In order to comply with Regulation (EC) No 1223/2009, a Product Information File (PIF) must be completed for all Cosmetics intended to be marketed within the EU.
As mentioned in Article 10 (1), one of the main elements of the Product Information File (PIF) is the Cosmetic Product Safety Report (CPSR).
“In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.- Article 10 (1) of Regulation (EC) No 1223/2009.”
The CPSR is comprised of two parts; Part A: Cosmetic Product Safety Information and Part B: Cosmetic Product Safety Assessment.
In accordance with Annex I of Regulation (EC) No 1223/2009, Part A of the CPSR is intended to collect the necessary data to justify the safety of the cosmetic product. As a minimum, it is required to contain the following:
• Quantitative and qualitative composition
• Physical/chemical characteristics and stability
• Microbial quality
• Impurities, traces in the product and information on the packaging material
• Normal and foreseeable use
• Exposure to the product
• Exposure to the ingredients
• Toxicological profile of the ingredients
• Undesirable effects of the product
As per Article 3, Part B of the CPSR is the actual evaluation of the safety of the cosmetic product and contains the following:
- A safety assessor’s expert opinion as to why the product is safe to be placed on the market.
- Warning and instructions for use on the label
- References of the assessor and approval of Part B
We free provide Part A documents, and provide Part B documents will have cost.