that the concentration of TiO2 could be kept below 1.0% by weight would not be possible,
thus reformulation could only aim at its complete substitution. However, substitution of TiO2 is
technically infeasible with the exception of very small markets for which TiO2’s brightness and
effectiveness are not a priority. Trade associations have advised that, in the past, there have
been issues with reduced TiO2 production capacity resulting in a worldwide shortage of TiO2 and
significant price increase, which caused a notable increase in raw material costs42. This
incentivised paint manufacturers to seek substitutes, but efforts were met by very limited
success. It has thus been confirmed in practice that it is not technically possible to fully match
the overall performance of the reformulated products to the originals based on TiO2. In any
case, reformulation of paint products would be a lengthy and costly process. Consultation has
revealed the following:

− Consumer formulations: it could take between 5 and 10 years to successfully

reformulate and qualify a suitable alternative to TiO2 in architectural (decorative)
coatings, depending on the application and test protocols required. Given that there
are many (thousands) of decorative coatings formulations already on the market, the
cost and time required to reproduce colour formulations and technical specifications
(i.e. testing to try matching the existing colour range, compatibility and stability) would
be vast and, for many SMEs, unachievable, resulting in withdrawal of the smaller
players from the marketplace; and

− Industrial formulations: it could take between 5 and 20 years to successfully

reformulate and qualify a suitable alternative to TiO2 in industrial paints, coatings,
printing inks and adhesives, depending on the application and test protocols required.
Some products (once they have been successfully reformulated) require at least 5 years
of testing and piloting before they can be approved for safe use in e.g. automotive or
aerospace applications, or on infrastructure projects. As above for consumer
formulations, the sheer number of products that would require reformulation would
mean that the time required and the cost involved would be very large and, for many
SMEs, unachievable, resulting in withdrawal of companies from the marketplace. It
would also result in many downstream users of paints, coatings, inks and adhesives,
relocating outside the EEA, as it would still be possible to import finished articles into
Europe.

Among all individual companies that have responded to a questionnaire, only two indicated that
some reformulation of some industrial paint formulations could theoretically be possible. One
of those indicated that reformulation would take longer than two years, while the other
indicated an estimated reformulation cost of €60 million.

42
AkzoNobel provides an indication of what percentage of variable costs is represented by the cost of TiO2
for manufacturers of paints and coatings. In 2015, this was estimated at 7% of raw material costs
(AkzoNobel, 2016). By comparison, all other pigments combined accounted for only 4% of raw material
costs (AkzoNobel, 2013).

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Box 4.2: Case study – The challenges of reformulating coil coatings to eliminate TiO2

The paints used for coil coating are probably among the most sophisticated paints. In the case of coil coating,
the liquid paint must have a rather low viscosity to make it possible to coat wet thickness sometimes below 10
µm and at the same time be curable within 8-20 seconds in hot air ovens (250 °C). The liquid paint is then a
complex mixture that has specific physical properties (rheology) and chemical properties (to have the correct
crosslinking rate in the curing step). Some coil-coating lines use powder coating. In this case, there is also a
difficult compromise between the rather short curing time and the kinetics for melting, flowing and
crosslinking.

Moreover, the coil-coated products are asked to reach a compromise between hardness and flexibility that is
unique in the world of paints. Coil-coated products are bent, stamped, folded, etc. after being painted. The
paint needs to avoid any cracking or loss of adhesion in this machining step, so it must be very flexible.
However, at the same time the surface must resist scratches in the machining process and its appearance
cannot be altered, so it must be very hard. This balance of hardness/flexibility is the result of a very
complicated formulation, even more complicated if you consider that the paint thickness usually cannot
exceed 25 µm.

Because of the balance between flexibility and hardness on the one hand, and the relatively low thickness on
the other, coil coating is such a technically demanding sector that the probability of finding alternative
solutions is quite low. When TiO2 became too expensive and appeared to be unaffordable (after its price
moved from US$2500 to over US$4000 per tonne between 2010 and 2012), major paint companies tried to
replace it in all types of paints, including paints for coil-coating. In some paint applications it was possible to
partly replace TiO2 with some extenders, where it is mainly asked to cover and where there is no requirement
about mechanical properties (for example some latex paints used in DIY as indoor paints). However, in the
case of coil-coating, this is simply not possible: after intensive R&D development, in the very best case some
companies could find lab alternatives to replace only 2-3% of the TiO2 loading, which is rather insignificant.
The main reason for this is that any substitution of the TiO2 makes it necessary to either increase the thickness
of the paint layer or to increase the concentration of the pigment (because no other compound has the same
hiding power and white intensity as TiO2). In both cases (higher thickness or higher pigment concentration),
the balance between flexibility and hardness of the coil-coated product would not be assured anymore and
this compromise is a sine qua non condition for a product to be painted before being machined. A higher
thickness would also have serious consequences on the coil-coating line, because of limitations in the oven’s
capacity (solvent concentration would increase and there would be a flammability concern) and because of
winding problems (tension should be increased to avoid coil-collapsing and this increase would damage the
paint layer).

In summary, in the case of coil-coating, the experts have identified TiO2 as the only option for white
pigmentation and as opacifier from all the known available materials both in terms of technical performance
and from a health, safety and environmental perspective. Hence, there are no known options for
improvement in this respect. If one could imagine that in spite of these technical hurdles some acceptable
alternatives are finally discovered one day, the time needed for becoming able to use these alternatives would
be very long. There are thousands of different products with a technical compromise as described above that
would need to be reformulated and validated through a 2-4 years outdoor exposure. Therefore, the
consequences of the proposed classification for TiO2 for the paint suppliers and for the availability of coil-
coated products on the market would be very significant.

Source: information submitted by the European Coil Coatings Association

• Compliance with waste management regulations: the discussion presented at the beginning of
Section 4 has shown that, irrespective of the relevance of the route of exposure to the
harmonised classification, the management obligations for certain types of waste would change
following the classification of the substance. The following table shows the types of wastes that
might become relevant to hazardous waste management regulations in different Member States
based on seven company responses to a questionnaire. The table identifies the following key
waste stream generated during the manufacture of paints:

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− Empty TiO2 packaging that contains (>1%) residues of the pigment;
− Off-spec paint that contains TiO2 as a component;
− Paint residues left in tanks and machinery during paint production;
− Sludges and cleaning waters;
− Solid wastes arising from filtration (e.g. filters, powders) and other cleaning activities;
− Waste from quality control and lab testing.

Some of this waste is already classified as hazardous due to the presence of hazardous
components, for example organic solvents used in the manufacture of solvent-based paints.
However, this would not necessarily mean that the Carc Cat 2 harmonised classification would
not be accompanied by adverse impacts. A French paint manufacturer has noted that
manufacturing waste which may be classified as hazardous but at a ‘low hazard level’ (i.e. water-
based paint which is non-toxic, non-corrosive, non-carcinogenic) can be disposed of as
hazardous through on-specific routes such as through cement plants or other heavy industries
capable of incinerating such waste. However, when the waste becomes ‘high level’ hazardous
(e.g. it is classified as CMR, toxic to the environment, etc.), those heavy industries do not accept
it anymore and specialist contractors need to be sought for specialist disposal (incineration that
can accept such types of wastes). This increases the costs of waste disposal.

While some other wastes (aqueous sludges) contain less than 1.0% TiO2 and would therefore
remain classified as non-hazardous even after the classification of TiO2 as a suspected
carcinogen, waste streams highlighted in grey colour in Table 4–3 would become hazardous
upon the introduction of the harmonised classification, if they contain more than 1.0% TiO2.
Examples include, (a) TiO2 packaging, (b) waste paint (off-spec and residues), (c) aqueous sludges
with >1.0% TiO2 and (d) filtering/cleaning residues. TiO2 is in an inhalable form only within its
empty packaging (to be classified as 15 01 10* Packaging containing residues of or contaminated
by hazardous substances) and in filtering/cleaning waste, if in powder form.

Process washings are often recycled and/or fully treated before leaving the site, and sub-
standard product is usually reworked into production thus the volumes of hazardous paint waste
would likely be small. However, the arising of hazardous waste would require segregation of
wastes, collection of hazardous waste by a specialised disposal company and a significant
relative increase in the cost of waste treatment.

Few consultees have been able to estimates of the costs involved. One company has suggested
that a change in hazard classification for off-spec paint and dust material from filtering
operations would increase waste management costs by 30%. Another company has estimated
an overall cost of €0.1 million for changing the treatment of waste already classified as
hazardous; this is on the basis of cost of €90-150/tonne for incineration of waste by a heavy
industry installation vs. a cost of ca. €400/tonne for incineration for CMR-classified wastes by a
specialist facility. A third company manufacturing thermoplastic paints has indicated a cost
increase for waste sorting and segregation of €15,000-20,000 per year;

• Increased administrative burden: if a Carc Cat 2 substance is present in a mixture at a

concentration ≥0.1% then a SDS must be available upon request (as per Note 1 under Table 3.6.2
of the CLP Regulation). Manufacturers of these products may receive an increased number of
requests for SDS. Moreover, the number of products that would need to be reported to national
Poison Centres would increase; and

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Table 4–3: Relevant waste streams for the use of TiO2 in paint manufacture
Process generating Type of waste Waste entry in LoW Example volume Is TiO2 Current waste
Typical TiO2 content
waste generated* inhalable? management
Raw material TiO2 packaging (bulk 15 01 06 >1% <0.001 kt/y Yes Non-hazardous.
handling bags, small bags) Mixed packaging ≤1% Landfilling or recycling
(‘absolute non-hazardous’)

Manufacture of paint Off-spec material 08 01 11* 10% 0.1 kt/y No Non-hazardous (e.g.
formulations Waste paint and varnish >1% 0.3-0.5 kt/y water-based paints) or
containing organic solvents or 1-10 kt/y hazardous (e.g. solvent-
other hazardous substances based paints)
(‘mirror hazardous’) Incineration or physical &
08.01.12 chemical treatment (both
Waste paint and varnish other haz/non-haz waste)
than those mentioned in 08 01
11 (‘mirror non-hazardous’)
Paint residues in tanks 08.01.12 1-5% <0.001 kt/y Yes Non-hazardous
and machinery after Waste paint and varnish other (thermoplastic plaint)
production than those mentioned in 08 01 Collected & recycled or in
11 (‘mirror non-hazardous’) very small quantities,
washed into interceptors
08 01 18 1% 1 kt/y No Non-hazardous
Wastes from paint or varnish >1% Physical & chemical
removal other than those treatment
mentioned in 08 01 17 (‘mirror
non-hazardous’)

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Table 4–3: Relevant waste streams for the use of TiO2 in paint manufacture
Process generating Type of waste Waste entry in LoW Example volume Is TiO2 Current waste
Typical TiO2 content
waste generated* inhalable? management
Cleaning water with 08 01 13* 1-20% 0.8 kt/y No Hazardous
liquid paint waste Sludges from paint or varnish >1% 3-4 kt/y Physical and chemical
containing organic solvents or treatment, incineration or
other hazardous substances recycling
(‘mirror hazardous’)
08 01 15*
Aqueous sludges containing
paint or varnish containing
organic solvents or other
hazardous substances (‘mirror
hazardous’)
Aspiration filter 08 01 21* From >1% to almost 0.001-0.005 kt/y Yes Hazardous or non-
residues, absorbent Waste paint or varnish remover 100% TiO2 0-0.5 kt/y (could be hazardous (depending on
materials (powders), (‘absolute hazardous’) damped contents and dust
floor sweepings 16 03 03* down with presence)
Inorganic wastes containing oil from Incineration, Reuse,
hazardous substances (‘mirror the mix Incineration, Physical &
hazardous’) process) chemical treatment
19 01 99
Wastes not otherwise specified
(‘absolute non-hazardous’)

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Table 4–3: Relevant waste streams for the use of TiO2 in paint manufacture
Process generating Type of waste Waste entry in LoW Example volume Is TiO2 Current waste
Typical TiO2 content
waste generated* inhalable? management
Industrial sludges 08 01 13* <1% N/A No Non-hazardous (e.g.
Sludges from paint or varnish (NB. with such a sludges from water-based
containing organic solvents or concentration, a water-- paints) or hazardous (e.g.
other hazardous substances based waste could not sludges from solvent-
(‘mirror hazardous’) be classified as based paints)
08 01 19* hazardous) Physical and chemical
Aqueous suspensions treatment (WB);
containing paint or varnish Blending or mixing prior
containing organic to submission to any of
solvents or other hazardous the operations numbered
substances (‘mirror hazardous’) D1 to D12 (SB)
08 01 20
Aqueous suspensions
containing paint or varnish
other than those mentioned in
08 01 19 (‘mirror non-
hazardous’)
06 05 03
Sludges from on-site effluent
treatment other than those
mentioned in 06 05 02 (‘mirror
non-hazardous’)
19 08 14
Sludges from other treatment
of industrial waste water other
than those mentioned in 19 08
13 (‘mirror non-hazardous’)
Waste thermoplastic 07 02 13 1-10% <0.001 kt/y No Non-hazardous
from laboratory Waste plastic (‘absolute non- Landfilling
testing hazardous’)
* data based on individual responses to questionnaire

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• Impacts on economies of scale: a potential loss of part of the market (mainly due to aversion of
consumers towards alarming labels, symbols and hazard statements) would make the
production of paints overall more expensive and thus EEA-made paint manufacture less
competitive. Companies, particularly smaller ones, might no longer have the production
volumes running through their factories to cover their overheads.

Economic impacts on downstream users (industrial and professional)

Users of paints and other coatings and related products would certainly be impacted too:

• Continued use of TiO2-based paints: downstream use of these products, especially transport,
handling, application and disposal, would have to be revised to reflect the legislative
requirements related to Carc Cat 2-containing mixtures. This would involve additional costs and
resources, and may impose limitations on production rates and capabilities. New equipment
may be required to be installed, new storage systems and disposal procedures would have to be
put in place – waste packaging that contained TiO2-based mixtures could be classed as
hazardous and would need to be disposed of accordingly.

Companies using TiO2-based products may be required by their customers to state that they are
using a product that contains a Carc Cat 2 substance in the production of an article (e.g. a
vehicle). This would potentially not be acceptable to many users further downstream in sectors
that produce finished items, articles or components or, for example, food packaging. Brand
owners are likely to therefore put pressure on the supply chain to replace TiO2. This would also
attract negative publicity and undue attention from the media, NGOs, professional users (e.g.
decorators) and the end consumer, even where the TiO2 inhalation risk is close to zero (labels,
food packaging, adhesives, painted objects, etc.) adding further pressure towards avoiding the
use of TiO2-based products even where the lack of health risk does not warrant such action.

In addition, importers and downstream users of paints newly classified as hazardous due to the
presence of TiO2 in concentrations above 1.0% by weight would need to submit information to
Poison Centres by 2020-2024 depending on the intended use of the mixtures (consumer,
professional or industrial). It must be noted, however, that in some EEA Member States
information on many or all paint products must be submitted anyway, therefore, the specific
impact from a Carc Cat 2 harmonised classification for TiO2 might actually be small;

• Impacts from a switch to alternative pigments: as noted above, alternative pigments with
equivalent technical and economic feasibility are not available. Any attempt to use alternatives
on a large scale would cause severe technical and performance difficulties and would damage
the image of EEA-based paint manufacturers.

At a more basic level, the availability of many of the potential alternatives is far lower than TiO2’s
therefore with the exception of abundant minerals such as calcium carbonate or kaolin, sourcing
the required volumes of pigments could prove challenging and would lead to production
problems and increased raw material costs. Even where reformulation would be practicable,
the results would not be acceptable, for instance:

− The durability of replacement exterior white coatings and other functional coatings
would be worse, so e.g. the finish on aeroplanes and cars would not be acceptable, if no
longer based on TiO2;

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− The number of coats required to achieve a result equivalent to that achievable with
TiO2-containing paints would increase and thus the time and effort required for
application of paints would increase; and
− Inks are applied at low film weights and TiO2 substitutes would not be able to achieve
the same opacity through the current standard printing procedures.

• Compliance with waste management regulations: consultation suggests that labelling waste
paint products as hazardous would affect:

− Wet waste handling at downstream user plants;

− Waste packaging (if not emptied completely);
− Waste documentation (waste transfer notes);
− Waste storage and transport (need to use registered hazardous waste carriers);
− Waste disposal (need to dispose at sites with the correct permits); and
− Waste paint recycling (possible impact on End of Waste permitting, etc.).

The following table summarises information collected from consultation. It confirms that waste
paint (and cleaning waters) and empty packaging would likely be classified as hazardous
following the introduction of the Carc Cat 2 harmonised classification for TiO2. Conversely,
demolition waste would be unlikely to contain more than 1.0% TiO2 thus would remain classified
as non-hazardous (at least as far as the pigment is concerned).

Table 4–4: Relevant waste streams for the use of TiO2 in downstream use and disposal of paints
Process Type of Waste entry in Typical Example
Is TiO2 Current waste
generating waste LoW TiO2 volume
inhalable? management
waste content generated*
Paint Paint 08 01 12 10% 100 kt/y No Non-hazardous
application residues in Waste paint and Incineration or
cans and varnish other landfilling
machinery than those
mentioned in 08
01 11 (‘mirror
non-hazardous’)
Waste 07 02 13 0-10% <0.001 kt/y No Non-hazardous
thermoplastic Waste plastic Landfilling
from (‘absolute non-
contracting hazardous’)
(waste from
cleaning out
boilers of
residual or
surplus
materials,
etc.)
Empty paint 15 01 02 Variable No Non-hazardous
packaging Plastic packaging residues Landfilling /
(‘absolute non- Recycling
hazardous’)

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Table 4–4: Relevant waste streams for the use of TiO2 in downstream use and disposal of paints
Process Type of Waste entry in Typical Example
Is TiO2 Current waste
generating waste LoW TiO2 volume
inhalable? management
waste content generated*
Paint removal Old paint 08 01 18 1-20% No (but Non-hazardous
from sanding Wastes from Yes for Landfilling
paint or varnish paint)
removal other
than those
mentioned in 08
01 17 (‘mirror
non-hazardous’)
Demolition Demolition of 08 01 18 <1% No/Yes Non-hazardous
painted Wastes from Landfilling
buildings paint or varnish
removal other
than those
mentioned in 08
01 17 (‘mirror
non-hazardous’)
17 01 07
Mixtures of
concrete, bricks,
tiles and ceramics
other than those
mentioned in 17
01 06 (‘mirror
non-hazardous’)
Empty paint 17 02 03 Variable No Non-hazardous
packaging Plastic (‘absolute residues Landfilling /
non-hazardous’) Recycling

End of life Cleaning 08 01 11* 1-10% 1 kt/y No Hazardous

disposal water with Waste paint and Landfilling
paint varnish
leftovers containing
(following organic solvents
professional or other
use) hazardous
substances
(‘mirror
hazardous’)
08 01 17*
Wastes from
paint or varnish
removal
containing
organic solvents
or other
hazardous
substances
(‘mirror
hazardous’)
* data from individual responses to questionnaire

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Plastic packaging, including plastic paint buckets, which contain of 1% or more of TiO2 would
become hazardous waste and would now fall under LoW entries 15 01 10* and (if used on
construction sides) under 17 02 04* rather than the entries identified in the table above. As
noted in guidance issued by the European Commission, a specific plastic waste can be hazardous
either because of the additives it contains or because the waste is contaminated with hazardous
substances43.

Recycling of formulations and articles would also be affected. For instance, it has been
suggested that it is very likely that steel and aluminium recyclability would be damaged in the
case of a change of classification of TiO2. Currently, coil-coated products (primary waste,
downgraded products, but also products at the end of their useful life) are recycled either
internally in the case of integrated plants or via scrap processing companies. The flows could
become seriously constrained following the classification of the substance as Carc Cat 2. In
another example, consultation suggests that in Germany alone 62 million plastic paint buckets
(plus 134 million metal coating cans) are recycled each year. This would no longer be possible in
case of a classification since the recycling facilities do not have the necessary permits. The
volumes of such waste across the entire EEA would be even higher.

A particular mention must be made of DIY stores across the EEA. As a matter of principle, the
retailers such as OBI, B&Q, Castorama, Brico, Leroy-Merlin, etc. do not wish to sell products
classified as carcinogenic, and in some cases (e.g. France) are legally obliged to store such products
off the shelves to prevent self-service of consumers. A harmonised classification for TiO2 would
encourage DIY retailers towards removing or scaling down their vast range of TiO2-containing DIY
products from shelves. On the other hand, DIY retailers would face significant challenges in
identifying and stocking replacement paint DIY products of a product range, quality and technical
performance equivalent to TiO2-containing formulations. These two conflicting drivers could cause
significant problems and result in a decline in the footfall in DIY stores and necessitate a switch in
business focus towards the professional rather than the DIY user. This, however, would mean a
significant loss of market, as will be explained below where impacts on consumers’ use of paints,
coatings and painted/coated objects are discussed.

Social impacts

Employment impacts

In the context of impacts on the competitiveness of EEA-based enterprises, under the Carc Cat 2
harmonised classification the focus needs to be on changes to production cost rather than on placing
of products on the EEA market, as the latter would not be under direct regulatory pressure.

More specifically, the legal obligations arising from a Carc Cat 2 classification could have cost
repercussions for the EEA industry both at the paint/coating/ink manufacture level but also
downstream. Increased manufacturing costs would harm the competitiveness of EEA companies vis-
à-vis their non-EEA competitors (as long as other jurisdictions did not follow the EU example on the
hazard classification of TiO2).

Box 4.3: Case study – Loss of TiO2 could mean more than the loss of white paints for EEA manufacturers

Although TiO2 is mainly used as a white pigment, the substance is used in approximately 100% of the order
book of the pre-painted metal manufacturers since this pigment is used not only for the whites but also as a
base pigment (along with black) to which other pigments are added to gain the final colour and obtain the
correct colour saturation. Many of their customers buy a range of colours in pre-painted metal from one
supplier. Even if loss of TiO2 only affected the whiter colours, to remove the most common colour which is
white, would affect not only the cost price of the remaining colours but stimulate the end customers to
buy/import the total package from alternative sources not regulated by European legislation. Without TiO2,
many European coil-coating lines would probably stop because this pigment would still be used out of the EEA
zone and imported as an acceptable final product (a phenomenon already seen with other substances, such as
anticorrosive pigments).

Source: information submitted by the European Coil Coatings Association

Loss of competitiveness among paint/coating/ink manufacturers could result in a variety of

reactions:

• Those EEA-based companies with affiliates or branches outside the EEA might consider
relocating some manufacturing operations where legislation is less stringent and thus
compliance and manufacturing costs are lower or alternatively outsource production; or

• Others with global operations might consider the adoption of variable protection standards
across operations both logistically unwelcome and reputationally risky and thus adopt measures
appropriate to a Carc Cat 2 substance across their global operations.

http://www.makingthelink.net/tools/costs-child-accidents/costs-road-accidents, accessed on 11 October

2016).

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Relocation of the production of DIY and professional architectural paints might not appeal across the
board as it is mainly a regional activity and the end product (e.g. a paint) would still be subject to
regulatory requirements such as labelling when placed on the EEA market; however, more severe
impacts might arise in relation to painted/coated/printed articles and the location of their
manufacture. For obvious reasons, the manufacture of finished articles outside the EEA would
become less costly and burdensome and thus more appealing. Thus, the local supply of raw
materials to manufacture these articles might be preferred on economic and supply security
grounds, so relocation of parts of the supply chain might occur. DIY retail chains might also face
increased competition from non-EEA e-commerce retailers who could supply consumers with TiO2-
based formulations without the customer being visually alerted to a carcinogenic classification label
and thus being less reluctant to purchase DIY paints that contain TiO2.

Impacts on intra-EEA competition

In terms of intra-EEA competition effects, in principle, these could be modest as the Carc Cat 2
harmonised classification would impact the vast majority (estimated at 80-90%) of paint products
placed on the market and effects and thus impacts would arise for the vast majority of paint
manufacturers, retailers and users. However, some market distortion might not be avoided for the
following reasons:

• Some paint manufacturers may have a strong presence in the market for ‘green’ or ‘eco-friendly’
products and thus rely on product differentiation through ecolabelling schemes (for which they
invested significantly to attain). The Carc Cat 2 harmonised classification for TiO2 would take
away this market advantage and could instigate a market turn to less ‘green’ products; and

• Paint manufacturers would consider reformulating their products to avoid the addition of
alarming hazard statements, pictograms and warnings on their packaging, particularly for
products intended for the consumers. Larger companies might have access to larger resources
that would allow then to finance any reformulation work; in comparison, SMEs and specialist
manufacturers might face greater hurdles in reformulating whilst maintaining the quality of their
final products and their competitive position in the market. SMEs, which represent over 85% of
CEPE’s membership of paint and ink manufacturers, might therefore be disproportionately
impacted by the introduction of the Carc Cat 2 harmonised classification for TiO2.

4.3.2 Plastics
Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the The plastics converting area covers a variety of sectors where TiO2
application may be used such as packaging, building and construction,
automotive, electric & electronic, medical, household, leisure,
footwear and clothes. The major sectors are packaging, building and
construction and automotive. TiO2 not only is used in the production
of white masterbatches, it is also used in a wide number of colour
formulations to obtain the desired colour.

60% to 70% of plastics articles end up with the consumer, while

between 30 and 40% of plastics articles end up in sectors such as
infrastructure, commercial and industrial, agriculture, etc.

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Estimated TiO2 tonnage Based on available information, plastics represent 25% of total
used demand for TiO2. In the EEA, this would translate into ca. 275
ktonnes of TiO2. Of this, 165-190 ktonnes will end up in consumer
products with a further 85-110 ktonnes being present in industrial
products (using the percentages shown above).

Estimated tonnage of Application EU production

products whose Plastic packaging (food, pharmaceuticals, other) 15.1 million t/y
functionality depends on Plastics in construction 8.2 million t/y
TiO248 Plastics in automotive 2.9 million t/y
Plastics in E&E 1.4 million t/y
Plastics in agriculture 0.7 million t/y
Plastics for consumer, household, furniture, clothing, footwear 8.2 million t/y
Total converted plastics 36.9 million t/y
Source: EuPC

Estimated value of markets The value of the relevant markets in the EU is described below.

Supply chain EU market value

Plastics conversion €170 billion
All plastics value chain (incl. polymer production and €270 billion
machinery)
All plastics value chain including resin manufacture (not €350 billion
only of TiO2 relevance)

According to PlasticsEurope, the multiplier effect for GDP for the

plastics industry is 2.4 (PlasticsEurope, 2015). Therefore, the overall
value including downstream markets is estimated at ca. €650 billion.

Estimates of Gross Value The GVA of plastics converting in 2013 according to Eurostat was
Added €118.4 billion for EU-28. Its breakdown among EU Member States is
provided below (with Germany, Italy, the UK and France being the
most important partners) (source: EuPC).

48
When EuPC undertook its market analysis, it considered products as functional units, i.e. products that have a
certain function; if the absence of TiO2 would have prevented those products from performing their function,
then those products were assumed to be potentially impacted by a harmonised classification. This applies
specifically to plastic packaging for which the high volume shown in the table not only includes products that
contain TiO2 in the plastic but also all those that are labelled with TiO2-containing labels even if they are
transparent and thus the plastic does not contain TiO2 (e.g. a PET bottle). Without a label there would be no way
of differentiating between products or enabling legible information such as a list of ingredients.

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Plastics converting GVA - Breakdown in EU-28 (total:€118.4 bn)
Rest of EU28
Spain 11%
3% Germany
Denmark
3% Germany Italy
28% United Kingdom
Poland
9%
France
France Poland
12% Italy
19% Denmark
United Kingdom Spain
15%

Number of users of TiO2 The main trade association, European Plastics Converters (EuPC) has
ca. 55,000 members. The breakdown of these enterprises per
Member States is given below (source: EuPC). It is estimated that
almost all companies in the converting sector, mainly SMEs, may be
potentially impacted by the increased regulatory burden associated
with the harmonised classification of TiO2.

Share in % in number of enterprises converting plastics per

country N = 55,000

Italy
16% Italy
Poland

Rest of EU28 Germany

26%
Poland United Kingdom
13%
Romania France
5%
Spain
Czech Republic
Czech Republic
5%
Germany Romania
Spain 12%
7% France United Kingdom Rest of EU28
7% 9%

Presence of SMEs The majority of companies in the sector are SMEs.

Number of stakeholders that Two European trade associations, EuPC and the European PVC
participated in consultation Window Profile and Related Building Products Association (EPPA) and
one national association, VdMi representing the German
masterbatch producers. EuPC incorporates the European
Masterbatchers and Compounders (EuMBC), an association
representing a relatively small number (fewer than 20) of large
masterbatchers who account for more than 70% of the
masterbatches and compounds manufactured in Europe49.

49
The number of EuMBC members represents only a small percentage of the overall number of
masterbatchers in the EU. For example, VdMi alone represents 22 German masterbatch manufacturers.

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In addition, an additional 10-25 individual companies active in the
plastics field (masterbatch formulation, profiles, consumer products)
have submitted completed questionnaires. Individual companies
represent almost 1 million tonnes of TiO2-containing products. In
addition, 3 responses were received to the questionnaire on waste
issues arising from a Carc Cat 2 harmonised classification.

Locations of stakeholders EuPC spans the whole of the EU-28 plastics conversion industry while
that participated in EPPA has members in Austria, Belgium, Denmark, France, Germany,
consultation Poland, Spain and the UK. The individual companies that have
participated have operations in many EU Member States (some
respondents own several plants).

Employment in the sector Plastics conversion in Europe encompasses 1.5 million jobs (of which
25,000 work on the manufacture of profiles). According to
PlasticsEurope the multiplier effect for jobs for the plastics industry is
almost 3 (PlasticsEurope, 2015). Therefore, the overall employment
including downstream markets can be estimated at ca. 4.5 million
jobs.

Relevant legislation

Table 4–5 summarises the legislation that would be of relevance to the use of TiO2 in plastics
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1.

Table 4–5: Relevance of different regulatory instruments and voluntary initiatives to plastic applications
of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant Relevant to plastics
legislation
CLP Yes, for masterbatch & compounds and their use. Not for plastics articles
Carcinogens and No
Mutagens at Work
Waste Framework Potentially.
It depends if there is a mirror entry in the list of waste. If not, then no impact
Industrial Emissions Potentially
REACH Annex XVII: No
Annex XIV: No
Article 31: No
Cosmetics Potentially.
TiO2 is on the positive list of the cosmetics regulation, as a colourant as well as a UV-
stabiliser used in cosmetics packaging. The regulation would have to be reviewed
following a risk assessment
Toy Safety Potentially
Impact not automatic
Food Contact Potentially but unlikely.
Materials TiO2 is authorised in the positive list. TiO2 classification does not cause an impact
immediately. There could be an impact in case EFSA re-evaluates TiO2. However, this
is unlikely since the proposed classification is carcinogen by inhalation, not relevant
for food contact. Reaction by customers may differ however

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Table 4–5: Relevance of different regulatory instruments and voluntary initiatives to plastic applications
of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant Relevant to plastics
legislation
Food Additives No
Medicinal Products No
Construction Potentially
Products
Biocides No
Medical devices No
RoHS Potentially (but less likely than for a Carc Cat 1B classification).
It is relevant but impact not automatic. The list of restricted substances would have
to be updated following a risk assessment
Tobacco additives No – but relevant to fibres applications of TiO2

Other Global Automotive Declarable Substance List (GADSL)

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of plastics

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
plastics manufacturers to use TiO2 and place on the market TiO2-containing articles:

• Hazard labelling and perceptions: hazard labelling requirements would arise for masterbatches
and compounds rather than plastics articles. Hazard labelling would not be relevant to
consumer products or professional users but only to industrial users. Yet, consumer views on
the presence of a suspected carcinogen in plastic products might have an adverse effect on the
market (NB. consumer-related products account for 60-70% of plastics containing TiO2)50. The
end users’ perception of buying products that contain, or are packed or stored in materials that
contain a suspected carcinogen would affect their buying behaviour (for instance, when
considering cosmetics, personal care products, food, food contact, pharmaceuticals). EuPC can
further recount past examples where a change in hazard classification has resulted in
reformulation in the short (additives for use in contact with food) to medium term (phthalate
plasticisers). In the case of TiO2, identifying a feasible alternative is currently impossible (see
discussion further below).

For industrial products, the above concerns would also apply to a certain extent. Classification
as a Carc Cat 2 substance could potentially trigger substitution especially from public
procurement (infrastructure, public building, supplies for public administration) but also from
some commercial sectors (outlets, shopping malls, etc.) but any such effect would be less
pronounced under a Carc Cat 1B harmonised classification. Pressure from customers might lead

50
It is worth noting the linkages between different applications of TiO2, here between plastics, paper and
printing inks. EuPC assumes that the majority of plastic packaging cannot be sold without a label as this
would not be a functional unit. This means also a transparent PET bottle or tray cannot be sold without use
of TiO2 as the packaging will be unable to perform its function. TIO2 pigment is used as a base colour on
the label in order to enable the printed text to be seen. It is the only pigment that allows adequate
legibility. For the time being the assumption is that 95% of packaging would be impacted.

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to the need to reformulate products which would more specifically impose constraints on
production organisation and significant R&D costs as well as the replacement of plastic with
alternative materials (metal, wood, cement, for example).

Masterbatchers and compounders (the majority of which are SMEs) could expect some negative
effects on their business if the Carc Cat 2 harmonised classification was adopted. Again, this
would be driven both by regulatory requirements and customer buying behaviour. TiO2 would
be stigmatised and, thus, even if it legally could be used, there could be a de facto drive towards
its substitution in consumer applications/products;

• Toys: see discussion on potential impacts on TiO2-containing paint use in toys. The continued
use of the substance might be allowed following a positive opinion by the SCCS, but market (and
consumer) perceptions and pressures might lead to efforts to substitute TiO2 in plastics used in
toys;

• Food contact materials: TiO2 is authorised in the positive list for use as a component of plastic
food contact materials and a harmonised classification that would apply to exposure by
inhalation might not have a direct impact on the use of the pigment. However, if consumers
were to be made aware of the presence of the pigment (e.g. via publicity or other campaigns),
they might become more reluctant to use such plastic articles;

• Global Automotive Declarable Substance List (GADSL): as in the case of paints, under the
GADSL a Carc Car 2 substance would not be “Prohibited” but would be “Declarable” thus making
it less appealing for automotive manufacturers and less marketable by plastics manufacturers;
and

• Waste management supply chain: as will be discussed below, the harmonised classification
could have a devastating effect on the recycling of plastic waste (be it building and construction
waste, packaging waste, etc.). This would lead to severe market and economic losses for the
waste value chain in the EEA.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification that could increase the
manufacturing costs and thus impact the profitability of EEA-based plastics manufacturers,
including:

• Cost of reformulation to eliminate TiO2: the unanimous view of the industry is that TiO2 cannot
be reformulated out of plastics in the vast majority of cases. In some limited cases, substitution
of TiO2 might be a practicable solution but would most likely constitute a case of regrettable
substitution. Key implications would be:

− The need to use pigments in much higher loadings than TiO2 in order to achieve the
required whiteness;

Additional additives would need to be included in the formulations, for instance

additional UV absorbers/blockers would be required to replace TiO2 functionality in
supporting the weatherability of the plastic articles; and

− Some alternative pigments may carry their own adverse hazard classifications; any and
all alternatives would have to be used in greater quantities to obtain a similar level of

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whiteness. Furthermore, such substitution would also require other non-colourant
additives to be added. These non-colourant additives would primarily include UV-
blockers.

In order to evaluate possible alternatives already used or evaluated, EuPC prepared a report on
alternatives which incorporates the views of members that responded to a EuPC questionnaire.
The report is reproduced below and whilst is specific to the plastics sector, it can be read in the
wider context of Annex 2 to the present report.

Box 4.4: Comparison of alternatives for TiO2 in the plastics industry by EuPC

The method used by EuPC was a grid questionnaire to evaluate TiO2 as well as the possible alternatives.
Possible alternatives were suggested based on information obtained in literature (Ruszala, et al., 2015; Zweifel,
et al., 2008) and respondents (members) were invited to propose other alternatives.

Respondents were asked to rate these possible alternatives on a Likert scale (1, the worst to 5, the best) for
the following properties: whiteness, food preservation, write-ability, opacity, weatherability, and chemical,
colour and mechanical stability.
The proposed alternatives included in the question were: calcium carbonate (CaCO3, CAS No. 471-34-1); zinc
oxide (ZnO, CAS No. 1314-13-2); different clay minerals: kaolin, talc, perlite, vermiculite, calcined clays and
flash calcined clays; cenospheres; and hollow spheres. Furthermore, a space for other comments was added in
order to give the possibility to the companies to contribute with qualitative remarks.

Sixteen (16) responses to the questionnaire were collected. All of them evaluated TiO2, particularly its
whiteness and colour stability. The results of TiO2 are highly positive for all properties, with all scores above
4.3, and a total average of all properties of 4.6, as shown in Table 4-6.

The most evaluated alternative is calcium carbonate, followed by zinc oxide, kaolin, and talc. On other
alternatives there were insufficient data to make general statements on the appropriateness of the alternative
for the plastic converting sector. Conclusions on the most prominent alternatives are as follows:

• Calcium carbonate: calcium carbonate has an average score of 3.0 which is comparable to other
alternatives, but low compared to TiO2. The whiteness of calcium carbonate is also an issue. One
respondent even suggested not considering calcium carbonate a pigment, but rather a filler additive.
Furthermore, as calcium carbonate is able to react with acid (CaCO3 + 2 H+ → Ca2+ + H2O + CO2), it
might be compromised in outdoor applications, which is reflected in the score of 2.17 for
weatherability;

• Zinc oxide: apart from being a less efficient whitening agent as determined by various scores,
respondents indicated that this substance is also classified as very toxic to aquatic life and very toxic
to aquatic life with long lasting effects51. Thus, substitution of TiO2 by zinc oxide might not be a
suitable option;

• Kaolin and talc: kaolin and talc are clay minerals which are generally considered to be fillers and not
pigments. The loading levels required to obtain similar whiteness as a plastic whitened with TiO2 are
much higher for these substances, which can cause problems in terms of the mechanical properties of
the plastic; and

51
It is notable that this hazard classification is of most relevance to the handling of the pigment rather than
its release from a plastic matrix. When used in plastics or other matrix materials/special mixtures, the
OECD Transformation Dissolution Protocol should be applied (OECD Guidance No. 29). The reduced
solubility of the substance is corrected for in its environmental classification.

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• Titanium dioxide: several companies remarked the fact that TiO2 is the only pigment that gives such
a white colour with stability. Several respondents indicated that to achieve similar properties as
plastics coloured with TiO2, one would need to add other additives with consequent substantial cost
increases for the end product. The same situation would be for UV absorbent properties. One of
them stated that “only TiO2, ZnO and lithopone are white pigments, the other alternatives CaCO3, clay,
talc, kaolin are fillers and do not impart really opacity to a film” and pointed out that TiO2 has good
weatherability. According to another respondent these alternatives are generally fillers developed for
incorporation into the polymer matrix alongside TiO2 in order to reduce cost. Great importance was
given to TiO2 for being a cost effective whitening agent. One respondent described TiO2 as:
“undoubtedly the most efficient and cost-effective material to provide opacity and whiteness to
plastics.” The fact of the need to add higher concentrations to achieve TiO2-like properties was
indicated as well. One respondent explained: “the best of the alternative materials would require four
or five times the concentration to achieve similar levels of opacity and would not approach the
whiteness provided by TiO2.” Some respondents concluded that currently, after having undertaken an
extensive evaluation of alternatives, there are no suitable alternatives to this compound available on
the market.

Even if the technical shortcomings of the alternatives could be disregarded, the cost of
reformulation would be significant. An individual masterbatch manufacturer has noted that
they would need to change 10,000 different formulations, the customers would have to review
their processes and all new products would have to be tested and re-certified. Other
stakeholders have suggested a reformulation cost as high as €4-10 million and a possible
timeframe for reformulation of several years.

