How to create your cosmetic Product

Information File?
By Marion Allayrangue Expert advice, Cosmetics comments

The Product Information File (PIF) is a key-element that is necessary to place your cosmetic products on
the European market. Aiming at gathering all the important information about your cosmetic product, it
represents a consequent amount of work and requires a sharp knowledge of Regulation 1223/2009 as well
as toxicological expertise. EcoMundo is proud to offer you this handy guide to give you all the clues to
create your PIF!

The Product Information File: a strategic document

WHAT IS THE PRODUCT INFORMATION FILE?

Enforced on 11th July 2013, the Cosmetic Regulation No 1223/2009 settles a new regulatory framework for
cosmetic and personal care products. It requires all actors of the cosmetic industry to constitute a Product
Information File (PIF) for each product that is placed on the European market.

This dossier, described in Article 11 of Regulation 1223/2009, aims at gathering all the relevant information that is
available for the cosmetic. That is why it includes various elements such as product identity, product quality, safety,
etc.

The PIF has to be kept by the Responsible Person for ten years from the date when the last batch of the product
was placed on the market.

WHAT IS AT STAKE FOR THE PRODUCT INFORMATION FILE?

Frequent controls

In accordance with Article 22 of the Cosmetic Regulation 1223/2009, the Member States regularly control the
cosmetic products that are placed on the European market in order to monitor their compliance with the Cosmetic
Regulation. If a default of compliance is noticed during the control, sanctions may be implemented.

It is therefore important to have a well-built and up-to-date Product Information File. This document is paramount for
both authorities and actors of the cosmetic industry.

HOW TO DRAFT YOUR PRODUCT INFORMATION FILE?

Regulation 1223/2009 imposes that the Product Information File must be constituted by the five parts detailed in the
following diagram:

1) DESCRIPTION OF THE COSMETIC PRODUCT

The role of this description

First of all, the description aims at establishing a clear link between the cosmetic product and its referring Product
Information File.

What must include the description?

In the description part of the Product Information File, you can include information such as:

-The exact name of the product

-The product’s code, identification, formula that enable to identify the product without any ambiguity.

-All the names in national language if the product is commercialized in various EU countries, and a description of
the function of the product (if it is not obvious).

2) PRODUCT SAFETY REPORT

The role of the product safety report

The product safety report must be established in accordance with Annex I of the Cosmetic Regulation.

It is the part of the PIF that assesses the safety of your cosmetic product.

What must include the Product Safety Report?

There are two distinct parts in the product safety report:

PART A : INFORMATION ON THE SAFETY OF THE COSMETIC PRODUCT

The purpose of Part A is to collect all necessary data to perform the product safety assessment. It contains:

1. Quantitative and qualitative composition of the cosmetic product

2. Physical/chemical properties and data on product’s stability
3. Microbiological quality
4. Impurities, traces, and information on the packaging material
5. Normal use and predictable reasoning
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Adverse effects and serious adverse effect
10. Information on the cosmetic product

PART B: SAFETY ASSESSMENT OF THE COSMETIC PRODUCT

Part B is a safety assessment that leads to a conclusion on the safety of your product. The person in charge of the
safety assessment takes into account all available information, check if there is no missing element, assess the risk
and then concludes on the safety of the cosmetic product.
Part B includes:

- Conclusion of the safety assessment

- Warnings and instructions that must be displayed on the label

- Scientific reasoning

- References of the person in charge of the assessment and of the approval of Part B

How to perform the Product Safety Report?

DATA THAT HAVE TO BE GATHERED FOR PART A

Steps What to do?

1) Quantitative and You have to provide:

qualitative formula of
the cosmetic product
 The list of raw materials and ingredients that figure in the composition of the
finished product (qualitative formula)
 The concentrations of these raw materials and ingredients (quantitative
formula)
 INCI names of ingredients, their functions and CAS numbers as to properly
identify ingredients used in the formula.

You have to gather the data from:

 Your raw materials supplier

 Your formulators
 Your regulatory department

Examples of data that have to be collected:

Identification of the raw material and its ingredients, origin of the ingredients
(synthetic, mineral, vegetal, etc.), function of the ingredients in the formula,
concentration, etc.

2) Physical/chemical You have to provide:

properties and data
on product’s stability
 The physico-chemical specifications of the raw materials and of the finished
product
 Information on product’s stability in predictable storage conditions
Steps What to do?

