New Directive Regarding Teeth Whitening Products

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.

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.

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