− 15 01 10* packaging containing residues of or contaminated by hazardous substances;

• Plastic waste from construction and demolition:

− 17 02 04* Glass, plastic and wood containing or contaminated with hazardous

substances from demolition activities;

• Entries which (can) contain plastic but do not explicitly refer to plastic, such as:

− 17 04 10* cables containing oil, coal tar and other hazardous substances;
− 17 06 03* other insulation materials consisting of or containing hazardous substances;
− 17 09 03* other construction and demolition wastes (including mixed wastes)
containing hazardous substances;

• Plastic waste from waste management operations:

− 19 10 03* fluff-light fraction and dust containing hazardous substances;

− 19 12 11* other wastes (including mixtures of materials) from mechanical treatment of
waste containing hazardous substances;

• Non-specified wastes which may contain plastic, such as:

− 16 02 15* hazardous components removed from discarded equipment.

On the other hand, several relevant waste categories are classified as ‘absolutely non-hazardous’,
including:

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• 02 01 04 Waste plastics (except packaging) from agricultural activities;
• 12 01 05 Plastics shavings and turnings from mechanical treatment of metals and plastics;
• 15 01 02 Plastic packaging;
• 16 01 19 Plastic from End-of-Life Vehicles;
• 17 02 03 Plastic from demolition; and
• 19 12 04 Plastic and rubber from mechanical sorting of waste.

Yet, these entries may well be replaced by hazardous ones. As discussed in Section 4.2.1, based on
draft guidance by the European Commission (dated 2015) the presence of a hazardous additive (in
this case TiO2 at concentrations above 1.0% by weight) could render specific plastic wastes as
hazardous. Such a change in hazard classification could have serious impacts on the recycling of
plastic waste. According to estimates available to EuPC52, between 600 and 700 ktonnes of plastics
from long life applications (construction, automotive, electric and electronic, excluding packaging)
are recycled. Over time, recycling may increase to, at least, 1,000 ktonnes/y. All of those streams
could be potentially affected since it is not feasible to segregate materials containing TiO2 (the large
majority) from others. For TiO2 used in packaging, due to their short lifecycle, the TiO2 will remain in
the packaging recycling stream for a short time once replaced by an alternative (except for longer
life packaging such as crates and pallets (which represent ca. 250 ktonnes/year). Knowing that the
margins of recyclers are typically low, any cost increase in the waste value chain, be it
administration/certification/validation or additional treatment operation etc., will place the
recyclers under pressure. As a consequence, any TiO2-containing plastic waste management
operation would come under risk.

Impacts on recycling could extend beyond recycling of post-consumer waste and also affect plastic
manufacturers as some of them may source 3rd party plastic scrap which they feed into their
manufacturing process as recyclate.

Social impacts

Employment impacts

Estimating employment impact without clarity on what economic and market impacts would arise is
difficult. Pressure from the supply chain to reformulate and increased regulatory burden at the
manufacturing step would put pressure on employment levels. Given the very large number of
workers in the sector, even a small percentage effect would result in a large number of job losses
(loss of 1% of EEA-based jobs would mean redundancy for 15,000 workers).

Impacts on the welfare of consumers

The proposed classification for TiO2 could have significant impacts on consumer choice and welfare.
The following impacts should be noted:

• Loss of certain types of consumer products from the market: a major impact on brands and
their ability to commercialise their products could be expected as a result of the business cost
and negative perceptions associated with a carcinogenicity hazard classification for a key
additive of many plastic articles;

• Loss of performance: if TiO2 were to be substituted, the durability of all materials exposed to
light in long life applications (windows, gutters, furniture, automotive interiors) would be

52
Based on a 2012 report by Consultic.

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significantly reduced. Alternative materials (such as wooden windows) would require periodic
re-painting; however, durable exterior architectural paints typically contain TiO2. Such
maintenance would therefore not be possible to be undertaken by members of the public. In
addition, if certain plastic packaging solutions for food or agricultural feedstock lost their
capability of protecting the goods from decomposition by radiation, spoilage might occur faster
and the quality of packed goods might be affected. Worsening of the physicochemical
characteristics of the polymeric matrices used, could in some cases result in a push towards the
use of more expensive polymers for the same application;

• Loss of consumer satisfaction: loss or marginalisation of TiO2 over negative perception and
consumer pressure would mean loss of design capability (dull, unstable colours); and

• Adverse impacts on public health: loss of TiO2 would make it very difficult to display
information important to the consumer (e.g. food ingredients, safety). TiO2 is the only
opacifying agent for plastic containers recognised by the European Pharmacopoeia’s Section 3.1.
Its presence is necessary for the absorption of UV radiation and thus the protection of the shelf-
life of a large number of light-sensitive pharmaceuticals. Similarly, TiO2 supports longer shelf-
lives for foodstuffs and cosmetics when used in packaging materials.

On the other hand, plastic waste streams within municipal waste (20 01 39 Plastics) are an ‘absolute
non-hazardous’ category and its management would not be directly impacted, although the
presence of a suspected carcinogen could have an impact on the recycling of such waste

Competitiveness and competition impacts

The increase in manufacturing costs and the supply chain pressure towards avoidance of TiO2 could
cause loss of turnover and worsening of the quality/performance of EEA-made plastic products.
Therefore, EEA-based plastics converters would be disadvantaged vis-à-vis their non-EEA
competitors who could import cheaper to make, better quality TiO2-containing articles into the EEA
which would bear no label indicating the presence of a suspected carcinogen.

The TiO2 business is a very global one; raw materials are easily sourced on the global market because
of the quantities involved (the savings on cheaper raw materials exceed the transportation costs).
Similarly, for the rest of the value chain, from powder to intermediate articles, it is reasonable to
expect that non-EEA players could obtain a competitive advantage to offer items such as films,
sheets, extruded parts, etc. to finished article producers. Over time, under the constant pressure of
market needs, a shift of the value chain to outside of EEA might be expected, for reasons of
proximity and integration with suppliers of masterbatches and other preparations based on TiO2.

Within the EEA, the plastics industry might lose some of the performance advantage it has versus
the manufacturers of alternative products (e.g. wooden window frames). An increased regulatory
burden could also drive consolidation in the industry, leading to less competition and SMEs would be
most vulnerable in the face of such a trend.

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4.3.3 Paper
Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the There are three key areas for TiO2 applications in the paper sector:
application
• Décor paper for laminate flooring and furniture and laminates
for packaging;
• Wallpapers; and
• Unlaminated paper for packaging and printing/writing.

The importance of TiO2 would appear to be higher for the first two
areas, although specific areas of packaging and printing also show a
dependence on the unique physicochemical properties of TiO2.

Estimated TiO2 tonnage It is estimated that the paper sector accounts for 12% of TiO2
used consumption. This would be equivalent to ca. 130 ktonnes/y. Based
on data available to Cefic (for the year 2013), laminates are the most
prominent area of use and accounts for ca. 80% of total paper
consumption, i.e. ca. 105 ktonnes/y.

Estimated tonnage of Application EEA production

products that contain TiO2 Paper laminates (data for respondents only) 250-500 ktonnes/y
Wallcoverings 244 ktonnes/y
Packaging and printing/writing paper (data for 40-50 ktonnes/y
respondents only)
NB. data are incomplete. CEPI statistics indicate the production of 35
million tonnes of graphic papers, 44.5 million tonnes of packaging papers
and 3.9 million tonnes of other papers in Europe (CEPI, 2016)

Estimated value of markets Application EEA market value

Paper laminates (data for respondents only) €500-750 million/y
Wallcoverings (IGI membership) €1.2 billion/y
Packaging and printing/writing paper (data for €25-50 million/y
respondents only)
NB. data are incomplete. A calculation can be made on the value of
laminated board:
- Average value of décor paper in laminate: €0.30/m² coated board
- Value of laminate: €5-15/m² of coated board
- Volume of laminated board consumed in Eurozone: 3 billion m²
- As both sides of board are coated 1.5×109 m2 × €10/m² = €15 billion

Estimates of Gross Value Information on the specific applications of concern is not available.
Added The entire paper industry in Europe has a turnover of €75 billion with
a value added of €15 billion, according to CEPI53. If the same % of
value added (20% = 15 ÷ 75) were to be used, the value added of the

53
Data available at: http://www.cepi.org/system/files/public/static-pages/CEPI_in_brief_infographic.jpg
(accessed on 13 October 2016).

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wallcoverings industry would be €0.24 billion and for the laminated
paper products €0.1-0.15 billion.

A 2011 report estimated that for every €1 of turnover made by pulp,

paper and board mills, €1.05 was being made upstream and €2.88
was being made downstream (Poyry, 2011). It is uncertain whether
the same ratios would apply for the products of interest here.

Number of users of TiO2 The number of users is uncertain. 54 EU-based wallcovering

manufacturers are members of the IGI trade association. CEPI, the
Confederation of European Paper Industries indicates that there are
515 pulp, paper and board producing companies in the EU54.

Presence of SMEs In the wider paper sector there is a large number of SMEs, however,
several are part of or owned by large enterprises. Within the
wallcoverings sector, the majority of companies are SMEs, but for
laminates, SMEs might be in the minority.

Number of stakeholders that 10-25 companies and <5 trade associations have submitted
participated in consultation completed questionnaires. In addition, only 1 response was received
to the questionnaire on waste issues arising from a Carc Cat 2
harmonised classification.

Locations of stakeholders Germany, Sweden and the UK are the countries where most
that participated in stakeholders who made a contribution are located in. With regard to
consultation laminate production, France, Germany, and Spain appear to be
important contributors to EEA production. Among wallcovering
producers Germany, the UK, the Netherlands and Italy host the
largest number of companies.

Employment in the sector According to a 2011 report (using data for the year 2008), the level of
employment in the pulp, paper and board industry in Europe was ca.
208,000 (Poyry, 2011). In the same year, the number of employees
upstream was estimated at 337,300 and downstream at 1,051,700.

Relevant legislation

Table 4–8 summarises the legislation that would be of relevance to the use of TiO2 in plastics
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1.

Table 4–8: Relevance of different regulatory instruments and voluntary initiatives to paper applications of
TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to paper
CLP Yes
Carcinogens and No
Mutagens at Work
Waste Framework Potentially

54
Data available at: http://www.cepi.org/node/20504 (accessed on 13 October 2016).

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Table 4–8: Relevance of different regulatory instruments and voluntary initiatives to paper applications of
TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to paper
Industrial Emissions Potentially
REACH Annex XVII: No
Annex XIV: No
Article 31: No
Cosmetics No
Toy Safety Potentially
Food Contact Materials Yes
Food Additives No
Medicinal Products No
Construction Products Potentially
Biocides No
Medical devices No
RoHS Potentially (but unlikely)
Self-adhesive labels may be used in packaging of electronic devices and they may
also be attached directly to the devices. Customers require that the paper has to
meet the demands of RoHS concerning restricted substances
Tobacco additives Yes – TiO2 may be used in cigarette paper

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of paints and coatings

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
paper manufacturers to use TiO2 and place on the market TiO2-containing articles:

• Hazard labelling and perceptions: the hazard labelling requirements of the CLP Regulation
would not apply to the final paper articles. Still, customers and consumers may be confused
about the implications of the carcinogenicity classification of TiO2 and develop a negative
perception on the products that contain it, even if the TiO2 in the final product is within a matrix
and it is not volatile or directly accessible. Customers (paper users) may not wish to handle
products that contain a carcinogen. In addition, decorative (also known as décor) paper is used
to manufacture articles that are present in consumers’ daily lives such as flooring, furniture,
doors, walls, facades and the widespread presence of a hazardous substance in bedrooms, living
rooms, kitchens, workplaces could have an adverse impact on the décor paper industry as well
as the ready-to-assemble furniture and flooring sector. Similar effects could be envisaged with
other consumer-facing applications such as paper for food packaging paper;

• Toys: see discussion above on paints and plastics. Market perceptions and pressures might
have a bearing on whether paper manufacturers consider substitution of TiO2;

• Food contact materials: the relevant CoE Resolutions on paper/board and inks list TiO2 as an
approved additive (NB. paper that is used in food contact articles but that is separated from the
food by a functional barrier is outside the scope of the paper/board Resolution). A Carc Cat 2
harmonised classification for the substance could lead to the review of its listing and its potential
removal; and

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• Setting precedence and an example for action by other jurisdictions: similar regulatory action
in other global regions could follow. This would further impact upon exports of EEA-made
products.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based paper manufacturers, including:

• Cost of reformulation to eliminate TiO2: given the typical concentrations of TiO2 in paper
formulations, a concentration of TiO2 as low as 1.0% by weight would not confer the desired
properties to the end products. For products where aesthetics, durability, wet opacity control
and light-weightness are important, namely laminates and wallcoverings, there are no feasible
alternatives that could be used to replace TiO2. TiO2’s high refractive index cannot be matched
by other pigments. Zinc sulphide might come close but it has to be added at higher loadings,
around 20-50% higher. There may be limited opportunities for partly replacing TiO2 with some
spherical plastic pigments which could contribute to a certain extent to shade and opacity, but
this would only be limited to some final applications, due to conversion conditions and final
product requirements55. As a result, estimates for the cost of reformulation cannot be provided
with confidence, although a figure of €0.4 million per company has been suggested in the field
of wallcoverings. In any case, lengthy trials would be required for any alternative to be tested.
Estimates for the length of such efforts range between 2 and 5 years without a guarantee of
success.

On the other hand, some current users of TiO2 have noted that in some limited cases, where
performance requirements are low, TiO2’s use may not be critical and could be replaced either in
part (for instance, by a composite pigment of calcium carbonate and TiO2 (but this too contains
TiO2)) or potentially in full (by aluminosilicate and magnesium aluminosilicate or higher loadings
of calcined clay and precipitated calcium carbonate). Talc and chalk might also be considered in
printing paper where opacity requirements are low, but these cannot really be considered
feasible alternatives for TiO2, as the latter is a relatively costly additive that is generally reserved
for paper grades that have a high opacity requirement. Again, reformulation would be
accompanied by considerable cost; and

• Compliance with waste management regulations: wastes relevant to paper manufacture are
listed on LoW under Chapter 3 (Wastes from wood processing and the production of panels and
furniture, pulp, paper and cardboard) and specifically under sub-chapter 03 03 Wastes from
pulp, paper and cardboard production and processing. All types of waste listed there are
‘absolute non-hazardous’ entries. A single questionnaire response received identifies two waste
streams of relevance with a TiO2 content potentially above 1.0%:

− Sludges with calcium carbonate (03 03 09 lime mud waste); and

− Fibre waste (03 03 10 fibre rejects, fibre-, filler- and coating-sludges from mechanical
separation).

55
Conversion of laminate paper and covering of wooden panels requires several process steps such as
printing, impregnating and pressing.

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These are currently classified as non-hazardous and would probably remain classified as non-
hazardous even after the introduction of the Carc Cat 2 harmonised classification for TiO2. In
both waste streams, TiO2 is not present in an inhalable form.

However, it is possible that the presence of a suspected carcinogen in concentrations above

1.0% might affect the management of these waste streams. TiO2-containing waste paper (broke
or paper “crumble”) may currently be directed to land spreading or energy recovery in an
incinerator. If the disposal of this TiO2-containing waste along these routes becomes less
attractive:

− Its handling and disposal would become costlier (NB. sludge and waste paper are
generated in volumes of thousands of tonnes each year); and
− Waste paper feedstock for incinerators would need to be replaced by fossil fuel thus
increasing the operating costs of the recipient incinerators.

Some paper manufacturers might wish to separate TiO2-containing sludge from water
purification from other waste streams. This is usually not possible due to mixing with other
production sludge (without TiO2) in a long water treatment plant circuit. If this were to become
possible with the intention of ceasing the recycling of TiO2-containing sludge, the cost increase
associated with the disposal of the waste (e.g. by incineration) would be very significant (one
paper manufacturer estimates the increase at the level of €200/tonne of sludge this increasing
waste management costs by €2-3 million/year).

Economic impacts on downstream users (industrial and professional)

The above discussion on impacts covers adequately the entirety of the supply chain for paper with
the exception of consumers (discussed further below) but also the management of end of life paper
waste. The Carc Cat 2 harmonised classification could have an impact on the management of some
paper waste, for example, 15 01 10* packaging containing residues of or contaminated by hazardous
substances.

19 12 01 Paper and cardboard from mechanical sorting of waste is classified as ‘absolutely non-
hazardous’ and would in theory remain unaffected; however, in practice since the paper/board may
contain TiO2, its recycling may become less attractive as there could be a risk of dust release during
the recycling process. Consequently, paper/board that contains TiO2 could become an unwanted
grade in the recycling system.

Social impacts

Employment impacts

Employment impacts may vary depending on whether TiO2-based products are critical to any one
company or not. The Global Wallcoverings Association (IGI) has suggested that all 26,000 jobs in the
sector would be at risk following the adoption of a Carc Cat 1B classification. Among the individual
companies that have made an input to the analysis of impacts from a Carc Cat 1B hazard
classification, the vast majority noted that jobs would be lost but that the scale of losses would
vary56. It would be likely that a Carc Cat 2 harmonised classification would have a less pronounced
impact.

56
The total employment of the respondents is ca. 3,600 workers of which at least 1,270 would likely lose
their jobs.

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Impacts downstream should also be taken into account, even though they cannot be quantified. A
Carc Cat 2 harmonised classification for TiO2 could affect the whole supply chain in the laminate
industry, including the décor paper producer, the laminate décor printer, the laminating companies,
as well as the wood based industry (furniture and flooring as well as wood board and panel
producers, since the demand for their products would decline).

Impacts on the welfare of consumers

A harmonised classification for TiO2, either Carc cat 1B or Carc Cat 2, could have notable impacts on
consumer choice and welfare. The following impacts should be noted:

• Loss of certain types of consumer products from the market: some consumer products would
become costlier to manufacture in the EEA with an impact on their competitiveness and
therefore their production may be affected, scaled back, relocated outside the EEA or
discontinued. Relevant products include wallcoverings with adequate opacity and lightfastness,
a variety of paper-based packaging and laminated products (flooring, furniture, etc.).
Wallcoverings are primarily sold on design and colour to make the products aesthetically
pleasing to the eye. White inks and coatings are used and manufacturers also blend white with
other colours to change the opacity levels to create pastel shades and increase the colour
gamut. Any effort to substitute TiO2 would reduce the product options available to the
consumer and would make products duller and unexciting;

• Increased cost and loss of performance: the use of alternatives in the place of TiO2 would
certainly increase production costs and impact upon the performance of paper products.
Surface treatment using décor paper, especially wood-based board product, delivers a high
performance, low cost, resistant and easily maintained surface at a very competitive cost.
Alternative surfaces are generally either less resistant or significantly more expensive
(paint/lacquers or veneer). Solid wood furniture requires the use of comparatively much more
wood and also more expensive wood to manufacture one unit of furniture or flooring. The
combination of low cost and high performance provides the consumers with an affordable, high
quality product.

Wallcoverings that do not contain TiO2 would be less durable to weathering, available in a
narrower variety of colours and would need to be replaced more frequently; and

• Loss of consumer satisfaction: TiO2-based products would suffer a loss of consumer confidence
with TiO2-free products, such as wallcoverings, offering poorer visual effects leading to a poorer
home and office environment. Paper-based articles such as diaries, bibles, etc. would become
bulkier with more ‘show through’ from page to page.

Notably, paper and cardboard waste (20 01 01 Paper and cardboard) generated as part of municipal
solid waste is an ‘absolute non-hazardous’ entry and should not be impacted by the Carc Cat 2
harmonised classification. However, the presence of a suspected carcinogen in consumer products
could have an indirect adverse effect on the levels of recycling of such waste.

Competitiveness impacts

Non-EEA products would not face the administrative and cost burden of the regulatory obligations
triggered by a Carc Cat 2 harmonised classification for TiO2 and thus non-EEA paper products that
contain TiO2 could become more competitive and would also be of better quality, if EEA-based
manufacturers attempted to substitute the pigment. In addition, paper and board produced within
the EEA are sold globally, both intermediate paper/board as well as converted products. An increase

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in operating costs would make the products exported from the EEA less competitive. For bulk
producers (e.g. DIY wallcoverings or laminates) price sensitivity is key and the proposed classification
could severely harm competitiveness.

Relocation (outsourcing) of activities outside the EEA could be a possibility, at least for certain
production steps (e.g. manufacturing of paper) and where companies already have facilities
established. However, such a step is not to be taken lightly and it is very doubtful that a harmonised
classification for TiO2 could instigate such a move. If relocation were to be considered, ancillary
industries would also be affected, for example, the wooden substrates industry (furniture and
flooring) would be affected as access to covering material would become more difficult.

4.3.4 Inks, toners, recreation colours and stationery products

Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the See discussion above on paints and coatings which are products
application closely related to printing inks. About 50% of screen and pad inks are
white, of which about 95% is manufactured using TiO2. Toner and
materials relevant to digital printing are similarly important to
everyday life, primarily in a business/office environment, but also for
consumers at home.

Estimated TiO2 tonnage As noted above, we assume that printing inks (but not digital printing
used inks, i.e. toner) account for ca. 4% of total TiO2 consumption, i.e. ca.
40 ktonnes/y. The consumption of TiO2 in toner is considerably
lower at a range of 30-150 t/y or more (toner contains 1-5% TiO2).

Estimated tonnage of Application EEA production

products that contain TiO2 Printing inks 0.6 million tonnes/y
Toner Unknown
The total quantity placed on the EEA market is
>3,000 tonnes/y
Artists, recreation and Unknown
school colours >1,000 tonnes/y based on consultation results
Stationery and Unknown
correction fluids >20,000 t/y based on consultation results
Members of the I&P Europe Association also place on the market:
- A small tonnage of industrial coatings (imported from outside the EEA);
- Paper for printing and writing;
- Special camera film (containing TiO2 as a whitener); and
- Plastic foils, special films and security cards

Estimated value of markets Application EEA market value

Printing inks €2.1 billion/y
Toner >€1 billion/y
Artists, recreation and Unknown
school colours >€0.1 billion/y based on consultation results
Stationery and correction Unknown
fluids >0.1 billion t/y based on consultation results

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As regards printing inks, the value of the printed material would
easily be 100-fold of the printing ink value, i.e. over €200 billion/y.

The market for toner-related products is also much larger and needs
to include electronic equipment that relies on the toner, i.e. printers
and copiers. Its value is estimated at over €10 billion/y.

Estimates of Gross Value The GVA of the EU paints, coatings and printing inks has been
Added provided above (€5 billion/y).

Number of users of TiO2 There are ca. 75 ink producers (members of the European Printing
Inks Association) and 20 artist colour producers across Europe. In
addition, there are at least 58 members of the European Writing
Instrument Manufacturers Association who use TiO2. Europe
Imaging & Printing Association (I&P Europe) has 32 member
companies.

Presence of SMEs As noted earlier, among CEPE’s membership of paint and ink
manufacturers more than 85% are SMEs. EWIMA also confirmed this
percentage noting that in the writing instruments industry most
companies are family-owned SMEs.

Number of stakeholders that 10-25 organisations, including trade associations. In addition, 5

participated in consultation responses were received to the questionnaire on waste issues arising
from a Carc Cat 2 harmonised classification.

Locations of stakeholders The key trade associations have members across the EEA. Individual
that participated in respondents are based in Austria, Denmark, France, Germany, Italy,
consultation the Netherlands, Spain, Sweden and the UK.

Employment in the sector As noted above, 110,000 workers are employed by paint, coating and
ink manufacturers in the EEA. Printing inks that contain TiO2 are in
use in the segment of printed packaging and are applied in small and
large print-shops. The employment in this segment of the graphic
industry in EEA is estimated at 50,000.

Relevant legislation

Table 4–9 (summarises the relevance of different legislative instruments to the use of TiO2 in
printing inks, toner and associated products after the adoption of a Carc Cat 2 harmonised
classification. Additional detail is available in Annex 1.

Table 4–9: Relevance of different regulatory instruments and voluntary initiatives to printing inks and
toner applications of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to inks
CLP Yes
Carcinogens and No
Mutagens at Work
Waste Framework Potentially
Industrial Emissions Potentially

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Table 4–9: Relevance of different regulatory instruments and voluntary initiatives to printing inks and
toner applications of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to inks
REACH Annex XVII: No
Annex XIV: No
Article 31: Yes
Cosmetics Yes.
For instance, relevant to cosmetic pencils, “tattoo stickers” or nappies
Toy Safety Potentially.
Might no longer be allowed to be printed with white or high-covering inks
(exemptions are a possibility)
Food Contact Materials Potentially, and depending on national rules on the use of CMR substances in
printing inks (CoE Resolution)
Food Additives No
Medicinal Products No
Construction Products No
Biocides No
Medical devices No
RoHS Potentially (but less likely than for Carc Cat 1B).
It is relevant but impact not automatic. The list of restricted substances would
have to be updated following a risk assessment
Tobacco additives Yes – TiO2 may be used in tipping inks (filter paper)
Ecolabelling scheme provisions (see Section 7.2.7).
Other NB. The EuPIA (European Printing Ink Association) Exclusion Policy would not
apply (see Section 7.2.4)

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of paints and coatings

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
inks, toner and recreation colours manufacturers to use TiO2 and place on the market TiO2-
containing formulations and articles:

• Hazard labelling and perceptions: the analysis presented above on the impact of the new
hazard labelling on consumer and industrial/professional user perceptions would apply here too
and perhaps impacts might be even more pronounced because (a) several of the products
referred to in this section are used by children and (b) some products may be in the form of
powders or generate dust which could heighten the concerns of users, thus leading to aversion
to using TiO2-containing products. For instance, in the case of toners, any dust seen on or
around the printer (from whatever source) would be seen as potentially containing TiO2 and so
be perceived as carcinogenic;

• Toys: see earlier discussion on paints. It is worth noting that TiO2 is present in significant
concentrations in many products such as painting materials which are sold to children, even very
young infants, and in some cases inhalation exposure to these products cannot be excluded. As
such, irrespective of whether the SCCS might issue an opinion allowing the listing of the
substance on Appendix A to Annex II (permitted uses of CMR substances), there will be

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significant market and consumer pressure towards the substitution of a suspected carcinogen in
such toy products;

• Cosmetics: some pencil manufacturers may also produce cosmetic pencils (e.g. lipliners and
eyeliners) and printing inks may be used in applications such as “tattoo stickers”. The cosmetic
industry asks the packaging manufacturer to comply with the Cosmetic Products Regulation, and
the packaging manufacturer/printer, to cover himself, asks the ink manufacturer to comply with
the Cosmetic Products Regulation, so to not use prohibited substances listed in Annex II of the
Regulation. The Carc Cat 2 harmonised classification for TiO2 would have impacts similar to
those for toys, i.e. a SCCS would be required (without a requirement to demonstrate the
unavailability of feasible alternatives) which may result in the substance being approved (or not)
for use in cosmetics. Still, market and consumer perceptions and pressures might lead to
attempts at substitution even if SCCS delivers a favourable opinion;

• Printing inks and food contact materials: whilst Carc Cat 2 substances fall outside the scope of
the EuPIA Exclusion Policy on printing inks (see Section 7.2.4), a specific CoE Resolution
(Resolution ResAP (2005)2 on “Packaging Inks Applied to the Non-Food Contact Surface of Food
Packaging” makes specific referenced to CMR 1A/1B/2 classifications falling within the exclusion
criteria listed in the accompanying Technical Document 1. As such, implementation of the
Resolution would mean that inks classified as Carc Cat 2 could no longer be used for non-food
contact on food packaging. CoE Resolutions are not legally binding, but are considered as
statements of policy for national policy makers of the Partial Agreement member states57. In
any case, the potential reputational damage from allowing the presence of a suspected
carcinogen in products available on the consumer market would encourage ink manufacturers to
aim to substitute the substance anyway; and

• Setting precedence and an example for action by other jurisdictions: similar regulatory action
in other global regions could follow. This would further impact upon exports of EEA-made
products.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based ink/toner/colour manufacturers,
including:

• Cost of reformulation to eliminate TiO2: information available from consultation shows a mixed
picture over the perceived ability of TiO2 users to reformulate their products in order to remove
TiO2:

− Consumer ink formulations: reformulation of consumer inks and associated products is

generally infeasible and this is particularly the case for the white inks used in flexible
packaging where alternative pigments with acceptable performance are not available.
One company who made an input to consultation particular has recounted past
research on alternatives (such as barium sulphate, lithopone, chalk) which has
confirmed that only TiO2 can deliver the quality required. Yet, if lower quality products
were to be acceptable, reformulation might be considered but would be distinctly
disadvantageous on economic grounds. The estimated costs of reformulation range

Similar to paints, importers and downstream users placing on the market mixtures that would be
newly classified as hazardous due to the presence of TiO2 in concentrations exceeding 1.0% by
weight would be required to submit information to Poison Centres by 2020-2024, depending on the
intended uses of their mixtures.

Finally, in relation to waste, implications on the handling of waste ink and printing toner would arise.

Social impacts

Employment impacts

Note that the discussion above on employment impacts on the paints sector incorporates ink
manufacturers. In comparison to a Carc Cat 1B classification, certain direct restrictions on key
products would still arise (toys, cosmetics, food contact materials in countries implementing the
relevant CoE Resolution), although the use of the substance in printing inks would fall outside the
scope of and the sectorally important EuPIA Exclusion Policy. In any case, given the customer-facing
nature of many applications and the strong likelihood of negative perceptions developing among
users and consumers, negative business impacts on the EEA ink/toner/colour industry would be
unavoidable and would lead to adverse employment impacts.

Such impacts cannot be quantified; by way of comparison, among those companies and associations
that have responded to a questionnaire on the impacts from a Carc Cat 1B harmonised classification
and which are relevant to inks, toners and ancillary products, an estimated ca. 1,500 jobs are
expected to be lost (8 questionnaire responses).

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Impacts on the welfare of consumers

A Carc Cat 2 harmonised for TiO2 could have notable impacts on consumer choice and welfare. The
following impacts should be noted:

• Loss of certain types of consumer products from the market: as noted earlier, formulations
currently sold to the consumer would either be sold with a potentially alarming hazard label
attached or, at least some of them, might be removed from the market either as a result of
regulatory pressure (i.e. unfavourable SCCS opinions for the use of the substance in toys and
cosmetics), voluntary action or market and consumer pressure. Efforts towards the substitution
of TiO2 could result in loss of products from the market, for instance, several shades of
recreational paints, writing inks, crayons, etc. Elimination of TiO2 from toners would render laser
printers and copiers unusable. Certain packaging articles such as paper bakery bags would be
hard to manufacture without TiO2. All flexible food packaging made of plastics in which product
information (e.g. batch number and consumption date) is printed with inks over a white area
would have to be redesigned or would need to be combined with an adhesive paper label, which
would impair the recycling of packaging waste;

• Increased cost and loss of performance: as TiO2 displays unsurpassed performance in the
applications of concern (alternative white pigments do not match TiO2 with regard to opacity,
whiteness and fastness properties), any reformulation of products would lead to the loss of
performance. If consumers did not have access to high quality art and school products, they
would need to use low quality products or use expensive electronic equipment such as
computers and tablets.

Food packaging articles in which white colour has a protective function against sunlight could be
replaced by more expensive and less recyclable alternatives involving multilayer materials (e.g.
increase use of aluminium foil on flexible packaging).

Printers and copiers using toner would not work without a toner, and people would have to
purchase new printers and copiers of the inkjet type58. Under certain circumstances (but not
always), the cost of running an inkjet printer might prove to be higher than the cost of a laser
printer59;

• Waste management and recycling impacts: disposal of waste inks might be affected (under
waste category 20 01 27* Paint, inks, adhesives and resins containing hazardous substances)
similar to waste DIY paint which might require separate collection and disposal. Whilst colours
are not typically recycled, ink and toner cartridges are but their recycling might be impacted by
negative perceptions among consumers;
• Loss of consumer satisfaction: removal of TiO2-containing recreation/school products from the
market would deal a blow to the creativity of children. For instance, a box of watercolours for
children would contain only 4 (black, orange, blue and sienna (brown)) instead of 12 colours
because the rest contain TiO2. A switch to electronic products could be envisaged. In addition,
as noted above, alternative pigments would generate poorer white colours.

58
TiO2 may also be used in inkjet inks as a white colourant. However, white ink is limited to a special purpose
and is not used in all products. As a result, the impact of the proposed classification would be limited.

59
The cost will depend, among other factors, on how heavily the printer is used. An example comparison can
be found here: http://www.itpro.co.uk/office-printers/innovation-at-work/25093/inkjet-vs-laser-printers
(accessed on 7 November 2017).

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Inkjet printers are not suitable for large volume printing, and takes more time for a print than
toner type printers; and

• Adverse effects on public health: elimination of TiO2 from the packaging construction would
lead to reduced opacity and thus reduced protection from light. This might lead to reduced
shelf-life of the packed goods.

Competitiveness impacts

As noted above, increased manufacturing costs (due to the cost of reformulation) would make EEA-
made formulations and articles less competitive when exported from the EEA. In any case,
reformulation, if at all possible, would result in loss in quality. As white is an essential part of the
colour shade range, customers located outside the EEA would prefer colours sourced from non-EEA
suppliers where the white colour of the range has a better quality, compared to a white colour
generated without TiO2.

In addition, users of TiO2-based formulations, e.g. packaging manufacturers, would be disadvantaged

as they would have to either adapt processes to allow their workers to use carcinogenic
formulations (at a cost) or switch to poor quality TiO2-free formulations. The use of TiO2-based
formulations outside the EEA would become cheaper and easier thus it would be more convenient
to move the use outside the EEA, generate articles and then import these into the EEA.

In the longer term, other global jurisdictions may also adopt the new hazard classification resulting
in a global impact which would create a level playing field but would still have a profound effect on
the users of TiO2-based inks, colours and toners.

4.3.5 Construction products and coatings

Key market descriptors

These products are generally considered to be part of the paints and coatings market but it should
be noted that applications are very diverse and may rely on different properties of TiO2. Within this
group, one may identify mass and specialty applications such as:

• Adhesives and sealants requiring whiteness, opacity, good dispersion properties and
weatherability for construction applications. In addition to white colour, TiO2 can be found in
virtually all sealant colours apart from black;

• Adhesives for non-construction applications, for instance, water-based gelatine adhesives for
the paper and cardboard industry which are used in the back lining of books60 or dispersion glues
such as those used to glue textile fibres on paper to generate wallcoverings61;
• Ablatives and fire protection coatings in which TiO2 offers fire resistance performance alongside
fire resistant/ intumescent components;

60
These glues are generally yellow, brown or beige. TiO2 is used to whiten the adhesive without changing
other technical properties like other fillers would do.

61
TiO2 is used to whiten the dispersion so it can be used as a masterbatch and the desired colour can be
added by the customer (i.e. the wallcovering manufacturer).

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• Fillers, grouts, mortars with "fresh colours" and good durability; and

• Photocatalytic active materials (cement) used in construction to reduce the concentration of

pollutants in the air. Photocatalytic cement can be used in concrete block paving, concrete road
surfaces, noise barriers, roof tiles and facades, to create durable photocatalytic active surfaces

The number of responses collected was not sufficiently high to allow for a detailed analysis to be
provided here, however the following can be noted:

• According to CEPE, construction materials such as plasters, caulks, fillers and mortars that
contain TiO2 are produced at a volume of 0.3 million tonnes per year and have a market value of
€0.55 billion;

• Across the 10-25 relevant organisations that returned a completed questionnaire on potential
impacts from a Carc Cat 1B harmonised classification, the volume of relevant TiO2-related
products produced in the EEA is ca. 50,000 tonnes with a market value of ca. €115 million/y.
Adhesives and sealants are the most prominent product groups in both volume and value terms.
The responding companies have operations in Belgium, the Czech Republic, France, Germany,
Greece, Hungary, Italy, Lithuania, the Netherlands, Poland, Portugal, Slovenia and the UK.

According to the Association for the European Adhesive and Sealant Industry (FEICA), the
European market for adhesives and sealants exceeded €13 billion in 2014. It is estimated that
close to 15,000 standard adhesive and sealant formulations are in use in Europe, based on five
formulation technology platforms: (a) reactive systems; (b) water-borne; (c) solvent-born; (d)
hot melts; and (e) based on natural raw materials. There are about 450 adhesive and sealant
companies in Europe manufacturing at some 700 sites. Several hundred of them are SMEs
(SMEs hold only 18% of the market and the top 60 companies account for about 80% of adhesive
and sealant sales in Europe). The European adhesive and sealant industry employs more than
41,000 workers, of which 6,000 are employed by SMEs (FEICA, 2015);

• The construction sector accounts for more than 5% of the total EU-28 (gross) value added62.
According to consultation, the sealant sector accounts for approximately 0.1% of the total
construction sector, therefore 0.005% of the total EU-28 value added; and

• As regards photocatalytic cement, fewer than five companies are believed to manufacture such
a product. Most of them are not SMEs.

62
Information available at http://ec.europa.eu/eurostat/statistics-
explained/index.php/Construction_production_(volume)_index_overview (accessed on 23 October 2016).

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Relevant legislation

Table 4–11 summarises the relevance of different legislative instruments to the use of TiO2 in
construction products after the adoption of a Carc Cat 2 harmonised classification. Additional detail
is available in Annex 1.

Table 4–11: Relevance of different regulatory instruments and voluntary initiatives to construction
products applications of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to construction products
CLP Yes
Carcinogens and No
Mutagens at Work
Waste Framework Potentially
Industrial Emissions Potentially
REACH Annex XVII: No
Annex XIV: No
Article 31: Yes
Cosmetics No
Toy Safety Potentially
Food Contact Materials Yes (adhesives)
Food Additives No
Medicinal Products No
Construction Products Yes
Biocides No
Medical devices No
RoHS Potentially (but less likely than for Carc Cat 1B).
It is relevant but impact not automatic. The list of restricted substances would
have to be updated following a risk assessment
Tobacco additives No
Other Global Automotive Declarable Substance List (GADSL)

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of paints and coatings

Potential loss of markets

A Carc Cat 2 harmonised classification would have impacts similar to (but also perhaps not as wide
as) those for paint manufacturers and thus the above analysis is not repeated here. In short:

• Hazard labelling would have an impact on user and consumer perceptions and would affect the
marketability of formulations containing TiO2, especially for DIY uses. There is no complete
overview of the affected markets. The information submitted to the online questionnaire would
suggest that the split between consumer and industrial applications (generally in the form of
mixtures) is 15 : 85 respectively;

• Under the GADSL a Carc Car 2 substance would not be “Prohibited” but would be “Declarable”
thus making it less appealing for automotive manufacturers and less marketable by
adhesive/sealant manufacturers; and

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• Similar regulatory action in other global regions could follow. This would further impact upon
exports of EEA-made products.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based manufacturers of construction
products, including:

• Cost of reformulation to eliminate TiO2: when asked whether reformulation of their products is
possible, the majority of companies indicated that it is not and as such estimates of the cost of
reformulation were not offered. In a few cases, some users of TiO2 noted that reformulation to
products of impaired performance might be possible. The cost of reformulation has been
estimated from €0.2 million to over €5 million. The time that would be required for
reformulation would be 1-5 years. Following reformulation, the new products would need to be
qualified by downstream users and some examples have been provided: re-qualification by
automotive OEMs may take up to 5 years and by the aerospace industry may take up to 10
years. Replacement of TiO2 would result in poorer quality products which would affect the faith
of customers in the industry as products would no longer be their usual brilliant white;

• Compliance with waste management regulations: limited information has been made available
through consultation. A sealant manufacturer has suggested that several types of waste re
currently mixed and the mixture ends up containing less than 1% TiO2. Following the
introduction of the Carc Cat 2 harmonised classification, wastes should be segregated and
disposed of separately. Segregation and storage costs might amount to €5,000 with an
additional cost of disposal of €10,000 (for an amount of waste in the range of 10-100 t/y, see
Table 4–12). For adhesives, some waste types currently classified as non-hazardous, might be
re-classified as hazardous, although some ‘absolute non-hazardous’ entries in the LoW may
continue to remain relevant to the users of TiO2. Empty TiO2 packaging might be classified as
hazardous, depending on pigment residues;

• Increased administrative burden: if a Carc Cat 2 substance is present in a mixture at a

concentration ≥0.1% then a SDS must be available upon request (as per Note 1 under Table 3.6.2
of the CLP Regulation). Manufacturers of these products may need to supply or receive an
increased number of requests for SDS; and

• Impacts on economies of scale: a potential loss of part of the market (mainly due to aversion of
consumers towards alarming labels, symbols and hazard statements) would make the
production of construction products overall more expensive and thus EEA-based manufacture
less competitive.

