Since July 11, 2013, when Cosmetics Regulation (EC) No. 1223/2009 came into force, a product information file (PIF) must be created for every cosmetic product placed on the market in the European Union. This file is kept, in electronic or paper form, at the address of the responsible person indicated on the packaging of the cosmetic product.
(For more information on the Cosmetics Regulation: https://www.neo-cosmetique.fr/la-reglementation-des-produits-cosmetiques/ )
There is no mandatory template, but the information file must contain the following information and data:
• A description of the cosmetic product:
This must clearly identify the finished product associated with the file and contain the product name and reference number, as well as the name and address of the responsible person. Each product placed on the market is associated with a product information file.
• The cosmetic product safety report:
The safety report must contain at least the data requested in Annex I of the Cosmetics Regulation:
PART A – Information on the safety of the cosmetic product:
- Quantitative and qualitative formula of the cosmetic product
- Physical/chemical characteristics and stability of the cosmetic product
- Microbiological quality
- Impurities, traces, information on packaging material
- Normal and reasonably foreseeable use
- Exposure to the cosmetic product and substances
- Toxicological profile of substances
- Undesirable effects and serious undesirable effects
- Information on the cosmetic product
PART B – Safety assessment of the cosmetic product:
- Conclusion of the assessment
- Warnings and instructions for use appearing on the label
- Reasoning
- References of the person responsible for the assessment and approval of Part B
The safety assessment of the cosmetic product, part B, is carried out by a person holding a degree or other qualification certifying university-level theoretical and practical training in pharmacy, toxicology, or medicine. This person plays a fundamental role, as no cosmetic product can be placed on the market without their approval. They give the final approval for a cosmetic product to be placed on the market.
- A description of the manufacturing method and a declaration of compliance with good manufacturing practices:
The information file must include evidence of compliance with GMP (Good Manufacturing Practices) and the method used for bulk manufacturing and packaging.
(If you would like to know more about manufacturing and packaging at Néo Cosmétique: https://www.neo-cosmetique.fr/production/)
- Evidence of the effect claimed by the cosmetic product:
It is mandatory to gather sufficient data to prove that the effect claimed on the cosmetic product is real. Many cosmetic claims can be made, and various types of evidence can be used to prove the effectiveness of the cosmetic product.
- Data relating to animal testing:
The responsible person must therefore ensure compliance with the obligations relating to:
On the one hand, the finished product: No animal testing on the finished product.
On the other hand, for raw materials: This is based primarily on their thorough knowledge of the raw materials used and the information provided by suppliers. Suppliers must indicate the nature of the tests carried out and their results, the date of the animal tests, and whether they were carried out under regulations other than the Cosmetics Regulation.
- Other information:
Proof of notification on the CPNP.
The cosmetovigilance procedure makes it possible to identify adverse effects in humans related to the use of cosmetics. The responsible person shall immediately notify the serious adverse reaction (SAR) and the measures taken to remedy it to the competent authority of the Member State where the SAR was observed.
At Néo Cosmétique, we can prepare the DIPs for your products.
For more information: contact: info@neo-cosmetique.fr
Sources:
Documents:
COSMED: Practical guide: The product information file
REGULATION (EC) No. 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of November 30, 2009 on cosmetic products.