Cosmetics Regulation EC 1223/2009

On the 30th of November 2009, the new European Cosmetic Regulation, EC 1223/2009, was published in the official journal of the European Commission, hence putting it into force. The EC 1223/2009 is aimed at replacing the current Cosmetics Directive 76/768/EEC.

Most of the provisions of this new regulation are expected to be applicable under specific application dates such as July 11th, 2013 or July 11th 2012 when mentioning the new database aimed at European Notifications.

The general objectives of this New Regulation are to cover the ubiquitous gaps from the current Directive, which lead to the several amendments in the past, and to once again, harmonize the European Market.

A Regulation, by definition, does not allow transposition into national legislations. As a consequence, a regulation has the power of superseding all national laws, preventing Member States from adjusting or adapting regulations for their own purposes. Hence, the main achievement coming with the Cosmetic Regulation 1223/2009/EC is bringing the EU cosmetic market to even greater uniformity.

The Cosmetic Regulation 1223/2009/EC aims, same as the Cosmetic Directive 76/768/EEC, at the free movement of cosmetic products within the EEA market but also and no less important at ensuring the safety of the users of cosmetic products in Europe. Cosmetics free to circulate within the market must acquire evidence to their conformity with the stipulated requirements in their respective Product Information File, thus ensuring a high level of protection of human health.

The novelty comes from assigning a greater responsibility to the EU Responsible Person (RP) by clearly indicating that Cosmetic products may be placed on the EU market only if an EU Responsible Person (RP) has been designated towards them;

- “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.4).

The Responsible Person is to ensure the Compliance with the relevant obligations set out in the Regulation: safety, Good Manufacturing Practices (GMP), Product Information File (PIF), composition-restricted substances, nano-materials, Labelling, Claims, serious undesirable effects (SUE) ,Animal Testing and EU Pre-Market Notifications of Cosmetic Products;

- “Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).

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