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Table 4–12: Relevant waste streams for the use of TiO2 in construction products manufacture
Process generating Type of waste Waste entry in LoW Example
Typical TiO2 Is TiO2 Current waste
waste volume
content inhalable? management
generated*
Sealants
Manufacture of Hardened pasty 07 02 15* Coloured products 40 t/y No Non-hazardous
coloured sealants sealants Wastes from additives other than those contain 1-2% TiO2. Incineration
Manufacture of Hardened pasty mentioned in 07 02 14 (‘mirror non- Paint component 0.25 t/y No
coloured pastes on paints hazardous’) (pigment) contain
silicon oil basis over 90% TiO2).
Transparent
products contain
no TiO2. These
wastes are
currently not
separated and
overall waste
contains ≤1% TiO2
Adhesives
Bagging of TiO2 into Empty TiO2 packaging 15 01 01 <1% <2 t/y Yes Non-hazardous
mixes (paper bags) Paper and cardboard packaging (‘absolute Landfilling
non-hazardous’)
Manufacture of TiO2- Residue in mixing 06 11 99 >1% <1 kt/y No Non-hazardous
containing dispersion vessels Wastes not otherwise specified (‘absolute Treatment by waste
non-hazardous’) contractor
Manufacture of TiO2- Residue in mixing 07 02 13 >1% No
containing latex vessels Waste plastic (‘absolute non-hazardous’)
compounds
Manufacture of TiO2- Residue in mixing 08 04 10 >1% No Non-hazardous
containing adhesives vessels Waste adhesives and sealants other than Treatment by waste
those mentioned in 08 04 09 (‘mirror contractor
hazardous’)
* data based on individual responses to questionnaire

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Economic impacts on downstream users (industrial and professional)

Users of adhesives, sealants and other construction products would be impacted in ways similar to
the users of TiO2-containing paints. By way of summary:

• Continued use of TiO2-based construction products: downstream use of these products,

especially transport, handling, application and disposal, would have to be revised to reflect the
legislative requirements related to Carc Cat 2-containing mixtures. This would involve additional
costs and resources, and may impose limitations on production rates and capabilities. New
equipment may be required to be installed, new storage systems and disposal procedures would
have to be put in place – waste packaging that contained TiO2-based mixtures could be classed
as hazardous and would need to be disposed of accordingly (see below);

• Information submission to Poison Centres: similar to paints and inks, importers and
downstream users placing on the market mixtures that would be newly classified as hazardous
due to the presence of TiO2 in concentrations exceeding 1.0% by weight would be required to
submit information to Poison Centres by 2020-2024, depending on the intended uses of their
mixtures;

• Impacts from a switch to alternative pigments: the quality of alternative pigments would not
match that of TiO2 and any attempt to use alternatives on a large scale would cause severe
technical and performance difficulties and would damage the image of EEA-based construction
product manufacturers;

• Compliance with waste management regulations: labelling construction products as hazardous

might affect that handling of waste that consists or contains such products. Implications for the
handling of demolition waste might also arise, as discussed for paints; and

• Impacts on DIY retailers: the discussion on impacts on DIY retailers who stock professional and
DIY paints (and alongside them a wide variety of TiO2-containing construction products) would
apply here with a potential reduction in their customer base a distinct outcome of the Carc Cat 2
harmonised classification.

Social impacts

Employment impacts

Through loss of market share (as a result of a restriction on consumer uses), loss of product quality
(following a reformulation) and loss of competitiveness against non-EEA manufacturers, it is possible
that job losses within the EEA would arise. There is insufficient information to allow the
quantification of such impacts.

Impacts on the welfare of consumers

The proposed classification for TiO2 could have notable impacts on consumer choice and welfare.
The following impacts should be noted:

• Loss of consumer products from the market: as noted above, consumer products that contain
more than 1.0% by weight TiO2 could be removed from the market, irrespective of the actual risk
of exposure by inhalation, as a result of market and consumer perception and pressure and/or
voluntary action. This would mean that the current range of DIY products (adhesives, sealants,
building materials, etc.) could become narrower;

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• Increased cost and/or loss of technical performance: formulations without TiO2 would have
worse weatherability and would become discoloured more quickly, leading to more frequent
(and thus costlier) replacement;

• Loss of consumer satisfaction: alternative formulations, particularly for consumer use would
generally be less white and would have worse weatherability. For example, white silicone
sealants are used in the majority of kitchens and bathrooms and their TiO2-free replacements
would not produce the same aesthetically pleasing effect;

• Waste management implications: disposal of waste construction products might be affected

(under waste category 20 01 27* Paint, inks, adhesives and resins containing hazardous
substances). Following the classification of TiO2-containing paint, leftover products might require
separate collection and disposal, thus increasing the cost and affecting the convenience of DIY
users; and

• Potential adverse impacts on public health: TiO2 is an irreplaceable component in intumescent

products and coatings. The function of TiO2 is as a nucleating agent and a main component of
the developed char. It is absolutely critical to product performance and there are no known
successful alternatives. These intumescent products are key and critical to the preservation of
buildings in the event of a fire ensuring there is time for people to escape safely. Therefore, the
very nature of these products is to preserve human life.

Competitiveness and competition impacts

Competitiveness impacts

As discussed for other applications earlier (e.g. paints and coatings), production of these products
outside EEA would become less costly. This would affect the competitive position of EEA-based
manufacturers and would make the import of TiO2-based formulations more attractive. On the
contrary, EEA-made TiO2-based formulations intended for export would become more expensive
and thus less competitive. It is possible that the larger manufacturers might consider relocating
their production facilities outside Europe and import the finished formulation back into Europe
instead. SMEs might not be able to do this and would either be forced to close or would have to rely
on third party toll producers outside of Europe to produce the finished formulation for them. This
would be a substantial loss of a significant business, particularly for construction applications, where
a large number of SME sealant formulators are producing sealant cartridges containing TiO2.

On the other hand, consumer products reformulated to eliminate the use of TiO2 would be of worse
quality than before and their exports to non-EEA markets would suffer. DIY retail chains might also
face increased competition from non-EEA e-commerce retailers who could supply consumers with
TiO2-based formulations without the customer being visually alerted to a carcinogenic classification
label and thus being less reluctant to purchase DIY products that contain TiO2.

Intra-EEA competition effects

Manufacturers who supply both consumers and industry/professionals would have a disadvantage
compared to manufacturers who supply only industry/professionals as they would potentially need
to supply two separate types of formulations with and without TiO2. This would increase the
logistical complexities and ultimately the cost of manufacture. In addition, customers may also be
given the incentive to turn to alternative products (e.g. boards rather than intumescent coatings).

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4.4 Specific impacts on downstream users of specialty
applications of titanium dioxide
4.4.1 Fibre applications
Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the Man-made fibres that rely on TiO2 for delustering and
application whiteness/opacity are widely used as articles for the production of
carpets, wallcovering in houses, hotels, offices, cars, airbags,
swimwear, garments (for example, viscose filament yarn which is
used in high-class, high-fashion textile products of the most well-
known and prestigious fashion brands), hosiery, laces, outwear,
sportswear, shoes, bags, tent, flags, backpacks, luggage, hygiene non-
wovens (diapers for babies and incontinence articles for adults,
viscose dull fibre uses in wipes, tampons and sanitary textiles), etc.
which are daily in contact with the consumers. The order of
importance would appear to be:

• Clothing textiles;
• Non-wovens and hygiene;
• Carpets and other household products;
• Automotive; and
• Others (geotextiles, fishing nets, etc.).

Delustered fibres are also used in cigarette tow (filters)..

Estimated TiO2 tonnage Uncertain – some literature sources suggest that fibres may account
used for 1-2% of TiO2 consumption; the 2013 Cefic data groups fibres into
the “Other” category which collectively accounts for 4% of total
consumption.
Estimated tonnage of Application EEA production
products that contain TiO2 Man-made fibres for textiles, carpets, non- 2-3 million tonnes/y*
wovens, etc.
Cigarette tow Unknown
* RPA estimate

Estimated value of markets Supply chain EEA market value

Man-made fibres for textiles, carpets, non- €7.5-10 billion/y*
wovens, etc.
Cigarette tow Unknown
* RPA estimate (Eurostat data for 2011-2015 show a turnover of €7.7-9
billion/y)

The combined value of the products sold by companies that

responded to the questionnaire on impacts from a Carc Cat 1B
classification is over €250 million/y.

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Estimates of Gross Value According to Eurostat, the value added of the manufacture of man-
Added made fibres in the EU was ca. €2.1 billion in 2014.

Number of users of TiO2 The European Man-Made Fibres Association (CIRFS) has 31 full
members, 9 associate members. The Global Acetate Manufacturers
Association (GAMA) has two member companies in the EEA.

Presence of SMEs The majority of fibre producers are large companies according the EU
definition of an SME. There are no SMEs among the acetate tow
manufacturers.

Number of stakeholders that Fewer than 10 organisations including the European Man-Made
participated in consultation Fibres Association (CIRFS) and the Global Acetate Manufacturers
Association (GAMA). A total of 7 questionnaire responses were
received on the last questionnaire on waste management impacts.

Locations of stakeholders CIRFS has member companies in Austria, Belarus, Czech Republic,
that participated in France, Germany, Ireland, Italy, Lithuania, Netherlands, Portugal,
consultation Romania, Slovakia, Spain, Switzerland, Turkey and the United
Kingdom. Its members account for ca. 85% of European production
of the main fibres within the scope of CIRFS (polyester, polyamide,
acrylic, viscose, acetate, elastane and aramid)64. Most important
locations include Germany, Portugal, Italy, Slovenia, Croatia, and the
UK.

Employment in the sector The total number of jobs in the man-made fibre industry is estimated
at around 20,000.

Relevant legislation

Table 4–13 summarises the legislation that would be of relevance to the use of TiO2 in fibre
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1.

Table 4–13: Relevance of different regulatory instruments and voluntary initiatives to fibre applications of
TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to fibres
CLP Yes - Only in receiving and handling raw materials
Carcinogens and Mutagens at Work No
Waste Framework Potentially
Industrial Emissions Potentially
REACH No
Cosmetics No
Toy Safety Potentially.
Impact not automatic
Food Contact Materials Yes
Food Additives No
Medicinal Products No

64
Information available at http://www.cirfs.org/Portals/0/Docs/2013%20CIRFS%20FACTSHEET.pdf (accessed
on 24 October 2016).

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Table 4–13: Relevance of different regulatory instruments and voluntary initiatives to fibre applications of
TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to fibres
Construction Products No
Biocides No
Medical devices No
RoHS Potentially
Tobacco additives Yes
Other: Yes
- OEKO-TEX® certification (see Section 7.2.8)
- Ecolabelling schemes (see Section 7.2.7)

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of fibres

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
fibre manufacturers to use TiO2 and place on the market TiO2-containing articles:

• Hazard labelling and perceptions: hazard labelling requirements would arise for masterbatches
and compounds rather than plastics articles. Hazard labelling would not be relevant to
consumer products or professional users but only to industrial users. Yet, consumer views on
the presence of a suspected carcinogen in consumer products might have an adverse effect on
the market. Due to the requirements of the production processes and the quality requirements
of the end products, TiO2 is present in fibres in the range of 0.1-1.5%. Most man-made fibres
come into contact with consumers in everyday life (this includes clothing, underwear, sports
clothing, etc.). TiO2 presence would affect consumers’ perceptions, even if the risk for consumer
exposure by inhalation is non-existent. Also, industrial users of the fibres might become
reluctant to use them in case their processes give rise to exposure to dusts;

• Restrictions under specific regulation: under regulatory regimes such as the Toy Safety
Directive and the regulations on food contact materials, the continued use of TiO2-containing
fibres would be dependent on securing an exemption or authorisation. For this, testing would
need to be undertaken to demonstrate that, for instance, the TiO2 in the polyamide and
polyester yarn is completely bound and strongly encapsulated in the polymer, making its
inhalation impossible. It can be estimated that commissioning such testing to specialist
laboratories would come at a cost of €1-1.5 million.

Directive 2014/40/EU on the manufacture, presentation and sale of tobacco and related
products impacts upon the use of additives classified as CMR substances and Decision (EU)
2016/787 sets out the priority list of additives in tobacco products and includes TiO2 into the list
and requires that manufacturers and importers submit enhanced reports on the safety of the
substance. As the Directive does not distinguish between Carc Cat 1B and Carc Cat 2 substances,
the harmonised classification would need to be taken into account in the generation of the
enhanced report for the TiO2 and might have an indirect role in making the substance more
susceptible to future regulatory action (a ban), even though the TiO2 is bound in the filter within
tow fibres;

• Food contact materials: polymer fibres find applications in food contact materials. A Carc Cat 2
harmonised classification on the use of the substance in food contact materials might arise could

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and these are discussed in Section 4.4.3 below (that section explains that for applications
covered by existing harmonised classification and where TiO2 has already been assessed and
authorised into a positive list, i.e. plastics, the likelihood of the substance being removed from
the Union List (Regulation No 10/2011) is low, taking into account that probability of exposure
by inhalation in this context is small);

• OEKO-TEX® certification and ecolabelling schemes: classification of TiO2 as Carc Cat 2 would
mean that textiles that contain the substance in their fibres could no longer attain these, thus
becoming less attractive to consumers who value these schemes and consider participation in
such schemes important in making purchasing decisions; and

• Quality of TiO2-free products: in the context of attempting to substitute TiO2 with a non-
hazardous alternative, it is not known if the manufacturing processes would deliver an
acceptable quality without TiO2, so replacement of TiO2 would lead to loss of sales and market
share.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based fibre manufacturers, including:

• Cost of reformulation to eliminate TiO2: elimination or reduction of TiO2 in fibres would mean
that the level of fibre lustre and whiteness required by consumers could not be achieved and the
number of affected products would be particularly large; this is already known through
industrial-scale tests. For specific uses of TiO2 reformulation could potentially be a technically
feasible option, however the requalification of these particular products in the value chain
would be a very complex, time consuming and costly process. It is not possible to be 100% sure
of the outcome as to whether or not these reformulated products would be accepted in the
marketplace or by appropriate regulatory or certifying bodies.

Some estimates on the time that would be required indicate that at least 2 years would be
needed and the associated cost could range between €0.5 and €2 million per company (NB. The
range is an estimate generated by the authors on the basis of company-specific inputs to
consultation). On top of that, additional costs would arise for the costlier raw materials used,
including an increase in the amount of fibre used,) for masterbatch formulation; this was
estimated by a fibre manufacturer at €0.3 million/y. Notably, for an alternative to give the
same results on fibres it would need to demonstrate properties similar to TiO2 (i.e. be an
insoluble chemically inert metallic oxide with a particles size below 1 μm).

On the other hand, for the use of TiO2 in cigarette tow, a TiO2-free product might be possible to
manufacture and this is currently being studied. Substitution, however, would likely be
accompanied by considerable cost; and

• Compliance with waste management regulations: the harmonised classification could increase
the cost of waste management for fibre manufacturers as some types of waste generated during
the manufacturing phase might be classified as hazardous. Table 4–14 summarises information
received from a total of seven questionnaire responses on the types of TiO2-containing waste
that arise during the manufacture, processing and disposal of fibres (all collected with the kind
support of the CIRFS trade association). The table identifies, where possible, the relevant LoW
entries and the waste management processes currently used. The following key points can be
made:

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− Relevant waste types that might be affected by the Carc Cat 2 harmonised classification
include (a) TiO2 packaging contaminated with the substance – currently handled as non-
hazardous, depending on the levels of TiO2 residue it might be classified as hazardous
(under 15 01 10* Packaging containing residues of or contaminated by hazardous
substances), (b) off-spec additive slurry batches – these may currently be already
managed as hazardous due to the presence of hazardous solvents, but this is not always
the case, (c) off-spec material that contains >1% TiO2 – again, some off-spec TiO2-
containing polymer may already be managed as hazardous due to the presence of
hazardous solvents but this is not always the case, and (d) solid residues from filtration
(greyed entries in the table). Potential for inhalation exposure to TiO2 might only arise
in relation to the disposal of packaging waste that contains TiO2 power residues;

− The cost arising from the above waste types being classified as hazardous as a result of
a Carc Cat 2 harmonised classification for TiO2 have been estimated to range from ca.
€4,000 per year for incinerating TiO2 packaging (instead of landfilling it) to €50,000 per
year for incinerating filter cake that contains TiO2 (although some companies may
already incinerate this waste stream).

Irrespective to the above increases in waste management costs, the most important waste-
related impact on fibre manufacturers arising from the Carc Cat 2 harmonised classification
would be that on recycling of off-spec and offcut material. Recycling issues would affect not
only those companies that use TiO2 as a raw material (alone or in a mixture) but also those
companies processing polymer that contains TiO2.

In the spinning process of polyamide yarns, there is always some amount of TiO2-containing
waste generated (spinning processes generate on average an equivalent of 10% waste for each
kg of yarn production). This type of waste is largely used in EU (and globally) as an input
material for engineering plastics and finally applied in the automotive industry, machinery,
household appliances, etc. At present, even if in the EU these pre-consumers scraps are
classified as waste, they can be considered as a very homogeneous waste (chemically it is a
polyamide polymer in a physical status of fibre instead of granule), containing a minor amount of
additives, such as stabilisers and pigments, including TiO2 at a level that exceeds 1.0%. For this
reason, the producer of the waste is paid for supplying the waste material, instead of paying for
its disposal. The classification of TiO2 as Carc Cat 2 would change the classification of this waste
to hazardous (HP7) and make its direct use ‘as is’ as raw material for engineering plastics
manufacture impossible. Moreover, the final product/article will also acquire the same hazard
classification. Options available to the waste producer would be:

− Pay to have the waste disposed of as hazardous (by incineration with disposal of final
ashes containing TiO2); or
− Install systems that would allow the “separation” of the polyamide from TiO2 and then
recycle the polyamide resin. This is not a simple or common industrial process65.

65
According to EU regulations, it is forbidden to go below the established limits by diluting hazardous waste
with other not hazardous or pure product, thus it would be legally almost impossible to recycle the waste
generated by fibre spinning operations.

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More generally, for fibres that contain TiO2, the hazardous waste classification of any post-
consumer (or pre-consumer) waste would seriously hinder recycling activities and therefore
circular economy policy implementation due to:

− The additional significant administrative and financial burdens of hazardous waste

managing and transporting through EEA Member States; and

− Limited national/regional authorisations of hazardous waste recycling activities, which

possibly could not be additionally extended, due to national/local legislation. This
means, that the EEA portfolio of available end-of-life/recycling solutions for waste
containing TiO2, would diminish.

Consequently, this might bring about a situation where (a) the producer of waste would no
longer have available the best available end-of-life/recycling solutions, (b) instead of making a
profit from sale of the waste they would need to pay for its disposal, and (c) waste might be sold
to non-EEA customers at a lower value.

A quick estimate of the increase in waste treatment costs from the proposed classification of
TiO2 on fibre manufacturers can be provided. For polyamide fibres, considering an average
waste equivalent of 10% for each kg of yarn production, the economic loss can be evaluated as
follows:

− Loss of income from the sale of waste: 10% × €1 = €0.1/kg yarn produced (where €1 is
the unit minimum price for the sale of 1 Kg of PA6 waste);
− Cost of disposal of the – now – hazardous waste: 0.1 × €0.15 = €0.015/kg of yarn
produced (where €0.15 is the average cost of the “waste to energy” (incineration)
disposal of 1 Kg of PA6 waste); and
− Total minimum loss estimate would therefore be €0.115/kg yarn produced; in view of
the often very limited contribution margin generated by nylon yarn, this loss might
offset most, if not all, of the profit.

A similar calculation for polyester fibres could also be provided, however, their TiO2 content is
typically lower than in polyamide and might not exceed 1.0% by weight, thus polyester fibre
waste would not be classified as hazardous.

Overall, the Carc Cat 2 harmonised classification would not equally affect all companies involved
in fibre manufacture; however, where TiO2 is used as a powdered raw material and during
polyamide manufacture the impacts of the substance’s hazard classification could have
significant adverse effects and costs for the recycling of TiO2-containing polymer waste.

SEA for TiO2

Given that this application area is strictly limited to industrial use, it is far less likely that substitution
of TiO2 would be given much consideration. In any case, eliminating TiO2 from its catalysts uses
would not be feasible. Inability of catalysts manufacturers to use TiO2 could have significant
repercussions on the production of chemical substances that rely on the relevant catalysts and also
on the users of those chemicals. One catalyst manufacturer has suggested that sales of a specific
type of TiO2 catalyst are associated with revenues of several millions of Euros. Loss of these
catalysts would also wipe out a market for the produced chemical worth several hundreds of
millions of Euros. Consequently, users of said chemical would need to source alternative products
which are known to have a higher market price, reduced performance and lifetime/durability.
Competitors of EEA companies along this supply chain would gain a market advantage if the use of
TiO2 would no longer be possible in the EEA and production of the chemical in question would move
outside the EEA with associated loss of added value creation from the industry and loss of jobs.

In relation to waste management, spent catalysts that contain more than 1.0% TiO2 might be
classified as hazardous waste under LoW entry 16 08 02* Spent catalysts containing hazardous
transition metals or hazardous transition metal compounds as would be TiO2 packaging containing
residues of the substance (15 01 10* Packaging containing residues of or contaminated by hazardous
substances). Thus, the cost of disposing these materials could substantially increase (unless these
materials are already classified as hazardous due to the presence of other hazardous components –
there is currently no information on this aspect).

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Overall, it can be assumed that in the field of catalysis, the impacts of a Carc Cat 2 harmonised
classification for TiO2 would probably be limited to the increased cost of worker protection measures
to be taken by companies handling TiO2 as a raw material and the management of spent catalysts as
wastes.

4.4.3 Food and feed additives and food contact materials

Key market descriptors

Limited information has been collected from consultation which does not allow the presentation of
sufficiently representative industry-wide figures. Given the numerous food categories in which TiO2
can be used, it is appropriate to assume that it is quite widely used as a food colour in the EEA. The
flexible packaging market in the EEA has a value of several billion euros and the value of the market
for food packaging inks is the range of hundreds of millions or euros (actual figures are confidential
and are not reproduced here).

Relevant legislation

Table 4–16 summarises the legislation that would be of relevance to the use of TiO2 in food and feed
additives applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification.
Additional detail is available in Annex 1.

Table 4–16: Relevance of different regulatory instruments and voluntary initiatives to food, feed additives
and food packaging applications of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to food
CLP Only in receiving and handling raw materials
Carcinogens and Mutagens at Work No
Waste Framework Potentially
Industrial Emissions Potentially
REACH No
Cosmetics No
Toy Safety No
Food Contact Materials Yes
Food Additives Yes
Medicinal Products No
Construction Products No
Biocides No
Medical devices No
RoHS No
Tobacco additives No
Other CoE Resolutions and the CEPE Code of Practice impact upon the use of
CMRs in food contact materials and articles

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for food, feed and food packaging manufacturers

All relevant uses or titanium dioxide

Compliance with national legislation on worker protection could become costlier for all users of TiO2
as a raw material through the introduction of stricter controls on the exposure to TiO2 powder.

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Titanium dioxide as a food additive

Possibilities for reformulation: there is no other white colourant approved under Regulation
1333/2008 that meets the performance of TiO2 and thus reformulation is not feasible. The only
other white additive is E170, calcium carbonate, which does not have the opacity of TiO2 and has
severe technical limitations as described in Section 8.4 of Annex 2:

• It is a much less effective white colour than TiO2. There are applications where the layer
thickness of a print on a foodstuff (for instance, prints on dark and milk chocolate) is too thin to
enable any other product to be opaque enough (and white/neutral in colour) in order to have a
clear visual effect;

• It will readily react with any acids present in foods to generate carbon dioxide and a (possibly
soluble) calcium salt with no white colouring properties;

• It could not be used as a colour in any foods with low pH as it would neutralise the acid present,
adversely affecting the product flavour, quality and possibly shelf life;

• It also could not be used as a white colour in cake batters, scone doughs, etc. since it would
interfere with the raising agent system;

• It could not be used as a replacement to produce white glitter powders since E555 (Potassium
aluminium silicate - mica) is only authorised for use as a carrier for titanium dioxide (and E172
iron oxides which produce red/brown colour glitter powders); and

• It is normally used in foods to function as an acidity regulator, anticaking agent, stabiliser or

nutrient source (of dietary calcium) rather than as a colour. It is also used as a firming agent in
many canned or bottled vegetable products.

Overall, calcium carbonate could not in practice be used as a viable replacement for TiO2 in most of
its current applications as a food colour.

Scope for a restriction on use and envisaged market losses: according to Article 6 of Regulation
1333/2008, a food additive may be included in the Community lists in Annexes II and III only if it
meets the following conditions and, where relevant, other legitimate factors, including
environmental factors:

1. It does not, on the basis of the scientific evidence available, pose a safety concern to the health
of the consumer at the level of use proposed.

2. There is a reasonable technological need that cannot be achieved by other economically and
technologically practicable means.

3. Its use does not mislead the consumer.

Recently, TiO2 was re-evaluated by EFSA (European Food Safety Authority, 2016) and it was
concluded that dietary exposure does not pose health concerns. Whilst a carcinogenicity
harmonised classification (either Cat 1B or Cat 2) might lead to the review of the evaluation result,
given the extremely low probability of exposure to TiO2 by inhalation through food and the lack of
feasible substitutes of equivalent performance, it may be presumed that an approval for the

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continued use of TiO2 could be secured. The mechanism for securing an approval would have to be
led by the Member States’ Food Safety Authorities.

However, classification of a food ingredient as Carc Cat 2 is likely to cause significant concern among
consumers and consequently a drop in sales of those products identified as containing the white
colourant.

Compliance with waste management regulations: wastes associated with the food industry are
described by LoW entries under the following sub-chapters:

• 02 02 Wastes from the preparation and processing of meat, fish and other foods of animal
origin;
• 02 03 Wastes from fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco
preparation and processing; conserve production; yeast and yeast extract production, molasses
preparation and fermentation;
• 02 05 Wastes from the dairy products industry; and
• 02 06 Wastes from the baking and confectionery industry.

All entries thereunder are ‘absolute non-hazardous’ thus the Carc Cat 2 harmonised classification for
TiO2 might not have a very pronounced impact66. On the other hand, TiO2 packaging would become
hazardous waste, depending on the level of residue in it, under entry 15 01 10* Packaging
containing residues of or contaminated by hazardous substances.

Titanium dioxide as an animal feed additive

TiO2 is present in Annex I of Regulation 1831/2003 under Category 2 (colourants). As no other white
pigment appears to be listed and following the discussion on food additives above, it would be
unlikely that its entry would be removed from the Annex. Nevertheless, its new classification might
make manufacturers of feed additives (as well as users, if they became aware of TiO2’s presence)
less inclined to use the substance or any animal feed that contains it.

Titanium dioxide as an additive in food contact materials

Possibilities and cost of reformulation: no other pigment can deliver the required performance in
terms of opacity and ink film thickness. TiO2 is used at large concentrations (e.g. 15-60%);
alternatives such as ZnS would require even higher concentrations and would still not be able to
provide the opacity and performance currently required by the packaging market.

The protective and decorative effect currently obtained with white inks (and in some other cases
with TiO2-coloured substrates like plastic film or paper) would no longer be achievable, forcing food
packaging manufacturers customers to develop new packaging designs and possibly the use of
different materials to compensate for the lack of hiding effect provided by white inks. This would
require significant effort in terms of new packaging development, validation, marketing, possibly
leading to an increased use of different material combinations (e.g. paper labels on plastic films) in
place of packaging that is to date consolidated, validated by tests, accepted by the authorities, and
trusted by the consumer.

66
It is worth noting that when consulting on the originally proposed Carc Cat 1B harmonised classification, a
company involved in the production of food for human consumption estimated that segregation of solid
and water waste plus installation of a water purification station would cost an estimated €0.3 million.

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Scope for a restriction on use and envisaged market losses: in respect of food contact materials,
the implications of the proposed classification on the use of the substance in the manufacture of
food contact materials is difficult to predict with certainty for a number of reasons:

• The existing legislation is not fully harmonised for the vast majority of food contact materials;
and

• If the Carc Cat 2 harmonised classification would specifically apply for exposure via the
inhalation route, this would clearly be of little relevance to the use of food contact materials.
Still, it cannot be certain how this will be viewed by the relevant authorities and approaches may
differ on the Member State level. Relevant industry organisations have noted a trend towards
stricter regulation on CMR substances in food contact materials both at transnational and
national level.

The discussion below explains the possible consequences of a Carc Cat 2 harmonised classification
and demonstrates that impacts in the field of food contact materials could potentially be severe, but
the lack of exposure by inhalation might prevent extensive market impacts and losses. The
following impacts may be envisaged:

• Impacts for food contact materials for which specific harmonised EU legislation applies: there
are two areas where specific legislation for food contact materials applies: plastics and active
and intelligent packaging. Under the relevant legislation, the following impacts might be
envisaged:

− Plastic food contact materials – the Union List: Recital 27 of the Plastics Regulation (EU)
No 10/2011 indicates that CMR substances should not be used in plastic food contact
materials or articles without previous authorisation. Authorised substances are
included in the Union list and TiO2 is currently an authorised substance, under entries
610, 805 and 873 in Table 1 of Annex I (see also Table 3–13), for use as an additive or
polymer production aid because safe use has been proven and accepted by EFSA based
on its current classification. Under Article 15(3), declarations of conformity with the
Regulation “shall be renewed when substantial changes in the composition or
production occur that bring about changes in the migration from the materials or
articles or when new scientific data becomes available”. In theory, the authorisation of
the substance might be reassessed by EFSA and this might result in lower limits for the
migration of TiO2 from food contact articles into food, or even a restriction forbidding
its use;
− Recycled plastic materials and articles: Regulation (EC) No 282/2008 on recycled plastic
materials and articles intended to come into contact with foods prescribes that only
authorised monomers and additives should be added to the recycled plastics and their
migration limits should also be respected by recycled plastic food contact materials.
Use of TiO2 in recycled plastic would be unlikely to be authorised, if it can no longer be
found on the Union List;
− Active and intelligent packaging materials: Regulation (EC) No 450/2009 requires that
CMR substances cannot be used in such materials and packaging even if not in direct
contact with food or the environment surrounding the food and even if they are
separated from the food by a functional barrier. Only substances which are included in
the ‘Community list’ of authorised substances may be used in components of active and
intelligent materials and articles. The Regulation does not describe an exemptions
procedure and as the Community list has apparently not been published yet, it is

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possible that the Carc Cat 2 harmonised classification, if introduced before the List is
published, may hinder the placing of TiO2 on the list;

• Impacts for food contact materials for which no specific harmonised EU legislation currently
exists: as described in Section 7.2.2 of Annex 1 to this document, where no harmonised rules
exist, the use of chemical substances in food contact materials needs to comply with the generic
provisions of the Framework Regulation (EC) No. 1935/200467 as well as with any applicable
national rules, Council of Europe (CoE)/ European Directorate for the Quality of Medicines
(EDQM) Resolutions, and other industry-led voluntary codes of practice. We may look at these
in turn:

− Framework Regulation (EC) No. 1935/2004: Article 11(5) of the Regulation prescribes
that, “The applicant or any business operator using the authorised substance or
materials or articles containing the authorised substance shall immediately inform the
Commission of any new scientific or technical information, which might affect the safety
assessment of the authorised substance in relation to human health. If necessary, the
Authority shall then review the assessment”. Article 12(1) also prescribes that, “On its
own initiative or following a request from a Member State or the Commission, the
Authority shall evaluate whether the opinion or the authorisation is still in accordance
with this Regulation, in accordance with the procedure laid down in Article 10, where
applicable. The Authority may, where necessary, consult the applicant”. The
classification for TiO2 as a Carc Cat 2 substance may therefore trigger a re-evaluation of
its authorisation for food contact use;
− National rules: Article 6 of Framework Regulation (EC) No. 1935/2004 notes, “In the
absence of specific measures referred to in Article 5, this Regulation shall not prevent
Member States from maintaining or adopting national provisions provided they comply
with the rules of the Treaty”. There are several CoE/EDQM Resolutions which exclude
the use of CMR substances from coatings, paper/board and printing inks in food contact
materials. TiO2 may currently be present in approved additive lists, however, the
classification of the substance under the CLP Regulation may trigger a re-evaluation of
such approvals or enforcement practice under national legislation that implements said
CoE/EDQM Resolutions. To what extent such re-evaluations may take place is
uncertain; one would have to study the national legislation of the 31 EEA member
states for each of the non-harmonised categories of food contact materials and articles
in their respective national languages to establish what the actual impact might be68;
and
− Industry initiatives: Sections 7.2.3-7.2.4 of Annex 1 explain the provisions of the CEPE
Code of Practice which prohibits the intentional use of CMR substances (monomers,
starting substances and additives) in coatings intended for use in food contact material
unless they have been authorised by EFSA and any set migration limits are respected.
On the other hand, whilst the EuPIA Exclusion Policy does not allow the presence of
Carc Cat 1B printing in ink components inside food packaging, not even behind a

67
Article 3 of the Framework Regulation applies under which food contact materials should not transfer their
constituents to food in quantities which could: (a) endanger human health; or (b) bring about an
unacceptable change in the composition of the food; or (c) bring about a deterioration in the organoleptic
characteristics thereof.

68
For instance, the new Belgian Royal Decree concerning Varnishes and Coatings intended to come into
contact with food stuffs (which is a national provision based on a CoE/EDQM Resolution) prescribes in its
Article 4 that substances classified as CMRs cannot be used.

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functional barrier, the Policy is not applicable on Carc Cat 2 substances. Overall, the
Carc Cat 2 harmonised classification would not have an impact on the use of TiO2 in
food contact material coatings under the CEPE Code of Practice, unless EFSA decided to
revoke the authorisation of the substance; similarly, the Carc Cat 2 harmonised
classification would not have repercussions on the use of the substance in printing inks
under the EuPIA Exclusion Policy. In any case, food contact materials manufacturers
might wish to avoid using coatings or inks that contain a suspected carcinogen and thus
voluntarily take steps to eliminate the use of the substance.

Overall, the landscape is somewhat uncertain in relation to food contact material-related

applications of the pigment:

• For applications covered by existing harmonised classification and where TiO2 has already been
assessed and authorised into a positive list, i.e. plastics, the likelihood of the substance being
removed from the Union List is low, taking into account that probability of exposure by
inhalation in this context is small. Accordingly, if EFSA did not elect to (or concluded not to)
revoke TiO2’s existing authorisation listings, the substance could continue being used as an
additive in the relevant food contact materials;

• On the other hand, it is important to consider the wider regulatory landscape. Existing EU food
contact legislation, existing food contact material resolutions of the CoE/EDQM (see Section
7.2.2 of Annex 1) and national food contact material legislation in EU Member States would
appear to refer to CMRs in general, without making any distinction between exposure pathways
and might not even distinguish between carcinogens of category 1A, 1B or 2. EFSA recently
proposed to the European Commission an updated, more severe risk assessment methodology
for chemicals in food and food contact materials69 thus there is a general trend towards stricter
regulation in food and food contact material safety70. It has further been suggested that
national authorities do not always follow EFSA advice and practice and therefore national
legislation may indeed focus on hazard rather than exposure and risk. Overall, since most recent
risk management measures (taken by the European Commission, the Coe/EDQM or the national
authorities) restrict the use of CMRs in general unless proven safe and included in a positive list
(at EU level if harmonised or at national level if not harmonised) without distinction between
exposure pathways, there is a possibility that national authorities may disregard the importance
of exposure pathway in their risk management approaches and restrict the use of TiO2 following
its classification as a Carc Cat 2 substance.

In any case, the presence of a suspected carcinogen in food contact materials and articles (in
plastics, labels, inks, containers, etc.) could bring about a major market change, a shift in public
opinion and unpredictable reactions from consumers. It is worth remembering that safety criteria
used for food contact materials are typically far stricter than for the evaluations of the safe use of
chemicals in general with limits of 10, 0.1 or even 0.01 ppb in food contact and drinking water
materials as opposed to 1.0-0.01% by weight for CMR chemicals in general, industrial and
professional use.

69
See Opinion No. 4357 of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids,
“Recent developments in the risk assessment of chemicals in food and their potential impact on the safety
assessment of substances used in food contact materials”, available at
https://www.efsa.europa.eu/en/efsajournal/pub/4357, accessed on 17 January 2017.

70
Manufacturers of food contact materials and articles may also wish to place on the market products that
contain no hazardous substances.

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On the basis of the above analysis and having received contributions from key industry
organisations, it may be concluded that the time required and the cost of reformulating all food
contact mixtures and articles, and of testing the reformulated products for compliance with food
contact and other legislation, and for testing consumer acceptance will be very high especially when
considering the food contact supply chain (in and outside the EU) as a whole.

Compliance with waste management regulations: issues of waste are addressed elsewhere in this
document, for instance, under paints (coatings), plastics, inks, etc.

Economic impacts on downstream users (industrial and professional)

Downstream industry impacts are mostly relevant to the food contact materials industry. As
explained above, any attempt to substitute TiO2 in formulations such as coatings or inks, could have
significant repercussions for food packaging manufacturers and potentially result in changes to
packaging materials used. Alternatively, pressures may develop from downstream actors (e.g. food
producers and/or retailers) who might face negative perceptions by consumers and thus request
that food contact materials used with the products they sell are free of TiO2. The scope for variation
in impacts between EEA Member States will be particularly wide given the significant role of national
regulatory frameworks in this industry sector.

Social impacts

Employment impacts

Insufficient information is available to estimate the total employment associated with the use of
TiO2. An industry association representing companies in the food industry has indicated that the use
of TiO2 is small in relation to other food ingredients handled (automatically or manually) and that it
is therefore unlikely that social impacts can be attributed to any ban imposed. The association has
stated that it would not anticipate any direct job losses in respect of the current usage of TiO2.

Impacts on the welfare of consumers

The Carc Cat 2 harmonised classification for TiO2 could have impacts on consumer choice and
welfare, depending on actions taken by enterprises currently involved in its use. The following
potential impacts should be noted:

• Loss of certain types of consumer products from the market: given the absence of other
approved white colourants of similar opacity and the low probability of consumer exposure to
TiO2 by inhalation, it can be assumed that market availability of foodstuff that contains the
substance would not be impacted. It is also worth noting that several TiO2-containing products
(e.g. confectionery) are deemed ‘discretionary products’, rather than staple goods, and so
consumers might be able to switch to other products in the range as food products could be
produced with different decorations. On the other hand, a greater impact on the market
presence of food packaging products could be expected. For example, white shopping and
paper bakery bags would be hard to manufacture without TiO2. If TiO2 were to be eliminated, all
flexible food packaging made of plastics which has product information (e.g. batch number,
consumption date) printed with ink over a white area could disappear, or be combined with an
adhesive paper label, which would hinder the recycling of the packaging waste;

• Increased cost and loss of performance: assuming a continued use of TiO2, impacts on food
products would be limited. If TiO2 were to be replaced by calcium carbonate (E170), additional
loadings would be required and the opacity of the feedstuff would be worse thus impairing the

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aesthetic properties of the product. On the other hand, in relation to food packaging, white
articles with a protective function against sunlight could be replaced by more expensive and less
recyclable alternatives involving multi-materials (e.g. increased use of aluminium foil or paper on
plastic flexible packaging). Alternative white pigments do not match TiO2 in terms of opacity,
whiteness and fastness properties and/or contain substances such as barium;

• Loss of consumer satisfaction: it is almost impossible to match the effects of TiO2 or TiO2-
containing pearlescent pigments with other ingredients. The absence of white from the
portfolio of colours available for the graphic communication of brand and product information in
packaging and food packaging would result in the disengagement of customers from their
preferred brands and a general perception of decreased quality in consumer goods or foods
applying this kind of “whiteless” packaging; and

• Adverse impacts on public health: any effort to substitute TiO2 would make it very difficult to
display information that is important to the consumer (e.g. food ingredients, safety). Since
packaged food would no longer be protected from light degradation due to the lack of opaque
films, there would be a significant increase in the likelihood of food poisoning resulting from
food going off in the packet before its sell-by date. This would probably result in reduced sell-by
dates, and increased volumes of food being discarded beyond this date. This would affect the
whole food supply chain (supermarkets etc.).

