This document aims to provide a general and simplified explanation of the mechanisms and

main provisions relative to complying with the EU REACH regulation.

The document has been created for engineering manufacturers of articles, particularly for
suppliers into the automotive and aviation industries. Inevitably some nuances have been
overlooked in order to help manufacturing businesses understand the general implications of
the regulation. It should not be used as a substitute for the applicable rules as they are
described in regulation (CE) No 1907/2006 and other applicable texts.
The authors cannot be held responsible for the consequences of any extensive or
inappropriate use made of the content of this document and are advised to seek independent
legal opinion on specific scenarios for their own businesses.
The authors of this document have based their interpretation on the documents available at the
time of writing. Some of these references may be modified, in particular through the REACH
Implementation Projects. Users are therefore encouraged to check for later versions of this guide.
 Authors

REACH / Interpretation guidelines The original French version

of this guide has been elaborated by
The English translation has been
achieved with the help of

Airbus S.A.S ASD

Messrs DELPET and COSTES Environment
1 rond point Maurice Bellonte M Muller
31707 BLAGNAC Cedex Gulledelle 94-b.5, B-1200 Brussels, Belgium
SAFRAN AGUSTA WESTLAND
Messrs BRIQUET and DUMONT Material Technology Scientist
and Ms FOURCAUDOT and EHS Departments
Messrs ZANOTTI & MARASI
2 Boulevard du Général Martial Valin Agusta spa, Via G.Agusta 520,
75724 PARIS cedex 15 21017 Samarate (VA)
FIM BDLI
Fédération des Industries Mécaniques German Aerospace Industries Association
Mss DAUBRESSE and de BAILLENX Air Transport, Equipment and Materials
39-41 rue Louis Blanc M BELITZ
92400 COURBEVOIE Atrium - Friedrichstrabe 60 - 10117 Berlin
EUROCOPTER
RENAULT Eurocopter France & Germany
Mss LUCCHINI and M ROLLAND Messrs BERTHIER & HIBON & BENATI
Technocentre -1 avenue du Golf & HELBIG
78288 GUYANCOURT cedex Marignane & Donauwörth
GIFAS ROLLS ROYCE
Commission Environnement Mrs PHILIPS, Mr MARSH, Dr THOMAS
et Développement Durable PO Box 31, Derby DE24 8BJ, England
M CORNESSE SAAB
8 rue Galilée - 75016 PARIS Corporate Environmental Affairs
Chemist and Occupational Hygienist
M SVENSSON
SE-581 88 Linköping - Sweden
SBAC
Public Affairs
Ms MACKEN
Salamanca square, London

Table of contents

Preambule / Glossary / References ____________________________________________________ 2

1/ Main definitions ______________________________________________________________________________________ 4
2/ Application area ____________________________________________________________________________________ 6
3/ Pre-registration ________________________________________________________________________________________ 8
4/ Registration ____________________________________________________________________________________________ 10
5/ Evaluation ______________________________________________________________________________________________ 14
6/ Authorisation ________________________________________________________________________________________ 16
7/ Restrictions ____________________________________________________________________________________________ 20
8/ Substances in articles ________________________________________________________________________ 21
9/ Information to be exchanged
within the supply chain ____________________________________________________________________ 24
10/ Downstream users __________________________________________________________________________ 26
11/ The agency ________________________________________________________________________________________ 28
Annex 1: structure of the regulation __________________________________________________ 29
Annex 2: Flow charts ______________________________________________________________________________ 31
Preambule
The European REACH regulation (Registration, Evaluation and Authorisation
of Chemicals) comes into force on 1 June 2007 with a gradual introduction of
the obligations through to 2018.
If your company is a manufacturer, importer or user of
chemical substances on their own, or contained in
preparations (i.e. in a solid, liquid or gaseous mixture of
chemical substances) or in the products you make
(these are called “articles” in REACH), you must take
into account the new provisions of REACH to be
permitted to continue to operate legally within the
European Union.
REACH will generate unprecedented changes in the
way information on the substances is exchanged and in
the distribution of responsibilities between the various actors all along the
supply chain. Each actor will have to strengthen the trace-ability of each of the
different substances that are used and incorporated into products.
REACH requires the compulsory registration of all substances that are sold,
imported, manufactured or used in quantities exceeding one tonne per year
(per legal entity).
Data on the hazardous nature of the substances and their uses must be
collected with the responsibility now falling on industrial manufacturers and
users (and no longer on the Member States as was the case with the previous
system). The sharing of data is compulsory in order to minimise the number
of tests required. Routes of exposure have to be identified, and recommended
risk management measures have to be given to downstream users.
This will result in a reduction in risk for the 30,000 most frequently used
substances throughout their life cycle and will gradually lead to the withdrawal
from the market of substances of highest concern.
A European Chemicals Agency based in Helsinki will
be responsible for implementing and monitoring this
new system. The agency will evaluate the information
provided by companies, which will result in the most
hazardous substances becoming candidates for
authorisation or restriction.
Furthermore, a change in the classification and
labelling of all chemical substances and preparations
is expected with the gradual adoption of the Globally
Harmonised System (GHS).
Most manufacturing businesses in the automotive,
aviation or similar engineering manufacturing industries,
will be downstream users in REACH and will have
obligations to provide information. Businesses could
also be importers of chemicals, metals and other substances, but are unlikely
to manufacture their own chemicals.
This document is a reference and interpretation guide specifically intended for
manufacturing companies working in the mechanical, aeronautical and
automotive sectors. It aims to highlight the main obligations of the new REACH
system and to help companies prepare for significant deadlines that will have
to be met in order to ensure business continuity. It attempts to provide simple
recommendations and links to the various sources of additional information in
order to assist with practical implementation.

2
Glossary Legal Person: In this document “Legal Person” refers to the
legal entities e.g. a company with a legal status
CAS: Chemical Abstract Service Only Representative: The legal person registered in the EU,
CMR: Carcinogenic, Mutagenic and toxic for Reproduction who is representing a non-EU company, thereby allowing
them to comply with REACH in their own right.
CSR/CSA: Chemical Safety Report & Chemical Safety
Assessment OSOR: One Substance One Registration
DNEL: Derived no effect level. The point below which the PBT: Persistent, Bioaccumulative and Toxic
hazardous substance is considered not to harm health PNEC: predicted no effect concentration: The predicted level
EINECS: European Inventory of Existing Chemical Substances below which the substance is expected to have no effect
ELINCS: European List of Notified Chemical Substances RIP: REACH Implementation Projects. The European
Chemicals Bureau (ECB) is responsible for developing the
European Union: in this document, this term refers to all the EU technical guidelines and IT tools required for putting REACH in
member States and some other countries that will be place and for its satisfactory operation. These activities are
implementing REACH and will be considered to be ‘inside the carried out in cooperation with the member States, industry
EU’ – namely Iceland and Norway. Note that Switzerland is and the non-governmental organisations in the form of RIPs
outside the EU for the purposes of REACH.
SDS: Safety Data Sheet
GHS: Globally Harmonised System for the classification and
labelling of dangerous substances and preparations SIEF: Substance Information Exchange Forums
IUCLID: International Uniform ChemicaL Information Database SVHC: Substance of Very High Concern
IUPAC: International Union of Pure and Applied Chemistry vPvB: Very Persistent and very Bioaccumulative

References
Regulation (EC) N o 1907/2006 of the European Parliament and of the Council of 18 December 2006
http://eur-lex.europa.eu/LexUriServ/site/fr/oj/2006/l_396/l_39620061230fr00010849.pdf
Directive N o 2006/121/CE of the European Parliament and of the Council of 18 December 2006 modifying Directive 67/548/CEE of the Council
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:FR:HTML
Directive N o 67/548/CEE of the Council of 27 June 1967
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31967L0548:FR:HTML
Directive 1999/45/CE of the European Parliament and of the Council of 31 May 1999
http://eur-lex.europa.eu/LexUriServ/site/fr/oj/1999/l_200/l_20019990730fr00010068.pdf
REACH Implementation Projects: these are working groups whose task is to draw up the guidelines required for the implementation of the
regulation, associating the Commission and the actors concerned. These documents will not have regulatory status.
- RIP 1:REACH process Description: Development of a detailed description of the REACH processes
- RIP 2: REACH-IT: Development of the IT system set up to support REACH implementation
- RIP 3: Guidance documents: Development of guidance documents for industry
- RIP 4: Guidance documents: Development of guidance documents for authorities
- RIP 5: Setting up the pre-Agency
- RIP 6: Setting up the Agency
- RIP 7: Preparing the Commission for REACH
http://ecb.jrc.it/reach/rip/
Website of the European Commission
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
http://europa.eu/pol/enter/index_en.htm
www.reach-compliance.eu

REACH / Interpretation guidelines - June 07

Websites for Germany
REACH Helpdesk: Federal Institute for Occupational Safety and Health (BAuA – Bundesanstalt für Arbeitsschutz und Arbeitsmedizin)
http://www.baua.de/de/Themen-von-A-Z/REACH-Helpdesk/REACH-Helpdesk.html_nnn=true
http://www.bdli.de
The Federation of German Industries (BDI) (BDI-REACH-HELPDESK)
http://reach.bdi.info/index.htm
Websites for Italy
www.federchimica.it
Websites for France
BERPC (in charge of the "Help Desk" in France)
http://www.berpc.fr/
Websites for United Kingdom
HSE (in charge of the “Help Desk” in the UK)
http://www.hse.gov.uk/
Email: ukreachca@hse.gsi.gov.uk
Websites for Sweden
Association of Swedish Engineering Industries
http://www.teknikforetagen.se/templates/index_en_1122.aspx
Association of Swedish Defence Industries (FIF)
http://www.defind.se/index_eng.html
Swedish Chemicals Agency (KemI)
http://www.kemi.se/default_550.aspx
3
1 - Main definitions
Article: an object which during production is given a special shape, surface
Article 3
or design which determines its function to a greater degree than does its
chemical composition.
An article may in turn be made up of an assembly of articles; according to this
definition, bolts, bearings, engines, cars or aircraft are considered to be articles.
A cleaning product is not considered to be an article when taken as a whole:
its packaging is an article; its content is a preparation.
Supplier of an article: any producer or importer of an article, distributor or
other actor in the supply chain placing an article on the market.
Registrant: the manufacturer or the importer of a substance or the
producer or importer of an article submitting a registration for a substance.
Distributor: any natural or legal person established within the Community,
including a retailer, who only stores and places on the market a substance,
on its own or in a preparation, for third parties.
Importer: any natural or legal person established within the Community
who is responsible for import.
Non-isolated intermediate: an intermediate that during synthesis is not
intentionally removed (except for sampling) from the equipment in which the
synthesis takes place.
Monomer: a substance which is capable of forming covalent bonds with a
sequence of additional like or unlike molecules under the conditions of the
relevant polymer-forming reaction used for the particular process.
Polymer: a substance consisting of molecules characterised by the
sequence of one or more types of monomer units (reacted form of a
monomer substance in a polymer) and distributed over a range of molecular
weights.
Preparation: a mixture or solution composed of two or more substances.
A paint or resin made up of several substances is a preparation. Composite
materials, alloys, lubricants, paints, varnishes, adhesives, etc. are
preparations.
Producer of an article: any natural or legal person who makes or
assembles an article within the Community.
Exposure scenario: the set of conditions, including operational conditions
and risk management measures, that describe how the substance is
manufactured or used during its life-cycle and how the manufacturer or
importer controls, or recommends downstream users to control, exposures
of humans and the environment. These exposure scenarios may cover one
specific process or use or several processes or uses as appropriate.
Substance: a chemical element and its compounds in the natural state or
obtained by any manufacturing process, including any additive necessary to
preserve its stability and any impurity deriving from the process used, but

