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Wednesday, November 27, 2013Congresses

Cosmetics Regulation: the Annex I Guidelines

© CosmeticOBS-L'Observatoire des Cosmétiques

Their publication was expected as early as 2012, and in any case before the Cosmetics Regulation came into force on 11 July 2013. The guidelines on Annex I to Regulation 1223/2009, dedicated to the Cosmetic Product Safety Report, finally arrived on 25 November 2013. A text that Giulia Ciarlo, from the European DG-Sanco, explained at the 11th edition of the Cosmetic Valley Perfumes and Cosmetics Congress.

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Annex I was a major novelty of Cosmetics Regulation 1223/2009, compared to the Directive it replaced. It describes the content of the CPSR, the Cosmetic Product Safety Report, which must appear in the Product Information File (DIP), introducing many obligations for the Responsible Person, particularly in terms of the data to be collected.

To be exhaustive, the list of information to be collected however raised many questions in cosmetic companies. Clarification was awaited, in accordance with Article 10 which states that “the Commission, in close cooperation with all interested parties, shall adopt appropriate guidelines allowing companies, in particular small and medium-sized enterprises, to meet the requirements laid down in Annex I.”

It is therefore these Guidelines that have finally been published. A text that Giulia Ciarlo, from the Health Technologies and Cosmetics Unit of the European DG-Sanco (Health and Consumers Directorate-General), put into context and explained at the Chartres congress.

Regulation 1223/2009 and security

Giulia Ciarlo thus began with a reminder of the fundamentals, returning first of all to the objectives of the Cosmetic Regulations:
• To ensure a high level of health protection
• Ensuring the functioning of the internal market

Some principles concerning the safety of cosmetic products: …

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