Competitiveness and competition impacts

Impacts on the competitiveness of EEA-based enterprises

When food or food contact materials are exported to extra-EEA markets (such as Turkey, North and
South America and Africa), increased manufacturing costs would hinder companies’ ability to
compete with local producers or extra-EEA producers who would not be affected by the new
harmonised classification. With few, if any, possible technical options the Carc Cat 2 harmonised
classification would provide additional stimulus for some companies to move production of food
contact materials to non-EEA countries with a lower regulatory burden (as well as lower labour
costs).

− 07 02 13* Solid wastes containing hazardous substances; and
− 15 01 10* packaging containing residues of or contaminated by hazardous substances
(for empty TiO2 packaging).

No questionnaire response was received from this industry sector; information on the scale of
the impact is not available.

Economic impacts on downstream users (industrial and professional)

The above discussion on impacts covers adequately the entirety of the supply chain for
pharmaceuticals, with the exception of consumers (discussed further below). It must be noted that
the pharmaceuticals sector has linkages to the use of TiO2 in other sectors, such as plastics, in
relation to the packaging used for pharmaceutical products.

Social impacts

Employment impacts

Employment impacts cannot be estimated as they would largely depend on whether TiO2 would
remain an approved excipient. If reformulation became necessary, the large cost of reformulation
and variations to marketing authorisations could have an impact on the levels of employment in the
pharmaceuticals sector, particularly among smaller companies.

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Impacts on the welfare of consumers

The Carc Cat 2 harmonised classification for TiO2 could potentially have notable impacts on
consumer choice and welfare, depending on the action taken by the manufacturers of
pharmaceuticals and nutraceuticals. The following potential impacts should be noted:

• Loss of consumer products from the market: if a reformulation was required, it can be
considered certain that reformulation of some products would prove too costly with their
consequent removal from the market;

• Increased cost and loss of technical performance: the cost of reformulation would most likely
be passed on to consumers (patients);

• Loss of consumer satisfaction: clearly, if TiO2 was classified as a suspected carcinogen, its
continued use in medicinal products would cause significant confusion and alarm among
patients. If TiO2 was substituted, the unsightly appearance of medicinal products without any
real health benefit would cause dissatisfaction and reduce patients’ confidence in the quality of
the products. Moreover, TiO2 has a very high level of stability under UV light enabling further
protection of the APIs of medicinal products, as is the case with the capsule shells of opaque
capsules, for example. Its substitution (as well as its removal from the packaging) could lead to
shorter shelf lives and expiry dates for medicinal products;

• Adverse impacts on public health: whether TiO2 would be reformulated out of products or
would continue to be used with higher manufacturing costs, ultimately the increased cost of
medication would be passed on to the national health services of EEA Member States. If
reformulation took place, pharmaceutical manufacturers might choose to use a potential TiO2
replacement with a less well understood safety profile and/or shorter history of use, thereby
increasing the risk of harm to consumers. In addition, the use of TiO2 alongside other colourants
enables pharmaceuticals manufacturers to produce medicinal products with a great variety of
colours. Coloured pharmaceutical products are highly desirable, since they support brand
identification and reduce the potential for medication errors. Without TiO2, the available colour
palette would be much more limited and as the number of possible colour options for
pharmaceutical products decreases, the probability of medication errors increases.

Competitiveness and competition impacts

Impacts on the competitiveness of EEA-based enterprises

EEA pharmaceutical companies also sell their medicinal products outside the EEA. An increase in
their cost of manufacture and their market prices would lead to lower sales figures outside the EEA.

Impacts on intra-EEA competition

Particularly for SMEs it would be difficult to invest in higher safety requirements for manufacturing,
or in reformulating products. It could be that some smaller companies would prove unable to hold
on to their full portfolio or face the risk of business closure. A concentration of the business activity
to some larger companies would be a possibility. The scale of such effects would crucially depend
on whether TiO2 would remain an approved excipient.

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4.4.5 Cosmetics
Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the TiO2 is widely used as a colourant as the only white base providing
application proper coverage available for all type of formulations, as an opacifier
or as UV filter and is chosen due to its safety, efficacy and
performance. TiO2 is one of the few globally approved UV
filters/sunscreen actives which are of relevance for global
formulations. TiO2 is regulated under the European Cosmetic
Products Regulation as a cosmetic colourant (CI 77891, Annex IV)
approved for all cosmetic products without any restrictions and as a
UV filter (Annex VI) with a maximum concentration of up to 25%.

Estimated TiO2 tonnage Relatively low (compared to uses such as paints, plastics, etc.) – less
used than 1% of total EEA consumption of TiO2 (but note below the
important impacts on a multitude of cosmetic products).

Estimated tonnage of According to Cosmetics Europe, a search in the Mintel Global New
products that contain TiO2 Products Database (GNPD) indicated that over 20,000 cosmetics
products launched in the last 5 years contained TiO2. This is over
10% of all European cosmetic product launches included in this
database. More detailed survey data from Cosmetics Europe
membership has not been made available.

Estimated value of markets Information specific to TiO2-based cosmetic products is not available.
More widely, the European cosmetics and personal care market was
valued at €77 billion at retail sales price in 2015 and is the largest in
the world. Skin care products are the largest segment with a total
value of €19.9 billion while the value of decorative cosmetics stands
at €10.7 billion per year (Cosmetics Europe, 2016b).

Estimates of Gross Value According to Cosmetics Europe, the cosmetics industry brings at least
Added €29 billion in added value to the European economy every year, of
which approximately €8 billion is contributed directly by the
manufacture of cosmetic products (the remaining €21 billion is
generated indirectly through the supply chain).

Number of users of TiO2 There are more than 5,000 enterprises manufacturing cosmetics in
Europe (source: Cosmetics Europe).

Presence of SMEs The vast majority of cosmetics companies are SMEs. In 2015, there
were 4,605 SMEs manufacturing cosmetics in Europe (source:
Cosmetics Europe).

Number of stakeholders that Three key trade associations have participated, Cosmetics Europe,
participated in consultation European Federation for Cosmetic Ingredients (EFfCI) and ASPA-
INGRECOS (the French member of EFfCI) plus a small number (<5) of
individual companies.

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Locations of stakeholders Cosmetics Europe represents companies across the EU. Its
that participated in membership consists of 27 national associations of the EU Member
consultation States and beyond, 17 major international companies, four
supporting association members, four supporting corporate
members and three correspondent members. Cosmetics Europe
represents more than 4,000 companies throughout the EU via the
active representation of its member national associations. EFfCI
represents more than 100 cosmetic ingredients companies in Europe.

Further downstream, there are 20,100 enterprises involved in the

wholesale of cosmetics (with significant numbers in Italy, Spain and
France) and 45,700 specialist stores and 55,000 outlets retailing
cosmetics. About half a million hairdressing and beauty salons (the
majority of which are also SMEs or micro-enterprises) also rely on the
use of cosmetics; the number of European spas is also growing and
may be a source of inward investment to Europe in the form of
“wellness tourism” (source: Cosmetics Europe).

Employment in the sector The cosmetics industry supports at least 2 million jobs, including
direct, indirect and induced economic activity. Of these, 152,000
workers are employed directly in the manufacture of cosmetic
products, and around 1.6 million workers are employed indirectly in
the cosmetics value chain (source: Cosmetics Europe).

Relevant legislation

Table 4–18 summarises the legislation that would be of relevance to the use of TiO2 in cosmetics
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1.

Table 4–18: Relevance of different regulatory instruments and voluntary initiatives to cosmetics
applications of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to cosmetics
CLP Only in receiving and handling raw materials
Carcinogens and Mutagens at Work No
Waste Framework Potentially
Industrial Emissions Potentially
REACH No
Cosmetics Yes
Toy Safety Potentially. Impact not automatic
Food Contact Materials No
Food Additives Yes
TiO2 used in cosmetics as colorant has to meet the
criteria purity of E171 also used in food
Medicinal Products No
Construction Products No
Biocides No (but Ag/Ti preservatives listed in Cosmetic
Products Regulation)
Medical devices No
RoHS No
Tobacco additives No

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Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of cosmetics

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
cosmetic manufacturers to use TiO2 and place on the market TiO2-containing formulations:

• Restriction under the Cosmetic Products Regulation and cost of securing an exemption: first
and foremost, the use of TiO2 is subject to the provisions of the Cosmetic Products Regulation.
Article 15(1) of the Regulation prescribes that “The use in cosmetic products of substances
classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No
1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in
cosmetic products where the substance has been evaluated by the SCCS and found safe for use in
cosmetic products. To these ends the Commission shall adopt the necessary measures in
accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this
Regulation”. Therefore, the immediate effect of the Carc Cat 2 harmonised classification would
be an initiation of a risk management procedure that can result in a ban on the use of the
substance (NB. classification under the CLP Regulation does not mean an automatic ban on the
use of a CMR substance in cosmetic formulations).

This risk management procedure may result in an exemption from the generic ban prescribed by
the Regulation. To secure such an exemption, the substance must be evaluated by the Scientific
Committee on Consumer Safety (SCCS) and found safe for use in cosmetic products. In
comparison to a Carc Cat 1B harmonised classification, this burden is lower (for a Carc Cat 1B
classification an exemption requires that a series of stringent conditions be fulfilled, i.e. that (a)
the substance complies with the food safety requirements as defined in Regulation (EC) No
178/2002; (b) there are no suitable alternative substances available; and (c) an application is
made for a particular use of the product category with a known exposure). In addition, the
evaluation by the SCCS of a Carc Cat 1B ingredient would need to take into overall exposure
from other sources and vulnerable population groups.

The use of TiO2 in cosmetic products is longstanding and an extensive toxicological data set is
available. The safety of TiO2 has been acknowledged by a wide range of scientific and regulatory
bodies throughout the world (e.g. EU EFSA, US FDA), resulting in its safe use in various products,
including food products. For cosmetic products, the SCCS has reviewed and concluded on the
safety of TiO2 on various occasions. The nano-form of TiO2 has been reviewed by the SCCS in
201372 and has been authorised for use as a UV filter in cosmetic products in August 2016. The
exemption procedure would require the industry to invest time and resources to screen
potential alternatives and to prepare a new safety dossier on the nano-scale and the non-nano
form of TiO2 for submission to the SCCS.

It is to be noted that such exemptions are not granted in a procedural or (semi-)automatic

manner, i.e. each application would be very carefully reviewed on whether an exemption is
actually warranted. There is precedence where applications for exceptions were not granted
although (in industry´s view) all conditions had been fulfilled.

72
Available at http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf
(accessed on 21 October 2016).

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In case an exemption would not be granted for use of TiO2 in cosmetic products, a very large
number of cosmetic products would be impacted and a very useful, safe ingredient would be
lost. Only two minerals UV-filters are on the positive list for use in cosmetics, TiO2 and ZnO;

• Consumer perceptions: if TiO2 was to be removed from cosmetic formulations, the

performance of products might not meet consumers’ needs and expectations and may thus lead
to loss of business for the affected product categories. If an exemption was granted for the
continued use of TiO2, the communication of such classification to the public (and the presence
of TiO2 in the list of ingredients) would pose the risk of causing unnecessary alarm among
consumers who may wish to avoid the use of cosmetic products that contain a carcinogenic
substance.

• Toys: Carc Cat 2 substances are not permitted to be used in toy cosmetics placed on the EEA
market, but possibilities for exemptions exist on the basis of (a) concentration, (b)
(in)accessibility of the substance. The SCCS would review the use of the substance and would
conclude as to whether it might be appropriate to list it in Appendix A of the Toy Safety Directive
(List of CMR substances and their permitted uses). Even if the substance were to be listed, the
continued presence of the substance in toys could cause reputational damage to the toy
manufacturers and thus they may put pressure on paint manufacturers to reformulate their
products to substitute TiO2; and

• Setting precedence and an example for action by other jurisdictions: similar regulatory action
in other global regions could follow. This would further impact upon exports of EEA-made
cosmetics.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based cosmetic manufacturers,
including:

• Cost of reformulation to eliminate TiO2: there is currently no guarantee that suitable

alternatives for TiO2 which are technically and economically feasible with the same efficiency can
be found. TiO2 has an excellent safety profile, as recently confirmed by the SCCS for its current
cosmetic uses. Other colourants, opacifiers and UV filters may be subject to scrutiny themselves
or less preferred by consumer (groups). In addition, these other materials may not be a suitable
technical alternative for TiO2 based on their function and task in the finished product,
performance of the finished product and conditions of use. There is currently no guarantee that
suitable alternatives which are technically and economically feasible with the same efficiency as
TiO2 can be found.

Reformulation of cosmetic products to substitute critical ingredients such as TiO2 cannot simply
be a one-to-one replacement and would require full R&D involvement including formulation,
packaging and stability assessment and conducting a regulatory and safety assessment. This
could be expected to lead to costs in the range of tens of millions of Euros spread over the
typical lead time for such reformulation programmes (3-8 years); and

• Compliance with waste management regulations: the following list shows the types of wastes
that might become relevant to hazardous waste management regulations in different Member
States. The scale of these impacts cannot be quantified due to lack of information

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− 07 06 11* Sludges from on-site effluent treatment containing hazardous substances;
and
− 15 01 10* Packaging containing residues of or contaminated by hazardous substances
(for empty TiO2 pigment packaging).

Economic impacts on downstream users (industrial and professional)

Impacts on professional users of cosmetic products would depend on whether SCCS (re-)approves
the use of TiO2 in cosmetic formulations. In addition, waste management of waste packaging that
contains TiO2 residues may be classified as hazardous and its handling might need to change.

Social impacts

Employment impacts

A discussion on the overall effects on employment across the EEA cannot be provided due to the
lack of specific information. The scale of any impacts would depend on whether the SCCS (re-
)approves the continued use of TiO2 in cosmetic formulations.

Impacts on the welfare of consumers

The Carc Cat 2 harmonised classification for TiO2 could have notable impacts on consumer choice
and welfare if it affected industry’s ability (or willingness) to use the product. The following
potential impacts should be noted:

• Loss of certain types of consumer products from the market: a restriction on the use of TiO2
would have an impact on the market availability of product variants used by consumers on a
daily basis, e.g. skin care products, toothpaste, make-up products (foundation, eye shadow,
depilatory products, etc.);

• Increased cost and loss of technical performance: replacements for TiO2, if available, could
make products costlier, e.g. due to increased manufacturing costs, increased ingredient costs
and higher dosage levels. For example, in sunscreens, TiO2 can be replaced by ZnO but the two
substances are different in terms of efficiency (and ZnO is a substance with an unfavourable
ecotoxicity hazard profile). Sunscreens would require increased UV filter dosages thus their
formulations would cost more, and would be undesirably whiter on the skin (in comparison to
nano-scale TiO2). Furthermore, alternative pearlescent pigments may not be available;

• Loss of consumer satisfaction: without TiO2 as a whitening pigment, make-up products and
other cosmetics would be less efficient and/or appealing for consumers; and

• Adverse impacts on public health: an important application of TiO2 is its use as a UV filter to
protect the public from skin cancer following exposure to the sun. Two mineral UV filters are
authorised under the Cosmetic Products Regulation: TiO2 and ZnO. ZnO contributes mainly to
UVA protection and has a relatively low performance against UVB radiation whilst TiO2 provides
UVB protection which is a major contributor to high Sun Protection Factor (SPF) products73.

73
Commission Recommendation 2006/647/EC notes that UVB radiation is the main contributor to increased
cancer risk, although, the risk generated through UVA radiation cannot be neglected. Furthermore, UVA
radiation is cause of premature ageing of the skin. Sunscreen products should contain both UVB and UVA

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Competitiveness and competition impacts

Impacts on the competitiveness of EEA-based companies

Whilst any restriction on the use of TiO2 in cosmetic products would apply equally to EEA-made and
non-EEA-made cosmetics placed on the EEA market, the EEA cosmetics industry is a major exporting
force and the proposed classification would cause increased manufacturing costs and thus loss of
competitiveness on the global level.

In case of classification of TiO2, there would be detrimental competitive effects in all cases. Even if
an exemption was granted and the use of TiO2 was allowed to continue EEA-based cosmetics
manufacturers would be disadvantaged because importers who manufacture outside of the EEA
area could manufacture their products at a lower cost.

In the longer-term, since many jurisdictions globally follow directly or indirectly the EEA Cosmetic
Products Regulation for products placed on their markets, any restriction in the EEA might eventually
result in similar action (and thereby loss of business, but also a more level playing field) elsewhere.

Impacts on intra-EEA competition

SMEs might be placed at a greater disadvantage by a TiO2 classification. Larger EEA-based

manufacturers of cosmetic products with a greater capacity to cover the costs of reformulation or
capability of moving certain production processes outside of the EEA would be able to reformulate
or relocate as they see fit and maintain a better competitive position in comparison to SMEs or
companies without an international footprint.

4.4.6 Elastomers
Limited information is available on the use of TiO2 in rubber products. In general terms, the
classification might increase some production costs (worker protection) but the incentive to
substitute TiO2 would be weak, particularly as the rubber industry does not supply formulations to
the general public. Where TiO2 is used as a pigment in non-black/coloured rubber components
(General rubber goods (GRG)), it would be difficult to identify a technically equivalent pigment. On
the other hand, tyres with white sidewalls containing TiO2 pigment could be replaced by tyres with
black sidewalls without any loss of performance. For other rubber applications where TiO2 is used as
a filler (e.g. in food-contact rubber articles for repeated use) the socio-economic importance of the
substance is unclear and thus impacts from its substitution cannot be described.

In terms of waste management, the relevant sub-chapters of the LoW would appear to be 07 02
Wastes from the MFSU of plastics, synthetic rubber and man-made fibres and 07 07 Wastes from the
MFSU of fine chemicals and chemical products not otherwise specified. Relevant ‘mirror entries’
could include those relevant to sludges containing hazardous substances (07 02 11*and 07 07 11*),
07 02 14* Wastes from additives containing hazardous substances and 07 02 16* Wastes containing
hazardous silicones. TiO2 packaging would also become hazardous waste, depending on the level of
residue in it, under entry 15 01 10* Packaging containing residues of or contaminated by hazardous
substances. On the other hand, rubber waste arising from the mechanical treatment of waste (for

protection. An increased sun protection factor (i.e. mainly UVB protection) should include an increase in
the UVA protection as well. Therefore, the protection against UVA and UVB radiation should be related.

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example sorting, crushing, compacting, pelletising) not otherwise specified (19 12 04) is classified as
‘absolute non-hazardous’. No information has been obtained through consultation.

The socio-economic parameters of rubber applications for TiO2 are not known, although it is
understood that the majority of GRG manufacturers are SMEs (>95%).

4.4.7 Pigment and pigment preparation manufacture

Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the TiO2 finds wide application in the pigments and pigments preparation
application sector, e.g. for both organic and inorganic pigments (including effect
pigments/pearlescent pigments) as constituent and for finishing and
coating (VdMi, 2016). Pigments and pigment formulations are the
basis of colouring a wide range of products: paints, coatings, plastics,
ceramics, rubber, etc. TiO2 is also used as a raw material for the
synthesis of Complex Inorganic Coloured Pigments (CICPs), which are
used widely in the ceramic sector and the plastics sector. For CICPs
in particular specific market descriptors are available and are
presented below. It should be noted that some pigment-related
discussion may appear elsewhere in this section (e.g. artists’ colours
are discussed under inks).

Estimated TiO2 tonnage Data encompassing all pigments are not available. Pigments and
used preparations are ultimately used in the other applications discussed
here and thus are considered under their respective applications.

Estimated tonnage of As above, all-encompassing data are not available although for CICPs
products that contain TiO2 a specific estimate of 11 ktonnes/y is available. The volume of
pigments/formulations produced by manufacturers who have
provided information to the questionnaire on the potential impacts
from the originally proposed Carc Cat 1B harmonised classification is
in the range of tens of thousands of tonnes.

Estimated value of markets The market value of pigments/preparations produced by

manufacturers who have provided information to the questionnaire
investigating potential impacts from the originally proposed Carc Cat
1B classification is in the range of €50-75 million/y with an additional
€35 million/y specifically relating to CICPs. The total annual turnover
of this sector is about €8.1 billion (Eurocolour, 2016; VdMi, 2016).

Estimates of Gross Value No data available.

Added
Number of users of TiO2 Eurocolour is the umbrella association for manufacturers of
pigments, dyes and fillers in Europe and, all together, it represents
about 100 companies within Europe (Eurocolour, 2016). For CICPs in
particular, an estimated 40 TiO2 users exist in the EEA with a further
30 manufacturers of ceramic decorating/glass colours.

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Presence of SMEs 75 % of Eurocolour’s members are SMEs (Eurocolour, 2016). Among
CICP manufacturers, 50-60% are SMEs, while the share of SMEs
among ceramic decorating/glass colours exceeds 80%.

Number of stakeholders that <10, including the industry associations Eurocolour, VdMi (Germany),
participated in consultation and a REACH Consortium but several pigment manufacturers may be
included under other applications below.

Locations of stakeholders Not provided here due to small number of participants. As regards
that participated in CICP manufacturers, these are located in Germany, Italy, the
consultation Netherlands, Spain and the UK with the most important
manufacturers being located in Spain and Italy. Manufacturers of
other ceramic pigments can be found in (at least) Belgium, Germany,
Italy, the Netherlands, Poland, Portugal and Spain.

Employment in the sector Eurocolour members have a total of 23,000 employees in Europe.
CICP manufacturers have a workforce of 2,000 employees.

Relevant legislation

Table 4–19 summarises the legislation that would be of relevance to the use of TiO2 in pigments
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1. The table distinguishes between the manufacture of pigments and
their downstream consumption.

Table 4–19: Relevance of different regulatory instruments and voluntary initiatives to pigments
applications of TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to pigment manufacture Relevant to pigment use
CLP Yes Yes
Carcinogens and Mutagens at Work No No
Waste Framework Potentially Potentially
Industrial Emissions Potentially Potentially
REACH No Article 31 only
Cosmetics No Yes
Toy Safety No Yes
Food Contact Materials No Yes
Food Additives No Yes
Medicinal Products No Potentially
Construction Products No Potentially
Biocides No No
Medical devices No No
RoHS No Potentially
Tobacco additives No Potentially

Impacts on the marketing and use of titanium dioxide-containing products

The focus here is on pigment manufacturers. Impacts on downstream users of pigments (e.g. paint
manufacturers, plastic masterbatch manufactures, etc.) are examined elsewhere in this document.

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Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
pigment manufacturers to use TiO2:

• Company policies and process and product requirements: for some companies the
classification of a raw material as a suspected carcinogen could give an incentive to discontinue
its use. Also, there are products that have been marketed as alternatives to pigments bearing
hazardous properties (e.g. chrome-based pigments) and as such the use of a raw material
classified as a suspected carcinogen could make such products unmarketable; and

• Customer perceptions: the Carc Cat 2 harmonised classification would result in pigment
formulations being similarly classified and being stigmatised irrespective of the risk of exposure.
This would disincentivise downstream users from using them as they would also need to take
measures for the control of the exposure of their workers to TiO2. Beyond emotional responses
to the presence of a Carc Cat 2 substance, customers may also need to adhere to Restricted
Substance Lists, particularly in the case of manufacturing consumer products, and thus would
avoid using TiO2-based pigments to prevent any negative impact on their reputation.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based pigment manufacturers,
including:

• Cost of reformulation to substitute TiO2: pigment and pigment preparation manufacturers may
be able to reformulate their products; however, this would be at the expense of performance,
the loss of variety of colour and functionality and at a considerable cost. Some past attempts to
implement alternatives have been unsuccessful; for example, alternatives have shown poor
brilliance of fluorescent colours. Some manufacturers, however, may be forced to reformulate
as their internal policies may prevent them from using a suspected carcinogen, even if its
performance cannot be matched by the available alternatives. No alternative for TiO2 is
available for the pearlescent pigments (specific properties mandatory for the expected
properties and performance profile). Neither is any alternative available for TiO2 as a raw
material for the synthesis of CICP (VdMi, 2016b).

Some estimates on the costs of reformulation have been provided and these would clearly
depend on the number and variability of the affected products. For instance, for one pigment
manufacturer, the cost would be ca. €200 per formulation and considering the number of
formulations affected (more than 20,000 formulations for synthetic resins and plastics), the total
cost could exceed €4 million. Another manufacturer expects a reformulation cost in the range
of €50,000-100,000. These costs would consume funds intended for other planned R&D and for
supporting regulatory-driven initiatives aimed at reducing or eliminating other molecules with
well-characterised and more widespread risks.

As detailed in Annex 2, known alternatives are much less efficient and thus would require higher
loadings to achieve the necessary opacity with negative impacts on cost, technical quality and
effectiveness, and ultimately the competitiveness, of the product;

• Compliance with waste management regulations: as previously discussed, TiO2 packaging that
contains residues at a level above 1.0% would be classified as hazardous. Some information on
wastes generated during the manufacture of pigments is shown in the table below based on a

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small number of questionnaire responses. It would appear that significant volumes of waste
pigment could be classified as hazardous following the classification of TiO2 as Carc Cat 2 (grey
entry in the table). Filter waste has also been identified as a relevant waste type although the
waste code obtained from consultation is doubtful (it is assumed that the correct one most likely
is 15 02 03 absorbents, filter materials, wiping cloths and protective clothing other than those
mentioned in 15 02 02 which would change to its ‘mirror’ entry 15 02 02* absorbents, filter
materials (including oil filters not otherwise specified), wiping cloths, protective clothing
contaminated by hazardous substances following the introduction of the Carc Cat 2 harmonised
classification for TiO2. Specific information on the associated costs is not available but it is
certain that costs of administration, handling, labelling and disposal would increase; and

Table 4–20: Relevant waste streams for the use of TiO2 in pigments manufacture
Process Type of Waste entry in Typical Example
Is TiO2 Current waste
generating waste LoW TiO2 volume
inhalable? management
waste content generated*
Manufacture Pigment 16 03 04 From <1% 400 t/y Yes Non-hazardous
of pigment waste Inorganic to >>1% Landfilling
preparations wastes other
than those
mentioned in
16 03 03
(‘mirror non-
hazardous’)
Air 08 02 01 >1% 20 t/y Yes Non-hazardous
extraction Waste coating
filter waste powders
(‘absolute non-
hazardous’)
* data based on individual responses to questionnaire

• Increased administrative burden: if a Carc Cat 2 substance is present in a mixture at a

Social impacts

Employment impacts

Quantified estimates across the pigment manufacturing industry cannot be provided due to the
relatively small number of companies that have contributed information by means of a completed
questionnaire. However, among those companies that have responded and on the assumption that
a Carc Cat 1B harmonised classification might be introduced, estimates of potential job losses ranged
between zero and 25% of their workforce. Any job losses under a less severe Carc Cat 2 harmonised
classification would arguably be more modest.

Impacts on the welfare of consumers

Pigments and pigment preparations are generally not sold to consumers (with some exceptions,
such as artists’ colours and the like which are considered in Section 4.3.4). Impacts may arise in
relation to the use of consumer products that contain TiO2-based pigments but these are discussed
under the other sector-specific applications presented elsewhere in this report.

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Competitiveness and competition impacts

Impacts on the competitiveness of EEA-based companies

EEA-based pigment manufacturers (and their customers) would see their products (a) perform
worse, and (b) cost more to manufacture, if reformulated to eliminate TiO2. The majority of
products are tailor-made, are developed for specific applications and are approved by customers.
New formulations would not hold approvals and would need to be tested and qualified by
customers. This would require time and be costly. Exports of EEA-made pigments would become
less competitive as non-EEA manufacturers supplying non-EEA markets would not need to declare or
be restricted by their continued use of TiO2.

If processed TiO2 (e.g. masterbatches in which TiO2 is inaccessible inside the plastic matrix) were
freely imported, the European downstream users (e.g. producer of masterbatches, pigment
preparations) would be confronted with a competitive disadvantage in the home market as well.

Under these circumstances the production of intermediates with TiO2 contents above 1.0% by
weight as well as the manufacture of finished products outside the EEA might become more
appealing.

Impacts on intra-EEA competition

Within the EEA, SMEs would likely be disadvantaged vis-à-vis their larger counterparts because of
limited capabilities (R&D, marketing, equipment) in order to protect their workers and formulate
feasible alternatives. Large companies with wide ranges of products would be better placed to cope
with a loss of TiO2-containing products compared to smaller businesses which concentrate on a
smaller product portfolio.

4.4.8 Ceramics
Key market descriptors

The key economic parameters of the use of TiO2 are summarised below.

Importance of the TiO2 finds wide application in the ceramics sector at different levels
application of the supply chain:

1. As a raw material used upstream from the manufacturer of the

ceramic product, such as:
− Raw material in the manufacture of CICPs which find
ceramic applications (e.g. tiles);
− Pigment in formulations for ceramic products (tiles,
bricks), including specialist pigment (TiO2 used as an
additive for the development of yellow colour in digital
tile printing); and

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− Opacifier in frits74, glazes (that contain frits) and enamels
– enamels can find industrial uses but also consumer
uses (e.g. tableware);

2. As a raw material for the manufacturer of glazes that are used as

photocatalytic coatings on construction products (e.g. certain
ceramic wall tiles or roof tiles, some sanitaryware, and R&D in
tableware); and

3. As an impurity in essential raw materials used by ceramics

manufacturers. Examples include:
− TiO2 is present in natural clays used in nearly every
“classic” ceramic product (or body preparation), such as
ceramic tiles, sanitaryware and tableware;
− Roof tiles and bricks;
− Refractory products; and
− Abrasive products (NB. these also include non-ceramic
products).

Estimated TiO2 tonnage Low – less than 1% of total consumption. In the enamel industry, ca.
used 1,000 t/y are used (Cerame-Unie, 2016).

Estimated tonnage of Application EEA production

products that contain TiO2 Frits and related TiO2 mixtures 230 ktonnes/y
General ceramics products (tiles, Unknown
bricks, sanitaryware, tableware)

Estimated value of markets Application EEA market value

Frits and related TiO2 mixtures €130 million/y
European ceramic tiles and porcelain €9 billion/y
enamel manufacturing sector (based on
Cerame-Unie data)

Estimates of Gross Value GVA data are unavailable.

Added
The European ceramic tiles and porcelain enamel manufacturing
sector in Europe has a turnover of around €9 billion and ca. 1/3 of it is
associated with the Spanish ceramic tiles manufacturing sector.

74
Frits are ceramic compositions that have been fused in a special fusing oven, quenched to form a glass, and
granulated. Frits form an important part of the batches used in compounding enamels and ceramic glazes.
TiO2 is added to frits for opacity and to achieve the intended mechanical resistance of the glazed article.

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Number of users of TiO2 Application Number of TiO2 users
Frits 34 companies plus
affiliates
Enamel products (companies using enamel 100-150 companies
coatings on cookware, hot water tanks,
silos, ovens, cooktops, architecture, etc.)
Tiles and brick manufacturers (Cerame- >700
Unie members)

The ceramics industry as a whole encompasses about 2,000

companies.

Presence of SMEs Application SME presence

Frits Large majority
Enamel products 80%
White flatware, hollowware and cookware Large majority

Ceramics industry in general 80%

NB. Spain’s ceramic tile manufacturers: 75%

Number of stakeholders that 10-25, including two industry associations and a REACH Consortium.
participated in consultation

Locations of stakeholders Application Locations

that participated in Frits Belgium, Czech Republic, France Germany,
consultation Italy, the Netherlands, Spain, the UK. Most
important manufacturers are located in Spain,
Italy and Germany. More than 80% of frits and
related mixtures are produced in Spain
Tableware Very many small manufacturers can be found
on Mediterranean islands (Malta, Majorca)

Employment in the sector Application Number of workers

Frits 3,200
European sector of ceramic tiles and porcelain 45,000
enamel
European ceramics industry in general 200,000
(Cerame-Unie members)
Note: the Spanish sector of frits, inorganic pigments and
preparations employs more than 3,500 workers, with the majority
involved in frits manufacture. The number of workers in tile
manufacture in Spain is 15,000

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Relevant legislation

Table 4–21 summarises the legislation that would be of relevance to the use of TiO2 in ceramics
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1.

Table 4–21: Relevance of different regulatory instruments and voluntary initiatives to ceramics (frits,
enamels, tiles, consumer ceramics) applications of TiO2 following a harmonised classification of Carc Cat 2
by inhalation
Relevant legislation Relevant to ceramics
CLP Yes
Carcinogens and Mutagens at Work No
Waste Framework Potentially
Industrial Emissions Potentially
REACH No
Cosmetics No
Toy Safety No
Food Contact Materials Yes
Food Additives No
Medicinal Products No
Construction Products Potentially
Biocides No
Medical devices No
RoHS Potentially
Tobacco additives No

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of ceramics

Potential loss of markets

Impacts on the ability of the ceramics industry to use TiO2 and TiO2-containing materials from a Carc
Cat 2 harmonised classification can be summarised as follows:

• TiO2 impurities in raw materials: a Carc Cat 2 harmonised classification would not cause
particular concerns over TiO2 impurities in key raw materials, as its presence is generally at levels
below 1.0%. This would not be the case with a Carc Cat 1B classification because minerals such
as kaolin, ball clays, vermiculite, refractory materials and zircon which contain TiO2 impurities
above 0.1% wt. are raw materials relevant to the ceramics industry75;

• Market and consumer perceptions: due to the presence of TiO2 as an impurity in key raw
materials, nearly every “classic” ceramic product (or body preparation) such as tableware,
sanitaryware, tiles, bricks, roof tiles, clay pipes, etc. contains a certain (low) amount of TiO2.
Theoretically, some market losses could be expected on account of the customers’ and end
consumers’ reaction to the presence of a suspected carcinogen in ceramic products; this could

75
The main European trade association, Cerame-Unie, had undertaken an in-depth analysis of the issue of
TiO2 impurities. If one considers the classic composition used for the production of porcelain stoneware,
comprising up to 18% of china clay (kaolin) and 32% of plastic clay with a relative content of TiO2 impurities
of 0.3% and 0.5%75 which leads to a total amount of TiO2 in the final product of 0.21%. Considering all the
other raw materials used such as feldspar, quartz and talc, it can be estimated that the total TiO2 content
ranges between 0.163% - 0.375%, i.e. above 0.1% (Cerame-Unie, 2017).

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make them reluctant to use mixtures and articles that contain TiO2, even if firmly contained
within a ceramic matrix. In applications where ceramic and enamelled articles frequently come
into contact with the consumer, the presence of a suspected carcinogen could become difficult
to defend; and

• Regulatory requirements: as far as food contact materials and articles are concerned, Section
4.4.3 has discussed the implications of the existing harmonised and non-harmonised EEA and
national legislation on the use/presence of carcinogenic substances in food contact materials.
The proposed classification for TiO2 could have adverse effects on the marketing of ceramic and
enamelled articles that are used for food contact.

Potential increases in operating costs

There are several implications of a harmonised Carc Cat 2 classification which could increase the
manufacturing costs and thus impact the profitability of EEA-based fibre manufacturers, including:

• Cost of reformulation to eliminate TiO2: possibilities for reformulation are non-existent for
good reasons:

− TiO2 is an impurity in the main raw materials used by ceramics manufacturers; and
− Where used intentionally, TiO2 is an indispensable component of frits and thereafter the
glazes and enamels manufactured. It is important to note the close links of these
applications to the manufacture of inorganic pigments which are used in the
pigmentation of ceramic structures; and

• Compliance with waste management regulations: no information has been collected from
consultation. In general, the harmonised classification could increase the cost of waste
management for ceramics manufacturers as some types of waste generated during the
manufacturing phase might be classified as hazardous. Some potentially relevant waste types
include:

− 10 12 11* Wastes from glazing containing heavy metals; and

− 15 01 10* packaging containing residues of or contaminated by hazardous substances
(for empty TiO2 packaging).

However, given that raw materials typical contain TiO2 impurities in concentrations below 1.0%
by weight, waste management implications would likely be limited.

Economic impacts for downstream users of ceramics

The above discussion on impacts covers adequately the entirety of the supply chain for ceramics
with the exception of consumers (discussed further below).

Social impacts

Employment impacts

It is not possible to provide a specific estimate on job losses. The number of jobs could be at risk as
a result of lost competitiveness would be notably lower than for a Carc Cat 1B classification.

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Impacts on the welfare of consumers

Although in principle use of TiO2 would be allowed to continue in the EEA, the proposed
classification would make the use of the substance costlier in the EEA. From a more theoretical
perspective, complete loss of TiO2-containing ceramic products from the consumer market could
have adverse consequences:

• The available range of colours would diminish. TiO2 allows tile manufacturers to transform the
clay body into a white colour. This either allows the product to be white or means that it can be
other light colours (white, yellow, metallic, grey, etc.). Alternative pigments cannot achieve the
same colouring; ceramic tiles coloured with orange pigments and with a characteristic brown
tonality would disappear; and

• The range of available tile products would be affected. Certain roof tiles/bricks could no longer
be produced. It would no longer be possible to manufacture enamelled hot water tanks/boilers
(N.B. ca. 90% of all hot water tanks used in Europe are enamelled hot water tanks). Without
TiO2-containing enamels, it would no longer be possible to manufacture enamelled cookware or
enamelled steel/cast iron sanitary ware. Replacement of enamelled hot water tanks with
stainless steel ones would not be affordable.

Competitiveness impacts

Based on available information, impacts on the competitiveness of EEA-based operators would likely
be limited as the increases to manufacturing costs are expected to be modest. In addition, in
comparison to a Carc Cat 1B classification the incentives for relocation of production would be far
less strong.

4.4.9 Glass
Key market descriptors

The key economic parameters for the use of TiO2 are summarised below.

Estimated TiO2 tonnage used Low - less than 1% of total.

Estimated tonnage of products No data specific to TiO2. More generally, in 2016, the EU-28
that contain TiO2 glass production reached a volume of 34.5 million tonnes of
which 956,000 tonnes were special glass76.

Estimated value of markets No data.

Estimates of Gross Value Added No data.

Number of users of TiO2 70 (special glass); 1,200 glass manufacturers across the EU77.

76
Information available at: http://www.glassallianceeurope.eu/images/cont/panorama-2016-eu28_file.pdf
(accessed on 29 August 2017).

77
Information available at: http://www.glassallianceeurope.eu/images/cont/gae-leaflet-may-
2012_1_file.pdf (accessed on 20 October 2016).

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Presence of SMEs 10% (special glass).

Number of stakeholders that <5.

participated in consultation

Locations of stakeholders that Brussels (but with members from Austria, Bulgaria, France,
participated in consultation Germany and the UK using TiO2 or TiO2-based products).

Employment in the sector No data specific to TiO2 use. More generally, the EU-28 glass
industry employs about 185,000 people (incl. processors)78.

Relevant legislation

Table 4–22 summarises the legislation that would be of relevance to the use of TiO2 in glass
applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification. Additional
detail is available in Annex 1.

Table 4–22: Relevance of different regulatory instruments and voluntary initiatives to glass applications of
TiO2 following a harmonised classification of Carc Cat 2 by inhalation
Relevant legislation Relevant to glass
CLP Yes
Carcinogens and Mutagens at Work No
Waste Framework Potentially
Industrial Emissions Potentially
REACH No
Cosmetics No
Toy Safety No
Food Contact Materials Yes
Food Additives No
Medicinal Products No
Construction Products No
Biocides No
Medical devices No
RoHS Potentially
Tobacco additives No

Impacts on the marketing and use of titanium dioxide-containing products

Due to the absence of regulation that directly affects the use of Carc Cat 2 substances in the
manufacture of glass products, adverse impacts from the harmonised classification of TiO2 would be
low and probably limited to a potential tightening of occupational exposure measures. Glass articles
do not contain TiO2 per se; as such no adverse reaction of consumers might be expected. Such
impacts are not possible to define with any degree of accuracy.