4
excluding any solvent which may be separated without affecting the stability of
the substance or changing its composition.
• A substance is characterised by a CAS number, and an IUPAC chemical
name.
• Examples: Methanal (Formaldehyde) - CAS No 50-00-0.
Nickel metal - CAS No 7440-02-0
Tetrachloroethylene (Perchlorethylene) - CAS: 127-18-4
Phase-in substance:
a substance which meets at least one of the following criteria:
1. it is listed in the European Inventory of Existing Commercial Chemical
Substances (EINECS);
2. it was manufactured in the Community, or in the countries acceding to the
European Union on 1 January 1995 or on 1 May 2004, but not placed on
the market by the manufacturer or importer, at least once in the 15 years
before the entry into force of this Regulation, provided the manufacturer or
importer has documentary evidence of this;
3. it was placed on the market in the Community, or in the countries acceding
to the European Union on 1 January 1995 or on 1 May 2004, before entry
into force of this Regulation by the manufacturer or importer and was
considered as having been notified in accordance with the first indent of
Article 8(1) of Directive 67/548/CEE, but does not meet the definition of a
polymer as set out in this Regulation, provided the manufacturer or importer
has documentary evidence of this.
Notified substance: a so-called ELINCS substance, for which a
notification has been submitted and which could be placed on the market
in accordance with Directive 67/548/CEE. These substances have a
‘notification number’.
Downstream user: any natural or legal person established within the
Community, other than the manufacturer or importer, who uses a substance,
either on its own or in a preparation, in the course of his industrial or
professional activities. A distributor or a consumer is not a downstream user.
A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a
downstream user.
Natural or legal person: This is the individual or legal entity (the legal REACH / Interpretation guidelines - June 07
company). Some legal entities may cover several business units, and some
businesses may contain several legal entities. Each Joint Venture company
or wholly-owned subsidiary company (e.g. a limited company) will have their
own legal identity in law. They must comply with REACH separately to the
main legal entity (the holding company). It is allowable for companies to
collect the data needed and organise for REACH at a corporate / group /
central entity level, but the reporting output to the REACH agency (ECHA)
has to be per legal entity.

5
2 - Application area
Article 2
As a general rule, the REACH regulation applies to all substances…

on their own;

or contained in preparations (mixture of at least

two chemical substances without the formation
of new substances);

or contained in articles.

All "ingredients", raw materials, consumables, components, alloys (and their

constituents), etc. are therefore potentially included.

The provisions to be implemented vary according to the hazardous

properties and the quantities of the substance manufactured or placed on
the market in the European Union.

6
 i
The minimum threshold above which the
provisions for a manufactured or imported
Two keys for substance apply is set at one tonne per year
entering the REACH accumulated per legal person. 1
system
Substances subject to authorisation are included
whatever their quantity (see chapter VI).

(1) See definition

The Regulation does not apply to:

• radioactive substances (if covered by EURATOM);
• substances subject to customs control that are not intended to remain in
the European Union and are not processed or transformed;
• non-isolated intermediates;
•the transport of dangerous substances by rail, road, inland waterway, sea
or air;
• waste (as covered by waste directives);
• nano-materials
• Specific substances, whenever this is necessary to preserve the interests
of the Defence of a Member State (if an exemption has been agreed with
the relevant defence agency).

Article 2.3

i Member States may make provisions to exempt

certain substances from REACH in the interests of
defence. Defence product suppliers will need to
ask national Defence Agencies for these substances
to be exempted for their applications.

REACH / Interpretation guidelines - June 07

7
3 - Pre-registration
REACH requires all substances manufactured/imported in the EU over 1 tonne
Articles 23 and 28
per year to be registered. To help ease this process a pre-registration
process has been established.
See
PRE-REGISTRATION sheet Principle
in annex 2 of this
document Using pre-registration, producers and importers of substances can benefit
from a phased registration timetable that will run between 2010 and
2018 depending on the nature of those substances and the quantities
manufactured and/or imported (see figure 1).

i
The pre-registration phase, which is voluntary, only
lasts from 1 June to 30 November 2008.
Substances that are not pre-registered will not be able
to benefit from the phased registration timetable (called
the transitional regime). These substances will need to
be registered immediately or will be illegal to supply.
Imported ELINCS substances (‘Notified Substances’) are
ALREADY registered - no pre-registration is required

Substances eligible for pre-registration

These are the substances that can benefit from a transitional regime.
These are essentially:
• EINECS substances;
• substances manufactured in the European Union, but not placed on the
market by the manufacturer or importer (at least once) since June 1992;

Substances benefiting from a Substances that do not benefit

transitional regime from a transitional regime
• EINECS substances • "New" substances, i.e.
• Substances manufactured in manufactured for the first time
the European Union, but not after the introduction of REACH
placed on the market by the • Substances that have not been
manufacturer or importer at least pre-registered.
once since June 1992.

"Catch-up" measures for "newcomers"

Consider the case that your company makes a substance that is eligible as
Article 28.6 a phase-in substance but the current production is less than 1 tonne per year.
If production increases to more than a tonne per year after 1 December
2008 and before the transitional regime ends, the company can still
participate as a phase-in substance as long as they notify the agency and join
the relevant ‘substance information exchange forum’ (SIEF), which are
explained more fully later. If this were not the case, the company would have
to register immediately, as would be the case for a non phase-in substance.

Who is responsible for pre-registration?

Responsibility lies with the legal person that is obliged to register the
substance (see chapter IV).
"The potential registrant" is the manufacturer or importer of a substance or
the producer/importer of an article (this applies only in the case where the
article contains one or more substances that are intended to be released
under normal or reasonably foreseeable conditions of use, see chapter VIII).

8
 1 june 2008 30 nov. 2008 30 nov. 2010 1 june 2013 1 june 2018

Pre-registration Registration deadlines

• CMR 1 and 2
All substances > 1t/year
benefiting • risk phrase
from a transitional R50/53 > 100 t/year • SBRT* • SBRT*
regime • other SBTR* > 100 t/year > 1 t/year
> 1000 t/year
* Substance Benefiting from a Transitional Regime

Figure 1: Registration deadlines for substances benefiting from a transitional regime

Manufacturers and importers of substances/preparations and the producers

of articles (where there is an intended release of a substance from the article)
must pre-register their substances. Failure to do so could result in placing
products on the market illegally, or the products will have to be withdrawn
until the full registration dossier is complete. Pre-registration gives
companies time to prepare their registration dossiers.

i
Most engineering manufacturing companies are
downstream users of chemicals/alloys/raw materials
rather than manufacturers of chemicals. Engineering
manufacturers will make ‘articles’ as defined in REACH.
Downstream users are advised to remind their suppliers of
the importance of pre-registration.
Caution: pre-registration is not a commitment to make a
registration at a later time and does not guarantee the
continued supply of the substance.
As a manufacturer of ‘articles’, it is essential to check
whether the substances in articles are ‘intended for release’
in normal or reasonably foreseeable conditions of use at any
point in their life cycle (including disposal). Such substances
will have to be pre-registered by the downstream user, if the
supplier is not already pre-registering them for that use.
The list of pre-registered substances will be published on
the Agency's website on 1 January 2009 at the latest. If a
substance does not appear on the list published by the
Article 28.5 Agency, the downstream user may notify the Agency of
the use of the substance, so that the potential registrants

REACH / Interpretation guidelines - June 07

can be informed

Articles 25 and 29 The data exchange system

Pre-registration allows the producers and importers of any given chemical
substance to:
• take part in substance information exchange forums (SIEFs);
• share information on the data required to write the dossiers;
• reach agreement on the classification and labelling of the substances;
• reduce the registration costs by sharing them;
• limit the tests on vertebrate animals.

Information to be provided
• the name of the substance along with its EINECS and CAS numbers if
they are available;
• the name and address of the producer or importer;
• the planned registration deadline;
• and the tonnage band.

9
4 - Registration
Title II Who must register?
There are two possible cases:
See PURCHASING • Manufacturers or importers of substances on their own or contained in
sheets in annex 2
of this document preparations must register the substances manufactured or imported in
quantities of more than one tonne per year;
• Producers or importers of articles in which substances are contained
must register each substance:
- present in articles in quantities greater than or equal to one tonne per year;
and
- intended to be released under normal or reasonably foreseeable
conditions of use;
and
- if the substance has not already been registered for this use.

i
Substances that are intended to be released have to be
registered. The conditions of intentional release include
both normal and reasonably foreseeable conditions of use.
For example, combustion products from an accidental
fire, are NOT intentional releases and do not have to be
registered.
The release of an extinguishant is an intentional release,
and the substances in the extinguishant do have to be
registered.
However, there is a clause in Article 7(5) that could
require combustion products to be registered, if they
are hazardous.
For example, Welding gives rise to the unintended
release of fume. This is not an intentional release, but
the substances being released from the article could be
hazardous. If the fume contains substances that are
considered hazardous by the Agency, then the Agency
may require the substances in the Article to be
registered under Article 7(5).

