Each cosmetic product marketed in the EU must have a PIF (Article 11 of the EU Cosmetics Regulation). In short, it is a collection of documents that shows the characteristics of a cosmetic product and demonstrates its safety and efficacy according to the EU regulatory requirements.
Elements of the Product Information File
More in detail, the PIF shall include:
- The description of the product
- The cosmetic product safety report (CPSR)
- A proof of compliance with Good Manufacturing Practices (GMP)
- The method of manufacture
- Data on animal testing
- And more
The CPSR consists of two sections: Part A – Cosmetic Product Safety Information and Part B – Safety Assessment Report (SAR).
Part A – Cosmetic Product Safety Information covers, among others:
- The product formula
- Raw materials (ingredients) specifications
- Lab testing results
- Details on impurities, traces, and packaging
- The intended use and target group
- The exposure to the finished cosmetic product and its ingredients
- Data on undesirable and serious undesirable effects
On the other hand, Part B – Safety Assessment Report by a qualified Safety Assessor is the toxicological evaluation of the cosmetic product that confirms it is safe for use. Hence, it comprises conclusions, reasoning, warnings to be labelled, and Safety Assessor credentials.
What you Need to Know
- Each and every cosmetic product must have a PIF
- The Responsible Person keeps the PIF for 10 years after the last batch of the product was placed on the market
- Competent Authorities can access the PIF upon request; therefore, it must be in a language they easily understood
- The PIF must be updated when necessary (changes in the product or the law)
What We Can Do For You
A complete and compliant PIF is an essential step towards selling your cosmetic products on the EU market. Thus, we have created a PIF compilation service: we will review your file to ensure it meets the EU requirements and will help you obtain the missing documents.
Are you afraid not to have all these documents? Do not worry, we are here to assist you. Usually, the producer of the finished product has these documents, and we can act as a contact point. Moreover, we will provide you with templates to fill in.
Do you need Lab Testing and the Safety Assessment Report? Check our dedicated services: we will help you obtain a SAR and the mandatory lab testing for your products.
Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
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