Similarly, due to the absence of TiO2 in glass articles, the Carc Cat 2 harmonised classification would
not have implications for the management of waste glass, but might affect waste generated during
glass manufacture, for example wastes falling under the following LoW entries:

78
Information available at: http://www.glassallianceeurope.eu/en/industries (accessed on 20 October 2016).

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• 10 11 09* Waste preparation mixture before thermal processing, containing hazardous
substances;
• 10 11 15* Solid wastes from flue-gas treatment containing hazardous substances;
• 10 11 17* Sludges and filter cakes from flue-gas treatment containing hazardous substances;
• 10 11 19* Solid wastes from on-site effluent treatment containing hazardous substances; and
• 15 01 10* Packaging containing residues of or contaminated by hazardous substances.

Reformulation to eliminate or reduce TiO2 presence would not be possible in glass products if the
same properties are required. TiO2 is not substitutable as a raw material, be it for glass manufacture
or decoration, because its use is essential to achieve a certain optical quality/property of the glass
which cannot be achieved otherwise. If a suitable substitute could be found (this is very unlikely),
the reformulation would be associated with costs far higher than the compliance costs.
Furthermore, even if an alternative to TiO2 use could be found, the formulation change may for
instance result in damage to the mould or require larger tubes. In other words, substitution would
not only be a matter of a new composition.

Social impacts

Employment impacts

No estimates can be provided.

Impacts on the welfare of consumers

TiO2-based glass offers significant health benefits – medical/public health protection, drug safety
(inertness of medical drug containers), eye protection and visual correction, high end medical
applications that save lives. However, if manufacture of these products in the EEA would be affected
as a result of the repercussions of the Carc Cat 2 harmonised classification for TiO2, they would be
imported as finished articles from outside the EEA and consequently consumers would still have
access to them.

If consumers still wished to buy EEA-made products which did not contain TiO2, they would be
forced to buy:

• Less effective optical products (thicker, less clear);

• Products which are less resistant to abrasion and hardness on the surface; and
• Products with spectral characteristics that would not meet the requirements of current
regulations, in particular in the pharmaceutical sector, where protection of medicinal products
from UV radiation would be worse.

Competitiveness and competition impacts

Manufacturing costs for EEA-based glass manufacturers could somewhat increase as a result of the
Carc Cat 2 harmonised classification for TiO2 but loss of competitiveness vis-à-vis their non-EEA
counterparts would likely be limited.

4.4.10 Medical devices

Key market descriptors

Information available is limited to dental restoration products. The Federation of the European
Dental Industry (FIDE) represents nearly 600 companies located in Austria, Belgium, Denmark,

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France, Italy, Luxembourg, the Netherlands, Spain and the UK. Among them, Germany, Italy, the UK,
France and Spain are the most important locations for manufacturers of dental restoration products
that contain TiO2. Many companies (85 %) of the dental industry in Europe are SMEs.

The volumes of TiO2-based products manufactured range from a few hundred kilograms to 100
tonnes per company per year.

In addition, most devices contain small amounts of TiO2 as pigment in plastic parts, as discussed
above.

Relevant legislation

Table 4–23 summarises the legislation that would be of relevance to the use of TiO2 in medical
device applications in the EEA, after the adoption of a Carc Cat 2 harmonised classification.
Additional detail is available in Annex 1.

Table 4–23: Relevance of different regulatory instruments and voluntary initiatives to medical devices
(dental restoration materials) applications of TiO2 following a harmonised classification of Carc Cat 2 by
inhalation
Relevant legislation Relevant to medical devices
CLP Only in receiving and handling raw materials
Carcinogens and Mutagens at Work No
Waste Framework Potentially
Industrial Emissions Potentially
REACH Potentially
Cosmetics No
Toy Safety No
Food Contact Materials No
Food Additives No
Medicinal Products No
Construction Products No
Biocides No
Medical devices No
RoHS Potentially
Tobacco additives No

Impacts on the marketing and use of titanium dioxide-containing products

Economic impacts for manufacturers of medical devices

Potential loss of markets

A Carc Cat 2 harmonised classification would have the following impacts on the ability of EEA-based
medical devices manufacturers to use TiO2 and place on the market TiO2-containing devices:

• Restrictions under the new Medical Devices Regulation: as opposed to CMR Cat 1A and 1B
substances, the new Medical Devices Regulation (EU) 2017/745 does not include any
concentration limit or labelling requirement for devices containing a Carc Cat 2 substance. As
such, the Regulation would not restrict the use of TiO2;

• Patient perceptions and market pressures: without labelling, the average patient would not
become immediately aware of the presence of TiO2 in the medical devices needed for his or her
treatment. As such, it would be unlikely that negative perceptions might develop. However,

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consumers might become aware of the new hazard classification of the substance and
potentially through information campaigns by NGOs, the presence of TiO2 in medical devices
might become more widely known. This could lead to negative perceptions among members of
the public.

In addition, medical devices are not excluded from the requirements of the REACH Regulation.
Substances and mixtures which are used in medical devices are comprehensively under an
obligation to be registered and approved as appropriate. Medical devices are only exempted
from REACH Title IV (Information in the Supply Chain) if they are used invasively or used in direct
physical contact with the human body. This means that medical devices, such as dental fillings,
that are introduced directly into the tooth by the dentist are exempted from REACH Title IV;
however, Title IV would apply if the medical device is processed by a dental technician before
application on the patient. This implies a lot of work without additional benefit for the patients
(German Medicines Manufacturers Association, 2016) and could potentially lead to reluctance to
use TiO2-containing materials.

Potential increases in operating costs

Cost of substitution of TiO2: although the Medical Devices Regulation would not require or instigate
the substitution of TiO2 from medical devices, the Carc Cat 2 harmonised classification would
encourage manufacturers of devices to seek alternatives. Whilst information for a variety of devices
containing TiO2 is not available, by way of example, substitution of TiO2 in dental restoration
products is discussed here.

In the field of dental restoration products, the replacement of TiO2 by another white pigment is not
feasible, because alternatives either do not achieve the same shading effect or must be used in
much higher concentrations, which could affect the performance of the product or result in
undesired toxicological effects compromising the biocompatibility of the products (German
Medicines Manufacturers Association, 2016). Some alternative white pigments are hazardous (e.g.
ZnO in respect of the aquatic environment) or show similar inhalation hazards as TiO2, based on their
particle size.

Due to their poor refractive indices, the loading of the alternatives would probably increase by a
factor of 10-100 in comparison to TiO2. This would consequently mean the use of a lower polymer
loading. This change to the formulation would lead to significant changes to the physical properties
of the materials to the extent that they would no longer meet the existing requirements.

In practice, without TiO2, the aesthetic restorative treatment would no longer be feasible in Europe
because TiO2 is an essential basic element for the colour scheme and the adjustment of translucency
and opacity of the materials. The result would be that essential materials could no longer be
produced. This would result in the complete re-development of many products involving significant
effort:

• Performance and aesthetics of products would need to be maintained and verified. TiO2
safeguards the stability and hygienic properties of the products and for dental impression
materials helps make the impressions scannable (e.g. allows the easy scanning of impressions in
the digital workflow for producing indirect restorations);

• Handling properties (usability of products) would have to be demonstrated;

• The shelf-life of products would need to be verified (this step alone can take several years);

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• Possibly, biological re-evaluations would be needed including animal testing according to ISO
10993-series79 and ISO 740580; and

• Possibly clinical evaluations (including clinical studies) would be needed. These re-evaluations
would be needed to verify the fulfilment of essential requirements of the Medical Devices
Directive to prepare a new declaration of conformity (EC marking).

Only after all these activities could reformulated products be brought onto the market to replace the
existing product portfolio in the EEA. As there are many products that would be affected, the
aforementioned activities would take years and be accompanied by significant costs for each
product. Finally, the replacement of TiO2 would require re-registrations in some non-EEA countries
which could take additional years and lead to additional high costs.

Overall, substitution of TiO2 in dental impression materials, particularly in the absence of direct
regulatory pressure towards it, would not be a feasible proposition.

Compliance with waste management regulations: waste management legislation would appear to
have limited impact. The only ‘mirror’ entries that are of relevance to the provision of healthcare to
humans are 18 01 06* and 18 02 05* Chemicals consisting of or containing hazardous substances, in
addition to TiO2 packaging that might be classified as hazardous waste. For dental care, waste such
as amalgam is already classified as ‘absolute hazardous’.

Social impacts

Employment impacts

Given the limited envisaged effects, no discernible effect on employment in the EEA can be
envisaged following the introduction of the Carc Cat 2 harmonised classification for TiO2.

Impacts on the welfare of consumers (patients)

Following from the above, the Carc Cat 2 harmonised classification would neither confer any
improvement to the protection of consumer (patient) health nor provide sufficient incentive for
substitution of TiO2 in medical devices. Its continued use, however, could cause confusion and
uncertainty among patients and might lead to a refusal of products containing TiO2.

Competitiveness and competition impacts

Due to the absence of discernible adverse impacts on the current users of TiO2, issues of
competitiveness and competition would be of limited relevance. However, any attempt to
substitute TiO2 by EEA-based companies could generate significant administrative burden and costs
and would impact upon their competitiveness.

4.4.11 Detergents
As noted in Section 3.4.17, TiO2 is present in certain detergent products at levels below 1% (with the
vast majority being <0.1%). As such a Carc Cat 2 harmonised classification would have a limited

79
Standard on the biological evaluation of medical devices.

80
Standard on the evaluation of biocompatibility of medical devices used in dentistry.

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impact on the manufacture and marketing of detergent products. However, it cannot be precluded
that some adverse publicity over the presence of a suspected carcinogen in consumer products
might ensue. This might provide an incentive towards substituting the substance on some detergent
formulations. It should be noted however that finding alternative pigments might not be technically
feasible.

Similarly, waste management implications are unlikely to arise. In a single questionnaire response
received, the presence of TiO2 in waste from the manufacture of solid rim blocks is discussed. Due
to its presence in concentrations below 1.0%, the Carc Cat 2 harmonised classification would not
impact upon the disposal of associated waste.

Consequently, impacts on consumers (e.g. product availability and performance) or on the

competitiveness of the EEA industry would likely be limited.

4.4.12 Biocides
JMAC Composite is the reaction mass of TiO2 and silver chloride and is a preservative active with
antimicrobial properties that reduces the spread of bacteria over the long term. It is claimed to have
low toxicity, non-sensitising performance and very low environmental impact. JMAC meets EU
Ecolabel standards for use in paints and coatings (Clariant, 2016).

Manufacturers of paints and coatings benefit from easy and economical formulation. The JMAC
biocides are effective at very small ppm addition levels and offer low viscosity liquid dispersion. Safe
handling is assured through the non-flammable and non-corrosive nature of JMAC (Clariant, 2016).

For in-can preservation, the excellent thermal and pH stability of JMAC biocides means they can be
used in a wide range of industrial applications, such as polymer emulsions, paints, sealants and
adhesives (Clariant, 2016). The product supports sustainable consumption of consumer products.

The Biocidal Products Regulation does not restrict the use of Carc Cat 2 substance. Therefore,
overall impacts on this sector from the harmonised classification would be very limited with the
exception of:

• Market losses arising in relation to ecolabelling schemes (TiO2-containing paints could not
qualify for any known ecolabel); and

• Cost increases associated with waste management requirements (‘mirror’ entries in the LoW
relating to chemical manufacture and waste packaging for TiO2) and, potentially, though the
introduction of stricter controls on occupational exposure to TiO2.

4.5 Summary of impacts on downstream uses of titanium dioxide

4.5.1 Key market metrics for downstream industry sectors and estimate of
overall downstream sector impacts
Table 4–24 summarises the key market metrics presented above for the different applications of
TiO2. As shown in the table, whilst for the major applications of TiO2 detailed information is
available, for the majority of minor applications, information is incomplete or non-existent.

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Table 4–24: Summary of key metrics of markets for the different applications of TiO2
Potentially affected
Application area GVA Number of companies Share of SMEs Number of workers Downstream markets
turnover
Paints & coatings Arch: €6.2 billion/y €5 billion 800 85% 110,000 Value: €750 billion
Ind: €8.2 billion/y Workers: 1,000,000
Constr: €0.55 billion/y (incl. 30,000 in DIY retail)
Plastics €270 billion €118.4 billion 55,000 >>50% 1,500,000 Value: €650 billion
Workers: 4,500,000
Paper and >€1.7 billion >€0.34 billion Wallcoverings: 54 CEPI >>50% Total sector: 208,000 Value: €4.9 billion
wallcoverings Total sector: €75 billion members: 515 (not for laminates) Workers: 1,051,700
Inks >€3.3 billion Included in paints & >150 >85% Included in paints above Value: €200 billion
coatings Workers: >50,000
Construction Included in paints & coatings No data Adhesives & sealants: 450 >>50% Adhesives & sealants: No data
products 41,000
Fibres €7.5-10 billion No data 42 >50% 20,000 Could be included in
plastics above
Catalysts No data
Food, feed and No data No data No data No data No data No data
packaging
Pharmaceuticals Total sector: €192 billion No data Total sector: 1,900 No data Total sector: 725,000 No data
Cosmetics Total sector: €77 billion Total sector: €8 Ingredients: 100 92% Total sector: 152,000 GVA: €21 billion
billion Cosmetic products: 5,000 Workers: 1,600,000
Distribution: 120,800
Elastomers No data
Pigments TiO2-specific: Unknown No data 100 75% 23,000
Total sector: €8.1 billion
Ceramics €174 million No data >200 >80% >50,000 No data
Total ceramics and enamel: Total sector: 2,000
€3 billion
Glass No data No data 70 10% Total sector: 185,000 No data
Total sector: 1,200 (incl. processors)
Medical devices No data
Detergents
Biocides

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More widely, the extent to which the additional regulatory burden, supply chain and consumer
perceptions and wider market dynamics would affect the use of TiO2 and the marketing of products
that rely on/contain TiO2 cannot be defined with accuracy.

There are also several cost elements that would arise on which limited reliable information is
currently available across the range of TiO2’s applications, for instance:

• Role of user and consumer perceptions: the classification of a key raw material like TiO2 as a
suspected carcinogen will unavoidably change perceptions of safety among the users of the
substance. Most crucially, many formulations and articles that contain significant
concentrations of TiO2 are placed on the consumer market and in the case of formulations will
be accompanied by labels that include alarming pictograms and hazard statements. Moreover,
products that contain the substance may be ingested (food, pharmaceuticals, nutraceuticals),
may come in contact with food (food contact materials) or come in contact with (textiles) or be
applied to the skin (cosmetics). Irrespective of the harmonised classification being specific to
the inhalation route and the lack of/very low inhalation exposure probabilities, consumers
would certainly develop very negative perceptions over the safety of all these products.
However, it is difficult to estimate with certainty how this would translate into market losses,
product withdrawals, reformulation attempts and costs;

• Probabilities of securing exemptions: exemptions from restrictions could be obtained for the
uses of TiO2 in toys and cosmetics. In addition, the review of existing approvals in the field of
food additives and pharmaceuticals might confirm the substance as being safe. This, whilst
some impacts might initially appear severe, mitigating action might be taken to moderate them;

• Changes to the cost of disposal of TiO2-containing waste: this report explains the types of TiO2-
containing wastes that are generated during the downstream uses of the substance and which
might be classified as hazardous. Yet, the information available is limited, mostly qualitative and
cannot be extrapolated to cover entire industry sectors. It is worth noting however an
important statistic from Cefic which suggests that classification of a waste as hazardous
increases the cost of its management by a factor of 2-3; and

• The cost of reformulation of products that contain TiO2: in some cases, some estimates have
been provided for different applications, but the cost in each sector and across sectors cannot
be estimated as the need for reformulation may vary across sectors and would depend on
whether certain exemptions can be secured or not (in toys, cosmetics, foods, pharmaceuticals).
In addition, in some cases, for example pharmaceuticals, reformulation would also result in
applications for variations to existing marketing authorisations. These could be accompanied by
a substantial cost which cannot be estimated at present;

Overall, there is significant uncertainty over the monetised scale of the impacts arising among
downstream users of TiO2 from a Carc Cat 2 harmonised classification. However, this cannot prevent
us from reaching some clear, general conclusions:

• The value of markets that could be affected would be very large. The combined estimated value
of paints, coatings, construction products, inks, plastics, fibres and wallcoverings that contain
TiO2 exceeds €300 billion. The value of downstream markets is a multiple of this. For paints and
coatings for instance, it can be estimated that downstream markets could be 50 times larger in
value;

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• The number of companies affected could be very large and most of them would be SMEs. For
instance, this report documents the existence of 800 paint and ink manufacturers, 55,000 plastic
converters, 55 wallcovering manufacturers, 5,000 cosmetics manufacturers. Further
downstream, distributors, formulators and users amount to hundreds of thousands of
companies;

• The number of workers whose employment might be affected is also large. Information
available for paints, coatings, construction products, plastics, wallcoverings, pigments, fibres and
cosmetics suggest an overall employment of over 2 million workers involved in the
manufacturing of formulations and articles that contain TiO2. Further downstream, the number
of workers handling and using these formulations and articles becomes considerably larger: an
estimated 1 million workers might use TiO2-containing paints and coatings and 4.5 million
workers are using plastics containing TiO2;

• Consumer uses would be particularly affected with potential impacts arising for toys, cosmetics,
food, food contact materials, pharmaceuticals as well as ecolabelled products (mostly paints and
inks). If consumers opted to avoid using DIY products, the cost of renovation and maintenance
of properties would significantly increase. The presence of a suspected carcinogen in a
multitude of products found in homes, offices, shops, vehicles, food and its packaging,
pharmaceuticals, cosmetics, medical devices, toys, magazines, detergents etc. could cause
significant market upset, changes in aesthetics, increased costs and ultimately a great source of
confusion and concern over exposure to TiO2 (which in most cases is minimal or non-existent);
and

• Industrial processes that involve TiO2 would become costlier in the EEA because of an increase in
waste management costs (and possible loss of recycling opportunities). Unilaterally classifying a
substance as ubiquitous as TiO2 as a suspected carcinogen would undermine the
competitiveness of the EEA industry.

4.5.2 Estimation of the impacts on EEA-based demand for titanium dioxide

Administrative burden
Overall impact

Reformulation costs

Economies of scale
Market losses Cost increases

Product labelling
Share of
% of total consumer use in
Application EEA TiO2 each application
area demand* area
Detergents 0-1% Up to 100% F  Low – TiO2 Low Significant impact
concentration too low to
require hazard labelling Market loss
but negative consumer assumptions:
perceptions might Consumer losses: 5%
develop Ind/prof losses: N/A
Biocides 0-1% Unknown; F  Loss due to loss of Waste management Low impact 
mostly used markets for some paint
industrially products. Market loss
Carc Cat 2 substances assumptions:
outside the scope of Consumer losses: N/A
Biocidal Products Ind/prof losses: 2.5%
Regulation
* in literature sources, some of the minor applications have been identified as accounting for 1% or more of total demand. These include catalysts, textiles, enamel and rubber. There is no concrete
information that would allow such a distinction to be made so all minor applications are assumed to account for up to 1% of total EEA demand.
** this is based on the estimate that DIY uses account for €3.5 billion/y out of €6.2 billion of the total architectural coatings market (based on CEPE data)

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• Provisions of ecolabelling/certification schemes: consumer products that currently meet the
criteria of ecolabelling schemes (EU Ecolabel, Blue Angel, Nordic Swan) or certification (OEKO-
TEX®) would no longer do so and might need to be reformulated or removed from the market.
In the absence of technically and economically feasible alternatives, products might altogether
be removed from the market;

• Restrictions under national Consumer Safety Legislation: assessing impacts under national
legislation is beyond the scope of the present project. As such, it cannot be certain what the
impacts on a national level might be, although some impacts are to be expected. By way of
example, in France a CMR 2 classified formulation has to be stored under lock (this provision
should shortly be amended to storage in a place not accessible to the public), hence such
formulations would still be stigmatised as potentially unsafe. More drastically, national
legislation implementing CoE Resolutions on additives for food contact materials could mean
that the use of TiO2 in coatings, paper/board or printing inks could come under regulatory
pressure; and

• Consumer perceptions of hazard/risk: given the ubiquity of TiO2 in all aspects of consumer,
public and personal life (food and its contact materials and packaging, medicines, medical
devices, furniture and flooring, printed material and wallpaper, ceramics and tableware, to
name only a few), and the new carcinogenicity labelling requirements that would arise, the
proposed classification would have a severe impact on consumer perception on the safety of
both formulations and articles that contain TiO2 and would significantly impact upon their sales
in the EEA. As previously noted, companies are not free to choose what they include in the
labels affixed to their products and may only label according to the CLP Regulation with any
transgression potentially leading authorities’ demands for product withdrawal.

On the other hand, and in contrast to a Carc Cat 1B hazard classification, there would be no scope
for TiO2 to be added to an Appendix of Annex XVII to the REACH Regulation which would ban the
placing on the market of mixtures for consumer use if they contained TiO2 in concentrations above
0.1% by weight.

Impacts on professional and industrial markets from the proposed hazard classification

Quantifying the impacts arising for professional and industrial downstream users is not as
straightforward because for most applications there are no specific regulatory requirements that
would restrict the use of the substance. Sections 4.3 and 4.4 of this SEA explain that impacts may
arise in a number of ways:

• Partial loss of consumer markets (for mixtures, in particular) would more generally affect
economies of scale (particularly for paints, coatings, inks and construction products
manufacture);

• Industry initiatives, though voluntary in nature, play a key role in the market acceptance of CMR
substances in certain sectors. As noted above, the CEPE voluntary Code of Practice for coatings
used in food contact materials could result in the substance being removed from coating
formulations if its authorisation was revoked by the European Food Safety Agency (EFSA);

• Some companies using TiO2 may have their own internal policies that prevent them from using
CMR substances, although it is less likely that this would be the case for a CRM Cat 2 substance
in comparison to CMR 1A/1B substances; and

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• Similar to consumers, the supply chain may be reluctant to use a Carc Cat 2 substance even
where legislation itself does not prohibit its use.

An important difference between the Carc Cat 2 and Carc Cat 1B hazard classification is that the
former does not trigger obligations for employers under the Carcinogens and Mutagens Directive
2004/37/EC (including the requirement to consider alternatives to TiO2), although legislation on the
national level and a revision of SDS (following an update to TiO2’s registration dossier) may require
employers to review their compliance with worker health protection rules.

Approach to estimating the decrease in demand for titanium dioxide in the EEA

The approach taken to estimating the decrease in TiO2 demand is informed by the analysis
presented over several pages in Section 4 but out of necessity requires assumptions and a degree of
informed but subjective judgement. The steps followed are:

1. Distinguish TiO2 consumption in each application area between consumer and

industrial/professional in order to quantify the respective percentages of total EEA demand for
TiO2.

2. For the vast majority of the specialty applications of TiO2, demand for TiO2 is uncertain and is
assumed to be <1%. In such cases, the following assumptions are made:

a. Where only consumer or only industrial/professional use of the substance takes place,
this is assumed to account for 0.5% of total EEA demand for TiO2.

b. Where both consumer and industrial/professional use of the substance take place, each
is assumed to account for 0.25% of total EEA demand for TiO2.

3. Impacts per application area described in Table 4–25 are classified as “Significant”, “Moderate”
or “Low”. In terms of projected loss of demand this translates into the following:

a. “Significant” loss: 25% of consumer-related consumption of TiO2 is assumed lost and/or

10% of industry-related consumption of TiO2 is assumed lost;

b. “Moderate” loss: 10% of consumer-related consumption of TiO2 is assumed lost and/or

5% of industry-related consumption of TiO2 is assumed lost;

c. “Low” loss: 5% or less of consumer-related consumption of TiO2 is assumed lost and/or

2.5% or less of industry-related consumption of TiO2 is assumed lost.

4. Table 4–26 can be generated on the basis of the above assumptions. The table suggests that
over 12% of the total TiO2 demand in the EEA would be lost following the introduction of the
Carc Cat 2 harmonised classification. The large majority of this would be due to a reduction in
demand in paint manufacture

Therefore, a reasonable assumption would be that 10-15% of current total TiO2 demand in the EEA
might be lost as a result of a Carc Cat 2 hazard classification of the substance. At the same time,
given the non-existent/minimal potential for inhalation exposure by consumers, no real benefit to
consumer health would accrue. It is acknowledged that.

By way of comparison, a previous version of this report which focused on the impacts from the
originally proposed Carc Cat 1B harmonised classification had estimated that the overall loss of
demand for TiO2 would be in the range of 25-50%. It is important to note again that quantification

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of the impacts from a classification of Carc Cat 2 is fraught by uncertainty even larger than for a Carc
Cat 1B classification and the above estimate is based on a series of informed assumptions. The scale
of impacts on the mass applications of TiO2 (paints, coatings, inks, plastics, paper) is not possible to
accurately scope, as they are invariably more likely to result from NGO, media and stakeholder
pressure than from regulatory requirements. The real impact may prove to be far more severe than
what is described here, particularly if user and consumer perceptions of the risks from exposure to
TiO2 dramatically deteriorate.

Table 4–26: Estimation of loss in demand for TiO2 in the EEA following the introduction of a Carc Cat 2
harmonised classification
Loss of total TiO2
Share of TiO2 Simplified share of Demand loss ratio
Application demand in EEA post-
demand TiO2 demand post-Carc Cat 2
area Carc Cat 2
C* I/P* C I/P C I/P C I/P
Paints and
20% 33% 20% 33% 25% 10% 5.00% 3.30%
coatings
Plastics 16.5% 8.5% 16.5% 8.5% 10% 5% 1.65% 0.43%
Paper 12% 0% 12% 0% 5% 0% 0.60% 0.00%
Inks <2% >2% 1% 3% 25% 10% 0.25% 0.30%
Construc- Incl. Incl. Incl. Incl.
- - - -
tion above above above above
Fibres <1% <1% 0.50% 0.50% 10% 5% 0.05% 0.03%
Catalysts 0% 1% - 1.00% - 2.5% 0.00% 0.03%
Food <1% 0% 0.50% - 25% - 0.13% 0.00%
Pharma-
<1% 0% 0.50% - 25% - 0.13% 0.00%
ceuticals
Cosmetics <1% <1% 0.25% 0.25% 25% 10% 0.06% 0.03%
Elastomers <1% <1% 0.25% 0.25% 5% 2.5% 0.01% 0.01%
Pigments <1% <1% 0.25% 0.25% 25% 5% 0.06% 0.01%
Ceramics <1% <1% 0.25% 0.25% 5% 2.5% 0.01% 0.01%
Glass <1% <1% 0.25% 0.25% 0% 2.5% 0.00% 0.01%
Medical <1% <1% 0.25% 0.25% 5% 0% 0.01% 0.00%
Detergents <1% 0% 0.50% - 5% - 0.03% 0.00%
Biocides 0% <1% - 0.50% - 2.5% 0.00% 0.01%
Total 101% Total 8.0% 4.1%
Grand total ca. 12%
* C: consumer, I/P: industrial/professional

4.6 Impacts on producers of titanium dioxide

4.6.1 Key market parameters for titanium dioxide
As shown in Table 3–3, there are 17 TiO2 production facilities in the EU plus one in Norway
(Fredrikstad). The majority of production is based on the sulphate process (see Section 3.1.2) and
the split between sulphate and chloride process is assumed to be 55:45. In terms of production
capacity, Germany leads with an assumed 32% of the total EEA capacity of over 1.4 million tonnes of
TiO2 (see Figure 3–2), followed by the UK (21%) and Finland (9%).

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Based on the information presented in Section 3.3, in the year 2015 (which has been used as the
basis of the analysis below) the figures shown in Table 4–27 applied.

Table 4–27: Key metrics of TiO2 market in the EEA (2015)

Value*
Parameter Volume (ktonnes/y)
(€million/y, approx.)
EEA demand for TiO2 1,100 2,660
EEA-made TiO2 consumed in the EEA 740 1,800
Non-EEA-made TiO2 consumed in the EEA 360 860
EEA exports of TiO2 360 860
* assumes a price of €2,400/t although the current price (Q3 of 2017) is higher, see below

4.6.2 Value of titanium dioxide market and profitability of EEA-based

operations
Value of the market

The market price for TiO2 has varied significantly over the years. The relevant IPPC BREF Document
documents a significant decline in prices from ca. US$7,000 per tonne in 1954 to just over US$2,000
in 2002 (European Commission, 2007). In the 2000s, the price of TiO2 increased so that, in 2012,
TiO2 was sold on average at around €3,000 per tonne (or ca. US$4,000/t)81. That increase did lead
some users to explore alternatives without success (as explained later in this document). The price
of TiO2 pigments has significantly declined since 2012. Recent price data for the Chinese market
(TIZE, 2016) suggest that, at the end of 2014, the price per tonne was ca. US$2,100 or ca. €1,700 per
tonne82. In addition, in July 2016, the average price of TiO2 in the North American market was ca.
US$1.215 per lb or US$2,675 per tonne or ca. €2,400 per tonne83 with a range of US$1.18-1.25/lb
(free delivered) for smaller-volume buyers (ICIS, 2016). The latest information on the price of TiO2
suggests that prices have increased to €2,600-2,850 per tonne (ICIS, 2017). If €2,700 is assumed to
be the average price in the EEA at present84, the value of the total market in the EEA can be
estimated at 1,107,000 tonnes × €2,700 per tonne = €3 billion per year85.

81
The average exchange rate for the year 2012 was US$1 = €0.778 (based on
http://www.ukforex.co.uk/forex-tools/historical-rate-tools/historical-exchange-rates, accessed on 20
January 2017).

82
The average exchange rate for the month of December 2014 was US$1 = €0.812 (based on
http://www.ukforex.co.uk/forex-tools/historical-rate-tools/historical-exchange-rates, accessed on 20
January 2017).

83
The average exchange rate for the month of July 2016 was US$1 = €0.904 (based on
http://www.ukforex.co.uk/forex-tools/historical-rate-tools/historical-exchange-rates, accessed on 20
January 2017).

84
It has been suggested that a high price correlation can be observed between world regions. There are only
minimal price differences which reflect costs of freight and duties between regions. Price differences
between the EEA and North America are influenced by the Euro-Dollar exchange rate fluctuations
(European Commission, 2014).

85
It is worth noting that past market research had assumed a gradual increase to the value of the market
until 2020 (Market Report Company, 2015; Zion Research, 2016).

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Profitability of titanium dioxide manufacturers

With regard to the profitability of the TiO2 manufacturing industry, some key points can be made:

• The TiO2 industry suffered a major downturn during the financial crisis in 2008-2009. It
recovered sharply in 2012 but then declined until late 2016/early 2017 when TiO2 prices started
rising;

• Data on Pre-tax Operating Income for all EEA plants for the year 2013 (generated by a third
party) have been supplied by consultees. These show relatively low levels of pre-tax income at
the time. Out of 18 plants, a minority had a negative pre-tax operating income margin and half
of all plants had a single-digit pre-tax operating income margin; and

• Since 2013, the decline has continued for several of the companies concerned (although on a per
plant basis, some may have shown some improvement). EBITDA data for the four largest
suppliers to the EEA market have been consulted (but cannot be reproduced here) and show
that, for some companies, EBITDA margin figures remain at single-digit figures86. Accordingly,
pre-tax operating income levels are even lower or negative. However, recent market price
increases for the pigment have markedly improved economics over the first half of 2017.

A previous version of this impact assessment which focused on impacts from the originally proposed
Carc Cat 1B harmonised classification for TiO2 had assumed that pre-tax operating income across the
industry is nil. This is unlikely to be correct at the end of 2017 given that the price of the pigment
has substantially improved during 2017.

Gross Value Added of titanium dioxide manufacture

There are several ways of calculating Gross Value Added (GVA); the “income” approach to
estimating GVA as this is the most straightforward. Under this approach, the definition is:

GVA = compensation of employment + gross operating surplus

The compensation of employment translates basically into the sum of salaries, national insurance
contributions, and possibly redundancy wages plus profits. On the other hand, in the previous
version of this report where the focus was on the proposed Carc Cat 1B classification, it had been
assumed that profits were nil, thus only compensation of employment was considered. This is no
longer accurate, given the recent market price increases for TiO2. It has not been possible to obtain
highly sensitive profit data from TiO2 manufacturers and thus we conservatively assume that the
gross operating surplus is equivalent to 3% of turnover in the EEA87. This is equivalent to €90 million,
based on a turnover of €3 billion.

86
Publicly available information corroborates this (Huntsman, 2016n; ICIS, 2016).

87
By way of example, in 2014 the gross operating surplus of the European chemicals industry exceeded 9%
of turnover (see http://ec.europa.eu/eurostat/statistics-
explained/images/9/96/Sectoral_tab2_analysis_of_key_indicators%2C_Manufacturing_%28NACE_Section_
C%29%2C_EU-28%2C_2014.png, accessed on 7 October 2017).

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As far as wages are concerned, information for members of TDMA is similarly limited. However,
there is information on employment levels which has been used as follows:

• Some companies have provided employment data per plant and these have been used;
• For some companies, data have been obtained from the open electronic literature;
• For others, where only total employment is known and data on capacity per plant are available,
workforce is allocated on the basis of production capacity share;
• Total employment in EEA has been estimated at ca. 8,150;
• Total labour costs for the manufacturing sector in each of the countries of interest are obtained
from Eurostat88 and are reproduced in Table 4–28; and
• An 8-hour day, 240 working days per year assumption is made for all workers in all countries.

The full calculations cannot be provided as they might potentially disclose sensitive information. The
overall labour cost is estimated at ca. €470 million/y.

Table 4–28: Total labour cost per hour in the manufacturing sector, 2015
Country Total labour cost per hour (€/h)
Belgium 43.3
Czech Republic 9.8
Germany 38.0
Spain 22.6
France 36.9
Italy 27.4
Netherlands 34.7*
Poland 7.6
Slovenia 15.4
Finland 36.8
United Kingdom 28.3
Norway 48.2
Source: Eurostat
* Value is for 2014; a value for 2015 was not available at the time of accessing the Eurostat database

Therefore, the GVA for the manufacture of TiO2 can be calculated at €470 million + €90 million =
€560 million; this is likely to be an underestimate as the assumptions made on the gross operating
surplus are conservative. The estimate presented for the compensation of employment, €470
million, should be consider a floor for the sector (and would reflect periods of poor profitability).

4.6.3 Analysis of economic impacts on titanium dioxide manufacturers

Titanium dioxide market outcomes from a Carc Cat 2 harmonised classification

Based on the analysis above, the proposed classification would result in the loss of up to 15% of the
EEA market for TiO2. Such a loss (but even a more modest one of 10% of total demand) would cause
a significant adverse impact:

• Capacity underutilisation would jeopardise the economic viability of EEA plants: in recent
years, there has been overproduction of TiO2 pigment, with an average capacity utilisation

88
Labour cost levels by NACE Rev. 2 activity, available at http://ec.europa.eu/eurostat/web/labour-
market/labour-costs/database (accessed on 31 October 2016).

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within the industry of just under 80% (Roskill, 2016). Capacity utilisation rates for TiO2 plants
were predicted to rise in 2016, normalise in 2017 and exceed 90% by 2018 and 2019 (ICIS,
2016b). If 15% (or even 10%) of the EEA market were lost, capacity utilisation of the EEA-based
TiO2 manufacturing plants would decline. TiO2 plants running at a capacity utilisation below 80%
or less cannot be sustained economically for any prolonged period of time. These plants have
very high fixed costs which must be absorbed over very high/nearly full capacity utilisation rates.
TiO2 production for some plants might become economically unsustainable and could lead to
consolidation (i.e. some plants might need to shut down to ensure profitability of the remaining
ones);

• Opportunities for increased TiO2 exports are small: unless the introduction of the new hazard
classification for TiO2 in the EEA is emulated by other jurisdictions, the use of TiO2 outside the
EEA would continue as normal and indeed non-EEA manufacturing could become more
competitive and thus more attractive. Thus, theoretically, EEA manufacturers of TiO2 might be
able to export increased volumes of TiO2 to non-EEA downstream users. Still, access to overseas
markets would be easier for the larger multinational producers, as opposed to the smaller ones
who may have a more regional focus and less capability of becoming competitive exporters. In
any case, all EEA-based TiO2 producers would be disadvantaged by additional freight and duty
costs, plus a costlier manufacturing base in the EEA. It is unrealistic to expect any significant
increase to the currently estimated 360 ktonnes/y TiO2 exports from the EEA;

• Spare capacity outside the EEA is significant: as shown in Section 3.3, EEA demand for TiO2
amounts to ca. 1.1 million tonnes per year, while global demand is at 5.9 million tonnes per year
and global capacity is 7.2 million tonnes. Hence, a surplus capacity of around 1.3 million tonnes
exists, which is similar to the current Western European capacity and exceeds current EEA
demand for the pigment. As a result, non-EEA TiO2 manufacturers (including multinationals
currently operating in the EEA) would be in a good position to take over the EEA market for the
pigment.

Overall, loss of 10-15% of the EEA market for TiO2 (in addition to the cost of regulation that TiO2
manufacturers would face, for example, on waste management (see discussion below)) would
probably lead to TiO2 plant closures in the EEA. This could have a significant knock-on effect on EEA-
based supply chains but also on non-EEA users of the pigment: EEA-made TiO2 is currently being
exported plus some TiO2 grades may only be made in European plants so these grades may no
longer be available to customers outside Europe.

Impacts on ancillary operations

Titanium chemicals

Many TiO2 manufacturing plants also produce high value titanium chemicals including titanium
tetrachloride, titanium oxychloride, titanium oxysulphate, and sodium titanate. These chemicals are
used in a wide range of process industries with applications including manufacture of titanium metal
and pearlescent pigments, surface treatment of metals and catalyst manufacture.

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Co-products of titanium dioxide manufacture

Overview

Both the sulphate and chloride manufacturing processes generate important co-products which are
placed on the market and form an essential part of the overall manufacturing scheme. Co-products
from TiO2 manufacture include:

• From the sulphate process:

− Iron salts, including copperas (ferrous / iron (II) sulphate heptahydrate, FeSO4.7H2O)
and ferric/iron (III) chlorosulphate, FeClSO4);
− Gypsum (calcium sulphate, CaSO4.2H2O);
− Sulphuric acid;

• From the chloride process:

− Iron salt, ferrous/iron (II) chloride (FeCl2);

− Hydrochloric acid; and

• Water treatment and agricultural products from further treatment of the above co-products.

Iron salt co-products

Manufacture of iron salts through the sulphate process: in the sulphate process, manufacturing
processes for the different hydration states of ferrous sulphate and ferric sulphate are interlinked,
with copperas (iron (II) sulphate heptahydrate) being the common starting point and quite probably
the highest volume iron compound manufactured (as shown in Figure 4–7). The following
manufacturing steps are involved:

• Preparation of ferrous sulphate heptahydrate (copperas) as a by-product of the sulphate process

for the production of TiO2;
• Preparation of ferrous sulphate monohydrate directly from the sulphate process for
manufacturing TiO2;
• Preparation of dry ferrous sulphate monohydrate and ferrous sulphate heptahydrate (copperas);
• Preparation of ferric sulphate from ferrous sulphate heptahydrate (copperas); and
• Preparation of ferric chlorosulphate from ferrous sulphate heptahydrate (copperas).

Uses of iron salt co-products: the most important applications for iron sulphates from the TiO2
sulphate manufacturing process are in potable and wastewater purification where they act as
coagulants or flocculants. Copperas is the main iron source for the production of iron based
chemical coagulants. They can also be used to eliminate H2S (odour) or to remove phosphate in
water. They are precursors to other iron-based substances such as oxides and hydroxides used as
pigments and they are used in horticulture and agriculture. Ferrous sulphate is a reducing agent and
as such is used to reduce harmful Cr(VI) to Cr(III) in cement; this is where filter salts are used due
their lower purity unlike copperas which can be used in water treatment and feed applications.

Ferrous chloride from the TiO2 chloride manufacturing process finds use in water treatment it acts as
a coagulant or flocculant. It can also be used to eliminate H2S (odour) or to immobilise elements
such as arsenic. It is also a precursor to other iron-based substances such as oxides and hydroxides
used as pigments.

