The safety-in-use of 10% carbamide peroxide (Opalescence) for bleaching teeth under the supervision of a dentist

Fears that the dentist-supervised use of a product that contains carbamide peroxide and that emits hydrogen peroxide may not be safe from the viewpoin ts of toxicity and cancer risk were engendered by unrealistic animal tests. These fears prompted the UK Government Departments of Trade and industry ( DTI) and of Health (DOH) to try ta prohibit the marketing of Opalescence (m anufactured by Ultradent Inc.). Faced with the fact that Opalescence had al ready been awarded a CE mark under the EC Medical Devices Directive, the DT I and DOH attempted to bring about its prohibition by reclassifying Opalesc ence as falling under the EC Cosmetics Directive, according to which the ma rketing of products containing more than 0.1% hydrogen peroxide is not perm itted.