This procedure is applicable to each legal person.

Careful attention should be given to the legal structure of the
Company to ensure the registration is applied at the appropriate level.

i
Not all subsidiary companies are necessarily a ‘Legal
Person’ in REACH. All companies that are legally
separate from a holding company (such as wholly
owned or part-owned subsidiaries with a separately
registered legal name) must comply in their own right.

"No data, no market" principle

i
The substances concerned that have not been
registered cannot be manufactured or placed on the
Article 5 market in the European Union.
Articles containing hazardous substances, that have
not been registered, have to be notified to the agency.

10
 Registration procedure
This is an administrative procedure for submitting a declaration to the
European Chemicals Agency supported by a technical dossier whose
content and complexity vary according to the quantity and hazardous
properties of the substance (article 10).
All companies that are obliged to register the same substance can create
a joint registration. The Regulation encourages joint submissions from
consortia of companies (OSOR principle: One Substance, One
Registration). Consortia and other companies registering the same
Article 11 substance will automatically be put in contact with each other by the
European Chemicals Agency by means of ‘substance information
exchange forums’ SIEFs. The purpose of these exchanges is to spread the
burden of registration and evaluation and to share the costs and reduce the
number of tests on animals.
Registrants can opt out of the SIEF and pay for their registration separately,
Article 4
but they will still be obliged to share animal testing data and to minimise
animal testing.
For confidentiality reasons, it is possible to appoint a third party
representative to accomplish the procedures requiring consultations with
other manufacturers and importers. In this case, the identity of the person
who has appointed a representative is not divulged by the Agency to the
other members of the exchange forum.

i
Manufacturers based outside the European Union may appoint
a natural or legal person established in the European Union to
Article 8
accomplish, on his behalf as an only representative, the obligations
incumbent on the importers.
Companies that purchase supplies from outside the
European Union are advised to encourage their non-
European suppliers to appoint such a representative
(if none is appointed, they will have to assume the
importer's obligations).

Notified substances
New substances (ELINCS), called notified substances in the sense of Directive

REACH / Interpretation guidelines - June 07

Article 24
67/548/CEE, are regarded as already being registered. The Agency will
grant them a registration number by 1 December 2008 at the latest.

Article 6.3
Polymers
The registration requirement does not apply to polymers.
However, all manufacturers or importers of a polymer must submit a request
for registration to the Agency for the monomer substance(s) or any other
substances that have not yet been registered by an actor situated
upstream in the supply chain if both the following conditions are met:
• the polymer contains 2 % weight by weight or more of that or those
monomer or other substances;
and
• the total quantity of that or those monomer or other substances totals one
tonne or more per year.

11
4 - Registration
Substances not subject to registration
The following substances are exempted from registration (as well as from the
"Downstream users" and "Evaluation" titles):
• The substances listed in annex IV of the REACH regulation as sufficient
information is available to consider that they represent a minimal risk.
Examples: CO2, Argon, Nitrogen, graphite, sugars, vegetable oils, fatty acid,
lecithins, etc.
The substances listed in annex V of the REACH regulation. This
essentially concerns:
- products of unintentional chemical reactions due to environmental factors, or
intentional chemical reactions in processes when they are not manufactured,
imported or put on the market;
- substances occurring in nature or elemental substances if they are not
chemically modified.
Example: when preparing a surface treatment bath, the mixture of two or
more substances makes it possible to create a new substance.
These two annexes will be revised by technical committees by 1 June 2008
at the latest.
Isolated intermediates that remain on the site and are transported are
exempted from chapter I of title II on registration except with regard to articles
8 and 9 and of title VII on Authorisation.
Product and process oriented research and development (PPORD)
Article 9
Substances manufactured in the European Union or imported for research and
development activity purposes and manufactured in quantities of more than a
tonne are exempted from registration for a period of 5 years.
To benefit from this, the developers of PPORD need to notify the agency as
soon as usage exceeds one tonne per year.

Content of the registration dossier

The registrant must complete a technical dossier that includes all the
relevant information that he has at his disposal, whether it is of a
physicochemical, toxicological or ecotoxicological nature, specifically:
Articles 10 and 12 • the identity of the manufacturers or importers;
• the identity of the substance;
• the identity of manufacturer(s)/importer(s);
• information on the manufacture and the use(s) made of the substance;
• the classification and labelling;
• guidance on safe use of the substance;
• the study summaries regarding the information derived from the application of
annexes VII to XI of the REACH regulation (relative to the requirements in the
area of standard information for manufactured or imported substances in
quantities of one tonne or more, 10 tonnes or more, or 100 tonnes or more);
• a request as to which of the information in article 119(2) the manufacturer or
importer considers should not be made available on the Internet in
accordance with Article 77(2)(e), including a justification as to why publication
could be harmful for his or any other concerned party’s commercial interests.
Furthermore, the registrant must draw up a chemical safety report for all
Article 14
substances subject to registration, for quantities of 10 tonnes or more per

12
 year per registrant. The chemical safety report is intended to help identify
the hazards and facilitate their subsequent control. It contains the chemical
safety assessment, either for each substance, or for a group of substances.
The chemical safety assessment includes:
• an assessment of the hazards for human health;
• an assessment of the physicochemical hazards;
• an assessment of the environmental hazards;
• an assessment of the PBT and vPvB aspects.
If the assessment proves that the substance is dangerous or meets the
criteria for being a PBT or vPvB substance, then exposure scenarios have to
be produced for each use of the substance, together with risk management
measures for each scenario.
The general provisions relative to submitting a chemical safety report are
given in annex I of the Regulation.
The data shall be entered and the registration or notification dossiers shall be
prepared using the IUCLID 5 software developed by the European
Chemicals Bureau (see figure 2).

REACH / Interpretation guidelines - June 07

Figure 2: IUCLID 5 software home page

Title IX Fee
Any request for registration must be accompanied by the required fee as
stipulated in title IX of the REACH regulation.
The registrant must pay the whole fee if he makes the declaration on its own.
He will benefit from a reduction of one third of the fee if he is a member of a
consortium of companies, or of 25% if an SME2.
The fees will be defined in a regulation of the Commission to be adopted by
1 June 2008 at the latest.
There will be three categories, depending on the quantities: 10-100 t, 100-
1.000 t, and more than 1.000 t. For substances produced in quantities of
less than 10 t/year, the fee will not be required when the registration dossier
includes all of the information stipulated in annex VII.
(2) Refers to EU definition

13
5 - Evaluation
This is the Agency's control tool. One of the key goals of REACH is to
Title VI
(Articles 40 to 54) significantly improve the control of dangerous substances through a
comprehensive evaluation process.

Articles 40 to 43 Dossier evaluation

The evaluation of the registration dossier includes an examination of the test
proposals made by the manufacturers and importers and a verification of the
conformity of the registrations.
The Agency automatically checks the completeness of each registration dossier
Article 41.5
electronically. The Agency will then check 5% of the registrations per tonnage
band in greater depth, by hand.
As a priority, the Agency checks registration dossiers that meet at least one of the
following criteria:
• part of the information that it contains has not been submitted jointly via the SIEF;
• there is a non-conformity in the submission;
• it concerns a substance mentioned in the Community rolling action plan
(see below).
Priority will also be given to test proposals for the substances that give the most
cause for concern.

Substance evaluation
The Agency will draw up a Community rolling action plan for a three-year
period that will indicate which substances must be evaluated each year.
Article 44
These priority substances will be chosen according to a hazard-based
approach.
The first draft of the rolling action plan will be presented by the Agency to
the Member States on 1 December 2011 at the latest. Furthermore, the
Agency will present annually to the Member States, on 28 February at the
latest, draft updates of the rolling action plan.
The evaluation will be carried out by the Member States under the
responsibility of the Agency, which is responsible for its coordination.
There is nothing in the Regulation indicating how many substances will be
evaluated each year.

Evaluation of intermediates
The isolated intermediates remaining on the site that are used under strictly
Article 49 controlled conditions are not subject to a dossier evaluation or to a
substance evaluation.
However, if there is any hazard, the authority of the State over the territory
on which the site is located may ask the registrant to transmit additional
information on the hazard that has been identified or recommend hazard
reduction measures.

14
Article 50 Rights of the registrants and downstream users
The registrants or downstream users can submit their remarks within 30 days
following receipt of the Agency’s decision regarding the test proposals, the
conformity of the registrations, and the results of the evaluation. The Agency
forwards them to the authority of the concerned State.

i All remarks received are taken into account and

consequently may modify the draft decision.

Article 54 Publication of the information relative to evaluation

No later than 28 February of each year, the Agency will publish a report
on its website on the progress made during the past year regarding
evaluation. This report will include, in particular, recommendations to
potential registrants in order to improve the quality of future registrations.

REACH / Interpretation guidelines - June 07

15
6 - Authorisation
Any substance considered to be of very high concern (SVHC) pursuant
Title VII
to articles 57 and 58 must not be used, manufactured or imported
without the prior authorisation of the Agency once it has been included
See
AUTHORISATION sheets
on a list given in annex XIV of the REACH regulation.
in annex 2
of this document This represents a major change from the system that has been in
place in the European Union until now, which will come to an end on
1 June 2007.

Principle governing the management Principle governing the management

of dangerous substances and of dangerous substances and
preparations regulation before preparations regulation with REACH:
REACH:
Any use of a substance of very
Everything that has not been high concern included in
banned is authorised annex XIV of the REACH
regulation that is not
authorised is prohibited

i
It is not substances as such that are authorised,
but particular uses of those substances.

Article 55 Goals of authorisation

• guarantee that the risks relative to substances of very high concern are
properly controlled throughout their life cycle;
• ensure that these substances are progressively replaced by other
substances or by the implementation of new technologies when they are
economically and technically available and viable.
Note: the definition of the term "properly controlled" is given in section
6.4 of annex II of the REACH regulation: for each exposure scenario, the
risk for people and the environment can be considered to be properly
controlled during the substance's life cycle if:
- the estimated exposure levels do not exceed the relevant derived no
effect level (DNEL) or predicted no effect concentration (PNEC)
and
- the probability and seriousness of an event occurring because of the
substance's physicochemical properties are negligible.
- For example, steel manufacturers will wish to prove that the risk posed
by nickel in stainless steel is negligible because the available nickel at the
surface of the steel is extremely low.

