July 28, 2019

The importing and distribution of cosmetic products in the EU is regulated by the Regulation (EC) No 1223/2009 of the European Parliament and of the council of 30 November 2009 on cosmetic products (hereinafter – the Regulation). Therefore for a cosmetic product to be made available on the EU market it is required to be in compliance with the requirements laid down in the Regulation.

According to the Regulation, 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 safety of the product is evidenced with a respective report after a safety assessment has been carried out. The safety report shall contain information on the quantitative and qualitative composition of the product, undesirable effects, foreseeable use and other information specified in the Annex I of the Regulation.

The compliance with the obligations set out in the Regulation shall be ensured by the “responsible person”. A responsible person is a legal or natural person established in the EU which is designated as a responsible person for the product placed on the EU market. For imported cosmetics a responsible person is the importer or the importer’s designated person who shall accept in writing. The responsible person shall keep all the required documentation listed in the Regulation and also a product information file.

A product information file shall contain information on the product such as, for instance, description of the method of manufacturing, description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product and other data referred to in Article 11 of the Regulation. It must contain also the cosmetic product safety report referred to above. 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.

Also, prior to placing the cosmetic product on the market, the responsible person needs to submit to the Commission, by electronic means, information about the responsible person, name of the product, country of origin, etc. Information should be submitted using CPNP – Cosmetic Products Notification Portal. The Commission will then make the information about the new cosmetic product available electronically to all competent authorities. Where any of the information changes, the responsible person or the distributor shall provide an update without delay.