Expertise Réglementaire et Toxicologique
Regulatory and Toxicological Expertise
Our aim is to assist you in the creation of innovative and effective products which are in line with european regulation, and safe for both human health and the environment.
The cosmetic Product Information File (PIF)
When a product is placed on the market, the responsible person shall keep a product information file (PIF) for a period of ten years following the date on which the cosmetic product has been placed on the market.
The PIF is a file required by the regulation (EC) n°1223/2009 which in particular allows to summarize the toxicological risks of the various compounds (Part A) and to assess the safety of the cosmetic product for human health (Part B) :
Information (Part A of the PIF)
- Quantitative and qualitative formula
- Physical/chemical characteristics and stability
- Microbiological quality
- Impurities, traces and packaging information
- Normal and reasonably foreseeable use
- Exposure to cosmetic product
- Exposure to substances
- Toxicological profile of the substances
- Undesirable effects and serious undesirable effects
- Information on the cosmetic product
Safety assessment (Part B of the PIF)
- Conclusion from the assessment
- Label warnings and instructions of use
- Reasoning
- Details of the person responsible for the assessment
Drafting of the PIF
ERTC drafts the cosmetic product safety report which is validated by a qualified expert in toxicology. We also carry out audits of the PIF.
The collection of the required informations for the drafting of the PIF can be made no matter where your partners are located around the world. ERTC has significant experience, in particular in Europe and America. We strive to make your files compliant within the required time limits.
ERTC collects and analyzes the data of your cosmetic products (part A of the PIF), evaluates their impact on human health (part B of the PIF) and carries out the safety report.
ERTC offers numerous solutions customized to your requirements, whether you don't have the required knowledge or don't have the required qualifications to legally place your products on the market.
Contact us in order to know the terms of our services.