Formal Requirements for the PIF
Product Information Files must be easily accessible to the competent authority. The Product Information File must be retained for ten years—counting from the date the last batch of the cosmetic product was placed on the market. The contents of the Product Information File include, among other things
- Description of the cosmetic product (formulation, manufacturing instructions, specifications, print materials, etc.)
- Safety report
- Description of manufacturing methods; proof of GMP
- Evidence of claimed efficacy (e.g., dermatological tests, if applicable)
- Information on animal testing datan
Safety Report
The core component of the Product Information File is the safety report (Article 10 of the EU Cosmetics Regulation). The safety report summarizes the results of the safety assessment, which includes information on impurities in raw materials, key properties of packaging materials, and systemic exposure. The safety assessment must be performed by a qualified safety assessor.
Diapharm reviews the available documentation from cosmetic manufacturers and, based on that, prepares the Product Information File.
