Teeth Whitening Legislation

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Apr 15, 2013
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The law relating to teeth whitening changed on 31 October 2012. The new law increases the percentage of hydrogen peroxide allowed in tooth whitening or bleaching products to 6%, subject to conditions which include first use by a dental practitioner or under their direct supervision. Until 31 October the previous law remained in force and this position statement relates to treatment provided after 31 October 2012.

Dental Protection welcomes the change in the law, which will allow practitioners to act in their patients’ best interests whilst remaining within the law. The legislation relating to tooth whitening is laid down by the European Union and the change to the law follows many years of lobbying by dental groups. The new law draws a clear line between the products that can legally be used for tooth whitening by dentists or under their direct supervision and the products that can be purchased by non-dental professionals.

The change follows as an amendment to the EU Directive 76/768/EEC concerning cosmetic products. The amending Council Directive 2011/84/EU was published in September 2011 requiring the UK Government to amend the law. The Cosmetic Products (Safety) (Amendment) Regulations 2012 (The ‘Regulations’) amend the previous regulations relating to tooth whitening.

The new Regulations allow the use of hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide to be used for tooth whitening. The maximum concentration that may be used for tooth whitening under the Regulations is 6% present or released. In very broad terms and as a general guide, a percentage expressed in terms of carbamide peroxide content will release one third of that level of hydrogen peroxide. Thus, the commonly used products containing 16% carbamide peroxide would be permitted under the revised Regulations because they would normally be releasing less than 6% hydrogen peroxide.

The Regulations set out that products containing or releasing up to 6% hydrogen peroxide can be used, subject to conditions:

To only be sold to dental practitioners
For each cycle of use, first use by a dental practitioner; or
Under their direct supervision, if an equivalent level of safety is to be ensured.
Afterwards to be provided to the consumer to complete the cycle of use.
Not to be used on a person under 18 years of age.
It is appropriate for the dentist to carry out an examination before embarking on a course of tooth whitening, to determine whether tooth whitening is a suitable treatment option for the patient. A detailed contemporaneous record should be kept of this examination, detailing the consent process including your discussion with the patient about the risks and benefits of the treatment.
 

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