NEW EU Directive Regarding Tooth Whitening Products - NEW!

This article comes as an update to the article “Debate on Tooth Whitening Products is Over” published in March 2010 which informed about the European Commission decision that tooth whitening products are classified as cosmetic products under Annex III, Part I of the Cosmetics Directive, 76/768/EEC.

The European Commission announced on the 20th of September 2011 that it welcomes the adoption of a new Directive on tooth whitening products!

Upon advice from the European Scientific Committee on Consumer Safety, the following guidelines have been adopted by the Commission and are to be implemented into a new Directive to be transposed into national legislation by each of the EU member states within 12 months.

• Only tooth whitening products with less than 0.1% hydrogen peroxide may be sold on the open market in the European Union.
• Products containing between 0.1%-6% hydrogen peroxide content may only be sold to dentists, and only under the following conditions:
•   The first use of each cycle of the product must be completed by a dentist as a clinical examination, after which use may be continued by the patient.
•   Use of these products by clients under 18 years of age is not permitted, even under supervision of a dentist.
• All tooth whitening products with hydrogen peroxide levels higher than 6% are banned in the European Union.

The new directive strengthens the Commission stance on Hydrogen Peroxide levels for the safety and health of all consumers in the European Union.
Cosmetic products may NOT bare the CE marking; they need to comply with the applicable regulation populated in the European Cosmetics Directive 76/768/EEC and the NEW Cosmetic Regulation EC 1223/2009.

To read more about the Cosmetic Directive & Regulation, Contact Us;

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