The 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%, subject to conditions which include first use by a dental practitioner or under their direct supervision and that the patient is 18 years of age or over.
The legislation relating to tooth whitening is laid down by the European Union and 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 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 is 6% present or released. In broad terms, 10% carbamide peroxide content would yield a maximum of 3.6% hydrogen peroxide. Thus, the commonly used products containing 16% carbamide peroxide are permitted because they would normally be releasing less than 6% hydrogen peroxide.
Conditions
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 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
The dentist should carry out an examination before embarking on a course of tooth whitening to determine whether it is a suitable treatment option. 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.
To only be sold to dental practitioners
Only dental practitioners can purchase tooth whitening products containing or releasing more than 0.1% hydrogen peroxide up to 6% hydrogen peroxide. This may lead to members 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 a cycle of tooth whitening treatment.
For each cycle of use, first use by a dental practitioner
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 in the mouth 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.
Dental Protection advises members to make a detailed contemporaneous record of the examination and the instructions given to the patient 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 that 0.1% hydrogen peroxide cannot be sold to patients at reception or by post. Members may wish to advise their patients of the risk of purchasing the products from an unregulated source.
Under direct supervision
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 tooth whitening, if an appropriate level of safety is ensured.
Trained and competent
Only dentists, therapists and hygienists can provide tooth whitening. Therapists and hygienists must have a prescription from the dentist before providing this treatment.
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. If a member is issuing a prescription to a hygienist or a therapist, they need to be confident that an appropriate level of safety is ensured.
Completing the cycle
After the first in-surgery application, the patient can be provided with the tooth whitening product for home use. The dentist’s duty extends to continuing to monitor the provision of top-up gels and ensuring this is in accordance with the patient's treatment plan. The dentist does not necessarily have to be physically present when the top-up gel is handed out, but the duty is to have a system that ensures what is handed out is in accordance with the specified treatment plan.
Advertising
Dental practices can advertise tooth whitening procedures using products containing or releasing up to 6% hydrogen peroxide. Any advertisements should comply with the GDC guidance and the Advertising Standards Authority Codes. Members who wish to use ‘discount deal’ sites should ensure they follow the relevant GDC guidance.
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 and the EU Directive. This means it is not possible to circumvent the Regulations by using a product that has a CE mark.
Under-18s
The Regulations and EU Directive specifically state the product must not be used on patients aged under 18.
The requirement that patients must be at least 18 years old has created an ethical dilemma for members who wish to act in the best interests of their patients but where the treatment is prohibited by the Regulations by virtue of the patient’s age.
In this scenario it is an individual clinical decision for the member whether to breach the Regulations to provide the treatment that the member considers is in the best interests of the child.
If a member wishes to provide treatment to a child in breach of the Regulations, they are advised to:
- Have a detailed discussion with the patient/parents, as part of the consent process. Ensure that patient/parents are fully informed as to the risks and benefits of both bleaching procedures, and the more interventive alternatives, including a discussion about the legal status of tooth whitening procedures and whether it is appropriate to delay treatment until the patient is 18 years of age
- Document all consultations carefully in the patient’s clinical notes
- 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.
The General Dental Council’s Position Statement on Tooth Whitening sets out that if it receives information or a complaint that a registrant is using a product in excess of 6%, in breach of the Regulations, the registrant may face fitness to practise proceedings and can expect the matter to be referred to the relevant Trading Standards department.
Above 6%
There are rare occasions where the pathology cannot be treated successfully by using products with the permitted concentration of hydrogen peroxide. This creates an ethical dilemma for the member who considers it would be in the best interests of the patient to provide tooth whitening using a product not permitted by the Regulations. If a member is considering using products that release or contain more than 6% hydrogen peroxide and thus breaching the Regulations, Dental Protection advises members to:
- Take individual therapeutic decisions in respect of each patient.
- Take advice if you have concerns or are approached by a Trading Standards Officer
- Ensure that patients are fully informed as to the risks and benefits of using a product containing or releasing more than 6% hydrogen peroxide as opposed to using a product using a lower concentration of hydrogen peroxide, including a discussion about the legal status of the tooth whitening procedures. Such discussions should present a fair and balanced summary of the relative risks and benefits of alternative treatment approaches and should not make any claims for the efficacy of one technique over another that cannot be substantiated
- Document all consultations carefully in the patient’s clinical notes
- Contact Dental Protection for advice
Members should appreciate that acting in the patient’s best interests is not a defence to a breach of the Regulations.
Reporting of adverse effects
If members are treating a patient who experiences an adverse effect, they are advised to keep a record of this.
Assistance
The revision of the Regulations to permit the use of higher strength products containing or releasing hydrogen peroxide has significantly improved the unsatisfactory ethical and legal dilemmas faced by dental practitioners in recent years. There remain some unwelcome anomalies, especially where patients aged under 18 are concerned, and we will continue to make representations in this regard.
Requests for assistance in relation to bleaching and tooth whitening procedures will be considered on their individual merits. Members who carry out these procedures in accordance with the law can seek the assistance of Dental Protection in the usual way if facing any kind of complaint or challenge.
A criminal act cannot reasonably be considered to be the normal practise of dentistry, however, and nor is it possible to 'go behind' the fact of a conviction when the case is subsequently referred to the General Dental Council, as would happen routinely in the event of a conviction of any dental registrant.
However, members who seek and follow the advice of Dental Protection in navigating this potential dento-legal minefield in the best interests of their patients can still look to Dental Protection for assistance and support.