Examples of data that have to be collected:

Physico-chemical specifications of the raw material and of the finished product,

Material Safety Data Sheets, organoleptical properties (color, odor, shape) , stability
test, etc.

3) Microbiological You have to provide:

quality
 The microbiological specifications of the raw materials and of the finished
product
 The conservation test of the cosmetic product.

You have to gather data from:

 Your formulator and regulatory department

 The microbiological expert, the quality manager
 The raw material supplier

Examples of data that have to be collected:

The microbiological specifications of the raw materials and of the finished product,
conservation test.

If the raw material or the finished product cannot induce a microbial development
(e.g. anhydric product, high alcohol rate…), it is not necessary to provide this data.
But a justification will have to be provided.

4) Impurities, traces, You have to provide:

and information on
the packaging
material  Data concerning the impurities and traces in the raw materials and/or in the
finished product
 Relevant data on the packaging materials

You have to gather data from:

 Your raw materials suppliers

 Your packaging suppliers
 The regulatory department or the quality manager for the data that concerns
the finished cosmetic product
Steps What to do?

Example of data you have to provide:

a- For impurities and traces

Analysis of the relevant impurities in the raw materials and in the mixtures, with the
necessity to prove that the forbidden substances are technically unavoidable.

b- For the packaging material

Compatibility test, FEBEA Questionnaire (Fédération des Entreprises de Beauté:

Federation of the Beauty Companies) AC Process (Article and conditioning),
compatibility test, etc. or a simple statement for compliance with Regulation
1223/2009.

5) Normal use and The purpose of this part is to enable the safety assessor to determine a relevant
predictable reasoning
exposure scenario that takes into account:

 The labeling
 The use instruction.

You have to gather data from:

 The Responsible Person

 The regulatory department
 The safety assessor

Examples of data that you have to gather:

Description of the product’s presentation (type of conditioning, packaging, etc.)

photo/print-ready final packaging, any other information for the user that refers to
the product’s use, etc.

6) Exposure to the The purpose of this part is to determine the parameters for the exposure of the
cosmetic product
consumer to the cosmetic product.

You have to gather data from:

 The Responsible Person

 The regulatory department
 The formulator
Steps What to do?

 The safety assessor

Examples of data that you have to collect:

Targeted population, zone and surface of application, particular conditions of the

skin, application mode, frequency of application, etc.

7) Exposure to The purpose of this part is to calculate the exposure of the consumer for each
substances
substance.

You have to gather data from:

 The safety assessor

Examples of data you have to collect:

Estimated value of the daily exposure to the cosmetic product, qualitative and
quantitative formula of the cosmetic product, skin absorption value, secondary way
of exposure, etc.

8) Toxicological This part aims at establishing the toxicological profile of the ingredients contained in
profile of the
substances the cosmetic product.

You have to gather data from:

 The safety assessor

 The toxicologist
 The regulatory department

Examples of data you have to collect:

Synthesis of the tests to perform, required toxicological data (cf. page 15) report of
the Scientific Commitee for Consumer Safety).

9) Adverses effects The purpose of this part is to collect all relevant data on adverse effects that may be
and serious adverse
effects induced by the use of the product once available on the European market.

Examples of data you have to collect:

Data on adverse effects and serious adverse effects in order to determine their
imputability, statistical data (link between the number of adverse effects and the
Steps What to do?

number of units of product placed on the market, etc.).

10) Information on You have to gather relevant and complementary information that complete the
the cosmetic product
assessment of the cosmetic product.

You have to gather data from:

 Your regulatory department

Examples of data you have to collect:

Non clinical tests, clinical tolerance tests, etc.

HOW TO REALIZE PART B?

In accordance with Annex I of the Cosmetic Regulation 1223/2009, the safety assessment of the cosmetic product
must be performed by a qualified safety assessor.

Part B contains:

- The conclusion of the safety assessment: an indication concerning the safety of the cosmetic product.

- Warnings and operating instructions that must be displayed on the label: you have to explicitly enumerate the
special precautions for use that have to be on the label (at least those that are mentioned in Annexes III to IV
according with the product’s ingredients) in order to ensure a safe use of the cosmetic product.

- Scientific reasoning: it is the part where the Safety Assessor explains in a clear, relevant and precise manner the
way he or she could conclude about the safety of the cosmetic product (analysis of the relevance and quality of the
data, etc.).

- References of the person in charge of the assessment and approval of Part B.

3) MANUFACTURING METHOD IN ACCORDANCE WITH THE GOOD

MANUFACTURING PRACTICES

The third part of your Product Information File must contain the manufacturing method of the cosmetic product as
well as a declaration of compliance to the Good Manufacturing Practices (GMP).

