BRUSSELS, Belgium: The Council of the European Union has adopted an amended directive on teeth whitening products. The directive sets out differentiated rules according to the level of hydrogen peroxide in accordance with advice from the European Scientific Committee on Consumer Safety. Tooth whitening or bleaching products containing up to 0.1 per cent hydrogen peroxide will continue to be freely available on the market to consumers. Products containing concentrations higher than 0.1 per cent and up to 6 per cent will only be sold to dentists.

For each cycle of use of the product, the first use will be by a dentist who will have first performed a clinical examination of the patient. The dentist will then provide access to these products for the remainder of the cycle of use. Persons under 18 years of age will not be allowed to use these products, even under the supervision of a dentist. Products containing more than 6 per cent have been banned. The Member States will now have 12 months to implement the Directive into their national legislations.

The previous European Cosmetics Directive only established a maximum authorised concentration of hydrogen peroxide—the main active ingredient in tooth whitening products—at the level of 0.1 per cent. However, in reality tooth whitening products containing levels of hydrogen peroxide higher than the maximum authorised concentration are widely used, the European Commission, which welcomes the adoption, states on its website.

The Council of European Dentists (CED) has stated that it considers the Council decision to be a very important step towards ensuring patient safety and removing any uncertainty as to how and by whom tooth whitening should be performed in the EU. The CED had called repeatedly for appropriate regulation of tooth whitening products at EU level in line with advice from the European Scientific Committee on Consumer Safety, which stressed that higher concentration products can be safe when used following clinical examination and under the supervision of a dentist.

Dr Wolfgang Doneus, CED President said: “This directive is refreshing because it recognises the unique role of the dental practitioner, enabling the bleaching process to be controlled properly and to ensure patient safety”. Dr Stuart Johnston, Chair of CED’s tooth whitening working group, said: “I am pleased to see the protection offered to the public by this long-awaited decision. It is now clear that tooth whitening is the practice of dentistry and it can be safely carried out by the dentist”.