ADF/PCD 2022
Wednesday, July 10, 2013Sector

Anne Dux: the new Regulation? Nobody's ready!


We have written about it, again and again: the new Cosmetics European Regulation, number 1223/2009, which replaces the current Directive, with many new obligations for companies as well as for the authorities, is fully enforced now, 11 July 2013. CosmeticOBS-L’Observatoire des Cosmétiques has asked Anne Dux, the Director of the Scientific and Regulatory Affairs in the French FEBEA association, whether everything is OK for its implementation. The answer: a clear No!

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“Nobody is ready,” Anne Dux begins with, “and I think the most ready stakeholders are the companies. However, many opinions by the SCCS and texts by the European Commission are still waited for. Further, Member States, including France, have not yet adapted their national laws …”

In fact, many essential points for an effective application of the text are expected.


An innovation in the Regulation: nano-ingredients shall be notified to the European Commission six months prior to their placing on the market, and validated by it, except if listed (thus, allowed) in the Annexes of the text.

“We are still waiting for the SCCS opinions about the main nano-ingredients used in cosmetics: titanium dioxide, zinc oxide, Carbon Black, some silica forms … This, even if the opinion given about zinc oxide dealt only with some qualities of nanos, leading to a request for further clarification by the SCCS for the others.”

This problem is not to be fixed before several months. Even if the opinions were released quite fast, then, an agreement between the Member States is needed, followed by a translation into the 24 languages of the European Union (for a Regulation, all the languages are equally authentic), a …

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