New Directive Regarding Teeth Whitening Products

Published 19 Feb 2012

The European Commission has recently issued a new Directive (Council Directive 2011/84/EU) regarding tooth whitening products, under which these are classified as cosmetics products. These were formerly classified as medical devices under the Medical Device Directive (MDD 93/42/EEC). The new Directive also makes reference to restrictions and conditions of use of hydrogen peroxide in teeth bleaching products.

According to the new Directive, only dental bleaching products with less than 0.1% hydrogen peroxide may be sold on the open market in the European Union. Furthermore, products having between 0.1%-6% hydrogen peroxide content may only be sold to dentists, while all other tooth whitening products with more than 6% hydrogen peroxide are forbidden in the European Union, as an additional measure on product safety for the European consumers.

Although cosmetics products do not need to bare the CE marking, they still need to fully comply with the regulations of the NEW Cosmetic Regulation EC 1223/2009 and the repealing Cosmetic Directive 76/768/EEC.

For more information, please read our PUBLICATION or contact us!

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