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How to create your cosmetic Product Information File?

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:

NB: it is possible to automate the creation and updates of the Product Information File thanks to specialized software solutions.


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 qualitative formula of the cosmetic product

You have to provide:

  • 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 properties and data on product’s stability

You have to provide:

  • The physico-chemical specifications of the raw materials and of the finished product
  • Information on product’s stability in predictable storage conditions

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 quality

You have to provide:

  • 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, and information on the packaging material

You have to provide:

  • 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

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 predictable reasoning

The purpose of this part is to enable the safety assessor to determine a relevant 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 cosmetic product

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

You have to gather data from:

  • The Responsible Person
  • The regulatory department
  • The formulator
  • 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 substances

The purpose of this part is to calculate the exposure of the consumer for each 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 profile of the substances

This part aims at establishing the toxicological profile of the ingredients contained in 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 and serious adverse effects

The purpose of this part is to collect all relevant data on adverse effects that may be 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 number of units of product placed on the market, etc.).

10) Information on the cosmetic product

You have to gather relevant and complementary information that complete the 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
illustration tests animaux

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.
logo cosmetic factory

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).


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Do not hesitate to contact our expert Sylvain De Backer by phone on +33 (0)1 83 64 20 54 for Europe and for North America please dial + 1 (778) 231-1607 or send an email at [email protected].



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