Creating a Product Information File (PIF) is a legal requirement for all cosmetic products placed on the market in the European Union, in accordance with Regulation (EC) No 1223/2009. The PIF contains the safety assessment carried out by a qualified expert (toxicologist). This file is updated as needed.
Location of storage
It is kept, easily accessible, in electronic or other format, at the address of the "responsible person," as defined in Regulation (EC) No 1223/2009. The PIF must be available at the address indicated on the product label, i.e., the address of the person responsible for placing the product on the market.
This is generally the manufacturer, the importer, or the authorized representative (if a third party is designated for this responsibility).
This address must be located in one of the Member States of the European Union. This address corresponds to the address of the responsible person as mentioned in Articles 11 and 19 of the Regulation.
Article 11.3 “The responsible person shall ensure that the competent authority of the Member State where the product information file is kept has easy access to this file in electronic or other format, at the address indicated on the labeling.”
Accessibility to authorities
The PIF must be easily accessible in paper or electronic format to the competent authorities of the Member State where the file is kept.
In France, this is the ANSM (National Agency for the Safety of Medicines and Health Products). The authority must be able to consult it without delay upon request.
Retention period
The PIF must be kept for 10 years after the last placing on the market of the batch of the cosmetic product. Even if the product is no longer sold, the file must be archived for this period.
Article 11.1 “When a cosmetic product is placed on the market, the responsible person shall keep a product information file on it. The product information file shall be kept for a period of ten years from the date on which the last batch of the cosmetic product was placed on the market.”
The product information file (PIF) must contain all the information necessary to demonstrate that a cosmetic product is safe, compliant, and correctly manufactured, in accordance with Article 11 of Regulation (EC) No 1223/2009. No specific template is required, but it must contain all the necessary elements. Here is an example of the information to be provided:
ADMINISTRATIVE DATA
- Declaration of opening and operation of the cosmetic product manufacturing and packaging establishment
- Name and address of the individual responsible for placing the product on the European market and for importing it
- Description, function, and category of the cosmetic product
- Reference of the latest formula manufactured, which is the subject of this application.
- History of previous formulas, if applicable
- Justification for notifying the product on the CPNP portal
COSMETIC PRODUCT SAFETY INFORMATION
- Qualitative and quantitative formula of the cosmetic product
- Physicochemical characteristics, impurities, and microbiological quality of substances and mixtures (ingredient combinations)
- Physicochemical characteristics, impurities, and microbiological quality of the cosmetic product
- Stability of the cosmetic product
- Microbiological characteristics of the cosmetic product
- Information concerning the packaging material and packaging
- Toxicological profile of substances and mixtures (ingredient combinations)
- Normal and reasonably foreseeable use of the cosmetic product
- Exposure data for the cosmetic product
- Information on the cosmetic product
- Cosmetovigilance monitoring / Adverse reactions and serious adverse reactions
- Public availability of information on the composition of the cosmetic product and on adverse effects
COSMETIC PRODUCT SAFETY ASSESSMENT
MANUFACTURING METHOD DESCRIPTION
- Declaration of conformity to Good Manufacturing Practices
- Manufacturing formula
- Detailed manufacturing process diagram or detailed operating procedure
- Packaging processes
- Relevant in-process controls
- Main types of equipment, according to batch size
- Coding of raw materials, bulk product, and finished product
- Special precautions for transporting bulk product (if applicable)
- Maximum shelf life between manufacturing and packaging before re-inspection
- Sampling method
- Batch identification methods
CLAIMS & EFFICACY
Evidence of claimed effects