The EU law relating to tooth whitening changed on 31 October 2012, effectively increasing the percentage of Hydrogen Peroxide contained or released in tooth whitening or bleaching products to 6%. Patients must be 18 years of age or more.
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 professional tooth whitening.
The 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 professional tooth whitening. The maximum concentration that may be used is 6% present or released.
Products containing 16% Carbamide Peroxide are permitted because they would normally be releasing less than 6% Hydrogen Peroxide.
Only dental practitioners can purchase tooth whitening products containing or releasing more than 0.1% Hydrogen Peroxide up to 6% Hydrogen Peroxide.
Products containing or releasing up to 6% hydrogen peroxide may be used, subject to the following conditions:
Firstly, carry out an examination
This is to ensure that whitening treatment is suitable for the individual patient. Record a detailed contemporaneous record of the examination and the instructions given to the patient at the first appointment.
Hygienists may provide treatment with the following conditions
The General Dental Council’s Scope of Practice sets out that hygienists and therapists can provide tooth whitening under the prescription of a dentist, if they are trained and competent. Thus hygienists and therapists can administer the first use of professional tooth whitening, if an appropriate level of safety is ensured. Dental Protection advises members that it is appropriate that the dentist is on the premises when the first use of the tooth whitening product is provided to the patient by a therapist or hygienist.
The dentist has a duty to monitor the provision of top-up gels and ensure this is in accordance with the patient’s treatment plan.
Dental practices are permitted to advertise professional tooth whitening procedures using products containing or releasing up to 6% Hydrogen Peroxide.
Medical Devices Directive
We are aware that some manufacturers in Europe are marketing tooth whitening products containing or releasing more than 6% Hydrogen Peroxide as medical devices. Even if a tooth whitening product is marketed as a medical device, it falls within the Cosmetic Products (Safety) Regulations 2008, the 2012 Regulations. This means it is not possible to circumvent the Regulations by using a product that has a CE mark.
The Regulations and EU Directive specifically state the product must not be used on patients aged under 18. If a member wishes to provide treatment to a child in breach of the Regulations, they are advised to contact Dental Protection for advice.
Breach of the Regulations
The maximum penalty for breaching the Regulations is a sentence of imprisonment not exceeding six months.
Keeping a record
If any patient experiences an adverse effect, dentists are advised to keep a record of this.