Effective from 31st October 2012, amendments were made to the 2008 Cosmetic Products (Safety) Regulations which changed the landscape of UK teeth whitening treatments, with regards to who can conduct teeth whitening treatment and the legal limits to the amount of the concentration of hydrogen peroxide (H2O2) that can be released in products sold off-the-shelf and by qualified dentists.
Products releasing less than 0.1% H2O2 contents of hydrogen peroxide are deemed safe for sale to all ages
EU Directive 2011/84 EU (which is an amendment to Directive 76/768/EEC) has set the safe level of hydrogen peroxide content to be sold directly to consumers, without the need to purchase through a dentist, as less than 0.1%.
This means products sold off the shelf in shops such as toothpastes, mouth rinses and teeth whitening solutions with less than 0.1% hydrogen peroxide contents are deemed safe to use for all ages.
Whiteners or bleaches containing between 0.1% and 6% H2O2 may only be sold through registered, qualified dentists
Higher concentrations of hydrogen peroxide may only be sold to consumers through GDC registered, qualified dentists on the basis that they are medically advised that the patient’s oral situation is safe.
However, teeth whitening treatment that cannot be sold off-the-shelf should not be made available to anyone under the age of 18 except in situations where it is needed to prevent and treat disease.
There are also guidelines which must be legally followed for teeth whitening treatments of these H2O2 concentrations:
- Appropriate clinical examination to determine the possibility of risk factors or other oral pathology issues
- Patients should not be exposed to H2O2 for prolonged periods, the means to ensure that frequency and duration of application is limited should be considered
- Treatments with more than 0.1% H2O2 contents are only to be made available to consumers through qualified dental professionals, with the intention of a clinical examination completed beforehand
For each cycle of use the first application may only be administered in the direct supervision of dental practitioners if there is an appropriate level of safety. After the first application, patients may then complete the cycle of use without supervision.
H2O2 concentrations of more than 6% may only be used for disease prevention and treatment
Products containing this concentration or higher are prohibited from use unless it is required for disease prevention or treatment, this is the case for patients of all ages.
Breaching Cosmetic Product Regulations is a criminal offence
Under The Cosmetic Products (Safety) Regulations 2008, breaching hydrogen peroxide concentration limits is a criminal offence, the prosecutions for which are brought together by Trading Standards.
Dental practices offering teeth whitening are also subject to GDC registrant standards (see Standard 1.8) that requires members to have provision for patient claims in the form of appropriate indemnities.