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FeTiO3
Ilmenite

H2SO4 Sulfate Process

FeSO4(aq)
∆
∆

∆ FeSO4.7H2O(s) +aq. Cl2

FeSO4.H2O(s) “copperas”, FeClSO4(aq)
damp crystals

[OX] ∆ Fe2(SO4)3.xH2O(s),
FeSO4.7H2O(s) Fe2(SO4)3(aq)
Dried “copperas H2SO4 x=5-9

Figure 4–7: Simplified process flow diagram for production of iron sulphates
Source: TDMA

Other uses of iron salts include:

• Biogas production;
• Use of iron chlorides and iron sulphates as reactive products/precursors, e.g. in the manufacture
of pigments and other iron compounds, also including use as a catalyst;
• Use of aqueous ferric chloride as a metal etchant;
• Land remediation applications;
• Laboratory chemicals;
• Agrochemicals; and
• Adhesives and sealants.

Gypsum co-product

Another co-product, gypsum, is formed from the solution resulting from the final stages of TiO2
washings. This solution is processed by sending it to a neutralisation plant. The neutralisation step
consists of adding lime (Ca(OH)2) or limestone (CaCO3) to the weak acid stream, generating a co-
product called red gypsum, formed mainly of gypsum and iron hydroxides (Gázquez, et al., 2014).

Red gypsum is essentially a waste for which extensive efforts have been made in recent times to
identify suitable uses. According to literature, red gypsum has agricultural use but can also be used
as a solidifying agent for loose clay soils to make them stable (for highways, etc.). Red gypsum,
blended with organic fertiliser, is also used for capping and landscaping activities of quarries, landfills
and contaminated sites. Finally, it can also be used in the cement industry (European Commission,
2007).

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Production volumes of titanium chemicals and co-products

The production volumes of titanium substances are substantial, particularly for titanium
tetrachloride. The REACH registrations for these substances identify volumes in the following
ranges:

• Titanium tetrachloride: 100,000 – 1,000,000 tonnes per year;

• Titanium oxychloride: 10,000 – 100,000 tonnes per year;
• Titanium oxysulphate: 1,000 – 10,000 tonnes per year; and
• Disodium titanate: 1 - 10 tonnes per year.

It is estimated that the total production volume for the above substances is in the order of a million
tonnes per year.

Iron sulphates represent the highest volume of the TiO2 industry by-products. The sulphate process
for the manufacture of TiO2 is the only production process for iron sulphates of any importance. It
produces up to 2.5 tonnes of copperas per tonne of TiO2 (European Commission, 2007; Environment
Agency, 2004). Exact annual production volumes are not available but a conservative estimate for
Europe would be over 2,000,000 tonnes of copperas and a smaller quantity (perhaps 20% of the
copperas volume) of the other iron salts (so called ‘filter salts’). These substantial volumes make
these iron compounds of high market importance and significant contributors to the overall
profitability of TiO2 manufacturing operations.

High volumes of gypsum are also produced, in the order of several hundreds of thousands of tonnes
per year.

Impacts from the Carc Cat 2 harmonised classification for titanium dioxide

Reduction of production and sales volumes

As described above, following the introduction of the harmonised classification, manufacture of TiO2
in the EEA would likely continue under conditions of capacity underutilisation thus leading to
potential plant closures. Irrespective of plant closures, a decline in demand for TiO2 would lead to a
decrease in TiO2 production volumes and a concomitant decrease in the production and sales of
titanium chemicals and co-products. For titanium tetrachloride and the other titanium chemicals
the affected TiO2 manufacturing plants collectively account for the majority of the volume placed on
the EEA market. Thus, downstream users of these products would likely be affected by any
shortages in supply. Similarly, a reduction in TiO2 manufactured volumes would result in a reduction
of the volumes of iron salts and red gypsum.

Importantly, any impact on the production and sales of titanium chemicals and the co-products
would further exacerbate the impacts on the profitability of TiO2 manufacture. For instance, the sale
and/or use of copperas is a necessity for ensuring the viability of the economics of the sulphate
route production process. As such, a decline in the sales of TiO2 arising from its harmonised
classification would instigate a self-feeding decline in the profitability of TiO2 plants as a whole.

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Impacts on sales from the presence of titanium dioxide impurities

Whilst all co-products contain TiO2 impurities above 0.1%, only some contain impurities that exceed
the 1% threshold that is relevant to the Carc Cat 2 harmonised classification. More specifically:

• Copperas contains less than 1% TiO2 impurities;

• Filter salts are less pure than copperas and contain more than 1% TiO2; and
• Red gypsum may contain more than 1% TiO2 as an impurity - this may vary by plant. Gypsum is
the major volume co-product that may contain more than 1% TiO2.

The downstream use of filter salts and red gypsum would be impacted, as these co-products would
be classified as Carc Cat 2 as result of the presence of TiO2 impurities. By way of example, ferrous
sulphate is used to reduce Cr(VI), a CMR, to Cr(III) in cement; being sold with impurities of a
suspected carcinogen above the 1% level could make users reluctant to use. In addition, for red
gypsum, the presence of a suspected carcinogen as an impurity would impede the valorisation of
this waste product and would make the development of new applications less attractive.

The sales of copperas might be impacted too. The salt is used as the main iron source for the
production of iron based chemical coagulants and in potable water purification. The presence of a
suspected carcinogen as an impurity even at a level below 1% might result in adverse user
perceptions of the safety of the product.

Waste management impacts

The classification of TiO2 as a Carc Cat 2 substance would have implications on the management of
waste that is generated during the manufacture of TiO2, titanium substances and co-products. Table
4–29 summarises information obtained from several TiO2 manufacturers. Some key parameters are:

• All waste types identified as relevant contain TiO2 at concentrations that exceed 1% and in some
cases, are significantly high;

• In general, the key waste streams are currently classified as non-hazardous and mostly fall under
‘absolute non-hazardous’ entries in the LoW;

• The most voluminous waste streams (digestion residues, neutralised solids, red gypsum),
containing TiO2-containing materials that could become available an inhalable form; however,
these wastes are typically handled as wet cakes thus reducing the likelihood of exposure; and

• The sulphate route to TiO2 would appear to be accompanied with higher volumes of TiO2-
containing waste.

Calculations made by industry experts would suggest that across the EEA the following
(approximate) volumes of key wastes arise (NB. the figures assumed a 90% capacity utilisation rate):

• Filter cake: 550 kt/y;

• Red gypsum: 2,700 kt/y;
• Sluice acid: 50 kt/y; and
• Digester (reactor) residues: 10 kt/y.

Overall, the total volumes of waste could be very significant, in the range of 3,000-4,000 kt/y.

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Table 4–29: Relevant waste streams for the manufacture of TiO2
Process generating Type of waste Waste entry in LoW Example volume
Is TiO2 Current waste
waste Typical TiO2 content generated per
inhalable? management
plant*
TiO2 manufacture via Off-spec pigment 06 11 99 >>1% <1 kt/y No Non-hazardous
either route Wastes not otherwise Landfilling
specified (‘absolute non-
hazardous’)
Sand/pigment 17 05 04 >>1% 1-10 kt/y Yes Non-hazardous
(mixture of SiO2 with Soil and stones other than Landfilling
TiO2) those mentioned in 17 05
03 (‘mirror non-hazardous’)
Mixed waste from 06 11 99 >1% 1 kt/y Yes Non-hazardous
TiO2 technology Wastes not otherwise Landfilling
(scales from specified (‘absolute non-
production vessels, hazardous’)
scrap parts and big
bags contaminated
with TiO2,
contaminated
sweepings from the
production areas,
etc.)
TiO2 manufacture via Neutralised 06 11 01 >>1% 10-100 kt/y Produced as Non-hazardous
the chloride route solids derived Calcium-based reaction damp Landfilling
from ore wastes from titanium cake so not
impurities dioxide production inhalable as
(‘absolute non-hazardous’) produced but
could
be if allowed
to dry
Sluice acid 06 01 06* >1% 1-10 kt/y No Hazardous
Other acids (‘absolute Re-use
hazardous’)

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Table 4–29: Relevant waste streams for the manufacture of TiO2
Process generating Type of waste Waste entry in LoW Example volume
Is TiO2 Current waste
waste Typical TiO2 content generated per
inhalable? management
plant*
TiO2 manufacture via Digestion (reactor) 06 11 99 >>1% 100-1,000 kt/y No, but could Depends if neutralised,
the sulphate route residue Wastes not otherwise become majority is.
specified (‘absolute non- inhalable if Landfilling
hazardous’) dried
Red gypsum from 06 11 01 >1% 100-500 kt/y No, but could Non-hazardous
acid neutralisation Calcium-based reaction become Landfilling
wastes from titanium inhalable if
dioxide production dried
(‘absolute non-hazardous’)
Titanium Filter cake 06 11 01 >1% 10-100 kt/y No, but could Non-hazardous
tetrachloride Calcium-based reaction become Landfilling and reuse
manufacture wastes from titanium inhalable if
dioxide production dried; also,
(‘absolute non-hazardous’) radioactive
components
will become
a hazard
* data based on individual responses to questionnaire (figures have been rounded)
Note: the table does not include other types of TiO2-containing waste that may arise during the operation of the TiO2 manufacturing plants but which have already been
discussed elsewhere in this document (i.e. empty packaging contaminated with TiO2, waste paint, etc.)

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All manufacturers who have made a contribution to this analysis (and who operate facilities in
several EEA Member States) anticipate that the classification of TiO2 as a Carc Cat 2 would render
these wastes hazardous. More specifically:

• In sulphate plants, digester (reactor) residue would be classified as a carcinogen. Some residue
may already be disposed of as hazardous waste but for those currently treated and disposed of
as non-hazardous waste the result of the Carc Cat 2 harmonised classification would be either
increased costs or viability problems, if a suitable disposal outlet could not be found. More
importantly, in terms of waste volumes, where outlets for co-products (red gypsum and
potentially filter salts) could not be found due to a change in hazard classification, the resulting
high volumes of hazardous waste could force plant closures due to cost or lack of suitable
disposal options; and

• In chloride plants, the main wastes would also be classified as hazardous. This would mean
significant disposal cost increases or viability problems if no hazardous waste outlets could be
identified.

It is recognised that the key entries in the table are ‘absolute non-hazardous’ and thus a change to
the hazard classification of one constituent of these wastes should not normally lead to the
classification of waste as hazardous if there are no corresponding ‘absolute hazardous’ entries in the
LoW (see the case of packaging which may switch from an ‘absolute non-hazardous’ entry to an
‘absolute hazardous’ one if a hazardous contaminant is present at relevant concentrations).
However, classification of these waste streams as hazardous could be a real possibility due to:

• The discretion of Member State authorities to deviate from the LoW: the Waste Framework
Directive in its Article 7(2) permits Member States to classify waste as hazardous even if it does
not appear as such on the LoW. Member States have to report this to the European Commission
and the Commission will consider a change of LoW. In this particular case, given the volumes,
high concentrations of the suspected carcinogen and the possibility of exposure by inhalation, it
is entirely possible that Member States would take action.

It is also worth remembering that there may be differences in the implementation of the Waste
Framework Directive on the Member State level. In 2010, the TiO2 industry in the UK was
successful in demonstrating through detailed modelling to the UK government that that landfill
sites used for the solid mineral waste can be recovered for agricultural use following a post-use
aftercare period of just 5 years compared to normally many decades. As such, the UK
government was convinced that a hazardous waste landfill tax rate for filter waste was
disproportionate. Following the introduction of the Carc Cat 2 harmonised classification, it
might be possible that the UK government might take a pragmatic approach and accept that this
waste remains non-hazardous. On the other hand, a further example has been given of the
Czech Republic. The Czech No. 185/2001 Law on wastes in its Article 6 stipulates: "Waste
generator is obliged to classify waste as hazardous if a) the waste has at least one of hazardous
properties stated in Commission Regulation (EU) no. 1357/2014 replacing Annex III to Directive
2008/98/EC on properties of waste which render it hazardous, b) the waste is stated in the List of
Wastes as the hazardous waste, or c) the waste is mixed or contaminated by some of the wastes
stated in the List of Wastes as hazardous”. In other words, if TiO2 is present at concentrations
above 1%, the waste is classified as hazardous irrespective of its LoW entry;

• The approach (i.e. sequence of actions) taken to using the LoW: the producer of waste or a
national authority might first establish that the waste hazardous and then seek to identify an

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appropriate LoW code which best describes the waste and its hazardous classification. Thus, the
‘standard’ ‘absolute non-hazardous’ entry might be considered irrelevant; and

• The perceived hazard characteristics of the waste: the above hazard classification activities are
likely to be influenced by two key factors: (a) the presence of significant concentrations of TiO2
in the waste, and (b) the potentially inhalable form of TiO2 in the waste. Key waste streams are
generated as solids with high moisture content where inhalation exposure to TiO2 is not
possible; yet, such material could become dry and dusty prior to its disposal (e.g. the capping of
the landfill cell) thus would lend itself to exposure by inhalation. This could lead Member State
authorities to insist that such waste be treated as hazardous.

Some estimates of the cost increases arising from the classification of waste as hazardous has been
provided. Organisation measures aimed at introducing separation of waste so that TiO2-containing
waste is not mixed with a different category of waste would cost an estimated €0.1-0.5 million per
plant. On the other hand, the storage, transportation and disposal of the hazardous waste would
increase waste management costs by €10-20 million/per year per company. Additional costs of
increased taxation might also arise; for example, in the UK the landfill tax rate would increase by a
factor of over 30 (from £2.70 per tonne to £86.10 per tonne) meaning an increased annual landfill
tax cost in the range of €5-10 million for UK manufacturers of TiO2.

Due to the absence of a complete set of data for all TiO2 manufacturers, the overall costs cannot be
estimated with accuracy. In addition, some of the estimates that have been provided has been
claimed to be confidential. However, taking into account the number of manufacturers (18), the
volumes of wastes involved and the company-specific cost estimates available, it could be realistic to
expect a cost increase in the range of several hundreds of millions per year, excluding loss of sales
for products that could no longer be achieved (e.g. gypsum) as a result of downstream users’
reluctance to use the classified material.

Conclusion on the economic impacts on titanium dioxide manufacturers from a Carc Cat 2
harmonised classification

The above analysis shows that the Carc Cat 2 harmonised classification for TiO2 would have
significant direct impacts on the demand for the substance, currently estimated at 10-15% of current
demand in the EEA. This will result in underutilisation of the capacities of TiO2 manufacturing plants
and will threaten their viability. Crucially, these direct impacts will be exacerbated by loss of
production and sales of ancillary products (due to the presence of impurities of a suspected
carcinogen) and the potential classification of important waste streams as hazardous thus requiring
costlier disposal and losing any potential of their reuse (this refers to red gypsum for which efforts
have been made to develop new applications). If indeed waste stream such as neutralised solids,
digestion residues, red gypsum and filter cakes require disposal as hazardous waste, due to the very
large quantities involved, the cost of waste management would become too high and thus render
the manufacture of TiO2 and of ancillary products uneconomical; as shown above, the cost of
changes to waste management as a percentage of the collective GVA of the manufacturers could
become unsustainably high. The TiO2 industry economics are well known to be very cyclical, and
such a severely increased waste management burden could well make the difference between the
continued viability of the operation during depressed periods of the cycle. In conclusion, the
harmonised classification could potentially result in the collapse of Europe’s TiO2 manufacturing
base, depending on the severity of impacts on waste management, which would likely vary across
the EEA Member States.

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4.6.4 Employment impacts
The total employment in the 18 TiO2 manufacturing plants in the EEA is estimated at ca. 8,150
workers. Specific figures per plant, company or country cannot be provided for confidentiality
reasons. A rough split among EEA Member States is provided in Table 4–30. The table also provides
the domestic employment multipliers for each country for the ‘chemicals’ sector, as presented in a
2012 study for the European Commission (which analysed 2005 data) (Stehrer & Ward, 2012).

Table 4–30: National shares of total employment in TiO2 manufacturing plants

Share of total number of workers Domestic employment multiplier
Country
in the EEA (chemicals sector)
Belgium 5-10% 2.2
Czech Republic 5-10% 2.3
Germany 30-40% 2.8
Spain 1-5% 2.7
France 5-10% 4.9
Italy 1-5% 3.3
Netherlands 1-5% 3.0
Poland 1-5% 2.7
Slovenia 10-20% 2.0
Finland 5-10% 2.6
United Kingdom 10-20% 3.3
Norway 1-5% 2.3*
Total 8,150 workers
Source: TDMA member information, employment data retrieved from the Internet
* in the absence of data, the EU-27 average is used

Using these multipliers for each Member State, it can be estimated that direct employment at TiO2
manufacturing plants creates ca. 22,800 jobs in the domestic economies (overall multiplier: 2.8).

If some TiO2 manufacturing plants were to stop production following the introduction of a Carc Cat 2
classification for TiO2 and a decline in demand for the substance, hundreds of jobs could be lost (by
way of illustration, 15% of 8,150 equals ca. 1,200 jobs) and, with them, a proportion of the relevant
indirect employment described above.

Taking into account the full range of impacts (decline in TiO2 demand, partial loss of production of
titanium chemicals and co-products, loss of market for co-products due to concerns over
carcinogenicity and drastic increases in waste management costs), the profitability of all TiO2
manufacturing plants would suffer and the number of plant closures and associated job losses would
be substantially larger, potentially affecting the entire workforce of the 18 manufacturing sites.

4.7 Impacts on upstream suppliers

4.7.1 Ore mining and slag production in the EEA
There is only one commercial mining operation in the EEA, the ilmenite ore deposit at Hauge i
Dalane on the southwest coast of Norway operated by Titania AS (owned by Kronos)89. The facility

89
Note that feedstock production does take place in the periphery of the EEA, in Ukraine.

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was founded in 1902 and has continuously produced ilmenite (FeTiO3), the most abundant titanium
mineral, since 1916. Currently, production stands at 850,000 tonnes of ilmenite concentrate90.
Global production of ilmenite in 2016 was estimated at ca. 5.86 million tonnes (USGS, 2017),
meaning that the Titania AS operations account for ca. 15% of global production (global production
of rutile is estimated at ca. 6.6 million tonnes per year (USGS, 2017)). Titania AS employs more than
280 personnel91, including apprentices, many of whom live in the nearby municipality of Sokndal.
The company has a long history of providing employment for local people and has education
programs with Universities and also has several apprentices and trainees every year92.

In addition, the TiZir Titanium and Iron facility (located at Hardangerfjord on the west coast of
Norway) is producing titanium slag and high purity pig iron (HPPI) (NB. the company has recently
decided to transition from sulphate to chloride titanium slag). It is the only such facility in Europe
and only one of five in the world. The current capacity is 230 ktonnes/y of titanium slag and the
titanium slag is predominantly sold to pigment producers93. Sales of titanium slag in 2014 and 2015
were ca. 178 ktonnes and 132 ktonnes respectively94. Levels of employment at the plant were over
200 employees (2013 and 2014 data suggest 236 and 214 employees respectively95).

4.7.2 Impacts on suppliers of feedstock, raw materials and utilities

It is understood that both these Norwegian companies sell the majority of their output to European
customers. Thus, the potential reduction in the size of the TiO2 manufacturing base in the EEA could
have adverse repercussions for the profitability of these mining and ore processing operations.
Levels of employment might be affected as a result of a Carc Cat 2 classification for TiO2. A Carc Cat
2 classification for TiO2 might lead to the following impacts for these upstream stakeholders:

• Ilmenite concentrate (Titania AS): publicly available financial information for the company
suggests a turnover of ca. €80-104 million in the period 2013-2015 with earnings before taxes in
the region of €23-28 million per year96. The majority of profits are assumed to be derived from
sales to European customers. If TiO2 production in the EEA was curtailed or collapsed, the
company would naturally aim to find customers overseas. The extent to which this would be

90
As indicated at http://kronostio2.com/en/manufacturing-facilities/hauge-norway and
http://www.ngu.no/sites/default/files/Focus%20nr4_TITANIUM_AND_IRON_TITANIUM%20%20DEPOSITS_
IN_NORWAY__v2.pdf (both accessed on 4 November 2016).

91
257 employees in 2015 according to http://www.proff.no/selskap/titania-as/hauge-i-dalane/-/Z0ITENO3/
(accessed on 4 November 2016).

92
Information available at http://kronostio2.com/en/manufacturing-facilities/hauge-norway (accessed on 2
November 2016).

93
Information available at http://www.tizir.co.uk/projects-operations/tyssedal-tio2/ (accessed on 2
November 2016).

94
Multiple sources – Information available at http://www.tizir.co.uk/investors/news-releases/ (accessed on 2
November 2016).

95
Information available at http://www.largestcompanies.com/company/Tizir-Titanium--Iron-AS-
275252/closing-figures-and-key-ratios (accessed on 2 November 2016).

96
Information available at http://www.largestcompanies.com/company/Titania-AS-140102/closing-figures-
and-key-ratios (accessed on 4 November 2016).

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successful and what the economic impacts would be is uncertain – freight costs would make
sales to overseas customers potentially uneconomic and there are not that many alternative
uses of ilmenite; and

• Titanium slag (TiZir): the 2015 annual reports of TiZir Titanium and Iron suggests total sales of
ca. 132 ktonnes in 2015 and ca. 178 ktonnes in 201497. The financial performance of the
company in 2015 was worse than the previous years with negative earnings before tax in 2015
down from €4 million in 2014 and €41 million in 201398. It must be noted however that the
company produces not only titanium slag but also pig iron and the financial results reflect profits
from sales of both products. As for the mining company above, if TiO2 production in the EEA was
curtailed or collapsed, this company would naturally aim to find customers overseas. The extent
to which this would be successful and what the economic impacts would be is uncertain.

The majority of feedstock currently used by EEA-based TiO2 manufacturers is sourced from non-EEA
suppliers. The volumes are particularly large. For instance, the relevant IPPC BREF Document notes
that sulphate plants may use on average 1.662 tonnes of ilmenite per tonne of TiO2 pigment
products and 0.956 tonne of slag per tonne of TiO2 pigment produced. If TiO2 production in the EEA
declined by an estimated 15%, the volume of TiO2 that would not be manufactured would be ca. 160
ktonnes per year. As a consequence, the volumes of feedstock that would no longer be imported
into the EEA would be in the range of hundreds of thousands of tonnes. More severe impacts on
TiO2 manufacture would naturally lead to greater impacts upstream.

The volumes of other raw material inputs are similarly large and some calculations can be made to
provide an order of magnitude of the volumes of chemicals that would no longer be consumed in
the EEA. The majority of these are widely used substances and are likely to be sourced from EEA
suppliers. The basis of the calculations are figures provided in the relevant IPPC BREF document
(European Commission, 2007) and are reproduced in Table 4–31.

Table 4–31: Raw material and energy input to TiO2 pigment manufacture according to the IPPC BREF
Document (excluding feedstock)
Input Unit Chloride process Sulphate process
Chlorine t/t pigment 0.201 -
Sulphuric acid t/t pigment - 3.250 (total, new + recycled)
Coke t/t pigment 0.366 -
Lime t/t pigment 0.137 -
Coal t/t pigment 0.090 -
Oil t/t pigment 0.005 -
Oxygen t/t pigment 0.467 -
Silica sand t/t pigment 0.049 -
Rock salt t/t pigment 0.016 -
Scrap iron t/t pigment - 0.150
Aluminium sulphate t/t pigment - 0.021
Hydrogen peroxide t/t pigment - 0.012
Calcium hydroxide t/t pigment - 0.363
Calcium chloride t/t pigment - 0.015
Calcium carbonate t/t pigment - 1.380

97
Information available at http://www.tizir.co.uk/wp-content/uploads/2016/04/Tizir-Ltd-Annual-Report-
2015.pdf (accessed on 2 November 2016).

98
Information available at http://www.largestcompanies.com/company/Tizir-Titanium--Iron-AS-
275252/closing-figures-and-key-ratios?currency=EUR (accessed on 4 November 2016).

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Table 4–31: Raw material and energy input to TiO2 pigment manufacture according to the IPPC BREF
Document (excluding feedstock)
Input Unit Chloride process Sulphate process
Aluminium hydroxide t/t pigment - 0.030
Caustic soda t/t pigment 0.104 0.090
Energy GJ/t pigment 17-29 23-29 with sulphuric acid neutralisation
33-41 with sulphuric acid re-concentration*
Source: European Commission (2007)
* Given different combinations of systems used across the EEA TiO2 industry for acid neutralisation and/or
acid reconcentration, the extreme ranges as in (a) and (b) above apply only as indicative levels for the
estimation of the overall energy efficiency in the TiO2 plant in question

The split between sulphate and chloride TiO2 production capacity in the EEA is 55:45 and this is
assumed to apply to the actual production volume of 1,100 ktonnes/y. Table 4–32 summarises the
volumes of raw material inputs (excluding feedstock) and energy into EEA-based TiO2 manufacture.

Table 4–32: Quantified raw material and energy input to TiO2 pigment manufacture
Input Input Unit
Feed - Ilmenite 1,540,000 t
Feed - Slag 580,000 t
Chlorine 100,000 t
Sulphuric acid 1,960,000 t
Coke 180,000 t
Lime 70,000 t
Coal 40,000 t
Oil 2,490 t
Oxygen 230,000 t
Silica sand 20,000 t
Rock salt 10,000 t
Scrap iron 90,000 t
Aluminium sulphate 10,000 t
Hydrogen peroxide 10,000 t
Calcium hydroxide 220,000 t
Calcium chloride 10,000 t
Calcium carbonate 830,000 t
Aluminium hydroxide 20,000 t
Caustic soda 110,000 t
Energy 27,100,000 GJ
* Equivalent to ca. 7,500 GWh

In total, the trade of ca. 4 million tonnes of raw materials would be at stake. If manufacture of TiO2
in the EEA would decline by only 15%, the amount of TiO2 production to be lost would be ca. 160-
165 ktonnes per year (90 ktonnes/y of the lost volumes would be normally produced via the
sulphate process and ca. 75 ktonnes/y of the lost volumes would be normally produced via the
chloride process) and the loss of demand for material inputs would be limited to ca. 0.57 million
tonnes of chemicals and ca. 1,100 GWh of energy. Some of these losses could be counter-balanced
by increased sales to non-EEA customers.

In conclusion, a reduction in the TiO2 manufacturing base in the EEA (with some plant closures being
possible) would result in considerable loss of turnover for the suppliers of feedstock, raw materials,
consumables, utilities as well as suppliers of all purchased services required to maintain and operate

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those manufacturing facilities. Those impacts would be significantly worse if Europe’s TiO2
manufacturing base were to collapse under the burden of lost sales and substantially increase waste
management costs.

4.8 Impacts outside the titanium dioxide supply chains

4.8.1 Impacts on industrial minerals that contain titanium dioxide impurities
Relevant industrial minerals and their markets

Introduction

Many industrial minerals contain TiO2 as a natural impurity up to 4% by weight (TiO2 is also a
common component in soils and marine sands). Examples include:

• Kaolin;
• Bentonite;
• Perlite;
• Mica;
• Diatomite;
• Ball clays;
• Refractory calcined clay (chamotte);
• Calcined bauxite;
• Brown fused alumina;
• Andalusite;
• Zircon (natural zirconium silicate);
• Synthetic mullite;
• Refractory clay; and
• Metal working slags.

TiO2 in the form of rutile is a widespread accessory mineral in many rocks (magmatic, metamorphic
and sedimentary), hence it is also present in industrially used hard rocks (e.g. granite).

A discussion on some of these minerals, including details of their applications and markets is
provided below. The combined market value of these minerals is very substantial and the market
value of products that rely on them is even greater.

Kaolin

Kaolinite is a clay mineral with the chemical composition Al2Si2O5(OH)4. It is also known as pigment
PW19 (Colour Index generic name) / 7004CI (C.I. Constitution number). It is described as “white clay
rock, mostly natural hydrated aluminium silicate with impurities of magnesium, iron carbonates,
ferric hydroxide, mica, quartz-sand, etc.” and the CAS Number 1332-58-7.

Anatase is an impurity in kaolin and the target is to remove the material through industrial
beneficiation processes. However, residues remain in kaolin end-products. The presence of TiO2 in
kaolin is up to 2.5%, i.e. exceeds the 1% by weight carcinogenicity category 2 classification limit.

Kaolin is used as an extender often to reduce the loading of TiO2. Due to the presence of TiO2
impurities in kaolin, however, kaolin would not be a suitable alternative for TiO2 if the proposed
classification for TiO2 was adopted.

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Kaolin currently finds a wide range of applications, including (IMA Europe, undated):

• Paper: in the bulk of the paper and to coat its surface. Examples include papers for magazines
and brochures, art paper, cartons and boxes, etc.;

• Ceramics: whitewares (tableware, sanitaryware, and wall and floor tiles);

• Fillers: its whiteness or near whiteness, make it suitable as a filler or pigment;

• Paint: calcined kaolins are widely used in satin and matt paints. Kaolin is particularly useful as a
partial replacement for TiO2 pigment, as noted above;

• Rubber: used in high value thermoplastic elastomers for a variety of applications and in rubber
insulation on high voltage power lines;

• Plastics: major application is in PVC cables where its main function is to improve electrical
properties. Other important applications include specialty films where it imparts anti-blocking or
infrared absorption characteristics. Chemically treated, calcined kaolin is one of the major
additives used in the manufacture of automotive parts based on engineering thermoplastics;

• Refractories: used to build structures subjected to high temperatures, ranging from simple to
sophisticated products, e.g. from fireplace brick linings to re-entry heat shields for the space
shuttles. In industry, they are used to line boilers and furnaces of all types-reactors, ladles, stills,
kilns and so forth;

• Fibreglass: improves the integration of fibres in products requiring strengthened plastics: cars,
boats and marine products, sporting goods and recreation products, aviation and aerospace
products, circuit board manufacturing, fibreglass insulation, fibreglass air filters, fibreglass tanks
and pipes, corrosion resistant fibreglass products, fibreglass building and construction products,
etc.; and

• Cosmetics and pharmaceuticals: ‘British Pharmacopoeia Light Kaolin’ (BPLK) is used in both
human and veterinary medicinal products, for example, to treat digestion problems and as a
constituent of poultices. It can also be used as an excipient in personal care products and in a
number of dietary products, plasters, foot-powders and in the specialised treatment of some
lung disorders.

The current production volume of kaolin in the EU is 4 million t/y and its consumption is around the
same. The market for kaolin in the EU is worth €300 million/y.

Bentonite

Bentonite is an absorbent aluminium phyllosilicate clay consisting mostly of montmorillonite. It

contains up to 2% TiO2 by weight, i.e. exceeds the 1% by weight carcinogenicity category 2
classification limit. It finds a variety of uses, including (IMA Europe, undated):

• Foundry: bonding material in the preparation of moulding sand for the production of iron, steel
and non-ferrous casting;

• Pelletising: binding agent in the production of iron ore pellets;

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• Construction and civil engineering: thixotropic, support and lubricant agent in diaphragm walls
and foundations, in tunnelling, in horizontal directional drilling (HDD) and pipe jacking. Also
used in Portland cement and mortars;

• Environmental markets: wastewater purification. Bentonite is the active protective layer of the
Geosynthetic Clay Liners;

• Drilling: mud constituent for oil- and water-well drilling;

• Oils / food markets: removal of impurities in oils where its adsorptive properties are crucial in
the processing edible oils and fats (soya / palm / canola oil). In drinks such as beer, wine and
mineral water and in products like sugar or honey, bentonite is used as a clarification agent;

• Agriculture: animal feed supplement, as a pelletising aid in the production of the animal feed
pellets, as well as a flowability aid for unconsolidated feed ingredients such as soy meal. It is also
used as an ion-exchanger for improvement and conditioning of the soil. When thermally
treated, it can be used as a porous ceramic carrier for various herbicides and pesticides;

• Pharmaceuticals, cosmetics and medical markets: filler in pharmaceuticals and antidote in

heavy metal poisoning. Personal care products such as mud packs, sunburn paint, baby and face
powders, and face creams may all contain bentonite;

• Detergents: laundry detergents and liquid hand cleansers/soaps;

• Paints, dyes and polishes: thickening and/or suspension agent in varnishes, and in water and
solvent paints.

• Cat litter;

• Paper: used in pitch control, de-inking for paper recycling and the manufacture of carbonless
copy paper; and

• Catalyst: employed in the alkylation processes to produce fuel additives.

The current production volume of bentonite in the EU is 3 million t/y and its consumption is ca. 2.7
million/y. The market for bentonite in the EU is worth €600 million/y.

Perlite

Perlite is an amorphous volcanic glass that has a relatively high water content, typically formed by
the hydration of obsidian. It is naturally occurring and has the unusual property of greatly expanding
when heated sufficiently. It is an industrial mineral and a commercial product useful for its light
weight after processing. Perlite may contain 0.2% by weight TiO2, i.e. it does not exceed the 1% by
weight carcinogenicity category 2 classification limit but its market would be impacted if TiO2 were
to be classified as Carc Cat 1B. It finds a variety of uses, including (The Perlite Institute, undated):

• Lightweight formed products;

• High temperature insulation;
• Simulated stone, masonry and wood products;
• Perlite volcanic glass as a hollow microsphere filler;
• Lightweight fillers for glass/reinforced polyester;

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• Perlite volcanic glass as a glass flake filler;
• Perlite concrete;
• Filtration (filter aid);
• Non-evacuated cryogenic and low temperature services;
• Well cements; and
• As an absorbent or carrier.

The current production volume of perlite in the EU is 0.65 million t/y and its consumption is around
the same. The market for perlite in the EU is worth €120 million/y.

Mica

Mica is a mineral name given to a group of minerals that are physically and chemically similar. They
are all silicate minerals, known as sheet silicates (because they form in distinct layers). Micas are
fairly light and relatively soft, and the sheets and flakes of mica are flexible. Mica is heat-resistant
and does not conduct electricity. There are 37 different mica minerals. The most common include
purple lepidolite, black biotite, brown phlogopite and clear muscovite (Minerals Education Coalition,
undated). Mica may contain up to 2% by weight TiO2, i.e. exceeds the 1% by weight carcinogenicity
category 2 classification limit.

It finds wide application, including (IMA Europe, undated):

• Automotive: mica is used in the production of bitumen foils that are attached onto the inner
vehicle frame structures to dampen vibrations;

• Brake pads and clutches: mica is added to frictional systems to impart better heat transfer in
conjunction with noise reduction;

• Decoratives: mica can be found in various products such as decorative paints, ceramics,
decorative concrete, post cards, wallpapers;

• Drilling: mica is used as a mud constituent for oil well drilling;

• Fibre cement: mica is used in highly engineered fibre cement to impart dimensional stability
either in moisturising conditions or in passive fire protection;

• Fire extinguishers: mica provides anti-caking & flowability;

• Foundries: mica is used for coatings in iron casting and to a limited extent in aluminium
production casting;

• Paints and coatings: mica is used in external renderings and anti-corrosive paints;

• Paper coatings: mica is used in packaging products as it provides protection from the water or
grease associated with the food;

• Plastics: mica acts as a reinforcing additive in the packaging industry and in the automotive
industry;

• Plasterboard and joint compound: mica is used primarily as an anti-cracking and reinforcing
additive;

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• Pearlescent pigments: mica can provide a pearlescent effect once it has been coated with TiO2
or Fe2O3;

• Rubber: mica is used either as a demoulding agent during the vulcanisation process, or as an
anti-sticking powder when several rubber pieces are stacked together; and

• Welding rods: mica brings added value both during the rod manufacturing step (easing the
extrusion) and the welding itself. During welding, the platy structure acts like a shield protecting
the molten steel from ambient air oxidation and moisture.

The current production volume of mica in the EU is 90,000 t/y. The market for mica in the EU is
worth €40 million/y.

Diatomite

The term diatomite is applied both geologically and commercially to the nearly pure sedimentary
accumulation of diatom frustules—the microscopic skeletons of unicellular aquatic algae belonging
to the class of golden brown algae, Bacillariophyceae. The sediments are fine-grained, highly
siliceous, and consist primarily of amorphous opaline silica with only minor amounts of organic
residue, secondary minerals, and co-deposited non-diatomaceous or crystalline clastic debris.
Synonyms in current usage include diatomaceous earth and kieselguhr (Minerals Education
Coalition, undated - b). Diatomite may contain up to 0.7% by weight TiO2 (i.e. it does not exceed the
1% by weight carcinogenicity category 2 classification limit but its market would be impacted if TiO2
were to be classified as Carc Cat 1B) and finds a variety of applications, such as (IMA Europe,
undated):

• Filter aids: because of its high degree of porosity combined with its low density and inertness,
diatomite makes an excellent filtration medium, used for antibiotics, beer, chemicals, edible oils
and fats, fruit juices, glucose, pharmaceuticals, solvents, sugar, vitamins, water, wine, and many
others;

• Functional mineral additives: the versatility of diatomite as a functional filler, in part as a result
of its unique particle shape, has led to its widespread use in a number of applications such as
paints, plastics, paper, insulating bricks, and dental mouldings;

• Carriers for active Ingredients and diluents: typical applications include: pesticide carriers and
catalyst carriers; and

• Aggregates: the aggregates are used as absorbents in a number of applications including floor
sweeping, the clean-up of hazardous wastes, oil and grease absorbents, and soil amendments.

The current production volume of diatomite in the EU is 0.1 million t/y and its consumption is 0.13
million t/y. The market for diatomite in the EU is worth €40 million/y.

Ball clays

Ball clay (also known as plastic clay) is an extremely rare mineral found in very few places around the
world. Ball clays usually contain three dominant minerals: from 20-80% kaolinite, 10-25% mica, and
6-65% quartz. In addition, there are other 'accessory' minerals and some carbonaceous materials
present. The wide variation both in mineral composition and in the size of the clay particles, results
in different characteristics for individual clay seams within a deposit (IMA-NA, undated). Ball clays

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may contain up to 2% by weight TiO2, i.e. exceeds the 1% by weight Carc Cat 2 classification limit.
Their applications include (IMA Europe, undated):

• Sanitaryware: ball clay provides plasticity and workability;

• Tableware: ceramic tableware utilises plastic clay to provide high plasticity and a good white-
fired colour, combined with kaolin, feldspar and quartz;

• Wall and floor tiles: combined with feldspar, kaolin and quartz, plastic clays are utilised for their
plasticity and bonding properties;

• Glazes and slips: plastic clays are also used in the production of coatings for ceramic products;

• Refractory clays: ball clays are used in refractory products such as kiln insulation and furniture;

• Construction ceramics: building materials such as bricks, clay pipes and roof tiles all contain
plastic clay;

• Electrical porcelain insulators: plastic clays are used in the electrical porcelain components that
provide insulation from high voltage currents;

• Chemical applications: plastic clays are used as fine fillers and extenders in polymers, adhesives,
plastics, fertilisers and insecticides; and

• Sealants: plastic clays are also widely used for lining landfill waste disposal sites, and for sealing
over them once completed.

The current production volume of ball clays in the EU is 12 million t/y and its consumption is around
the same. The market for ball clays in the EU is worth €400 million/y.

Vermiculite

Vermiculite is a member of the phyllosilicate, or sheet silicate, group of minerals. It has the unique
ability to expand to many times its original volume when heated - a property known as exfoliation.
The majority of applications call for vermiculite in its exfoliated form (IMA Europe, undated - b).