Obligations arising from a request for authorisation

Analyse the availability of alternative options and examine the risks that
they include along with their technical and economic feasibility.

16
Article 57 Which substances are concerned?
Authorisation relates to substances of very high concern:
• Category 1 and 2 CMR substances;
• Persistent, Bioaccumulative and Toxic substances (PBT);
• very Bioaccumulative and very Persistent (vBvP) substances;
• substances with endocrine disrupting properties.
The Agency will make its first recommendation concerning substances of
very high concern to be included as a priority in annex XIV of the REACH
regulation no later than 1 June 2009. The Agency will make other
recommendations every two years at least with a view to including other
substances in annex XIV of the REACH regulation.
The substances included in Annex XIV of the REACH regulation are
classified in two distinct groups depending on whether it is possible to
control the risk properly (substances with a danger threshold) or impossible
to control it (substances without a danger threshold).

Article 60 The authorisation procedure

i
The authorisation procedure is independent from the
registration procedure. Substances already considered
dangerous and known to meet the criteria can be subject
to authorisation, regardless of their registration status.
Authorisation is required without any minimum
threshold for the quantity manufactured or imported.
Authorisation applies to substances on their own, in
preparations or within articles, and regardless as to
whether they are intended for release or not.

Member states will identify candidate substances for authorisation. The

Agency will prioritise these substances according to guidelines from REACH
implementation projects 4.3 and 4.5. The recommendation to require
authorisation for a substance will then be made by the Agency, and issued
by the European Commission.

REACH / Interpretation guidelines - June 07

REGISTRATION AUTHORISATION
Timetable introduced gradually Authorisation is necessary for any use
according to the quantities and is independent from the
manufactured, imported or used quantity of the substance used.
each year (subject to pre-registration). Established on a case-by-case basis
and for a time-limited period.

i
The authorisation is granted for a time-limited period
on a case by case basis. Authorisations will only be
granted if a substitution plan is in place

The authorisation may be revised or suspended at any time. This is most likely to
happen if information regarding viable replacement substances is made available.

17
6 - Authorisation
There are two ways to apply for an authorisation
• By demonstrating that the risk from the use of this substance is properly
controlled throughout its life cycle (article 60.2);
• By demonstrating that the socio-economic advantages provide a greater
benefit than the risks from the use of the substance for human health or the
environment and that there are no appropriate replacement substances
or technologies (article 60.4, 60.5).

i
Substances classified as CMR cat. 1 and 2 without a
threshold, PBT, vPvB and substances with endocrine
disrupting properties, must have a socio-economic
case for an authorisation to be considered.

Article 62 Who can apply for an authorisation?

The requests for authorisation may be submitted by:
• the manufacturers or importers of the substances;
• the downstream users.

i
A downstream user must only use a substance subject
to authorisation if the conditions of the authorisation
granted to a company situated further up the supply
chain are met. The user has three months to notify the
Agency.
If none of the companies in his supply chain holds an
authorisation, the user is advised to find another duly
authorised supplier, failing which, the user will have to
seek the authorisation.
It is possible to apply for a joint authorisation, covering
several sites and several businesses, if it relates to the
same use (s) for a substance.

Authorisation exemption

i
Exemptions from the authorisation process will be by
exception as they will apply only to substances with
thresholds and for which the risk can be properly
controlled. The majority of substances of very high
concern should be considered as not having a threshold.
However, if the risk is properly controlled, the
downstream users may request exemptions for their uses
when the Agency publishes the list of substances for
which an authorisation is being sought on its website.
The deadline for submitting this request is 3 months after
the substance has been put on this list.

18
 Content of the dossier to be sent to the Agency
All dossiers must contain:
• The identity of the substance(s);
• The name and contact details of the person(s) submitting the request;
• The use(s) for which the authorisation is being requested;
• The chemical safety report;
• The analysis of the replacement solutions, examining the risks as well as
their technical and economic feasibility.
In the case of a request for an authorisation based on the socio-economic
advantages provided by the use of this substance or if a substitute has been
identified, the dossier must also contain:
• a substitution plan with an action timetable
• a socio-economic analysis

Article 61 Revising authorisations

The authorisations granted are only valid until the expiry date (sunset date)
fixed on a case-by-case basis.
To renew an authorisation, a revised report must be sent to the Chemical
Agency by the holder at least 18 months before the authorisation expires.
The Commission may decide to withdraw, suspend or modify the
authorisation at any time for the reasons below:
• if the circumstances have changed since the initial request was made (health
or environmental hazard or socio-economic impact);
• if new information on possible replacement substances has been made
available;
• in the case of a serious and imminent risk for human health or the
environment;
• if an environmental quality standard has been breached by the holder of
the authorisation.

REACH / Interpretation guidelines - June 07

Title IX Fees
The fee stipulated in title IX of the REACH regulation must accompany all
requests for registration.
In all cases a reduced fee is set for SMEs.

19
7 - Restrictions
Title VIII The restriction system in REACH extends what already existed in
and Annex XVII previous regulations. Annex XVII of the Regulation carries over the
of the REACH restrictions that existed in Directive 76/769/CEE.
regulation
From now on, the Commission or a Member State may submit restriction
proposals relative to the manufacturing, placing on the market or use of a
substance.
The restriction procedure makes it possible to keep a "safety net" for
controlling the risks that have not been taken into account elsewhere in
REACH.
The restriction may apply to a substance on its own or contained in an article
or preparation.
Examples:
Toluene CAS No 108-88-3: Shall not be placed on the market or used as
a substance or constituent of preparations in a concentration equal to or
higher than 0,1 % by mass in adhesives and spray paints intended for sale
to the general public.
Trichlorobenzene CAS No 120-82-1: Shall not be placed on the market or
used as a substance or constituent of preparations in a concentration
equal to or higher than 0,1 % by mass for all uses except: as an
intermediate of synthesis, or as a process solvent in closed chemical
applications for chlorination reactions, or in the manufacture of 1,3,5-
trinitro-2,4,6-triaminobenzene (TATB).
Until 1 June 2013, a Member State may maintain existing stricter restrictions
Article 67.3
concerning annex XVII applicable to the manufacturing, placing on the market
or use of a substance.
The Commission will publish an inventory of these restrictions by 1 June 2009
at the latest.

20
8 - Substances in articles
Article 7 Definition
and RIP 3.8
According to REACH an article is defined as an object which during
production is given a special shape, surface or design which determines
See ARTICLES
sheets in annex 2 its function to a greater degree than does its chemical composition.
of this document

Article 3.3

The purpose of RIP 3.8 is to define the boundary between preparation and
article (examples of cases under discussion: steel strip, parts made of glass, etc.).

Case where a substance present in articles must be

registered
Pursuant to article 7.1 of the Regulation, any producer or importer of articles
Article 7.1
must register a substance present in these articles if all the following
conditions are met:
a) The substance is present in those articles in quantities of more than a
total of 1 tonne per year per producer or importer;
AND,
b) The substance is intended to be released* under normal or reasonably
foreseeable conditions of use;
AND,
c) The substance has not already been registered for that use.
*The definition of "intended to be released” is not yet clearly defined.
However when a substance is released in the normal condition of use of the
article, and essential for its function it is considered as an intended release
e.g. ink in a cartridge.
When this substance is present in quantities greater than 10 t/year, the
producer or importer is required to produce the chemical safety report
(see chapter IV of this document).
As such the producer or importer of articles should be encouraged to pre-
register the substance that meets criteria a) and b) in 2008 (see chapter 3 of
this document).
Example: REACH / Interpretation guidelines - June 07
A company identifies that criteria a) and b) are met for a substance, whilst
assessing substances for REACH during 2007.
The substance in question (non CMR) is present in several articles. When totalled,
the quantity of the substance is 8 tonnes/year: Therefore the phase-in registration
deadline is in 2018 (date for quantities comprised between 1 and 100 t).
In order to benefit from the phase-in and not have to register until 2018, the company
must pre-register the substance between June and November 2008.
Following pre-registration, the company will be kept informed about the progress
of the work of the SIEF, which will be driven by manufacturers (or importers)
making >1000 tonnes/year.
In 2018, the company will have access to all the work previously generated by
the SIEF. The company will only have to add to the registration dossier,
information on uses (their own, and uses downstream in their supply chain) that
have not already been covered by a registration made earlier (2010 or 2013) by
someone else.

21
8 - Substances in articles
Article 7.2 Conditions when the presence of a substance of very
high concern in an article must be notified
If an article contains one or more of the substances of very high
concern included on the “candidate list” of substances (published on
the Agency's website), then this/these substance(s) must be notified to
the Agency pursuant to article 7.2 if all the following conditions are met:
• the substance is present in these articles in quantities totalling more
than 1 tonne per producer or importer per year;
AND,
• the substance is present in these articles in a concentration higher
than 0.1% weight by weight;
AND,
• the producer or importer cannot exclude the exposure of humans and
the environment under normal or reasonably foreseeable conditions of
use, throughout the life cycle and including disposal*;
AND,
• the substance has not already been registered for that use
*In the case where the producer or importer can exclude this exposure,
he no longer has to make any notification, but must provide appropriate
instructions for the article's end-user.
The obligation to notify applies as from 1 June 2011. Whenever a
Article 7.7 substance is added to the "candidate list", a period of six months is
allowed for the notification for that substance.
The elements making up the information to be notified are given in point
4 of article 7.

i
The obligation to inform the agency of the presence of
substances on the candidate list applies to everything
supplied after 1 June 2011.
This information is expected to be kept up to date for all
products sold after this date.
For example, if an article is sold in June 2011, and the
candidate list has 30 new substances added to it in 2020,
the notification information must be updated for the
Article 33
product that was sold in June 2011, if it is still operating.
However, the company is given 6 months in which to comply.

Conditions where the supplier of articles must

transmit information on the composition of the article
Any supplier of articles (producer, importer, distributor) containing a substance
on the candidate list and identified with a concentration higher than 0.1%
weight by weight, must submit:
• to the article's end-user: the "sufficient information available to him to allow
safe use of the article". This information must include, as a minimum, the
name of that substance (art. 33.1).
• to the consumer who asks for it: "sufficient information available to him to
allow safe use of the article". This information must include, as a minimum,
the name of that substance. The relevant information must be provided
free of charge within 45 days of receipt of the request (art. 33.2).

