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COSMETIC PRODUCT INFORMATION FILE

When a cosmetic product is placed on the market, its responsible person must keep a product information file (Article 11 of the Cosmetics Regulation). The file must be kept for ten years, starting from the day the last cosmetic product batch was placed on the market. The responsible person must keep the product information file readily accessible in an electronic or other format at their own address, where it must be available to the competent authority of the Member State in which the file is kept.

 

The file must be updated if necessary and contain the following information:
a) A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
b) Cosmetic product safety report (Article 10(1) of the Cosmetics Regulation);
c) A description of the method of manufacturing and a statement on compliance with the good manufacturing practice referred to in Article 8 of the Cosmetics Regulation;
d) Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
e) Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.