Article 11 of the Cosmetic Regulations precisely defines the information that must be held in the PIF. Among them: the Cosmetic Product Safety Report (CPSR).
Under Article 11.2.b, the PIF must contain “the cosmetic product safety report referred to in Article 10.1.”
Article 10.1 states: “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 describes the structure and content for the safety assessment of a cosmetic product placed on the market:
“The Responsible Person shall ensure that:
(a) The intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment
(b) An appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources
(c) The cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
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3. Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of …