22
This obligation will come into force on the date the Agency publishes the list
of substances that are "candidates for authorisation" established pursuant
to article 59.1, and only for the substances given on that list.

i
The obligation to inform the agency of the presence of
substances on the candidate list that are within articles,
applies once the candidate list starts to be populated.
It is understood that products supplied before 1 June 2007
cannot be ‘articles’ because it is before the introduction of
REACH. However, all products sold after this date are
either preparations or articles and have to comply.
The candidate list will change regularly, and so the
information provided to customers has to be kept up to
date. If the customer sells the product (bought after 1
June 2007) to a third party, then the information has to be
supplied to the third party free of charge.
There is no concept of ‘second hand’ product, or ‘legacy’
product in REACH. When a second hand product is sold,
the same information requirements will apply. For
products first sold before 1 June 2007, the owner is
obliged to provide information when they sell the product
as second-hand

REACH / Interpretation guidelines - June 07

23
 within the supply chain
9 - Informations to be exchanged
The key element in the REACH system for communicating information relative to
Title IV
substances is the Safety Data Sheet (SDS).
Certain items of information must nevertheless be provided to the various actors
even in the absence of a SDS (art. 32).
The Safety Data Sheet must be written in the official language of the Member State
in which the dangerous substances and preparations are placed on the market.
Safety Data Sheets are not required for dangerous substances in articles, because
this is covered in article 33.

Goal of the Safety Data Sheet

The SDS is a tool that is used to transmit the appropriate safety information on the
classified substances and preparations to the users immediately downstream.
The goal is to allow employers to determine whether dangerous chemical agents
are present in the workplace and evaluate any risk for the health and safety of
workers resulting from their use.

i
Reminder: each company that is a downstream user of
substances needs to check its own country’s current
laws and regulations for the control of chemical risk in
the workplace and in particular for CMRs. It is likely that
REACH will add to existing requirements.

Article 31.6 and Compulsory content of the SDS

annex II
SDSs must conform to a "compilation guide" which is included in annex II of
the Regulation.

Content of the
Safety Data Sheet
1 Substance/preparation/company identification
2
3
4
5
Identification of the hazards
Composition/information on ingredients
First- aid measures
Fire-fighting measures
+
• Exposure scenarios
6 Accidental release measures
7 Handling and storage (main elements of the
8 Exposure controls / personal protection chemical safety report:
9 Physical and chemical properties CSR)
10 Stability and reactivity
11 Toxicological information • Use categories
12 Ecological information
13 Disposal considerations
14 Transport information
15 Regulatory information
16 Other information

Section 1 of the SDS includes the registration number along with the
Article 31
uses covered by the SDS.

Who must provide an SDS?

The supplier of a substance or preparation must provide the user of
the substance or preparation with an SDS in a greater number of
situations than in the past:
• when the substance is a dangerous substance or preparation;
• when the substance is Persistent, Bioaccumulative or Toxic (PBT) ;
• or very Persistent and very Bioaccumulative (vPvB);
• or when it is included in the list of substances that are candidates
for authorisation.

24
 i
Therefore, more substances and preparations will need
to have a SDS than previously.
Note that alloys are considered ‘special preparations’ in
REACH (REACH Annex II), and therefore will require
safety data sheets.

Coherence between the SDS and the chemical safety

assessment (exposure scenarios appended to the SDS)
The information contained in the SDS must correspond to the information
contained in the substance's chemical safety assessment when this
assessment was made by the manufacturer or importer (quantity > 10t/year).
Any actor in the supply chain who has to draw up a chemical safety report
must append the "relevant exposure scenarios" to the SDS. There are cases
when a downstream user has to create a chemical safety report – see section X.
The exposure scenarios describe the operating conditions, hazard management
measures and the substance use recommendations. The substance's complete
life cycle must be taken into account.

Article 32
Obligations when an SDS is not required
For substances and preparations not subject to an SDS, the suppliers must
nevertheless provide a certain amount of information to the user at the latest at
the time of the first delivery (of the substance on its own or in a preparation) that
follows the entry into force of the Regulation, i.e. 1 June 2007.
This information should contain:
• the registration number(s) (as soon as it(they) are available);
• a "declaration" indicating whether the substance is subject to authorisation;
• details regarding any authorisation granted or refused in the supply chain concerned;
• details on any restriction that may have been imposed.
Registration numbers and authorisation details will not be available on 1 June
2007, however restrictions can still apply.

Other information and communication obligations

Duty to communicate information up the supply chain
Article 34
When a downstream user obtains new information on dangerous properties or
any other information that could raise doubts on the appropriate nature of the

REACH / Interpretation guidelines - June 07

risk management measures identified in the Safety Data Sheet that he has been
supplied with, he must pass this information on to the actor immediately above
him in the supply chain.
Distributors transmit this information to the actor or distributor situated
immediately above them in the supply chain.
This should result in updated exposure scenarios being created and flowed
back down to users.
Access to information for workers
Employers must grant their workers and their representative’s access to adequate
Article 35
hazard and risk management information when an SDS is required (article 31) and
when an SDS is not required (article 32). This information concerns the substances
or preparations that these workers use or to which they may be exposed.
This provision already exists in law for many Member States, including French
Labour Law and UK Law via the Control of Substances Hazardous to Health.
Obligation to keep information
Manufacturers, importers and downstream users must keep the information
Article 36
they have collected for at least 10 years after the date on which they
manufactured, imported, supplied or used the substance for the last time, in
order to comply with the requirements of REACH.

25
10 - Downstream users
New obligations are imposed on downstream users of substances
Title V
and preparations.
They require far greater communication between the various actors in the
supply chain (down and upstream).
Each downstream user has to check the conditions under which the
substances are used and check with suppliers if the conditions of use are
covered by the registration or authorisation processes.
If the conditions of use are not covered, the downstream user has two options:
1. to pass the corresponding information related to their conditions of
use to their suppliers.
2. to cover their conditions of use by their own assessment (refer to the
flowchart in annex of this document and legal articles).
- In this way, the downstream users are expected to contribute to assessing
the chemical safety of substances.

What is a downstream user?

Article 3.13
According to the Regulation, a downstream user is any natural or legal
person established within the [European Union], other than the
manufacturer or the importer, who uses a substance, either on its
own or in a preparation, in the course of his industrial or professional
activities.
Distributors or consumers are not downstream users.

What information must the downstream user pass up

to the supplier and why?
When a downstream user receives an SDS containing the registration
Articles 37.1 and .2
number(s) of a substance, the downstream user can check whether their
use is listed amongst the "identified uses" in section 1 of the SDS.
If this is not the case, the downstream user has twelve months from
receipt of the SDS in which to send the supplier, a "brief general
description" of the use with a view to making it an identified use, which will
be covered by an exposure scenario appended to the SDS by the supplier.
The supplier must pass the information up to the immediately higher actor,
and so on up to the manufacturer/importer. The user must provide "sufficient
information" to make it possible to establish an exposure scenario.

When must the downstream user draw up a Chemical

Safety Report?
A Chemical Safety Report (described in chapter IV) must be created by a
Article 37.4
downstream user if the use of the substance/preparation is not covered by the
SDS (unless covered by the derogations described in the next point). This
requirement will arise if:
• The downstream user does not inform the supplier of a specific use which
represents a departure from the conditions described in the SDS's exposure
scenario (for reasons of confidentiality or quite simply because the user has
forgotten to inform the supplier);
• When the downstream user has given the supplier all the information for an
"identified use" and the supplier advises against it. The supplier must then
"immediately inform the Agency and the downstream user in writing of the
reasons for that decision" (these reasons must be related to the protection of

26
 human health or the environment). The supplier may nevertheless sell the
substance to the downstream user, but with this unadvised use included in
the SDS (or equivalent of the SDS for substances that are not dangerous).
Furthermore, the downstream user must submit the information stipulated in
Article 38.2
article 38.2 to the Agency:
• The company contact details;
• the registration number;
• the identity of the substance and of the manufacturer, importer or other
supplier, a general description of use;
• a proposal for additional tests on vertebrate animals if considered necessary.
The downstream user must inform the Agency if the classification for a
substance is different from that of the supplier.

Case where the downstream user does not have to

draw up a Chemical Safety Report even though his
use is not covered by the SDS
The downstream user does not have to draw up a Chemical Safety Report if:
Article 37.4
• an SDS does not have to be appended to the substance or preparation;
• the supplier is not obliged to establish a Chemical Safety Report;
• The substance or preparation is used in a total quantity of less than 1 tonne
per year*;
• The downstream user implements or recommends an exposure scenario that
implements the same or more onerous risk controls over those given the
exposure scenario given in the SDS;
• the substance is present in a preparation at a concentration lower than the
concentrations indicated in article 14, paragraph 2 (concentration limits given
in various earlier directives for hazardous substances, or if there are no stricter
concentrations for the substance, at least 0.1% w/w);
• the downstream user uses the substance for the purpose of research and
development activities*
*In this case the user must nevertheless pass on the information stipulated in
article 38.2 to the Agency:
• The company contact details;

REACH / Interpretation guidelines - June 07

• the registration number;
• the identity of the substance and of the manufacturer, importer or other
supplier, a general description of use;
• a proposal for additional tests on vertebrate animals if considered necessary;
• if the downstream user’s classification of a substance is different from that
of the supplier.

Application of downstream user obligations

Downstream users must comply with the requirements relative to chemical
Article 39
safety evaluation no later than 12 months after receipt of a registration
number (which is notified to them by their suppliers in the SDS).
Downstream users must comply with the requirements relative to the
communication of information no later than 6 months after receipt of a
registration number.
It is in the interest of downstream users to pass information up the supply
chain, if use and exposure category recommendations have been made.

27
11 - The agency
A European Chemicals Agency (ECHA) is established for managing and
Title X
implementing the technical, scientific and administrative aspects of the
REACH regulation.
It will provide the Member States and European institutions with the "best
possible scientific and technical advice on questions relating to chemicals
which fall within its remit" (article 77).
The Agency will be based in Helsinki (Finland).
It will be inaugurated on 1 June 2007, and be operational on 1 June
2008. Meanwhile, the European Chemicals Bureau (ECB) will continue to
implement the current regulations on new and existing substances.

