Documents for marketing of cosmetic products
The Product Information File (PIF) is a mandatory document for the marketing of cosmetic products. Regulation (EC) Nº 1223/2009 tells us that we must have a PIF for each cosmetic product marketed, and also maintain it for up to ten years after the last batch of said product has been placed on the market.
This filed 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 the event that effects are claimed by the cosmetic product, evidence to prove these.
- Information about animal experimentation.
- Safety report.
- Part A: Information about Safety
- Part B: Safety Assessment
This safety report is divided into two parts. Part A contains the information on the safety of the cosmetic product, while Part B is the safety assessment of the cosmetic product. This safety assessment (Part B) must be carried out by a person who holds a diploma or other recognised official qualification after the completion of a university degree in theoretical and practical studies in pharmacy, toxicology, medicine or a similar discipline, or studies recognised as equivalent by a Member State.
Subsequently, in accordance with article 13 of Regulation (EC) Nº 1223/2009, before launching a product on the market, we have to notify the European Cosmetic Products Notification Portal (CPNP).
In this notification to the European portal, all the key points of the product are collected, such as the name, the ingredients of mandatory declaration or if the product contains CMR substances or nano-materials. Additionally, this notification is attached to the PIF for the correct identification of the cosmetic product.
Azierta’s experts in cosmetic products can provide personalised advice on your products, answer any questions you may have and help to guarantee the success of your project.