Article 3 of EU Regulation 1223/2009 on cosmetic products (‘the Regulation’)1 states that: “a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use”.
As stated in Article 10 of the Regulation, in order to ensure compliance with Article 3, the Responsible Person (RP) must, before placing the product on the market, ensure that it 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 Cosmetic Product Safety Report (CPSR) – Part A
The structure and contents of the CPSR are described in Annex I of the Regulation. Part A of the CPSR contains the minimum information on the cosmetic product that must be used to support the safety assessment conclusion given in Part B. Very importantly, in addition to this minimum information, the safety assessor may use any additional relevant data. On the other hand, if any of the minimum information is not considered necessary (e.g. considering the product type), the absence of these data must be clearly justified.
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