Composition
The European Chemicals Agency will be comprised of:
• a Management Board
• an Executive Director
• a Risk Assessment Committee
• a Socio-economic Analysis Committee
• a Member State Committee
• a Forum for Exchange on Information on Enforcement
• a Board of Appeal (all appeals will be suspensive)
• a Secretariat

Tasks
The tasks assigned to the Agency are detailed in article 77, the main ones
being:
- managing the registration process;
- managing the dossier evaluation process;
- coordinating the substance evaluation process;
- putting in place the databases and keeping them up-to-date;
- providing advice and assistance;
- providing technical support;

28
Annex 1 : Structure of the regulation
TITLE I General issues
TITLE II Registration of substances
TITLE III Data sharing and avoidance of unnecessary testing
TITLE IV Information in the supply chain
TITLE V Downstream users
TITLE VI Evaluation
TITLE VII Authorisation
TITLE VIII Restrictions on the manufacturing, placing on the market and use of
certain dangerous substances and preparations
TITLE IX Fees and charges
TITLE X Agency
TITLE XI Classification and labelling inventory
TITLE XII Information
TITLE XIII Competent authorities
TITLE XIV Enforcement
TITLE XV Transitional and final provisions
ANNEX I General provisions for assessing substances and preparing chemical
safety reports
ANNEX II Guide to the compilation of safety data sheets
ANNEX III Criteria for substances registered in quantities between 1 and 10 tonnes
ANNEX IV Exemptions from the obligation to register in accordance with article 2(7)(a)
ANNEX V Exemptions from the obligation to register in accordance with article 2(7)(b)
ANNEX VI Information requirements referred to in article 10
ANNEX VII Standard information requirements for substances manufactured or
imported in quantities of 1 tonne or more
ANNEX VIII Standard information requirements for substances manufactured or
imported in quantities of 10 tonnes or more
ANNEX IX Standard information requirements for substances manufactured or
imported in quantities of 100 tonnes or more
ANNEX X Standard information requirements for substances manufactured or
imported in quantities of 1000 tonnes or more
ANNEX XI General rules for adaptation of the standard testing regime set out in
annexes VII to X
ANNEX XII General provisions for downstream users to assess substances and
prepare chemical safety reports
ANNEX XIII Criteria for the identification of persistent, bioaccumulable and toxic
substances, and very persistent and very bioaccumulable substances
ANNEX XIV List of substances subject to authorisation
ANNEX XV Dossiers
ANNEX XVI Socio-economic analysis
ANNEX XVII Restrictions on the manufacture, placing on the market and use of certain
dangerous substances, preparations and articles

29
30
Annex 2 : Flow charts
Table of contents

HOW TO READ THESE FLOWCHARTS ______________________________________________________________________________________________ 32

PURCHASING SHEET 1
I AM PURCHASING A SUBSTANCE ON ITS OWN, WHATEVER
THE QUANTITY MAY BE ________________________________________________________________________________________________________________________________ 33

PURCHASING SHEET 2
I AM PURCHASING A PREPARATION, WHATEVER
THE QUANTITY MAY BE ________________________________________________________________________________________________________________________________ 34

NOTES FOR THE PURCHASING A SUBSTANCE

AND PURCHASING A PREPARATION SHEETS ____________________________________________________________________________ 35

ARTICLES SHEET 1
I PRODUCE OR IMPORT ARTICLES ______________________________________________________________________________________________________ 38

ARTICLES SHEET 2
DOWNSTREAM COMMUNICATION AS A "SUPPLIER OF ARTICLES" ______________________ 39

NOTES FOR THE ARTICLES SHEETS __________________________________________________________________________________________________ 40

PRE-REGISTRATION SHEET ______________________________________________________________________________________________________________________ 42

NOTES FOR THE PRE-REGISTRATION SHEET __________________________________________________________________________ 43

AUTHORISATION SHEET 1
VIGILANCE ______________________________________________________________________________________________________________________________________________________________ 45

NOTES FOR THE AUTHORISATION SHEET 1

VIGILANCE ______________________________________________________________________________________________________________________________________________________________ 46

AUTHORISATION SHEET 2
USING A SUBSTANCE SUBJECT TO AUTHORISATION ________________________________________________________ 47

NOTES FOR THE AUTHORISATION SHEET 2

USING A SUBSTANCE SUBJECT TO AUTHORISATION__________________________________________________________ 48

31
 How to read these flowcharts

These flowcharts must be read from top to bottom and horizontally.

The symbol represents the entry point to the flowchart.

There are three different types of boxes:

Decision gates, where the

answer is "yes" or "no"

Action

Information

The black arrows link the boxes to each other. They may indicate a flow of
information or data, a piece of advice, a regulatory obligation, etc.

32
 PURCHASING Flowchart 1
My company purchases a SUBSTANCE
ON ITS OWN, whatever the quantity
may be (e.g. trichloroethylene, copper, hydrochloric acid, etc.).
Is the substance The M/I does not have to register:
supplied (directly or via no checks are required for registration.
a distributor) by a manufacturer NO
Check whether the substance is subject
or importer (M/I) who manufactures to the authorisation rules
or imports it in quantities see Authorisation flowchart
of > 1 t/year

YES
For each substance imported:
Is the supplier Pre-register and then register
in the EU, for imports > 1 t/year.
or if the supplier is outside NO Create a CSR if > 10t/year
IMPORTER (see note 6).
the EU, do they have an “only
representative” in the EU? Request an authorisation if it is
See note 1 subject to authorisation.
See Pre-registration
and Authorisation flowcharts

YES

DOWNSTREAM USER
M/I or their only representative will need For continuity of supply, check
to pre-register and register the that pre-registration / registration
substance. will take place

Does the supplier Apply the recommended risk management measures.

cover our use in the SDS YES See note 5
or in an exposure scenario? If the substance is subject to authorisation,
see AUTHORISATION sheet

REACH / Interpretation guidelines - June 07

NO

Choose whether
to inform the supplier in YES Advise the supplier of the use with
writing of the way my company sufficient information to identify the
uses the substance exposure scenario
See note 2.

NO
M/I Supplier includes YES
The company departs from the conditions the use in the SDS
described in the SDS but, for reasons of Exposure scenarios
confidentiality, the M/I is not informed

Draw up a "downstream user"

Chemical Safety Report, except in It is formally advised against this
certain cases: see note 4 use in the SDS (art. 37.3). See note 3.

33
 PURCHASING Flowchart 2
I am purchasing a PREPARATION,
whatever the quantity may be
(lubricant, alloy, paint, surface treatment solution)

Is the preparation
supplied (directly or via a
YES distributor) by a manufacturer NO MY COMPANY IS AN
or importer situated in the EU, or by a IMPORTER
manufacturer outside the EU who
has appointed an only
representative?
The preparation itself does not have to be
registered. All substances within the
preparation have to be registered.
To do this they first have to be identified,
together with their concentration
Are one or more thresholds, to calculate the quantity of each
YES of the substances NO substance and determine my obligations
manufactured / imported under REACH (See note 6)
in quantities
>1 tonne/year?

MY COMPANY IS Supplier does not 1 or more

A DOWNSTREAM have to register. NO substance(s) present YES
USER in quantities
< 1t/year?

See the left-hand Check whether the

part of the previous supplier is subject to
SUBSTANCE ON the authorisation rules Pre-Register if required
ITS OWN flowchart: (see (see PRE-REGISTRATION sheet)
"downstream user" AUTHORISATION and then register each substance
Flowchart) bought in quantities of + 1t/year
(see note 6).
For any substance imported in
quantities of + 10t/year, create a
Chemical Safety Report, except
if its concentration meets the conditions
of art. 14.1 (see note 7)

Apply the risk

management
Does the preparation measures
Monitor the candidate list and contain one or more
annex XIV "Substances subject YES NO recommended
substance(s) likely in the SDS or
to authorisation". to be subject
See AUTHORISATION sheet the exposure
to authorisation? scenarios, when
using the preparation.

34
Notes for the PURCHASING
A SUBSTANCE and PURCHASING
A PREPARATION flowcharts
Remark: in the flowcharts "I" corresponds to a legal entity: a company with
three subsidiaries represents 4 distinct legal entities.

Note 1. Importation: reminder

By importation, we mean procurement from a country situated outside the
European Union. For the record, the States of the European Union are:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, the Netherlands, Poland, Portugal, Rumania, Slovakia,
Slovenia, Spain, Sweden and the United Kingdom. Norway, Iceland and
Liechtenstein will be considered WITHIN the EU for REACH (these countries
will also apply the regulation), and Switzerland is OUTSIDE the EU.

Note 2. Identified use

When a company receives an SDS accompanied by one or more
registration numbers (registration made by the manufacturer/importer*) the
user can check whether the use is listed amongst the "identified uses" on
the SDS. If that is not the case, the downstream user has twelve months
from receipt of the SDS to provide a "brief general description" of the use,
with a view to making it a use identified by the manufacturer/importer,
which will be covered by an exposure scenario appended to the SDS.
The downstream user informs the supplier who must pass the information
up to the immediately higher actor, and so on up to the
manufacturer/importer. The downstream user must provide a sufficient
amount of information to make it possible to establish an exposure
scenario. (Art. 37.1 and 37.2)
* The user company will receive these numbers between 2010 and 2018.
This is because amongst its suppliers it will have manufacturers/importers
who will have to register in 2010, others in 2013 and others in 2018.

REACH / Interpretation guidelines - June 07

Note 3. Unadvisable use
Under the terms of article 37.3, the manufacturer or importer of the
substance may advise against a use but only for reasons of protection
of health or of the environment. When this occurs, the
manufacturer/importer must inform the relevant downstream user, and
the Agency. The manufacturer/importer must include this "unadvised
use" in the Safety Data Sheet (point 16). The manufacturer / importer
must update the SDS or other risk management information, before the
substance/preparation is next supplied.

Note 4. Obligation to establish a "downstream user" chemical

safety report: principle and exceptions
• Principle:
Art. 37.4 states that if a use is not covered by an exposure scenario
appended to the Safety Data Sheet, then the downstream user must

35
 create a Chemical Safety Report (CSR) described in annex XII of the
Regulation. This "downstream user" CSR contains less data than the
CSR created by the manufacturer or importer, but the requirements are
still considerable.
> It is recommended that businesses collaborate with others that have the
same uses for a substance in order to spread the costs.
The downstream user must also tell the Agency that they have prepared a
CSR (art. 38.2) and provide basic information about the use and the
relevant substance registration(s).
• Derogations:
Article 37.4 gives six cases in which the user does not have to create a
CSR:
a) the substance or preparation does not require an SDS
b) the immediate upstream supplier was not obliged to create a Chemical
Safety Report
c) The substance or preparation is used in a total quantity of less
than 1 t/year*
d) The user will implement risk management measures at least
equivalent to one recommended in the SDS
e) the substance is present in a preparation at a concentration lower than
the concentrations indicated in article 14.2
f) The substance is being used for product and process R&D activities,
provided that the risks for human health and the environment are properly
controlled, and provided that the agency has been notified with basic
information about the use, as per article 38.2.

