The new law increases the percentage of hydrogen peroxide allowed in tooth whitening or bleaching products to 6%, subject to conditions, including first use by a dental practitioner or under their direct supervision.
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, a percentage expressed in terms of carbamide peroxide content will release one third of that level of hydrogen peroxide. So, the commonly used products containing 16% carbamide peroxide would be permitted under the revised regulations as they would be releasing less than 6% hydrogen peroxide.
"Securing this change has been a long, frustrating process, and the time it has taken to achieve has been detrimental because the number of cowboy bleaching outlets has increased. Although overdue, this is a positive step that will, I hope, mean a new era for patient safety. To make that a reality, Trading Standards will need to wield its new power against non-dental professionals effectively, and the GDC will need to maintain its efforts to prosecute such individuals. Dentists can help by reporting breaches to both bodies. This change is not the end of the road of course; we must now re-focus on the issues of the use of higher strength products and whitening for patients aged under 18. But this is a significant step, and it should be recognised as such" Dr Stuart Johnston
Member of the BDA Principal Executive Committee and chair of the Council of European Dentists Tooth Whitening Products Working Group
Only for you
Under the regulations, only dental practitioners can purchase tooth-whitening products containing or releasing up to 6% hydrogen peroxide. This may lead to dental professionals being asked to provide tooth-whitening products to individuals who are not under their care. It could be construed as a breach of the regulations if a dentist (or a practice) sold tooth-whitening products containing or releasing more than 0.1% hydrogen peroxide to someone other than a patient undergoing tooth-whitening treatment.
There is a risk that a patient who has not had appropriate instruction on loading a home tooth-whitening tray with the tooth-whitening product and who has not received instruction on fitting the tray could be at risk of swallowing excess material. The requirement that the first use of each cycle is by a dental practitioner (or under their direct supervision), helps to allay these concerns.
The regulations do not set out how long the trays must remain in the mouth for the first use. This will be a clinical judgement. Make sure you keep a detailed contemporaneous record of the instructions given at the first appointment.
The requirement that the first use of each cycle is by the dentist (or under their direct supervision) means that tooth-whitening products containing or releasing more than 0.1% hydrogen peroxide cannot be sold to patients at reception or by post.
The regulations do not set out who can provide tooth whitening under the dentist’s direct supervision. However, the GDC’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. So, hygienists and therapists can administer the first use of tooth whitening, if an equivalent level of safety is ensured.
Trained and competent
The regulations do set out that the treatment is under the ‘direct supervision’ of the dentist but do not define this. In Maintaining Standards, the GDC used the term ‘direct personal supervision’ to indicate when the dentist was to be on the premises.
After the first in-surgery application, the patient can be provided with the tooth-whitening product for home use. If the patient requires additional product for that course of treatment, the product should be dispensed by the dentist or hygienist/therapist.
The change in the law means dental practices can advertise tooth-whitening procedures using products containing or releasing up to 6% hydrogen peroxide. However, some ‘power bleaching’ and other in-surgery bleaching techniques rely on the use of products that contain or release more than the permitted 6% levels of hydrogen peroxide. It would be unwise to state, suggest or imply that such techniques are being offered and information placed in the public domain, such as practice websites, should take great care to avoid any words or images that would suggest the availability of these services.
Medical devices directive
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 regulations and the EU Directive. This means it is not possible to circumvent the regulations by using a product with a CE mark.
The regulations and EU Directive state the product should not be used on patients aged under 18. This means it is only possible to test products containing or releasing up to 0.1% hydrogen peroxide on patients under 18. It has been suggested that tooth-whitening products could be classified as a medical devices and, as such, The Cosmetic Products (Safety) (Amendment) Regulations 2012 do not apply. However, even where a product is marked with a CE mark, the regulations do apply. This may create a dilemma for dentists who consider it would be in the best interests of a patient under 18 years of age to provide tooth whitening to an isolated non-vital tooth. If a dentist wishes to provide treatment, they are advised to have a discussion with the patient/parents and document all consultations. In providing treatment in breach of the regulations, dental professionals leave themselves vulnerable to a complaint.
Breach of the regulations
The Consumer Protection Act 1987 imposes a criminal liability on those breaching safety requirements, which include a breach of the Cosmetic Products (Safety) (Amendment) Regulations 2012. The maximum penalty for breaching the regulations is a sentence of imprisonment not exceeding six months. The local authority has a duty to enforce safety provisions within its area. A Trading Standards officer has a right of entry into a dental practice (at a reasonable hour and on production of credentials, if asked) under Section 29 (2) of the Consumer Protection Act 1987.
Reporting of adverse effects
The EU, as part of the agreement to change the Directive, demanded there should be reporting of adverse effects. If dental professionals are treating a patient who experiences an adverse effect, they are advised to keep a record of this.
Indemnity and assistance
The proposed relaxation in the regulations to permit the use of higher strength products will significantly improve the unsatisfactory ethical and legal dilemmas that have been faced by dental practitioners, but some unwelcome anomalies remain and Dental Protection will make representations in this regard.
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.
Members of Dental Protection are welcome to discuss this or any other issues. Call the helpline (0845 609 4000) or email [email protected]