Vermiculite contains 0.5% by weight TiO2 (i.e. it does not exceed the 1% by weight carcinogenicity
category 2 classification limit but its market would be impacted if TiO2 were to be classified as Carc
Cat 1B) and finds a variety of applications including (IMA Europe, undated)

• Animal feedstuffs: vermiculite is used as a support and carrying medium for a range of nutrients
such as fat concentrates, vitamin preparations and molasses;

• Bitumen coated screeds: vermiculite, coated with a bituminous binder, can be used as a dry,
lightweight roof and floor screed;

• Lightweight concretes: vermiculite concretes may be used for in situ roof and floor screeds and
in the fabrication of pre-cast products. Vermiculite concretes can also be used around back
boilers and as a fire back support material;

• Vermiculite plasters;

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• Loose-fill insulation: loose-fill vermiculite can be used between joists in lofts for house
insulation;

• Boards, panels and premixed coatings: these coatings have been used in the petrochemical
industry and tunnel construction;

• Refractory and high temperature insulation: vermiculite for refractory and high temperature
insulation is normally bonded with alumina cements, fire clays and silicates to produce a wide
range of vermiculite products which, depending on type and application, can withstand hot face
temperatures of up to 1,100 °C;

• Steelworks and foundries: vermiculite is used for hot topping molten steel to reduce heat loss
from ingots and ladles and generally as a loose-fill insulator;

• Silicate bonded shapes and blocks: pressed vermiculite block insulation can be used in high
temperature kilns, furnaces, combustion plants, boilers, wood burning stoves and night storage
heaters;

• Automotive industry: vermiculite is now used extensively in the friction lining industry (e.g.
brake and clutch linings) as a safe alternative to asbestos;

• Horticulture: vermiculite is well established as a growing medium; and

• Packaging materials: exfoliated vermiculite is a useful packaging medium.

Currently, ca. 18,000 tonnes of vermiculite are produced each year in the EU (in Bulgaria) (USGS,
2016b). No data are available on the value of the market in the EU.

Refractory materials

TiO2 is also present, up to 4%, in a number of naturally occurring minerals that are used in the
refractory industry including refractory calcined clay (chamotte), calcined bauxite, brown fused
alumina, andalusite, zircon silicate, synthetic mullite, refractory clay, as well as kaolin and bentonites
that were discussed above (Cerame-Unie, 2016; German Refractory Association, 2016)99.

The European Refractory Producers Federation brings together 160 members located in Austria,
Belgium, the Czech Republic, France, Germany, Italy, Netherlands, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain and the UK. These companies would be affected by the proposed
classification and it is estimated that the proposed classification would impact 40% to 50% of all
refractory products (Cerame-Unie, 2016). With regard to the tonnage of potentially impacted
refractories, the European Refractory Producers Federation estimates that TiO2 occurs as an
impurity in nearly all silica-based refractories and about 80% of the high alumina refractories.
According to statistics held by the Federation, this amounts to 1.3 million t/y manufactured in the
EU.

99
TiO2 can also be found in metal working slags. A range of 0.5 to 1% is typical in blast furnace slags. Quoted
quantities are 35 million t/y for blast furnaces in the EU. Although X-ray fluorescence analysis might detect
titanium in a sample which is conventionally reported as TiO2, in some materials the titanium might be
present as titanates. Any classification change needs to be clear on what it applies to.

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The value of the EU refractory market in 2014 was ca. €4.8 billion/y; therefore, a simple analogy
would suggest that €2-2.5 billion worth might be affected by the proposed classification for TiO2. In
2014, the industry employed over 17,000 workers100.

Abrasives

TiO2 can be present as an impurity in the abrasive grains used in the abrasive industry at a
concentration of up to 0.5% by weight (with the exception of pure white fused alumina, which is free
of Ti)101. According to the Federation of European Producers of Abrasives (FEPA), the abrasives
industry represents an annual turnover of €3.5 billion in Europe, of which two-thirds (2/3) are
bonded and coated abrasives (€2.3 billion) and 10% are ceramic abrasives (vitrified bonded). There
are 150 abrasives production plants in European countries employing ca. 20,000 workers, with 80%
involved in the manufacture of bonded and coated abrasives and 30% involved in the manufacture
of ceramic abrasives products.

Zircon

Zircon is a mineral belonging to the group of nesosilicates and it is natural zirconium silicate, ZrSiO4.
Ilmenite (FeTiO3), rutile (TiO2) and zircon minerals are mined together as co-products. The
downstream processing of zircon, however, leaves TiO2 as an impurity at 0.1-0.5% by weight in the
zircon. Therefore, the proposed classification for TiO2 would impact on the industry as classification
rules mean that zircon would carry the same classification as TiO2.

Ceramics account for the single largest share of demand with about 50%102 as a whitening agent in
the body of porcelain tiles, followed by refractory and foundry (30%)103, followed by zirconia,
zirconium chemicals and metal. Minor uses include friction materials, welding rods and zirconium
alloys.

There are 10 EU-based companies involved in the marketing of zirconium products in the EU
alongside a smaller number of non-EU companies. The most important countries in this market
include France, Spain, Italy, Germany and the UK.

The volume of zircon consumed in the EU is estimated at 325 ktonnes/y (according to the USGS, no
production takes place in the EU) and has a market value of just over US$300 million (or over €275

100
Figures based on a visual assessment of statistics available at http://www.pre.eu/ (accessed on 28 October
2016).

101
There have also been suggestions that ilmenite or titanium slag may also be used as abrasives.

102
Information available at http://www.zircon-
association.org/Websites/zircon/images/Resources/EICF_160417_presentation_web.pdf (accessed on 28
October 2016).

103
Foundry applications are mostly relevant to China.

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million) per year104. It is worth noting that the TiO2 feedstock demand is the principal driver of zircon
supply105.

Summary

A summary of the key information on the aforementioned minerals is provided in . The total market
value of these minerals and products exceeds €6.2 billion a year but it must be understood that
downstream uses of these minerals are of a value much higher than what is shown in this table.

Table 4–33: TiO2 impurities and markets for selected minerals and products (and scale of impact of TiO2
classification)
Impacted by TiO2
TiO2 Value of EU
classification EU production EU market
Mineral impurities market
Carc Cat Carc Cat (million t/y) (million t/y)
(%) (€billion/y)
2 1B
Kaolin >2.5   4 4 0.3
Bentonite >2   3 2.7 0.6
Perlite 0.2   0.65 0.65 0.12
Mica <2   0.09 No data 0.04
Diatomite <0.7   0.1 0.13 0.04
Ball clays <2   12 12 0.4
Vermiculite 0.5   0.018 No data No data
Refractory <4   1.3 No data >2
materials
Abrasives 0.5   No data No data 2.5
(ceramic)
Zircon 0.1-0.5   - 0.325 0.275
Total affected - >20 >18 >3.3
by Carc Cat 2
Total affected >21 >20 >6.2
by Carc Cat 1B
Source: consultation

Impacts from a Carc Cat 2 harmonised classification for titanium dioxide

If TiO2 were to be classified as Carc Cat 2 (or Carc Cat 1B), several industrial minerals would also have
to be classified in the same hazard category if the TiO2 impurities exceeded the relevant
classification limit (1% by weight for Carc Cat 2 and 0.1% by weight for Carc Cat 1B). This could affect
their handling, processing, use and waste disposal.

As shown in the table above, on the basis of typical TiO2 levels present in these minerals, kaolin,
bentonite, mica, ball clays and refractory materials would be impacted; these minerals have a
combined EU market size of over 18 million tonnes per year and an EU market value of over €3.3
billion. Conversely, minerals such as perlite, diatomite, vermiculite, abrasive grains and zircon would
not be affected as their TiO2 impurities are below the 1% by weight level.

104
A value per tonne of just below US$1,000 per tonne has been obtained from http://www.zircon-
association.org/assets/files/KnowledgeBank/EICF_160417_presentation_web.pdf (accessed on 25 August
2017). An exchange rate of US$1 = €0.917 has been used (as of 28 October 2016).

105
Information available at http://www.zircon-
association.org/Websites/zircon/images/Resources/EICF_160417_presentation_web.pdf (accessed on 28
October 2016).

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Impacts would arise as a result of:

• New labelling, which could drive user perception and might have an impact on the cost of
handling of the minerals; the presence of the new carcinogen might appear on the safety data
sheet which might increase user resistance - even though the TiO2 is not readily available for
inhalation. Contrary to a Carc Cat 1B classification, users would not be obliged by the
Carcinogens and Mutagens Directive to actively consider alternatives and strengthen their
worker health and safety protection measures; nevertheless, some companies routinely publish
and implement black lists of materials to be avoided on grounds that they are CMR; and

• New waste management requirements, as the presence of TiO2 in concentrations above 1%

could render relevant waste streams as hazardous thus requiring different handling and
disposal.

4.8.2 Impacts on manufacturers and users of other poorly soluble powders

In its 14 September 2017 opinion, RAC acknowledges that the carcinogenicity profile described for
TiO2 is not exclusively characteristic to TiO2 but applies to a group of chemicals with similar toxicity
profile addressed as “poorly soluble low toxicity (PSLT) particles”. As such, the classification of TiO2
sets a precedent for a subsequent classification of all other PSLT powders regardless of each and
every substance's human health carcinogenicity data. Other PSLTs which may be impacted include
carbon black, inorganic coloured pigments, iron oxides, cerium oxide, aluminium oxide, magnesium
oxide and plastic dusts.

In this context, the ultimate classification for TiO2 would be a cause of significant problems in two
key areas:

• All poorly soluble powders that could replace it (including minerals such as kaolin, chalk, talc,
etc.) could be suspected of causing carcinogenicity in humans in a similar manner. As such, the
hazard classification of TiO2 would not offer any discernible additional protection to workers’
health as its direct alternatives would have an equivalent carcinogenicity hazard profile; and

• The manufacture, handling, use and disposal of other poorly soluble powders, if similarly
classified for carcinogenicity, would become more costly and burdensome in the EEA thus
leading to further loss of competitiveness of EEA businesses.

A case study of potential impacts is provided for carbon black (and associated materials) overleaf.

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Box 4-3: Case study – Potential impacts on the carbon black industry from the proposed classification for
TiO2

Carbon black (EC No. 215-609-9, CAS No. 1333-86-4) is virtually pure elemental carbon in the form of colloidal
particles that are produced by incomplete combustion or thermal decomposition of gaseous or liquid
hydrocarbons under controlled conditions. Carbon black is mainly used as a reinforcing agent in tyres and
other rubber products. A small percentage is used as a colourant in polymers for indirect food contact use.
Carbon black is also in the top 50 industrial chemicals manufactured worldwide, based on annual tonnage,
which currently stands at 8.1 million t/y106.

There are four EU-based companies involved in the manufacture of carbon black and seven companies in total
that place carbon black on the EU market. The most important EU Member States within the carbon black
market are the Netherlands and Italy as they both host carbon black manufacturing plants. It is estimated that
2,600-3,200 workers are employed in the carbon black industry in the EU.

The EU market for carbon black had a volume of 2 million tonnes in 2014, of which rubber goods (mostly tyres)
represented 88% of consumption, followed by plastics (5%), printing inks (4%), coatings and paints (1%) and
other small applications such as activated carbon, concrete/bricks, papers/toners and road fillers (collectively
accounting or 2%) (Jung & Bouysset, 2015).

As described above, the proposed classification for TiO2 would potentially pave the way for the classification of
carbon black and other substances, for example, fumed alumina (which is used in adhesives, sealants, chemical
mechanical planarization and cosmetics)) and activated carbon (which is used in a large variety of uses
including as an industrial and consumer filtration medium for potable water and other consumable beverages).
Such a classification would have a profound adverse impact on the use of the substances; it would make their
handling, use and disposal in the EEA more burdensome and costly and could lead to loss of competitiveness
among manufacturers of these substances but also EEA-based downstream users.

If a carcinogenicity classification encouraged users to seek alternatives, impacts on consumer welfare might
arise; as the majority of carbon black is used as a reinforcing agent in car and lorry tyres, it imparts important
safety properties to the rubber of a tyre, specifically rolling resistance, durability and longevity. Simply stated,
consumer and lorry tyres would be less safe and would wear out much sooner (i.e., ca. 10,000 miles lifespan)
without the use of carbon black. In another example, activated carbon acts as a filtration medium and
removes harmful impurities and unpleasant odours in potable water and other beverages. Its classification
might restrict its use in food and beverage processing, possibly compromising food and beverage quality &
safety.

Furthermore, given the EU’s regulatory influence, this classification could be adopted by other countries and
would greatly increase the possibility of product liability legal actions, and worker compensation claims.

Source: information submitted by a leading carbon black manufacturer

4.9 Impacts on the environment

Making the continued use of TiO2 more burdensome and encouraging the substitution of the
substance could have adverse impacts on the environment. This is elaborated with specific
examples overleaf.

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Information available at http://www.carbon-black.org/index.php/what-is-carbon-black (accessed on 28
October 2016).

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Impact category Relevant Description
applications

Imports of finished All In many applications, cheaper, imported finished articles might replace more expensive EEA-made ones; as a result, there would be
articles into the EEA an increase in CO2 emissions from increased transportation of the articles into the EEA.

Alternatives and All Obtaining sufficient volumes of alternatives: the energy required to produce TiO2 is high and, as such, the ecological footprint of its
their impacts on the production is significant. However, the alternatives to TiO2 are, like TiO2, based on minerals that are extracted from the earth. A
environment significant new investment and infrastructure would need to be put in place to meet the significantly increased demand for the
alternatives. This would have its own significant ecological footprint, which would not be as optimised as has been currently
achieved through the 90 years of experience of industrial use of TiO2. In addition, the current TiO2 extraction and processing
activities (typically outside the EEA) would become redundant and significant volumes of equipment and construction waste from
this decommissioning would be generated.

All Adverse effects of alternatives: some alternatives to TiO2 are accompanied by an environmental hazard classification (e.g. heavy
metals or zinc-based pigments). Substitution of TiO2 with one of those substances might thus increase ecological pressure on the
environment. With specific regard to cosmetics, an increased use of organic UV filters as TiO2 substitutes would lead to higher
volumes of them being released into the environment with potentially long-term adverse effects onto the flora and fauna. Spherical
plastic particles that can be used as substitutes are products based on mineral oil and require significant amounts of energy to
produce and convert for use and there are concerns about their release to the aquatic environment.

Alternatives to TiO2 would need to be used at higher loadings and TiO2-free articles would need to be replaced more often. Painting
would require larger amounts of TiO2-free paint thus leading to the generation of increased amounts of waste (empty paint tins).
Production of bulkier products (for example, paper products) would impact on packaging and delivery costs, therefore affecting the
environmental footprint of some products.

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Impact category Relevant Description
applications

Adhesives / Fibres Natural vs. petrochemical products: gelatine glues that contain TiO2 are based on a by-product from animals and constitute a re-use
/ Paper of otherwise discarded material. The alternative would be hot melts which are more expensive and based on polymers that originate
from the petrochemical industry. If these products were replaced, it would be by less environmentally friendly and would result in
costlier and less recyclable products. On the other hand, if TiO2 used in fibres were to be substituted, the poorer quality of the
synthetic fibres would cause a shift to natural fibres. The global environmental impact would be much worse due to high land use,
increased water and energy consumption, increased use of fertilisers and transport in the context of a projected increase of world
population and limited technical closed loop recycling possibilities for natural fibres in comparison with the synthetic ones.

Particleboard based furniture often utilises manufacturing residues or reclaimed wood as raw material and therefore the
combination of décor paper and particle board contributes to high resource efficiency and the establishment of a circular economy.
Décor paper is produced using mainly forest cellulose and TiO2. The pulp comes from forest managed in a sustainable way (certified
by external third parties as FSC and PEFC) and it is a renewable and carbon neutral raw material. Plastic films that could replace this
paper are based on fossil fuels.

Durability All (examples: Because of the superior durability of TiO2-based paints, coatings, plastics, etc. any alternative would lead to the generation of higher
paints, coatings, emissions, more waste and the need to re-paint/coat or replace more often. Maintenance of buildings would increase; raw materials
plastics) would be used more frequently and replacement of wooden parts would become common practice. This would go against the
principles of sustainable development.

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Impact category Relevant Description
applications

Air quality Construction Substitution of TiO2 would mean loss of photocatalytic applications: NOx are one of the most critical groups of air pollutants in
products urban areas. One of the options to reduce the concentration of these pollutants in the air is to create photocatalytically active
surfaces in appropriate locations and TiO2 is, so far, the only photocatalyst providing the required characteristics. In Directive
2008/50/EC, the European Union set upon local authorities a maximum limit of 40 µg nitrogen dioxide/m3 in the ambient air at the
local authority level and defined potential fines for authorities which fail to meet that limit (as an annual average). In July 2015, the
European Commission reprimanded Germany for persistently exceeding the limit for many years107. If the federal, state and local
governments continue to fail in taking sufficient action to reduce pollution of these harmful gases, there may be proceedings, and
following that high fines may also be imposed on individual cities and local authorities (up to €50,000 per day and location is the
possible penalty).

The use of photocatalysis in TiO2-containing products leads to environmentally friendly and sustainable decomposition of harmful
gases and solids indoors (such as nicotine and tar). Various harmful substances are not simply collected in filter materials (which are
often disposed as hazardous waste) but decomposed into harmless compounds. There is currently no comparable technology
available.

If the increased regulatory burden would impact upon the use of TiO2 as a photocatalyst, this would bring to the end the widespread
use of photocatalysis as an environment-friendly and sustainable technology for air cleaning.

Fibres Automotive applications: if synthetic fibres for wet laid processes could not be produced any more with a suitable quality due to the
elimination of TiO2 from fibre processing, they would not be available for filter products for the automotive industry. Maintenance
intervals/mileages would have to decrease to a level unseen for decades and there would be higher engine oil consumption /
material consumption/maintenance costs during a car’s life.

Catalysts Impact from loss of catalysts used to prevent atmospheric emissions: inability to produce SCR catalysts could have adverse
environmental impacts and a significant number of these SCR catalysts used globally are manufactured in the EEA. Particularly in
countries outside the EEA with lower fuel quality, users would not be able to use SCR technologies for automotive applications and
alternative technologies are sensitive to low fuel quality. This might delay the implementation of SCR technologies in such countries
for years.

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Information available at http://www.fr-online.de/wirtschaft/stickoxid-und-feinstaub--europameister-im-luft-verpesten-,1472780,34274106.html (accessed on 23 October
2016).

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Impact category Relevant Description
applications

Energy consumption, Paints & coatings, Electricity consumption and heating: if the availability of white and bright architectural paints on the market diminished, a higher
efficiency and plastics consumption of electricity could be expected due to the use of darker colours in the home/office. In relation to exterior coatings, a
management negative impact would be expected on the heat management of buildings due to reduced light reflectivity. White colours contribute
to a global lowering of temperature because of their solar reflectance (cf. temperature of a white roof <50 °C and a dark one >80 °C);
reducing the availability of light colours would probably result in more energy-demanding, resource inefficient air conditioning with,
ultimately, a potential impact on global warming. In addition, TiO2 is used to make plastic roofing material and profiles (windows)
which reflect light, thus causing buildings to heat up less in hotter climates. This reduces the need for air conditioning. Substitution
of this roofing material with less effective material would thus increase energy consumption and the CO2 footprint.

Similarly, the reflectivity of road marking lines would be affected meaning that the white lines might not be as visible thus raising the
need for more/better lighting on roads. The potential for a higher number of accidents would mean, apart from increased injuries or
deaths, more delays on the roads and, in turn, this increased congestion would also have a negative environmental impact as more
vehicles would be running for longer therefore creating more potentially harmful emissions into the atmosphere than would
otherwise be produced.

Inks Photovoltaic applications: photovoltaic modules are covered with white ink films to increase efficiency. Without TiO2-containing
white inks it would not possible to achieve this effect, so efficiency would decline.

Glass Glass applications: if the EEA industry was discouraged from using TiO2, there would be costs to the environment, as TiO2-based
glass offers significant benefits in sustainable construction materials – self-cleaning windows reduce maintenance and extend
building lifetime, while coatings reduce the need for heating and cooling of buildings which is responsible for a large amount of CO2
emissions.

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Impact category Relevant Description
applications

Waste management Plastics and fibres Impacts on plastics recycling: reclassification of plastic waste as hazardous due to the presence of TiO2 as a carcinogen would have
and recycling an effect on the recycling of such waste. Unless a specific exemption is introduced in Annex III of the Waste Framework Directive (on
the basis of the critical route of exposure being irrelevant to plastic waste), up to 1.25 million tonnes of recycled plastic products
would be at stake. Their recycling prevents the release of an estimated 1.8-2.4 million tonnes of CO2 equivalents per year, according
to the EuPC, through the increased use of virgin resins.

Synthetic fibres allow good, proven and effective recycling techniques, such as mechanical recycling of the PP family in the
Engineering Plastic sector; mechanical recovery of PET that is applied in fibres production; chemical recycling of polyamide back to
feedstock monomer; plus, new innovative techniques currently in progress. A harmonised classification of TiO2 as a carcinogen could
make recycling of fibre waste more difficult, if not impossible if the waste is classified as hazardous. By way of example, using
recycled PET polymer from PET bottles for fibres is a sustainable alternative to virgin PET polymer, with just 25% of the carbon
footprint compared to virgin polymer use. If regulatory controls on TiO2 became too burdensome, significant amounts of this high
value secondary raw material would have to be exported to operations outside of the EEA. PET (and polyamide) recyclate is slightly
discoloured due to the thermal history of the material. This discoloration is masked/reduced by TiO2. If the continued use of TiO2
would become unattractive, consumer acceptance for recycled fibre products (for example, in the bedding sector) would be reduced.

Food packaging If it was no longer possible to use TiO2 in food packaging, then some information (which is presently provided by means of printing
inks), would be delivered using adhesive paper labels. The mixing of materials would seriously hinder the ability of the current
processes to recycle the packaging material. This could result in the growth of the non-recyclable waste fraction (which to date has
been decreasing) and an increase in the amount of waste destined for landfill or energy recovery.

Furthermore, due to the lower shelf life caused by the lack of TiO2, increased amounts of packed food will have to be disposed of. If
more packaging materials are printed outside the EEA, due to the non-availability of TiO2 based inks within Europe, then the carbon
footprint of the packaging will increase as a result of longer transport routes.

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5 Conclusions

5.1 Why and how the proposed classification would impact the
EEA
This report has explained that, should the Commission and REACH Committee agree with the RAC’s
proposal of a Carc Cat 2 harmonised classification for TiO2, six drivers of impacts on the EEA industry
and consumers would come into action:

1. Restrictions: there is existing legislation that restricts or otherwise controls the marketing and
use of substances that are classified as Carc Cat 2 in specific industry sectors and markets (e.g.
cosmetics, food contact materials or toys).

2. Negative consumer perceptions (especially as a result of labelling): industrial/professional user

and, primarily, consumer perceptions would play an important role. Irrespective of the route of
exposure (which is critical in assessing risks from exposure to TiO2), presence of a Carc Cat 2
substance in a vast number of industrial processes as well as products placed on the market,
many intended for consumer use (e.g. DIY paints, adhesives, sealants, etc. but also food and
pharmaceuticals as well as cosmetics) would be perceived by users in a negative way.
Consumers would not be able to understand the fundamental difference between a Carc Cat 1B
and a Carc Cat 2 classification or in any way be able to evaluate the importance of the exposure
route.

3. Increased administrative burden from and costs of waste management: this report has shown
than in many sectors several waste streams which are currently classified as non-hazardous, may
be re-classified as hazardous following the introduction of the Carc Cat 2 harmonised
classification due to a TiO2 content that exceeds 1.0% by weight. Waste management cost
increases would particularly impact the manufacturers of the pigment given the very large
volumes of potentially relevant waste streams generated at each manufacturing location.

4. Damage to the EEA manufacturing base: the direct impact of a Carc Cat 2 harmonised
classification would be the loss of up to an estimated 15% of the EEA market for TiO2; this,
combined with losses from sales of ancillary products and the increased cost of waste
management would jeopardising the viability of (at least some) EEA-based TiO2 manufacturing
plants. Looking at the downstream supply chains for TiO2-containing formulations and articles,
these are particularly long and diverse; for instance, paints containing TiO2 are applied to
myriads of surfaces/articles which, in turn, find their way into vast numbers of different complex
end products. Manufacturing outside the EEA, where the carcinogenicity classification for TiO2
would not apply, could become more competitive and thus more attractive, and whilst it may be
impossible to quantify all impacts that would arise along the supply chains, it is clear that
adverse impacts would magnify as the scope and the value of markets increases along those
chains.

5. Lack of technically feasible alternatives: there is a lack of feasible alternatives for TiO2 for the
vast majority of its uses therefore substitution could not be a feasible solution to an increased
regulatory burden associated with the continued use of the substance. More specifically:

a. There is no alternative on the market with technical properties, e.g. brilliance, colour
strength, opacity, pearlescence and price-performance ratio, similar to TiO2. The range

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of colour shades achievable (e.g. in paints) without TiO2 is very narrow compared to the
present range. Bright opaque colours available today would be unachievable.

b. No known alternative can demonstrate the weatherability of TiO2. This is based on

TiO2’s exceptional stability to heat, light and weathering plus its ability to absorb UV
radiation, a critical property in the field of cosmetics, packaging and construction e.g. by
preventing degradation of paint films and embrittlement of plastic articles.

c. No known alternative holds approvals for use in certain consumer applications where
authorisation of additives is required before use. Only approved white colours can be
used in food and pharmaceuticals and TiO2 is the only white pigment which is approved
for use as a colouring agent in food and pharmaceutical applications.

d. Some applications must use TiO2. No other substance could replace TiO2 as a raw
material in the production of Complex Inorganic Coloured pigments (e.g. rutile
pigments). In its use as a photocatalyst, no real alternative exists with the same
performance.

Overall, there are no viable alternatives for delivering whiteness to polymeric or synthetic
materials (paints, plastics, paper) as effectively or efficiently as TiO2. Some potential
alternatives may pose a hazard to human health and/or the environment. Importantly, if
TiO2 is classified as a Carc Cat 2 substance, other less white pigments (being poorly soluble
powders themselves) would also meet the requirements for the same hazard classification,
if they were to be tested to the same level as TiO2.

6. Adverse side-effects on unrelated supply chains: the classification of TiO2 would pave the way
to the potential classification of other substances, either because they are themselves poorly
soluble (see Point 5 above) or because they contain TiO2 impurities at a level that exceeds 1.0%
by weight. This would generate adverse impacts along the respective supply chains.

5.2 Impacts on the manufacture and supply of titanium dioxide in

the EEA
In total, there are 17 TiO2 manufacturing plants in the EU plus one in Norway (as well as two known
manufacturers in Ukraine). Germany, the United Kingdom, and Finland combined represent over
60% of EEA production capacity for TiO2.

EEA production represents almost 20% of the total worldwide production and amounts to ca. 1,100
ktonnes/y. Of this, 67-68% is sold in the EEA and the rest is sold to customers outside the EEA. The
total value of the TiO2 manufactured in EU plus Norway is estimated at ca. €3 billion and the Gross
Value Added to the EEA economy is estimated at ca. €560 million. The breakdown of TiO2’s
applications shows that paints, coatings, inks, plastics and paper account for 98% of total demand
for the substance, with paints and coatings accounting for more than half of the total – importantly,
exposure of the end users of these products is non-existent. The remaining 2% covers a wide range
of minor but specialist applications (with each one still potentially accounting for the consumption of
thousands of tonnes of TiO2).

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The range of impacts resulting from a Carc Cat 2 classification for TiO2 manufacturers in the EEA
include:

• Capacity underutilisation: this report estimates a significant direct impact on downstream uses
of TiO2 from a harmonised classification of Carc Cat 2 corresponding to the loss of 10-15% of
total TiO2 demand in the EEA. This impact would arise from a combination of regulatory
pressures and negative user perceptions. Loss of demand, and the introduction of this
harmonised classification, would not result in a corresponding increase in consumer and worker
health protection. Due to the high fixed costs in the manufacture of the substance, a
substantially high capacity utilisation is required to ensure profitability for each plant. Capacity
utilisation in recent years has generally been low and any further decrease would jeopardise the
economic viability of at least some TiO2 manufacturing plants in the EEA;

• Loss of production of ancillary products: TiO2 manufacturing plants also produce co-products
such as titanium chemicals, iron salts, sulphates, inorganic acids, aluminium substances, etc. If
demand for, and production of, TiO2 declined, production (and associated sales) of these by-
products would also be affected. Moreover, certain co-products (iron filter salts) also happen to
contain more than 1.0% TiO2 impurities by weight, meaning that they would also be classified as
carcinogenic when placed on the market and this would impact upon their use for a number of
their established uses; and

• Higher cost of waste management: if wastes with a TiO2 content above 1.0% by weight were to
be classified as hazardous, the cost and complexity of their waste management would
dramatically increase. There are several waste streams generated at the TiO2 manufacturing
sites which amount to several thousand tonnes per year. Whilst these are currently disposed of
as non-hazardous, the Carc Cat 2 harmonised classification might lead to them being classified as
non-hazardous given their volumes, risk for exposure to TiO2 by inhalation and the possibility of
EEA Member States opting to make use of Article 7(2) of the Waste Framework Directive which
permits Member States to classify waste as hazardous even if it does not appear as such on the
LoW (as far as can be ascertained, this option does not appear to have found any/wide use so
far). Moreover, red gypsum would be very unlikely to continue finding useful downstream
applications as an industrial raw material leading to loss of sales which currently support the
profitability of TiO2 production. The excess cost associated with waste management could be in
the range of hundreds of millions of Euros.

Overall, loss of demand for and sales of TiO2 and co-products would have a severely detrimental
effect on the EEA TiO2 manufacturing base. If those impacts were to be accompanied by changes to
waste management costs, the EEA might experience a (partial) collapse of its TiO2 manufacturing
base.

The TiO2 manufacturing industry in the EA currently employs an estimated 8,150 workers and is
responsible for the creation of ca. 22,800 support jobs within the domestic economies of the
relevant EEA Member States. These jobs would be at risk if TiO2 plants were to shut down due to
them no longer being economically viable. It can be envisaged that TiO2 manufacturing activities
outside the EEA would be expanded in order to meet global demand for the pigments thus,
effectively, transferring jobs from the EEA to non-EEA locations.

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5.3 Impacts on the supply of feedstock and raw materials and
energy to titanium dioxide manufacture in the EEA
There is no mining of titanium ore in the EU, yet there is an ilmenite mine in Norway as well as an
ore processor generating TiO2 slag, also in Norway. These two companies are understood to
currently sell most of their outputs to European customers. Adverse impacts to TiO2 market in the
EEA from the adoption of a Carc Cat 2 harmonised classification could have notable negative
consequences for the two companies which would be forced to seek customers outside the EEA.
The rest of the significant volumes of feedstock required by EEA manufacturers of TiO2 are sourced
from overseas suppliers.

As far as suppliers of other raw materials and energy are concerned, a total annual trade of ca. 4
million tonnes of chemicals and an annual demand for over 7,500 GWh of energy would be place in
jeopardy with the scale of impacts depending on the scale of reduction in EEA-based TiO2
manufacturing operations. Closure of TiO2 manufacturing plants in the EEA would result in
significant loss of turnover for the suppliers of feedstock, raw materials, consumables, utilities as
well suppliers of all purchased services required to maintain and operate those manufacturing
facilities.

5.4 Impacts on downstream users of titanium dioxide in the EEA

There are four main areas where impacts may arise for downstream users:

• Compliance with horizontal legislation (primarily relating to labelling and to waste

• Use of TiO2 in products awarded with a label under a recognised ecolabel scheme: TiO2 could
no longer be used in products that hold an ecolabel, such as the EU Ecolabel, the German Blue
Angel and the Nordic Swan, which lists CMR properties under their exclusion criteria.
Classification of TiO2 as Carc Cat 2 would also mean that textiles currently awarded the OEKO-
TEX® certification could no longer attain this. Loss of those awards would make the impacted
products less attractive to consumers who value these schemes and consider such ecolabel
schemes important in making purchasing decisions. In addition, the harmonised classification
could trigger substitution of TiO2-containing products in public procurement (infrastructure,
public building, supplies for public administration) processes (EEA Member States may run their
own Green Public Procurement initiatives). The harmonised classification would have an effect
in the context of green building certification schemes such as BREEAM (Building Research
Establishment Environmental Assessment Method), which have relied on an eco-label approach
to point scoring; and

• Use of TiO2 in articles intended for use in the automotive industry: under the Global
Automotive Declarable Substance List (GADSL) a Carc Car 2 substance would not be “Prohibited”
but would be “Declarable”, thus making it less appealing for automotive manufacturers and less
marketable by paint manufacturers.

It is worth noting that even where an exemption or derogation can be obtained, measuring the
bioavailability of TiO2 with the aim of establishing that risks to consumers are acceptably low could
be costly. For instance, if testing were to be undertaken to demonstrate that the TiO2 in the
polyamide and polyester yarn is completely bound and strongly encapsulated in the polymer,
making its inhalation impossible, the cost of commissioning such testing by specialist laboratories
has been estimated to be €1-1.5 million.

On the other hand, even where the existing legislative framework allows the continued use of a Carc
Cat 2 substance, market and consumer perceptions and pressures might lead to attempts at
substitution or product withdrawal from the market, as is elaborated below.

5.4.3 Market losses due to negative market and consumer perceptions of the
safety of titanium dioxide
The Carc Cat 2 harmonised classification would unavoidably raise doubts on the part of buyers, users
and consumers, about the safety of TiO2 as a raw material and of products and mixtures that contain
it.

As far as consumer uses are concerned, under the CLP Regulation, TiO2-based formulations would be
accompanied by appropriate hazard labelling including a pictogram, a signal word, a hazard
statement and several precautionary statements. The labelling requirements for Carc Cat 2 would
be very similar to the non-expert consumer eye to those of Carc Cat 1B. In any case, a pictogram of
an ‘exploding person’, and the terms “Warning” and “Suspected of causing cancer”, even if the
inhalation exposure route was to be specified, would cause alarm among users. Companies placing
TiO2-containing mixtures on the market would not be free to choose what they include in the labels
affixed to their products and may only label according to the CLP Regulation.

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In certain countries in particular, e.g. France, there is a ban on self-service in stores for potentially
carcinogenic formulations which could physically prevent consumer access to these products.
Consumer uses that would be particularly vulnerable to the development of negative perceptions
among users would include formulations such as paints, inks, adhesives, sealants, detergents as well
as products which consumers have significant exposure to and for which safety aspects play a critical
role, such as food (and its packaging which may contain TiO2 through a multitude of routes: coatings,
inks, labels, container material), pharmaceuticals, cosmetics and textiles. In addition, mixtures and
articles intended for use by children (toys, school paints, inks, etc.) might also attract negative
publicity because they contain TiO2. Precisely to avoid such negative publicity, industrial users of
TiO2 might opt for substituting TiO2 (where feasible) or removing products from the market, which
could lead, for example, to the vast majority of paints no longer being available for use by school
children.

Even for professional and industrial users, the presence of hazard labelling for TiO2 could cause
unwillingness to handle and (potentially) be exposed to the pigment and its formulations and could
encourage employers to seek alternative pigments. From a different perspective, as TiO2 would be
stigmatised, some brand owners would likely put significant pressure on the upstream supply chain
to replace TiO2. This would also attract negative publicity and undue attention from the media,
NGOs, professional users and the end consumer (even where the TiO2 inhalation risk is zero), thus
adding further pressure towards the avoidance of use of TiO2-based products even where such
action is unnecessary as there is no risk of exposure via inhalation.

5.4.4 Feasibility and cost of substituting titanium dioxide

TiO2 concentrations of 1.0% by weight could not achieve the desired technical characteristics in its
formulations and past attempts at finding alternatives to the substance have failed. For example,
concerted efforts have been made towards the replacement of TiO2 in paint formulations in
response to its high market price. Those efforts failed as it was only possible to substitute a small
proportion of the overall TiO2 loading if performance standards were to be met. Substitution of TiO2
is technically infeasible with the exception of very small niche markets for which TiO2’s brightness
and effectiveness are not a priority. Only a very small percentage of colour shades can be achieved
without TiO2.

For applications where TiO2 is an indispensable raw material, e.g. the manufacture of Complex
Inorganic Pigments, its replacement is de facto impossible. For certain other applications, e.g. as a
UV filter in cosmetics and the packaging for pharmaceuticals, and as a white food colourant and a
pharmaceutical excipient, there are no approved alternatives that could match the technical
performance and efficiency of TiO2.

TiO2 is used in a vast number of products. By way of a single example, TiO2 is used in the great
majority of coloured pharmaceutical and dietary supplement tablets and capsules, either as a sole
colourant or in combination with other pigments to produce a range of colours. Reformulation to
remove TiO2 would clearly be an enormous (and very costly) task.

Downstream users of TiO2 consulted for this study have, therefore, consistently argued that
reformulation to technically feasible TiO2-free products is not possible. If the technical
characteristics of the new formulations were to be disregarded, the time required for reformulation
would in any case be significant109 and the costs would be very large due to the testing and trialling

109
Examples from consultation: (a) consumer paints: 5-10 years; (b) industrial paints: 5-20 years; (c) consumer
inks: 2-5 years; (d) printer toners: 2-10 years; (e) industrial inks: 5 years; (f) cosmetics: 3-8 years; (g) fibres:
over 2 years.

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required (for pharmaceuticals alone, testing the stability of the formulations would necessitate an
unprecedented volume of tests), the increased volumes of less efficient pigments needed (e.g. 20-
50% higher for ZnS) and the need for new additives (e.g. new UV absorbers/blockers in construction
plastics)110.

In conclusion, reformulation is not a realistic proposition in the vast majority of TiO2’s applications.
If, however, reformulation was pursued under pressure from regulation and from the supply chain,
(a) it would lead to a greyer world and (b) the cost of manufacturing would increase as a result of the
investment cost of reformulation (see details above) and the lower efficiency of alternative
pigments. Small companies in particular could not easily absorb the costs of reformulation so would
need to pass these on to customers, thus rendering their products more expensive and their market
position less competitive. Furthermore, replacement of TiO2 would result in poorer quality products
which would affect the faith of customers in the TiO2-free products.

5.4.5 Increases to operating costs and associated loss of competitiveness and

competition
Following from the discussion above, it is to be expected that operating costs of downstream users
of TiO2 would increase due to:

• Increased costs of waste management;

• Increased administrative burden (provision of SDS, provision of information to Poison Centres);
and
• Losses of economies of scale if some products are removed from the market.

If EEA-made products were to become costlier to manufacture, it would be unavoidable for them to
become less competitive relative to non-EEA made products sold both within and outside the EEA
market. For bulk producers, price sensitivity is key and the proposed classification could severely
harm them. In addition, and for obvious reasons, the manufacture of finished articles outside the
EEA would become less costly and burdensome and thus more economically appealing.

Although relocation of the production of important TiO2-containing products, such as DIY and
professional architectural paints, might not appeal across the board as it is mainly a regional activity,
over time and under the constant pressure of market needs, a shift of the value chain to locations
outside the EEA could be expected, for reasons of proximity and integration with suppliers (unless
non-EEA jurisdictions quickly follow the EEA example and introduce their own similar hazard-based
limitations on the use of TiO2).

Within the EEA, the increased regulatory burden could also drive consolidation in the industry,
leading to less competition. SMEs would be most vulnerable in the face of such a trend. SMEs have
limited capabilities (in terms of R&D, marketing, equipment) for protecting their workers and
formulating feasible alternatives. Large companies producing a wide range of products would be
better placed to cope with a loss of TiO2-containing products compared to smaller businesses which
concentrate on smaller product portfolios.

Finally, it should be understood that adverse impacts would not only affect the users of TiO2 but
would permeate the supply chain. Many examples can be provided here, e.g. DIY stores could see

110
Quantified estimates from consultation: (a) paints: up to €60 million; (b) plastics: €4-10 million; (c)
consumer inks: €0.05-5 million; (d) industrial inks: €5 million; (e) pigments: €0.05-4 million; (f) fibres: €0.5-2
million.

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their sales to DIY enthusiasts coming under pressure; or packaging manufacturers would be forced
to redesign packaging structures (which could impair established recycling processes).

5.4.6 Conclusion on economic impacts

In general, the manufacture of TiO2-containing mixtures and articles and their use in the EEA would
become more complex and thus costlier, without delivering any contribution to the protection of
human health. This would impact upon the competitiveness of supply chains based in the EEA,
although, unlike a Carc Cat 1B classification, a Carc Cat 2 harmonised classification would not offer
substantial incentive for companies to relocate outside the EEA as its implications on worker health
protection would not be as direct.

