An article and an annex of the Cosmetics Regulation 1223/2009 display the principles of requirements in terms of the assessment of the safety of cosmetic products. The CPSR (Cosmetic Product Safety Report) is thus rigorously codified and must be prepared (and updated) in accordance with these provisions.
Article 10 of the Regulation 1223/2009 is dedicated to the safety assessment. It states that:
“1. 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.
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.”
Article 11.2.b adds that “the cosmetic product safety report referred to in Article 10(1) shall be contained in the PIF, the Product Information File.”
Its content is detailed in the Annex I, and comes as underneath:
The cosmetic product safety report shall, as a minimum, contain the following:
PART A – Cosmetic product safety information
1. Quantitative and qualitative composition of …
