Cosmetics

On 11 July 2013, the European Union Cosmetics Regulation No. 1223/2009 that sets out detailed requirements about documents that must be produced by companies marketing cosmetic products came into force and replaced the “Cosmetics Directive”. The new documents include the Cosmetic Product Safety Report (CPSR) and an updated version of the Product Information File (PIF).

 According to Article 10 of Regulation EC No 1223/2009, in order to demonstrate that a cosmetic product complies with Article 3 (“Safety”), 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 (CPSR) is set up in accordance with Annex I. 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. The CPSR should demonstrate 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.

The cosmetic product safety report shall, as a minimum, contain the “Cosmetic product safety information” (i.e., quantitative and qualitative composition of the cosmetic product, physical/chemical characteristics and stability of the cosmetic product, microbiological quality, impurities, traces, information about the packaging material, normal and reasonably foreseeable use, exposure to the cosmetic product, exposure to the substance, undesirable effects and serious undesirable effects, toxicological profile of the substances) and the “Cosmetic product safety assessment” (assessment conclusion and labeled warnings and instructions of use).

When a cosmetic product is placed on the market, the responsible person shall keep a product information file (PIF) for it (Article 11). The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. The PIF should contain among others the CPSR referred to in Article 10(1).

We prepare cosmetic product safety reports (CPSR) for the cosmetic products of our clients in accordance with the relevant regulations, such as the German Cosmetics Ordinance (KVO) and the EU Cosmetics Directive (1223/2009).