Documents for the marketing of cosmetic products

The Product Information File (PIF) is a mandatory document for the marketing of cosmetic products. Regulation (EC) No. 1223/2009 states that we must have an PIF for each cosmetic product marketed, and additionally maintain it for up to ten years after the last batch of said product has been placed on the market.

This file consists of:

• A description of the cosmetic product establishing the link with the PIF.
• Description of the manufacturing method, and a declaration of conformity with Good Manufacturing Practices.
• In case effects on the cosmetic product are being claimed, evidence to prove it.
• Information on animal testing
• Safety report
  • Part A: Information about Safety
  • Part B: Safety Assessment

This safety report is divided into two parts, Part A containing the Cosmetic Product Safety Information, and Part B, concerning the Cosmetic Product Safety Assessment. This safety assessment or part B must be carried out by a person in possession of a diploma, or other officially recognized qualification, following the completion of a university course of theoretical and practical studies in pharmacy, toxicology, medicine or similar discipline, also considering studies recognized as equivalent by a Member State.

Subsequently, according to Article 13 of Regulation (EC) No. 1223/2009, before launching a product on the market, we have to make a notification to the European Cosmetic Products Portal (CPNP).

In this notification to the European portal, all the data related to the exact identification of the product are collected, such as the name, the ingredients of compulsory declaration, or if the product contains CMR substances (Carcinogenic, Mutagenic and/or Reprotoxic) or nanomaterials. Additionally, it is common to attach this notification to the PIF for correct identification of the cosmetic product.

In Azierta, we have experts with extensive experience in cosmetic products, who can offer personalized advice for your cosmetic business, resolving any questions, and collaborating in detail, with the success of your project.

Contact us!