Changes to the consumer market as a result of restrictions under sectoral legislation and shifting
consumer opinions and perceptions on the safety of TiO2-based formulations would affect the EEA
market for the end products and such market losses could translate upstream to attempts to
substitute TiO2, increased production costs and loss of market share and profits. This could result in
some (parts of) supply chains in the EEA becoming less competitive vis-à-vis their non-EEA
counterparts.

Based on data collected as part of this study and assumptions presented in this report, it would be
reasonable to expect that a decline in demand for TiO2 combined with adverse effects on consumer
and user perceptions would mean the loss of a proportion of overall current demand for TiO2 in the
EEA, which can be tentatively estimated at 10-15%. This would not be accompanied by a
corresponding improvement in consumer health protection as inhalation exposure to TiO2 in its free,
powder form is non-existent.

5.4.7 Impacts on employment

It is not possible to quantify the potential impacts on employment in the EEA. However, it is clear
that the number of workers potentially affected is particularly large. For instance, 110,000 workers
are involved in the manufacture of paints and printing inks in the EEA and the number of workers
involved in the application of paints (at construction sites, industrial production lines, etc.) is
estimated to be around 1 million. In the plastics sector, 1.5 million workers are involved in the
manufacture of plastics with an estimated 4.5 million workers handling and using the plastics further
downstream. Based on the assumption that between 10% and 15% of EEA demand for TiO2 might
be lost following the adoption of the proposed classification, the number of jobs potentially lost
could be of the order of thousands across the EEA.

5.5 Impacts on actors outside the titanium dioxide supply chains

Many industrial minerals contain TiO2 as a natural impurity up to 4% by weight with most containing
more than 1.0%. This means that if TiO2 were to be classified as Carc Cat 2, several industrial
minerals would also have to be classified as Carc Cat 2. This would affect their handling, processing
and use. Information available suggests that EEA markets for minerals of a combined volume that
exceeds 20 million tonnes per year and a combined market value of over €3.3 billion per year
would potentially be impacted. In addition, TiO2 manufacturing plants not only produce TiO2, they
also are capable of generating several by-products. A scale back in the manufacture (and sales) of
TiO2 would also mean a reduction in the volumes of ancillary products and by-products produced
(and sold). Moreover, some of these products (such as iron filter salts) contain TiO2 as an impurity in

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concentrations that exceed 1% by weight. As such, they would need to be classified and labelled as
suspected carcinogens when placed on the EEA market.

The Carc Cat 2 harmonised classification for TiO2, if adopted, would set a precedent for the
subsequent hazard classification of other poorly soluble powders regardless of each and every
substance's human health carcinogenicity data. This would (a) effectively render the known
alternative white pigments unsuitable as replacements for TiO2, and (b) make the manufacture,
handling and use of such poorly soluble powders more costly and burdensome in the EEA, thus
leading to further loss of competitiveness of EEA businesses along the relevant supply chains.

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Montazer, M., Pakdel, E. & Bahzandia, A., 2011. Novel feature of nano-titanium dioxide on textiles:
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7 Annex 1: Legislation of relevance to hazard
classifications under consideration

7.1 EEA-wide legislative requirements

7.1.1 Classification and labelling
Table 7–1: Key parameters of relevant legislation – Classification & labelling
Key parameters Details
Relevant legislative Regulation 1272/2008/EC
instruments
It would affect the labelling of TiO2 as placed on the market and products
containing TiO2. It would require changes to labelling and SDS of mixtures.
Packaging may need to be changed and new information needs to be provided
to national Poison Centres. The CLP Regulation does not apply to cosmetics,
food and feed additives, medical devices, human and veterinary medicinal
products.

Labelling provision:
• Pictogram:

• Signal word = Danger

Table 7–6: Key parameters of relevant legislation – REACH provisions on Safety Data Sheets (SDS)
Key parameters Details
Relevant legislative instruments Regulation 1907/2006/EC – Article 31
The supplier of a substance or a mixture shall provide the recipient of the
substance or mixture with a safety data sheet compiled in accordance with
Annex II:
(a) where a substance or mixture meets the criteria for classification as
hazardous in accordance with Regulation (EC) No 1272/2008
Description of Carc Cat 1B (…)
potential impact classification The supplier shall provide the recipient at his request with a safety data
sheet compiled in accordance with Annex II, where a mixture does not
meet the criteria for classification as hazardous in accordance with Titles I
and II of Regulation (EC) No 1272/2008, but contains:
(a) in an individual concentration of ≥1 % by weight for non-gaseous
mixtures (…) at least one substance posing human health or environmental

manufacturing practice for materials and articles intended to come into
contact with food. It introduces general rules for all business operators in
the supply chain, and specifies that quality assurance and control systems
are established and implemented. All printing inks intended for use on
food packaging are in the scope of this Regulation. Its Annex introduces
detailed rules, which relate to processes involving the application of
printing inks to the non-food contact side of a material or article.

Regulation EU/10/2011 (Plastics Regulation incorporating the Union List):

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Table 7–11: Key parameters of relevant legislation – Food Contact Materials
Key parameters Details
according to Recital 27, substances that are classified as carcinogenic
should not be used in food contact materials without previous
authorisation and should therefore not be covered by the functional barrier
concept.
Plastic multi-layer materials and articles: substances not listed in the
Union list or provisional list may not be classified as a carcinogen in
accordance with the criteria in sections 3.6 of Annex I of the CLP Regulation.
Multi-material multi-layer materials and articles: substances classified as a
carcinogen in accordance with the criteria in Section 3 of Annex I of the CLP
Regulation cannot be listed in the Union list or provisional list.

Coated and printed plastic materials and articles are covered by the scope
of the Plastics Regulation. Plastics held together by adhesives are also
covered by its scope. However, substances used only in printing inks,
adhesives and coatings are not included in the Union list because these
layers are not subject to the compositional requirements of the Plastics
Regulation. The only exceptions are substances used in coatings which
form gaskets in closures and in caps. The requirements for printing inks,
adhesives and coatings are intended to be set out in separate specific
Union measures. Until such measures are adopted, they are covered by
national law113. If a substance used in a coating, a printing ink or an
adhesive is listed in the Union list, the final material or article has to comply
with the migration limit of this substance, even if the substance is used
in the coating, printing ink or adhesive only.
Even though colourants fall under the definition of additives, they are not
covered by the Union list of substances. Colourants used in plastics are
covered by national measures. Certain colourants, in particular, cadmium
pigments, are regulated by EU legislation on chemicals and listed in Annex
XVII of the REACH Regulation. They have to comply with the general safety
requirements of Article 3 of the Framework Regulation (EC) No 1935/2004
and are subject to risk assessment in line with Article 19 of the Plastics
Regulation.

TiO2 is currently an authorised substance, under entries 610, 805 and 873 in
Table 1 of Annex I, for use as an additive or polymer production aid. No
TiO2-specific migration limits are provided hence, in accordance with Article
11, a generic specific migration limit of 60 mg/kg applies and in accordance
with Article 12 an overall migration limit for plastic materials of 10
milligrams of total constituents released per dm2 of food contact surface
(mg/dm2) applies. Article 15 (3) states that when new scientific data are
available the declaration of compliance shall be renewed; however, the
new classification (based on pre-existing toxicological data) may not qualify
as ‘new scientific data’.

Regulation 282/2008/EC: only authorised monomers and additives should

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7.1.10 Colouring matters for medicinal products
Table 7–14: Key parameters of relevant legislation – Colouring matters for Medicinal Products
Key parameters Details
Directive 2001/83/EC
Regulation 1901/2006
Relevant legislative instruments
Directive 2009/35/EC
Regulation 1333/2008 (see above)
Directive 2001/83/EC: It is a legal requirement according to Directive
2001/83/EC on the Community code relating to medicinal products for
human use as amended that excipients which are used must comply with
the relevant European Pharmacopoeia (Ph Eur) monograph.
Carcinogenic potential is included in toxicological and pharmacological
tests.
Testing required:
• In respect of substances having a close chemical analogy with
known carcinogenic or carcinogenic compounds;
• In respect of substances which have given rise to suspicious
changes during long-term toxicological tests; and
• In respect of substances which have given rise to suspicious results
in the mutagenic-potential tests or in other short-term
carcinogenicity tests.

Regulation 1901/2006: Regulation 1901/2006 on medicinal products for

paediatric use includes a Commission Statement with which the
Commission requested the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency to draw up an opinion on
Description of Carc Cat 1B the use of these categories of substances as excipients of medicinal
potential impact classification products for human use, on the basis of Articles 5(3) and 57(1)(p) of
Regulation (EC) No 726/2004.
The CHMP delivered its opinion in October 2007; this states, “In the event
that CMR toxicity has been identified for an excipient, the rule is to avoid
and replace this excipient. In the rare cases where this would not be
possible, the use of such CMR excipients in a medicinal product would only
be considered after careful evaluation of the benefits of the medicinal
product in the target patient population versus the potential risks (…) any
risk identified for an excipient and in particular a CMR substance, would be
acceptable only on condition that this excipient cannot be substituted with a
safer available alternative, or that the toxicological effects in animal models
are considered not relevant for humans (e.g. species specific, very large
safety ratio), or where the overall benefit/risk balance for the product
outweighs the safety concern with the product. Overall, the use of any
excipient with a known potential toxicity, and which could not be avoided or
replaced, would only be authorised if the safety profile was considered to be
clinically acceptable in the conditions of use, taking into account the
duration of treatment, the sensitivity of the target population and the
benefit-risk ratio for the particular therapeutic indication” (European
Medicines Agency, 2007)114.

114
Interestingly, the opinion also states, “For non-genotoxic rodent carcinogens (which are known to be
around 50% of molecules tested in life span rodent carcinogenicity studies) only those for which the
mechanism of tumorigenesis (including the route of administration) has been identified as relevant for man,
should be carefully considered before a decision is taken to include them in a pharmaceutical product. It is
important to highlight that many of the substances positive in the carcinogenicity studies are specific rodent

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Table 7–14: Key parameters of relevant legislation – Colouring matters for Medicinal Products
Key parameters Details
Directive 2009/35/EC: colouring matters used to colour medicinal products
for human and veterinary use must abide by the rules on colouring matters
in Annex II to Regulation (EC) No. 1333/2008 and Regulation 231/2012 (that
has repealed Directive 95/45/EC) laying down the specific purity criteria
concerning colours for use in foodstuffs apply to medicinal products. A
Carc. Cat 1B classification would result in the review and potential de-
authorisation of TiO2
Directive 2001/83/EC: no differentiation between carcinogenic category in
the legal text but this may be taken into account in the carcinogenic-
potential testing.

Regulation 1901/2006: there may be a possibility that it could be easier to

Carc Cat 2 obtain an authorisation with a category 2 carcinogen as the evidence for
classification classification as carcinogenic category 2 is considered to “limited”. This is
not a guarantee.

Directive 2009/35/EC: the same rules should apply for Category 2

Carcinogens as this Regulation is based on Reg. 1333/2008 and Regulation
231/2012
Applicability (multiple sectors vs. Single
single sector)
Potential adverse impact on: I/C
- Industry (I)
- Professionals (P)
- Consumers (C)
Hazard
Driver of impact Risk (incl. 
on society availability of
alternatives)
Depends on the type of variation required for the existing Authorisation
dossiers (European Commission, 2013):
- A replacement of the excipient would require a variation Type IAIN
which requires immediate notification;
- Qualitative or quantitative changes in one or more excipients that may
have a significant impact on the safety, quality or efficacy of the
Immediacy of potential impact medicinal product requires a major variation Type II; or
- A reduction of the shelf life of the finished product as packaged for
sale would require a variation Type IAIN which requires immediate
notification.
It would also be dependent on food additives legislation. Timing would
depend on the completion of the review of the new scientific data for a
removal of TiO2 from the Annex of Regulation 1333/2008

It is important to point out that several pieces of relevant legislation would certainly impose a
regulatory burden on the TiO2 supply chain and the outcome of such efforts made cannot be
predicted with any certainty. There are application areas where a Carc Cat 2 hazard classification

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could cause major problems but where rapid, successful action by interested parties could mitigate
impacts. Typical examples are the cosmetics, toys, food, pharmaceuticals applications where a risk
assessment would need to be undertaken to take into account the new classification. For instance,
for cosmetics, securing derogations could be a challenging task as there are only 15 months between
the CLH being added to Annex VI of the CLP and the Cosmetics Regulation annexes being updated
with a review of the existing authorisations for TiO2 (as a colourant and UV filter) by the SCCS.
Therefore, the time for obtaining an SCCS opinion on safe use is very short. It is understood that it
can take up to 2 years to prepare an SCCS dossier. If cosmetics companies would be interested in
safeguarding the use of TiO2, they would need to prepare a dossier for the SCCS opinion as soon as
possible.

More widely, a carcinogenic classification of any kind for a substance would still have significant
implications in retail / consumer, professional and industrial settings even if the use of the substance
is not restricted by legislation.

7.2 Other regulatory provisions

7.2.1 National Health and Safety at Work and Consumer Safety Legislation
Assessing impacts under national legislation has been outside the scope of this project. As such it
cannot be certain what impacts would arise on the national level but it is reasonable to assume that
some requirements and controls would apply to a Carc Cat 2 substance.

In relation to workers, the new classification might result in a tightening of national Occupational
Exposure Limits (OELs). For instance, it has been suggested that the current OEL in the UK is set at
10 mg/m3 but following the classification of the substance as a carcinogen, it might be reviewed and
might become an order of magnitude lower. This would have an impact on use of dry TiO2 pigment
in member facilities in terms of LEV and PPE provision, and in terms of monitoring worker exposure.
Downstream users might be required to implement additional measures to manage the risks to
workers of exposure to TiO2 dust.

In relation to consumers, a relevant example is national French legislation according to which a CMR
2 classified formulation has to be stored under lock (this provision should shortly be amended to
storage in a place not accessible to the public), hence such formulation would still be stigmatised as
potentially unsafe. In Germany, past legislation would ban the marketing of paints classified as Carc
Cat 2 to consumers, but this will no longer be the case through an amendment of the legislation in
early 2017.

7.2.2 Food contact materials

Regulatory provisions outside the harmonised framework

Introduction

EFSA is responsible for “risk assessment of food contact materials (FCMs) and articles (FCAs)” for
which it has received a mandate from the European Commission, and that mandate does not cover
all food contact materials and articles. Risk assessment for non-harmonised FCMs and FCAs is carried
out by the CoE/EDQM whilst drafting a new resolution, or by the national authorities whilst
preparing new national provisions. The European Commission is responsible for “risk management”
of harmonised food contact materials and articles while national authorities are responsible for non-
harmonised FCMs/FCAs whilst relying in most cases on CoE/EDQM resolutions.

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Framework Regulation (EC) No. 1935/2004 includes a long list of materials and articles in its Annex I
but, in practice, so far specific rules have been set out for a few of them. The following rules on food
contact materials and articles apply:

• Harmonised rules on active and intelligent materials under Regulation (EC) No 450/2009, and
plastics under Regulation 10/2011 (NB. as shown in Table 7–11, there is legislation on ceramics
and regenerated cellulose film but these do not have a direct relevance to TiO2);

• Council of Europe (CoE) Resolutions on coatings, paper and board, and printing inks. Although
these CoE Resolutions are guidelines, they are used by most national competent authorities to
check compliance of non-harmonised food contact materials and articles with Article 3 of the EU
Framework Regulation. Several of these Resolutions are under review. This review work is
confidential and it is understood that there is also a confidential draft CoE/EDQM Framework
Resolution that concerns the use / presence of CMRs food contact materials and articles. The
existing Resolutions are presented below; and

• National rules on a variety of food contact materials and articles. Pending the adoption of
more specific EU measures, food contact materials must also comply with any relevant national
legislation in different EU Member States. Literature suggests that specific pieces of national
legislation on different types of materials are currently in place in 19 EU Member States
(Baughan, 2015). Member States such as Finland and the Netherlands, for example, maintain
national requirements for paper and board, while Germany has established Recommendations
concerning paper and board for different end-uses (e.g., baking and filter papers). On 25
September 2016, the Belgian Federal Public Service (FPS) Public Health and Safety of the Food
Chain and Environment released a Royal Decree on varnishes and coatings intended to come
into contact with foodstuffs, which was planned to come into force on 1 January 2017.
According to the decree, the following substances can be used intentionally to make coatings
intended for food contact: those substances listed on the Annex I to Regulation (EU) No 10/2011
on plastics, those approved by a Member State, those approved by the European Food Safety
Authority, those that do not migrate to a detectable amount in the food, and those that are not
classified as CMR, and are not in nano-form (Food Packaging Forum, 2016).

More generally, national regulations may include positive lists for substances, impurity
specifications, and sanctioned test methods. For Member States without specific requirements
for paper and board (e.g., the United Kingdom, Denmark, and Sweden), such materials are
required to be safe, which can be established through references to national positive listings, EU
Directives, evaluations by the EU Scientific Committee on Food (now the European Food Safety
Agency), clearances in other jurisdictions (e.g., clearances under the U.S. Food and Drug
Administration's food additive regulations), and CoE Resolutions (Misko, 2004).

CoE Resolution on coatings

In relation to coatings in food packaging, there is a Council of Europe (CoE) Resolution, namely,
Framework Resolution ResAP(2004)1 on coatings115 intended to come into contact with foodstuffs.
The Resolution is not legally binding and applies to coatings which in the finished state are intended
to come into contact or which are brought into contact with foodstuffs and are designed for that
purpose. The following types of coating are covered (CoE, 2004):

115
Coatings are defined as the finished material prepared mainly from organic materials applied to form a
layer/film on a substrate in such a way as to create a protective layer and/or to impart certain technical
performance.

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• Coatings for metal packaging;
• Flexible packaging coatings; and
• Heavy-duty coatings.

In accordance with the Resolution, coatings should meet the following conditions:

• They comply with the requirements of the EU Framework Regulation;

• They are manufactured in accordance GMP;
• They do not transfer their constituents to foodstuffs in quantities exceeding 10 mg/dm2 of
surface area of material or article (mg/dm2) (overall migration limit). However, this limit is 60 mg
of the constituents released per kg of foodstuff (mg/kg) in the following cases:

− Articles which are containers or are comparable to containers or which can be filled,
with a capacity of not less than 500 ml and not more than 10 litres;
− Articles which can be filled and for which it is impracticable to estimate the surface area
in contact with foodstuffs; and
− Caps, gaskets, stoppers or other similar devices for sealing;

• They do not transfer migrating components not listed in “Technical document No. 1 – List of
substances to be used in the manufacture of coatings intended to come into contact with
foodstuffs” which have MW < 1000 D in quantities which could endanger human health. These
non-listed substances of MW < 1000 D should be subjected to appropriate risk assessment,
taking into account dietary exposure as well as toxicological and structure activity
considerations.

TiO2 is listed in ‘List 1 of additives’ as an additive not subject to any restriction of specification. On
the other hand, ‘Silver chloride (20% w/w) coated onto titanium dioxide (80% w/w)’ is listed in the
Appendix to the ‘List 1 of additives’ and a restriction or specification for it are pending (CoE, 2009).

It should be noted that this Resolution as well as those discussed below apply to the States members
of the Partial Agreement in the Social and Public Health Field; these include: Austria, Belgium,
Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

CoE Resolution on paper and board

Of relevance to paper and board is Council of Europe Resolution AP (2002)1. As above for coatings,
the Resolution is not legally binding but serves as an important reference and applies to all food
contact paper, including coated board and paper layers in multilayer materials, but excluding non-
wovens. Paper that is used in food contact articles but that is separated from the food by a
functional barrier is outside the scope of the Resolution (Baughan, 2015). According to the
Resolution, paper and board used for all food contact applications under normal or foreseeable
conditions of use should meet the following conditions (CoE, 2002):

• Comply with the requirements of the EU Framework Regulation;

• Be manufactured in accordance with GMP;
• Be of suitable microbiological quality;
• Not release substances which have an antimicrobial effect on foodstuffs; and
• Comply with restrictions on the migration of lead, cadmium, mercury and pentachlorophenol.

Technical Document No. 1 contains the lists of additives which may be used in the manufacture of
paper and board materials and articles intended to come into contact with foodstuffs. TiO2 is

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present in List 1, the list of additives assessed, without any restriction or specification but rather
with the indication “Acceptable” (CoE, 2009b).

CoE Resolution on printing inks

In 2005, the CoE Committee of Ministers of the Partial Agreement in the Social and Public Health
Field adopted the Resolution ResAP (2005)2 on “Packaging Inks Applied to the Non-Food Contact
Surface of Food Packaging”. CoE Resolutions are not legally binding, but are considered as
statements of policy for national policy makers of the Partial Agreement member states. The
Resolution imposes the following requirements (CoE, 2005):

• Printed materials and articles intended to come into contact with foodstuffs, should not, in their
finished state and under normal and foreseeable conditions of use, transfer their constituents to
foodstuffs in quantities which could endanger human health or bring about an unacceptable
change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics
thereof, in accordance with Article 3 of Regulation (EC) No. 1935/2004;

• The substances in packaging inks should be selected in conformity with the requirements for the
selection of packaging ink substances as set out in Technical Document No.1;

• The packaging inks should be manufactured in accordance with the guides for good
manufacturing practice;

• The packaging inks should be applied in accordance with converters’ good manufacturing
practices;

• The printed or overprinted varnished layer of finished printed material or article should not
come into direct contact with food;

• Global and specific migration from the finished printed material or article should not exceed the
relevant limits; and

• There should be no, or only negligible, visible set-off or migration from the printed or varnished
non-food contact layer to the food contact surface.

Technical Document No.1 (CoE, 2007) includes among its exclusion criteria CMR 1A/1B/2 substances.
Substances which, however, are classified as category 1A, 1B, or 2 but are evaluated by (a) Scientific
Committee(s) and as a result can be used under the specified conditions, are admitted. No
restriction is currently imposed on TiO2.

Impacts from a harmonised hazard classification for titanium dioxide

Impacts from a Carc Cat 1B classification

If TiO2 were to be classified as Carc Cat 1B, it would fail the exclusion criteria for printing inks. As far
as coatings and paper/board are concerned, the listings of TiO2 might be reviewed as a consequence
of its new hazard classification.

However, consultation for the purposes of this analysis has suggested that a Draft CoE/EDQM
General Resolution is in preparation which will (once approved) stay above all existing Coe/EDQM
resolutions and guides. According to consultees, Article 3.3 of the Draft General Resolution, titled
“General concentration threshold for non-evaluated substances, measured in food (or simulants)”,

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prescribes that, “Non-evaluated substances shall only be used in the manufacture of food contact
materials and articles if migration or release into food is not detectable. A general concentration
threshold of 0.01 mg/kg foodstuff of a given substance is applied to demonstrate absence, with the
exception of carcinogenic, mutagenic or toxic for reproduction (CMR), or substances in nano-form,
including their impurities that shall not be transferred at all”.

Impacts from a Carc Cat 2 classification

As the details of national legislation across 31 EEA Member States are not known, it cannot be
certain how the provisions for different carcinogenicity classification categories would vary. The CoE
Resolution on printing inks covers all CMR categories, therefore classification of Carc Cat 2 would
affect the use of TiO2 in printing inks in the same way as a Carc Cat 1B one. In addition, no specific
reference to hazard categories is made in the CoE Resolutions on coatings and paper/board and as
such, a Carc Cat 2 classification, similarly to a Carc Cat 1B one, could potentially lead to the listings
(approvals) of TiO2 being reviewed.

7.2.3 CEPE Code of Practice for coated articles where the food contact layer
is a coating
In the absence of harmonised regulations for coatings in direct contact with foodstuffs (beyond the
general provisions of Article 3 of the Framework Regulation 1935/2004/EC), CEPE, the trade
association for paints, printing inks and artists’ colours in Europe, has taken the initiative to develop
a Code of Practice which describes how compliance with the Framework Regulation can be
demonstrated for direct food contact coatings (CEPE, 2009). The Code of Practice is of a voluntary
nature and applies to the food contact surfaces of the following:

• Coated light metal packaging up to a volume of 10 litres;

• Coated metal pails and drums with volumes ranging from 10 to 250 litres;
• Coated articles with volumes 250 to 10,000 litres;
• Heavy duty coated articles having a volume >10,000 litres;
• Coated flexible aluminium packaging; and
• Printing inks and coatings in direct food contact.

TiO2 is currently listed under Annex III (Incomplete List of Additives, an appendix to List C) without
any limitation on migration or other use condition; this list reflects the substances authorised under
Framework Regulation (EC) No. 1935/2004 under which TiO2 is authorised by virtue of its listing
under Regulation EU/10/2011 (the Union List). The Code of Practice does not incorporate a
mechanism for exemptions being granted for the use of specific substances; it rather allows the use
of intentionally added CMR substances if they have been reviewed in accordance with its Articles 4
and 5. According to Article 5 of this Code of Practice, additives which have been evaluated by
SCF/EFSA, classified in list SCF 0-4 and used in compliance with specific migration limits or other
restrictions can be used in such coatings, even if they are CMR substances. Thus, EFSA can authorise
a substance classified as a CMR and hence the CEPE Code of Practice would then authorise its use as
well. In other words, the actions of EFSA following the implementation of the proposed
classification for TiO2 would dictate whether TiO2 remains an authorised additive under the CEPE
Code of Practice or not.

The trade associations listed below are recommending this Code of Practice to their member
companies (CEPE, 2009):

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• APEAL – The Association of European Producers of Steel for Packaging;
• CEFIC FCA – The CEFIC Food Contact Additives Panel;
• CEPE – The European Council of Paint, Printing Ink and Artists’ Colours Industry;
• FoodDrinkEurope – The confederation of the food and drink industries of the EU (formerly CIAA);
• European Aluminium – The European Aluminium Association (formerly EAA);
• EMPAC – The European Metal Packaging Association;
• EPRA – The European Phenolic Resins Association;
• EWF - The European Wax Federation;
• CEFIC HARRPA – The CEFIC Hydrocarbon and Rosin Resins Producers Association; and
• PlasticsEurope Epoxy Resins Committee.

In summary, the role of the voluntary Code of Practice following the classification of TiO2 as a
carcinogen would depend on whether the relevant scientific bodies (e.g. EFSA) would continue to
consider TiO2 safe for use or not. Moreover, the Code of Practice covers the intentional use of all
CMR substances (Cat 1 and 2). As such a classification of Carc Cat 2 would not have any material
difference to a Carc Cat 1B one as far as the use of TiO2 in coatings for food contact materials is
concerned. Notably, national initiatives are also known to exist.

7.2.4 EuPIA Exclusion Policy for printing inks and related products
The European Printing Ink Association (EuPIA) could not support the aforementioned CoE Resolution
as adopted, because it was believed not to be practicable. The substance inventory lists were not
sufficiently comprehensive, and did not provide protection for consumer health or reflect current
practices (EuPIA, 2012).

Independent of these legal initiatives and in the absence of specific EU legislation, EuPIA developed a
Guideline setting out a mechanism for the selection of raw materials for food packaging inks. Raw
materials are selected in accordance with the “Selection scheme for packaging ink raw materials” of
the EuPIA Guideline and with specific purity requirements. The inks are formulated and
manufactured taking into account many individual and varying parameters relating to the substrate,
application and end use in order to minimise the potential for migration of ink components into food
and to allow the final package to comply with the legal requirements of Regulation (EC) No
1935/2004 and other existing regulations. Packaging inks are formulated and manufactured in
accordance with the EuPIA Good Manufacturing Practices (EuPIA, 2016).

EuPIA has established an Exclusion Policy (which evolved from an earlier Exclusion List). The EuPIA
Exclusion Policy applies to the manufacture and supply of all types of printing inks and related
products, for use in any application and on any substrate. Although the EuPIA Exclusion Policy does
not impose any legal obligations, it has the full support of all EuPIA members. Printing ink
manufacturers who are not members of EuPIA are also invited and encouraged to apply the criteria
of the Exclusion Policy (EuPIA, 2016b).

Raw materials excluded by the Policy, and which must therefore be avoided in the formulation of
printing inks, are those substances or mixtures classified in one or more of the CLP hazard
classes/categories listed in Group A and Group B on the following page. CMR 1A/1B are to be found
in Group A. Furthermore, the substances in Groups C to G (listed in Annex 1 of the Policy) are
excluded regardless of whether or not they fall under the hazard criteria of Group A or B.

For specific technical and performance reasons it may be necessary, in an individual ink, to use a raw
material that contains a substance classified according to Group A or B. This exception may only be
applied where the concentration of the substance in the raw material is below the limits at which

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the raw material will be classified and labelled. A decision to use such a raw material should be
made only:

• If no suitable alternative raw materials are available;

• After an appropriate risk assessment has been carried out on the ink manufacturing process;
• After a risk assessment has been carried out, in conjunction with the converter, on the
application and end use of the printed product.

When a raw material currently used becomes included in one of the categories in this Exclusion
Policy by reason of re-classification, by default EuPIA members are expected to substitute this
material as soon as practicable. A time frame of six months is normally regarded as appropriate.

If, after technical investigation, it is found not to be possible to replace a raw material in the short
term for a specific application, an exemption from substitution can be granted according to the
following rules:

• For hazards listed in Group A, the explicit approval of the EuPIA Technical Committee is required.
A list of exemptions approved under this procedure is provided in Annex 2 to the Policy; and

• For hazards listed in Group B (only), it shall be the responsibility of the individual member
company to conduct a risk assessment and to demonstrate that safe use is assured (in their own
manufacturing, in customers’ operations and/or in the final printed product as appropriate).

Importantly, a classification of Carc Cat 2 would mean that the substance would fall outside the
scope of the exclusion criteria, thus its use would not be prohibited.

7.2.5 Global Automotive Declarable Substance List

The Global Automotive Declarable Substance List (GADSL) needs also be considered. The GADSL
covers declaration of certain information about substances relevant to parts and materials supplied
by the supply chain to automobile manufacturers. The information is applicable to the use of these
parts or materials in the production of a vehicle up to its usage and relevant to the vehicle’s re-use
or waste disposal.

The GADSL provides a definitive list of substances requiring declaration with the target to minimise
individual requirements and ensure cost-effective management of declaration practice along the
complex supply chain. The scope is to cover declarable substances in the flow of information
relevant to parts and materials supplied throughout the automotive value chain, from production to
the end of life phase. The GADSL only covers substances that are expected to be present in a
material or part that remains in the vehicle or part at point of sale and shows which substances are
regulated. This is a voluntary industry initiative designed to ensure integrated, responsible and
sustainable product development by automobile manufacturers and their supply chain. Its purpose
is to minimise individual requirements and ensure cost effective management of declaration practice
along the large and complex global supply chain116.

If TiO2 were to be classified as Carc Cat 1B, automotive OEMs via the GADSL would require that the
substance is not contained in products supplied to them. On the other hand, classification of TiO2 as
Carc Cat 2 would render the substance a “Declarable” one but it would be unlikely to make it a
candidate for a “Prohibited” substance classification.

116
Additional information is available at http://www.gadsl.org/.

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7.2.6 CE marking
Implications of a Carc Cat 1B harmonised classification

Those products which are subject to a CE mark have to undergo a conformity assessment which
assesses the products characteristics and whether they meet EU harmonised standards before an EC
Declaration of Conformity is issued. The CE mark will be given if the product meets the conformity
assessment under the legislation it is subject to. Whilst there is no general rule for carcinogens for
CE markings, the classification of TiO2 as Carc Cat 1B would mean that some products might not be
able to attain a CE mark. Relevant affected products may include:

• Toys: Directive 2009/48/EC on toy safety specifies in detail the essential requirements to be
fulfilled by manufacturers, importers or distributors, to prove that their product complies with
EU regulations and finally, to be able to affix the CE marking. Annex II to the Directive specifies
the safety requirements products have to comply with. In accordance with this Annex,
substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category
1A, 1B or 2 under Regulation (EC) No 1272/2008 shall not be used in toys, in
components of toys or in micro-structurally distinct parts of toys (although derogations can
be granted); and

• Ecodesign of energy related products: the Ecodesign Directive (2009/125/EC) is a framework

Directive that sets the ecodesign requirements related to the environmental parameters that
manufacturers have to meet in order for their products to carry the CE marking. The Directive
calls for particular attention to the use of substances classified as hazardous to health and/or the
environment according to Council Directive 67/548/EEC, the precursor to the CLP Regulation.

The new Regulation (EU) 2017/745 on Medical Devices also makes some generic references to
chemical risks but no specific requirement on CMR substances in relation to the CE marking is made.

Implications of a Carc Cat 2 harmonised classification

For toys, provisions for a Carc Cat 2 substance would appear to be same as Carc Cat 1B, except that
there is a slight difference in derogation criteria which means that the use of a Carc Cat 2 substance
might be granted a derogation where Carc Cat 1B would not and the generic concentration limit is
1% up from 0.1%. For ecodesign of energy related products, CE marking provisions would appear to
be the same for both hazard classification categories.

7.2.7 Ecolabelling schemes

Implications of a Carc Cat 1B harmonised classification

Article 6(6) of Regulation (EC) No 66/2010 on the EU Ecolabel stipulates that the EU Ecolabel may
not be awarded to goods containing substances or preparations/mixtures meeting the criteria for
classification as toxic, hazardous to the environment, CMR, in accordance with the CLP Regulation,
nor to goods containing substances referred to in Article 57 of the REACH Regulation. The EU
Ecolabel is awarded to many categories of products, including:

• Personal care products;

• Cleaning products;
• Clothing and textiles;
• Footwear;
• Paints and varnishes;

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• Electronic equipment;
• Coverings;
• Furniture and bed mattresses;
• Gardening products
• Household appliances;
• Lubricants;
• Certain household items (sanity tapware and flushing toilets and urinals); and
• Paper products.

For instance, Commission Decision 2014/312/EU establishing the ecological criteria for the award of
the EU Ecolabel for indoor and outdoor paints and varnishes prescribes that the final product
formulation, including all intentionally added ingredients present at a concentration of greater than
0.010%, shall not, unless expressly derogated in its Appendix, contain substances or mixtures
classified as toxic, hazardous to the environment, respiratory or skin sensitisers, or carcinogenic,
mutagenic or toxic for reproduction in accordance with the CLP Regulation.

National and regional ecolabelling schemes may also include exclusion criteria that relate to
carcinogenicity properties. For instance, ready-to-use paints (wall paints) cannot be awarded the
German Blue Angel ecolabel if they contain CMR substances (Blue Angel, 2015). Similarly, for an
indoor paint or varnish to be awarded the Nordic Swan, the mixture cannot be classified as CMR 1 or
2 (Nordic Ecolabelling, 2015).

Implications from a Carc Cat 2 harmonised classification

There appears to be no difference between Carc Cat 1B and Carc Cat 2 in the known schemes, as
provisions on carcinogens are based on a carcinogenicity classification in general (H350 or H351).

7.2.8 OEKO-TEX® Standard

Implications of a Carc Cat 1B harmonised classification

The OEKO-TEX® Standard 100 is a worldwide consistent, independent testing and certification
system for raw, semi-finished, and finished textile products at all processing levels, as well as
accessory materials used. The central focus of the OEKO-TEX® Standard 100 has been the
development of test criteria, limit values and test methods on a scientific basis. Among the limit
values, there is a list for dyestuffs and pigments classified as carcinogenic and this list would likely
include TiO2 following its proposed classification.

On the issue of TiO2 in the textile sector, it has also been noted by stakeholders that in the spinning
process of man-made fibres there is always some amount of waste generated which contains TiO2
(used for delustering of the fibres). This type of waste is largely used in EU (and worldwide) as an
input material for other industries (e.g. engineering plastics and composite materials) and can be
applied in automotive industry, machinery, household appliances, etc. The potential classification of
TiO2 as Carc Cat 1B consequently means a complete change of evaluation of the above goods by the
final consumers.

Implications from a Carc Cat 2 harmonised classification

There appears to be no difference between Carc Cat 1B and Carc Cat 2. There is at least one Carc
Cat 2 substance already listed under colourant.

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7.2.9 Other provisions
The presence of a ubiquitous substance classified as a suspected carcinogen in a multitude of
products could also have a bearing on risk-based materials declaration systems or other initiatives
which focus on hazardous substances. Consultation has for instance referred to:

• IEC 62474, the international standard for the management of declaration of materials and
substances in E&E products;

• ISO TS 16949, in the future IATF 16949, is a standard aimed at the development of a quality
management system that provides for continual improvement, emphasising defect prevention
and the reduction of variation and waste in the automotive industry supply chain; and

Lower hiding powder exhibited by pigments other than TiO2 could also be counterbalanced by
deposition of thicker layers, but these layers are then more difficult / impossible to dry or cure, nor
will they perform any longer the required functionalities. This could be particularly important in
processes such as printing, but also more widely would impact upon the efficiency of any coating
operation.

117
Available at: https://echa.europa.eu/documents/10162/48252319-d727-42aa-8b3e-bb97cb218f0e
(accessed on 22 August 2016).

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Other important features of TiO2 pigments are excellent resistance to chemical attack, good thermal
stability and resistance to ultraviolet (UV) degradation. Rutile pigment is more resistant to UV light
than anatase, and is preferred for paints, plastics, especially those exposed to outdoor conditions,
and inks. On the other hand, anatase pigment has a bluer tone than the rutile type, is less abrasive
and is used mainly in indoor paints and in paper, ceramics, rubber and fibre manufacture. Both
rutile and anatase pigments can be made more resistant to photodegradation by coating the
pigment particles, which also improves their dispersibility, dispersion stability, opacity and
brightness (Gázquez, et al., 2014).

As a result, there is no white pigment that can match the opacity, hiding power, cost-efficiency,
inertness and weatherability of TiO2. It is important to note that several of the pigments identified
above are mineral fillers widely considered to be suitable as extender pigments. Such pigments can
be (and in some cases, have been) used to partly replace TiO2 in formulations, primarily for cost
reasons. Their performance however cannot match that of TiO2 as they have a relatively low
refractive index of ca. 1.5. When the surrounding medium is air with a refractive index of 1.0, the
difference in the two index values produces substantial light scattering, so that extender pigments
appear white. However, when such alternative pigments are dispersed in other media, e.g. a paint
binder which itself has a refractive index of ca. 1.5, they scatter light very poorly and appear much
more transparent. Considering matrices such as paints, extender pigments may also have an
adverse effect on other physical properties such as consistency, gloss (Zorll, 2000), stability and
scrub resistance (film toughness) (Karakaş, et al., 2015). Whilst, on a case-by-case basis, TiO2 might
be technically possible to replace, particularly where technical requirements are not stringent, in
order for opacity and hiding power to be acceptable, increased loadings of the alternatives may
need to be used, thus imparting poor cost-efficiency on the alternatives.

A more recently developed technology is that of organic pigments, effectively opaque polymer
systems. These have been used in interior and exterior coatings as hollow-sphere polymeric
pigment that allow paint manufacturers to reduce the raw material cost (i.e. the cost of TiO2) of their
formulations. For instance, such a commercial product claims to offer “significantly increased light
scattering efficiency while maintaining paint performance”, “greater cost savings while providing
equal hiding”, and “a comparatively low binder demand [so that] the total PVC [Pigment Volume
Concentration] can be slightly increased without sacrificing paint performance” (Dow, 2010)118.
However, this is not a solution if complete elimination of TiO2 from the formulations is required;
also, the integrity of the hollow spheres plays a significant role in the performance of such products
(NB. products from other companies are available, the above is only one example).

8.2 Hazard profile of alternatives

Table 8–2 presented an overview of the hazard classification of alternative white pigments. It is
acknowledged that other alternative systems may exist but, in terms of hazard profiles, the focus
here is on alternative substances rather than materials.

The list of alternative white pigments includes several heavy metal compounds. Lead-based
pigments in particular are far more hazardous than TiO2; they currently find very little use, if any, as
they have been replaced by TiO2. Zinc oxide and zinc phosphate have unfavourable environmental
hazard profiles.

8.4 Information from consultation

Table 8–4 summarises information on specific alternatives that has been collected during the first
round of consultation with downstream users. This information confirms that no alternative appears
to be feasible as a substitute for TiO2. The table also includes some information available on the
ECHA website from the public consultation on the proposed classification for TiO2. It is worth noting
that an assessment of alternatives specific relevant to plastics has been provided by EuPC and has
been incorporated into Section 4.5.2.

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