What is GMP?
The Good Manufacturing Practices (GMP) of cosmetic products are a set of practical and organizational
requirements in respect of which the product has to be manufactured. This concerns particularly the control of
human, technical and administrative factors.

These guidelines aim at respecting the hygiene and safety of the product.

NB: This declaration of compliance has to be included in each Product Information File of each cosmetic product.

How to prove one’s compliance to Good Manufacturing Practices?

In order to respect the Good Manufacturing Practices, the product has to be manufactured in compliance with the
ISO 22716 standard.

In order to prove this compliance, it is necessary to perform an internal or external audit.

4) PROOF OF THE EFFECT CLAIMED

This part of the Product Information File must contain support information in order to substantiate the claims of the
product.

Every claim of the cosmetic product is concerned by that obligation, whatever the means of communication or
marketing channel, and whatever the targeted audience: consumers, professionals, etc.

The choice of the adequate and appropriate way to substantiate a claim has to be made by the Cosmetic brand.
Depending on the type of product and the claim that is made, several possibilities:
Claim substantiation means that you must provide the proof of the effect claimed. For that purpose, you have the
choice between three main ways to substantiate your claims.

The first one is the use of experimental studies, from in silico (meaning performed on computer), in vitro (meaning
performed with cells or molecules outside their biological context), etc. You can perform different types of
experiment, from studies conducted on volunteers to investigator evaluation, as long as methods are reliable and
reproducible.

The second way to collect evidence to back up your claim is the use of consumer perception tests, based on
parameters that consumers can observe of feel. The sample of volunteers should be statistically representative of
the target population. And most importantly, the questionnaire used to gather impressions should be neutral to be
valid, meaning questions should not influence answers.

Finally, the use of published information such as scientific publications or market data is a good addition to the first
two methods but cannot be sufficient on its own.

5) DATA REGARDING ANIMAL TESTING

The Product Information File must contain data regarding experimentations on animals that were performed by the
manufacturer, its agents or supplier. The data may concern the safety assessment or development of the product,
its raw materials and/or ingredients.

What kind of information should I include?

In the case where no animal testing has been performed, a simple declaration that says so should be included in
the PIF.

Consequently, if a test has been performed on animals, it is necessary to mention in the Product Information File
information such as:

 Identification of the animal testing

 Identification of the ingredients that were used
 Date of the animal testing
 Place of the test
 Information on the entities that performed the test
 Legal objective of the animal testing and justification of this objective
Warning: the PIF may have to be frequently updated!

NUMEROUS REGULATORY UPDATES

Regulation 1223/2009 is updated every 3 months on average, each time an amendments its published. It is highly
possible that some information in your Product Information File become obsolete.

Thus, the PIF must be updated each time new scientific data or new regulatory requirements are published or each
time the cosmetic brand is aware of a change that affects the formula, e.g. a change of manufacturer.

Tip to efficiently create and update the Product Information

File: the use of a software

AUTOMATE THE CREATION OF THE PRODUCT INFORMATION FILE

The volume of data must be collected, stored and analyzed in order to create the Product Information File is
consequent.

It could save a lot of resources to use a computer tool software to support the data collection task. Such software
could:

 Create your own database of cosmetic products, and link them with their raw materials and cosmetic
ingredients
  Store all the documents relating to your products, raw materials and ingredients with an optimal organization of
the documents
 Benefit from a database of toxicological profiles enabling to directly perform the safety assessment of the
product
 Calculate your Margins of Safety using a specific calculation tool
 Be alerted as soon as a regulatory updates have an impact on one or several ingredients contained in your
formulations.

EcoMundo has designed an expert software solution called COSMETIC Factory that supports from A to Z the
creation of your Product Information File.

AUTOMATE THE UPDATES OF YOUR PRODUCT INFORMATION FILES

The PIF update is as important as its creation insofar as the ingredients that are under restriction are detailed into
the Annexes of the Regulation 1223/2009 that is updated on average every three months. Thus, you need to keep
informed of the latest regulatory updates and also make a permanent link between the regulated substances and
the substances and ingredients that are contained in your cosmetic products.

It is therefore very convenient to be able to use one’s own database of products and ingredients that is granted by
COSMETIC Factory, insofar as the computer tool sends you alerts any time a regulatory change impacts your
products portfolio. You can thus be immediately ready to update the corresponding Product Information File(s).