Note 5. Application timetable

The obligations to:
- draw up a Chemical Safety Report
- implement risk management measures
apply no later than twelve months following receipt of the registration
number provided by the supplier in the SDS.
Your company will have twelve months following the receipt of the
registration number (notified by the supplier in the SDS), in which to
inform the supplier of your company’s use of the substance.

Note 6. Identifying substances in preparations

An importer may import several preparations containing the same
substance. For each preparation, the total annual quantity of each
substance has to be estimated (% of substance in preparation X mass
of preparation bought per annum, averaged over the last 3 years). This
has to be summed together with the amount of the same substance
within all other preparations, with sufficient accuracy to identify which
tonnage band the substance will fall into. This in turn will identify the
expected date of registration, if it is a phase-in substance (see pre-
registration flowchart).

36
Note 7. Chemical Safety Report that must be established by the
importer of a substance or preparation
For any substance imported in quantities of + 10t/year, the manufacturer
or importer must establish the Chemical Safety Report (CSR) stipulated in
article 14 and described in annex I. The CSR contains an evaluation of the
chemical safety (health hazards, physicochemical hazards, environmental
hazards, persistent and bioaccumulative nature).
When the substance is contained in a preparation, art. 14.2 states that a
CSR need not be created if the substance's concentration is lower than
the lowest of the following levels:
a) the applicable concentrations, defined in the table in article 3,
paragraph 3, of Directive 1999/45/CE;
b) the concentration limits given in annex I of Directive 67/548/CEE;
c) the concentration limits given in annex II, part B, of Directive
1999/45/CE; the concentration limits given in annex III, part B, of
Directive 1999/45/CE;
e) the concentration limits mentioned in an agreed entry in the
classification and labelling inventory established pursuant to title XI of
the Regulation;
f) 0.1 % weight by weight (w/w) if the substance meets the criteria laid
down in annex XIII of the Regulation.
When creating the CSR for a preparation, it is possible to create a CSR for
each substance on its own, or for the preparation as a whole (art. 31.2).

REACH / Interpretation guidelines - June 07

37
 ARTICLES flowchart 1
My company produces or imports articles
Two series of questions must be asked in succession

Article 7.1 Article 7.2

Is a substance Is there a substance

intended to be released that is a "candidate
NO from the article, under normal NO for authorisation" present
or reasonably foreseeable in quantities of + 1t/year and a
conditions? concentration> 0.1 % weight
by weight?
Cf. note 2

YES YES

Can exposure
Is it present of humans and the
NO in the articles YES
environment be excluded
in quantities of (under normal or reasonably
+ 1 t/year? foreseeable conditions
of use),

Subsequent downstream
users of the article must
YES be provided with
"appropriate
instructions", and at
the very least, the
NO name of the SVHC
YES Is it already NO substances present
registered for at > 0.1 % w.w. For
that use? further details for SVHC
substances used in
making articles, see
AUTHORISATION
flowchart

YES Is the substance NO

already registered
No obligations apply with for that use?
respect to article 7.1
(obligation to register
substances in articles) Provide the Agency
with the information
No obligations apply with stipulated in article 7.4
respect to article 7.2 (see note 4).
(obligation to notify of For further details for
substances in articles). SVHC substances used
in making articles, see
Pre-register the AUTHORISATION
substance and then flowchart
register it. See note 1 and
PRE-REGISTRATION flowchart
If this substance is present
in quantities of + 10t/year,
create a Chemical Safety
Report (see note 5).

38
 ARTICLES Flowchart 2
Downstream communication
as a "supplier of articles"
(producer, importer, entity placing on the market)

Is there a substance
that is a "candidate for
authorisation" (e.g. on the
YES candidate list) present in the article NO
at a concentration
> 0.1 % weight by weight?
Or is there an Annex XIV
substance in
the article?

Provide all available information to allow the article I am not under any obligation
to be used in complete safety and including, at least, the pursuant to article 33
name of the ‘candidate list’ / SVHC substance(s)
in the article:
- to the user of the article: art. 33.1
- to subsequent downstream users, if they ask
(information to be supplied free of charge within 45 days
of receipt of the request): art. 33.2
See note 6

REACH / Interpretation guidelines - June 07

39
 Notes for the ARTICLES
Flowcharts
Remark: in the flowcharts "I" corresponds to a legal entity: a company with
three subsidiaries represents 4 distinct legal entities.

PREAMBLE
• Lack of clarity on obligations relating to substances in articles.
An article, in the REACH sense, is an "object which during production is given
a special shape, surface or design which determines its function to a greater
degree than does its chemical composition". Parts and components are
therefore articles.
There are only two provisions (art. 7 and art. 33) in the Regulation that cover
the obligations regarding the substances in articles. There are still a large
number of issues that need to be resolved:
• on the basic definition of an article (is steel strip a solid preparation or an
article? The European Commission has not yet reached its decision),
• on the calculation of the tonnage or concentration thresholds (should we
consider the article as a whole, or each material? Do different part numbers
represent different articles?),
• on the notion of "substance intended to be released under normal or
reasonably foreseeable conditions of use".
Answers are expected in application guidelines written by the Commission and
representatives of industry, RIP 3.8 (RIP for Reach Implementation Project).
• Optimistic presumption…
REACH presumes that all producers know all of the substances in all of the
articles they produce or import. Some preparations used to manufacture
articles or other preparations, can have variable constituents even if they
conform to a specification. Therefore even two batches of the same standard
material could lead to different obligations within REACH.

Note 1. Possibility of an obligation to register for a substance

"intended to be released" by the article.
Article 7.1 of the Regulation states that any producer or importer of
articles must register a substance present in these articles if all the
following conditions are met:
a) The substance is present in these articles in quantities greater than or
equal to a total of 1 t/year per producer or importer;
b) The substance is intended to be released under normal or reasonably
foreseeable conditions of use;
c) The substance has not already been registered for that use.

Note 2. Presence of a substance that is a "candidate for

authorisation" in an article, above certain concentration and
tonnage thresholds (art. 7.2).
Amongst the substances said to be of "very high concern", the Agency
will identify certain substances on a "candidate list for authorisation".

40
These candidate substances will then be included, or not, in annex XIV
"Authorisation" (this means: prohibited unless authorised). An initial list
will be drawn up by the Agency in 2008 or, at the latest, by 1 June 2009.
Other recommendations will be added to this list every two years.

Note 3. Can exposure of humans and the environment be excluded

(under normal or reasonably foreseeable conditions of use),
including disposal?
If exposure can be proven to be prevented, then Article 7.3 states that the
producer/importer does not have to provide the information to the Agency.
The producer/importer still must provide "appropriate instructions" to the
user of the article.
At present, no explanation is available defining exposure of human beings and
of the environment, including disposal.

Note 4. Information to be provided to the Agency relative to

article 7.2
This information must be provided:
- if a substance of very high concern is present in the articles in quantities
above the stipulated thresholds,
- and if that substance has not been registered
- or if the producer/importer cannot exclude exposure to that substance
(see note 3)
Article 7.4 gives the list of information to be provided: identity of the
producer, identity of the substance, its classification, a brief description of
the use(s) made of the substance(s) contained in the article.
Entry into force of the obligation to notify: from 1 June 2011, then six
months after a substance has been included on the above-mentioned list.

Note 5. Chemical Safety Report

For a substance "intended to be released" present in quantities of > 10t/year,
the producer or importer of articles must create the Chemical Safety Report
(CSR) provided for in article 14 and described in annex I. The production of
this report is expected to be time consuming and expensive.
The CSR includes a chemical safety evaluation (identifying the health REACH / Interpretation guidelines - June 07
hazards, physicochemical hazards, environmental hazards, persistent and
bioaccumulative nature).

Note 6. Communication of information to the user of the article

and the end consumer if he asks for it
This communication of information is provided for in article 33. It applies once
the 0.1 % concentration threshold is passed (the tonnage used/imported/
manufactured is irrelevant). It applies to all "suppliers of articles", which includes the
producer, importer, distributor or any other actor in the supply chain who places an
article on the market.
It is required for any substance identified by the Agency as being a "candidate
for authorisation" (see note 2). The obligation will come into force as soon as
the list identifying this type of substance is issued by the Agency (2008 or, at
the latest in June 2009).

41
 PRE-REGISTRATION Flowchart
My company needs to pre-register
substances that are:
- imported in quantities of > 1t/year, as substances on their own or in preparations,
- intentionally released from articles that are imported or manufactured in quantities
of >1t/year,

Is it an ELINCS I do not have

Is it a "phase-in" NO YES to pre-register
substance? substance?
(with a ‘Notification’ (or register).
See note 1 See note 4.
number)

YES NO

The substance is eligible It is a "non phase-in"

for pre-registration. substance.

It is not eligible for pre-registration.

The substance must be registered
immediately. See note 3
Decision to pre-register
to benefit from the NO
transitional registration timetable
(see note 2)?

Provide information to the Agency

(see note 7).
YES

Provide the information to the Agency

between 1 June and 30
November 2008 (see note 5).
Has the substance
already been registered
NO
by someone else?

Automatic membership of the

Substance Information
Exchange Forum (SIEF) Begin the process
(see note 6). to register the
substance
YES immediately. It is
illegal to supply
unregistered
On 1 January 2009 the Agency substances if they
publishes the list of pre-registered The Agency provides the contact have not been
substances on its website (name, details of the registrant(s) who have pre-registered, after
numbers, registration deadline). already registered, and passes on 30 January 2009.
the company’s contact details. It will take at least this
long to complete the
process.
As a user of substances
check that the substances The company must agree with
used are included on this list; registrants how to share registration
if not, inform the Agency data, and registration costs.
(art. 28.5). See note 7

42
Notes for the
PRE-REGISTRATION Flowchart
Remark: in the flowcharts "I" corresponds to a legal entity: a company with
three subsidiaries represents 4 distinct legal entities.

