What are the documents required before placing the product on the EU market?

What are the documents required before placing the product on the EU market?

Author:Kasey Beauty Time:2019-10-21

One of the major requirements specified in EC No. 1223/2009 is that the company should be responsible in keeping a product information file (PIF) for each product placed on the EU market at a single address within the EU that is indicated on the label. As a whole, the PIF is a compilation of the following information:

• Description of the product which enables the PIF to be clearly attributed to the cosmetic product such as the exact product name consistent with the product name used when notifying the product or an internal reference that uniquely identifies the product and formulation
Method of manufacture and a certificate or a statement on compliance with good manufacturing practice (GMP) standard ISO 22716
• Claims substantiation, if applicable
• Labeling and photograph of the corresponding packaging
• The cosmetic product safety report (CPSR)
The CPSR is the most important part of the PIF and is composed of two parts: cosmetic product safety information and cosmetic product safety assessment. The main documents to be included in the cosmetic product safety information are:
• Qualitative and quantitative composition of the product with INCI ingredient names, CAS and EINECS/ELINCS numbers, ingredient functions and concentrations of each raw material
• Physical, chemical and microbiological specifications of the raw materials and their toxicological profiles
• Physical, chemical and microbiological specifications of the finished product and test reports (e.g., stability test, challenge test, etc.)
• Packaging specifications
• Exposure to the product and the substances
• Intended use of the product
Any data on undesirable effects from using the cosmetic product

This product dossier shall be readily accessible and available in a Language easily understood by the competent regulatory authority of the Member State where the responsible person for this product is based. It shall be kept for a period of ten (10) years following the date on which the last batch of the cosmetic product was placed on the market.

What are the documents required before placing the product on the EU market?

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