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Monday, November 7, 2011Regulation

Cosmetics Regulation: Notification

©L'Observatoire des Cosmétiques

Notifying cosmetic products to the European Commission is one of the major innovations of the Cosmetics Regulation (Regulation CE N° 1223/2009), implemented since July 11, 2013. This notification is, for companies, a heavy burden that should be started up as soon as possible.

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The Directive on Cosmetic Products did not foresee a harmonized notification in Europe, but required two steps at the national level in each Member State:
• a notification of products to the competent authority (in France, the three Poison Centers in Lyon, Marseille and Paris) "for purposes of prompt and appropriate medical treatment in the event of difficulties". This information is used only for "the purposes of such treatment". (article 7.3),
• a declaration of establishment to the competent authority (in France, the Afssaps), that is the address of the place of manufacture or of initial importation of the cosmetic products before the latter are placed on the market (article 7 bis. 4).

In its Article 13, the Cosmetics Regulation make it mandatory that any product, new or already marketed, be notified for the entire European Union, before being placed on the market. This is a simplified and centralized electronic procedure.
This notification replaces the notification to the Poison Centers, but not the declaration of establishment that France wants to retain (as it is allowed to).

The document allows for an 18-month transition period: from January 11, 2012, to July 11, 2013, notification is optional. Then, it is mandatory for …

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