Note 1. "Phase in" substances that can be pre-registered to benefit

from the registration timetable
These are the substances that meet the following criteria:
a) they are mentioned in the EINECS inventory (present on the market before
September 1981),
b) or are manufactured in the Community or one of the countries that joined on
1 May 2004, but that has not been placed on the market at least once in the
last 15 years.
The inventory of 130,000 EINECS substances can be consulted on the
website: http://ecb.jrc.it/existing-chemicals/. They have a numbering code
comprised between 200-001-8 and 400-010-8.

Note 2. Transitional registration timetable

Pre-registering between June and December 2008 makes it possible to benefit
from the transitional registration timetable, which is as follows:
- 2010 for substances manufactured or imported in quantities greater than
1000t/year, for category 1 or 2 CMR substances manufactured or imported in
quantities greater than 1t/year, and for substances highly toxic for aquatic
organisms (R50/53).
- 2013 for quantities comprised between 100t/year and 1000t/year
- 2018 for quantities comprised between 1t/year and 100t/year.
In the absence of pre-registration, the manufacturer or importer must register in
2008, which should not often be the case.

Note 3. "Non phase-in" substance that must be registered in 2008

Today, a very small number of substances are concerned since this concerns

REACH / Interpretation guidelines - June 07

new substances in the sense of REACH (commercialised after this text has
come into force) and the substances manufactured but not placed on the
market before 1992.
They are subject to articles 26 and 27.

Note 4. ELINCS substances that have not been pre-registered

Because these substances have already been very well evaluated, they are
considered to be already registered: the Agency will grant them a registration
number no later than 1 December 2008. They are subject to article 24 (see art.
24.2 in particular).
The list of 3,000 ELINCS substances can be consulted on the website:
http://ecb.jrc.it/new-chemicals/
Their numbering code starts at 400-010-9.

Note 5. Information to be provided for pre-registration

This does not represent a great deal of information. Article 28 stipulates that
each registrant must provide the Agency with the following information:

43
 a) the name of the substance, its EINECS and CAS numbers or, if they are not
available, any other identity code;
b) The registrant’s name and address, along with the name of the person to be
contacted; and if the registrant has appointed a representative as allowed for
in article 4: the name and address of that representative;
c) the deadline envisaged for the registration and the quantity band;
d) and for substances that can be "grouped together" because of their
structural similarity (annex XI, section 1.3 and 1.5): same information as in
point a) above.

Note 6. Substance Information Exchange Forum (SIEF). Financing of

the cost of the information to be provided at the time of registration.
A forum will be created for each substance, and will bring together all the
"registrants" who have pre-registered the substance in question (art. 29). The
purpose of a forum is to facilitate exchanges of information and data in order to
avoid repeating studies unnecessarily.
If studies have already been carried out, article 30.1 gives the procedures that
their owner(s) share with the other registrants: the goal being to fix the costs of
sharing in a fair and transparent way. If the owner of an existing study refuses to
"share" it, alternative solutions are provided for in articles 30.3 and 30.4.
If, for an item of information required by REACH, there is no relevant study
available, a single study will be carried out by one of the participants in SIEF,
acting on behalf of the others (see art. 30.2).

Note 7. Procedure to be applied if it is decided to not pre-register a

substance
On the face of it, we do not think that this will be a likely voluntary choice of
the manufacturing companies concerned (but it could be a commercial
strategy for certain manufacturers of substances and preparations, which
will thus be "REACHed" before their competitors "REACH" theirs). However,
in theory, the procedure described below will also apply to those who
"forget" to pre-register.
The Agency is asked whether the substance has already been registered by
another company. The request to the agency needs to contain the information
defined in article 26.1.
The Agency will then inform my company whether:
• the substance has not yet been registered: consequently my company must
register.
• it has already been registered by one or more earlier registrant(s); in which case
the agency passes on contact details to all parties. If the substance was
registered less than twelve years earlier, article 27 organises the procedures for
"sharing" the data with the earlier registrant(s), the goal being to reach an
agreement on a fair and transparent cost.
Note: Pre-registration of substances manufactured or imported for
the first time after 31 December 2008, or intended to be released by
an article manufactured or imported for the first time after 31
December 2008.
Article 28.6 stipulates the "catch-up" provisions: it is possible to take advantage of
the transitional timetable, provided the required information has been provided to
the Agency within six months of the first manufacturing/importation (see note 4).

44
 AUTHORISATION FLOWCHART 1
Checking / Review

Does my company
use substances of
NO Monitor whether it is likely to become
a substance of very high concern.
very high concern (SVHC)?
See note 2
See note 1

YES

Regularly check to see if substances used

Are any of the substances NO by the company have been added:
on the candidate list? the substance could be included
See note 3 on the candidate list later (the list is
updated regularly)

YES

The Agency invites all the interested

parties to submit their information
to it within a given time

Submit information
to the Agency on uses

REACH / Interpretation guidelines - June 07

Is the substance included NO Continue to monitor: the substance could

in the priority substances be included in the Priority Substances
recommendation? Recommendation later.
See note 4

YES

Submit remarks within 3 months

Monitor inclusion in see the "Authorisation"
of publication to obtain exemption
annex XIV flowchart 2
if applicable.

45
 Notes for the AUTHORISATION
flowchart 1
checking / review
Preamble
The substances subject to authorisation will be listed in annex XIV.
The authorisation procedure applies whatever the quantity.
The authorisation does not cover a substance, but identified uses of the
substance.

Note 1. Substances of very high concern are (Art 57):

• Category 1 or 2 Carcinogenic, Mutagenic or Toxic for Reproduction (CMR)
substances (see Directive 67/548)
• Persistent, Bioaccumulative and Toxic (PBT) substances (see Annex XIII)
• very Bioaccumulative and very Persistent (vBvP) substances (see Annex XIII)
• substances with endocrine disrupting properties, or substances causing a
level of concern equivalent to the substances indicated above

Note 2. Substances that are likely become a substance of very high

concern (Art. 59.4)
The Commission and the Member States may submit a dossier to the Agency
on a substance that it or they consider meets the "very high concern" criteria.
The Agency publishes opinions on these dossier on its website.
All the interested parties can submit their information to the Agency within a
given deadline.
We can assume that the Cat. 3 CMRs will, in all likelihood, be considered
candidate substances (e.g. formalin).

Note 3. List of candidate substances, that is to say the list of

Substances identified with a view to being included eventually in
annex XIV (Art. 59 & 83.3)
The list will be published by the Agency on its website (see point 6.1.1 of the
Commission's FAQ – February 2007).

Note 4. The Agency's recommendation regarding the substances

to be included as a priority in annex XIV (Art 58.3 & 58.4)
The Agency will make its first recommendation no later than 1 June 2009. It will
publish it on its website.
The priority is given to the substances that have PBT or vPvB properties, or that
have highly dispersive applications, or products in large quantities.
All the interested parties have 3 months in which to submit their remarks
regarding the uses that should be exempted and why.

46
 AUTHORISATION flowchart 2
Using a substance subject to
authorisation
Is the substance NO No authorisation
in annex XIV? required

Check & review

YES (see Authorisation sheet 1)

Are my company’s NO
uses exempted
in annex XIV?

Are my company’s YES

YES uses exempted from Authorisation
Authorisation by the is not required
Authorisation Regulation?
is not required see note 1

Monitor revisions made

NO to the Regulation
Monitor revisions made to annex
XIV to see if this changes

Is my company
NO the importer
YES
of the substance?

REACH / Interpretation guidelines - June 07

Is the use
covered by an NO
YES authorisation granted
to an actor further up the
supply chain?

• Notify the Agency YES Is the substance NO

• of the use the substance in really indispensable?
accordance with the
authorisation
See Note 2
Ask for an authorisation replace the substance
for each use. (possibility of using
See note 3 it until its sunset date)

Draw up an authorisation
dossier

47
 Notes for the AUTHORISATION
flowchart 2
Using a substance subject to
authorisation
Note 1. Uses exempted by the Regulation (Art. 56)
• Use of substances in the framework of scientific research & development
activities (< 1 tonne/year)
• Use of substances in the framework of research & development activities
focussing on products and processes: annex XIV lists these exemptions
and the maximum quantity that can benefit from them.
• Uses in biocide products that come within the scope of Directive
98/8/CE;
• Uses as fuels covered by Directive 98/70/CE of 13 October 1998
regarding the quality of petrol and diesel fuels;
• Uses as fuels and combustibles in mobile or fixed combustion
installations consuming products derived from mineral oils, and uses as
fuels and combustibles in closed systems.
• Uses in materials intended to enter into contact with foodstuffs, entering
into the scope of Regulation (CE) No 1935/2004, there is an exemption
for the substances that are subject to authorisation only because they
have cat. 1 or 2 CMR properties, or because they have been identified
per article 57, point f) (substances with endocrine disrupting properties or
with an equivalent level of very high concern) only because of the hazards
for human health.
• Uses of substances when they are contained in preparations:
a) for PBT, vPvB substances, or substances with endocrine disrupting
properties or with an equivalent level of very high concern: below a
concentration limit of 0.1 % weight-by-weight (w/w);
b) for all of the other substances, below the lowest concentration limits
specified by Directive 1999/45/CE or annex I of Directive 67/548/CEE
that give rise to the preparation being classified as dangerous.

Note 2. Notification (Art. 66) and labelling (Art.65)

• Notification: the downstream users that use a substance in compliance
with an authorisation granted to an actor in their supply chain send a
notification to the Agency within three months of the first delivery of the
substance.
• Labelling: the holders of an authorisation and the downstream users of
an authorised substance who include the substance in a preparation
must mention the authorisation number on the label.

Note 3. Deadlines (Art 58.1.i & 58.1.ii)

When the Commission decides to include a substance of very high
concern in annex XIV, it stipulates the transitional provisions, i.e.

48
- the "expiry date" (sunset date) from which it is prohibited to place the
substance on the market and use it, except if an authorisation is
granted;
a date (at least 18 months before the sunset date), before which
each registrant must send its request if it wishes to continue
to use the substance or place it on the market after the sunset
date; these uses will continue to be authorised after the sunset
date until a decision has been reached on the request for
authorisation.

REACH / Interpretation guidelines - June 07

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CONCEPT DESIGN HCSGM 20070398 - GETTY IMAGES NEIL BEER - JUNE 2007 - PRINTED IN FRANCE