The Cosmetic Directive 76/768/EEC was created in order to allow a free circulation of cosmetic products within the European Union. The directive provides rules and regulations with which manufacturers must comply in order to sell their cosmetic products within the 27 EU Member States, EEA and EFTA countries.
In accordance with the Directive 76/768/EEC every manufacturer must perform a Safety Assessment for each finished cosmetic product before it is placed on the EU market. Safety Assessment stands for the assessment of the safety for human health of the finished product. The process usually involves researching the ingredients for hazardous properties, determining safe levels according to industry benchmarks and regulatory limits, estimation of exposures according to EU guidance, and providing margins of safety where appropriate. It will include information such as general toxicological profile of the ingredients, their chemical structure and their level of exposure.
In order to comply with the Cosmetic Directive, the Safety Assessment of products should be performed by a person who holds a diploma as defined in Article 1 of Directive 89/48/EEC in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline; Moreover it shall be carried out in accordance with the principle of good laboratory practice laid down in Council Directive 87/18/EEC.
The Safety Assessment Report, as a key document for marketing cosmetics in the EU, needs to be a part of a package of information, which the non-EU Manufacturer needs to send to his appointed European Authorized Representative (E.A.R.) so that those files can be readily available for inspection by the Competent Authorities.
Note: Non-EU Manufacturers of cosmetic products must appoint a European Authorized Representative established within the European Community, to act as the “responsible one placing the product on the market” and to keep accessible for the relevant Competent Authorities, all the pertinent documentation, including the Safety Assessment Reports.
Once the Safety Assessment Report is done, the E.A.R. on behalf of the Manufacturer can proceed with the actual notification/registration of the cosmetic product to the relevant Member State Competent Authorities.
Note: Non-European Manufacturers are advised to appoint a European Authorized Representative in order to ensure compliance with EU Directives at all times.