The law relating to tooth whitening changed on 31 October 2012. The law increased the percentage of hydrogen peroxide allowed in tooth whitening or bleaching products to 6%, subject to various conditions outlined below. This position statement relates to treatment provided after 31 October 2012.
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 Irish Government to amend the law. The European Communities (Cosmetic Products) (Amendment) Regulations 2012 (The ‘Regulations’) amend the previous Regulations relating to tooth whitening.
In familiarising themselves with the new Regulations, members might wish to review the Dental Council’s guidance entitled Tooth Whitening – Guidance to the Dental Profession
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 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 with reference to Ireland 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
- 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.
To only be sold to dental practitioners
Under the Regulations, only dental practitioners can purchase tooth whitening products containing or releasing 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 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 some of the product.
The requirement that the first use of each cycle is by a dental practitioner (or under their direct supervision) helps to allay these concerns as it allows the dental professional to demonstrate the amount of material to be used and how to load and seat the tray. This would therefore decrease the risk of the patient inadvertently using an excess of product, which would increase the risk of the product being swallowed.
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 for members. Dental Protection advises members to make a detailed contemporaneous record of the instructions given to the patient at the first appointment, which becomes central to demonstrating their compliance with the law.
The requirement that the first use of each cycle is by the dentist means that tooth whitening products containing or releasing more that 0.1% hydrogen peroxide cannot be sold to patients at reception or by post.
There are a considerable number of suppliers operating on the internet who are prepared to sell tooth whitening products to the general public. Patients who have received a set of trays for a course of tooth whitening by a dentist or under his/her direct supervision may be tempted to purchase products elsewhere for further courses of tooth whitening. As some of these unregulated products could be dangerous, members may wish to advise their patients of the risk of purchasing the products from an unregulated source, as part of the tooth whitening instructions.
Under their direct supervision, if an equivalent level of safety is to be ensured
While the Regulations do state that tooth whitening can be carried out under the supervision of a dentist ‘where an equivalent level of safety is ensured’, the document does not set out precisely who can provide tooth whitening under a dentist’s direct supervision and nor does it specify the minimum conditions under which the procedure can be carried out under the supervision of a dentist.
It would seem that the European Council deliberately left the logistics to be further developed by each of the European states individually when transposing the legislation. The vagueness of the Regulations on this point has raised the legitimate query as to whether hygienists are legally permitted to perform tooth whitening.
There is no specific reference in the legislation to hygienists performing tooth whitening and the Regulations do not explicitly prohibit or sanction same. The conditions under which hygienists are permitted to work are laid down by the Dentists Act 1985 and a Scope of Practice providing more detail as to the tasks that hygienists are entitled to carry out was published by the Dental Council in September 2005. Tooth whitening is not listed in the Code of Practice as a task that hygienists are permitted to undertake.
In its Guidance on Tooth Whitening, the Dental Council clarified that in Ireland tooth whitening can only be carried out by a registered dentist and as the regulatory framework currently stands, dental hygienists or orthodontic therapists are not permitted to perform tooth whitening. This contrasts with the position in some other European countries, most notably the UK, where dental hygienists and therapists can provide tooth whitening under the direct supervision of a dentist.
Dental Protection advises therefore that while the Regulations seem to envisage tooth whitening being performed under the direct supervision of a dentist, the position in Ireland is that only registered dentists can perform the procedure. Members should be aware that the performance of tooth whitening by a hygienist or therapist is contrary to the Dental Council Guidance and may leave the practitioner concerned vulnerable to Dental Council proceedings.
Afterwards to be provided to the consumer to complete the cycle of use
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 who is trained and competent to provide tooth whitening. The additional product should not be dispensed by other team members.
Individual therapeutic decision
As with any treatment, Dental Protection would expect members to ensure that tooth whitening is an appropriate treatment and that the consent process is thorough and carefully documented. As per Dental Council guidance, members should also ensure that a note of all instructions given to the patient is included in the patient record.
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/whitening techniques rely on the use of products which contain or release more than the permitted 6% levels of hydrogen peroxide. It would be extremely unwise to state, suggest or imply that such techniques are being offered to members of the public 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 or the practice’s willingness to act contrary to the law.
The Dental Council has made clear that dentists who advertise bleaching techniques using products containing or releasing greater than 6% hydrogen peroxide leave themselves exposed to possible IMB/Dental Council proceedings. Any advertisements should comply with the Dental Council’s Code of Conduct Pertaining to Public Relations and Communications and the Advertising Standards Authority Codes. Members who wish to use discount deal sites should ensure they follow the Dental Council guidance.
Medical devices directive
Dental Protection is 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 Regulations and the EU Directive. 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 should not be used on patients under 18. This means it is only possible to use products containing or releasing up to 0.1% hydrogen peroxide on patients who are under 18. It has been suggested by some practitioners that tooth whitening products could be classified as medical devices and as such the European Communities (Cosmetic Products) (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 legal and ethical dilemma for members who consider, for example, that it would be in the best interests of a particular patient less than 18 years of age to provide tooth whitening to an isolated non-vital tooth. The member may consider that other treatments, for example crowns or veneers, would be unnecessarily destructive to the tooth/teeth. 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 the 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 – this is essential in order to demonstrate that appropriate discussions have taken place with the patient – and their parent(s) where applicable – before the procedure is carried out.
Members are advised to refer to the current Dental Council guidance regarding tooth whitening as well as the Joint Dental Council/Irish Medicines Board statement which provides helpful advice on the treatment of patients under the age of 18. The Dental Council advises that where a clinical assessment concludes that the most appropriate course of treatment is to use a tooth whitening product containing hydrogen peroxide up to 6%, consideration should be given firstly to appropriately licensed alternatives.
Other than this, providing tooth whitening treatments to patients under 18 should only be considered where there is no appropriately licensed alternative available or the dentist is satisfied, on the basis of authoritative clinical guidance, that a tooth whitening product is as safe and effective as an appropriately licensed alternative.
In providing treatment in breach of the Regulations, members should recognise that they could leave themselves vulnerable to a complaint being made to the Irish Medicines Board and/or Environmental Health Officers of the Health Service Executive (HSE) – see below Breach of the Regulations.
The use of products containing or releasing more than 6% hydrogen peroxide is a breach of the Regulations. Dental Protection would expect members to comply with the law, where compliance is in the best interests of the patient. Dental Protection encourages members to weigh the risks of using a product against the benefits of that product when considering if a particular treatment is in the patient’s best interests. This is particularly the case when an alternative product may provide the same or similar benefits with fewer risks.
If a member considers it is in a patient’s best interests to use a product containing or releasing more than 6% hydrogen peroxide and a member chooses to use this product, they may be challenged on the use of the product by Officers of the Irish Medicines Board and/or Environmental Health Officers of the HSE.
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.
- Avoid advertising the use of tooth whitening products containing or releasing more than 6% hydrogen peroxide as this may constitute intent to supply the goods. It is also likely to attract unfavourable attention from the Irish Medicines Board and/or the HSE.
- Take advice if you have concerns or are approached by an Officer of the Irish Medicines Board or an Environmental Health Officer of the HSE.
- 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 – this is essential in order to demonstrate that appropriate discussions have taken place with the patient before the procedure is carried out.
Breach of the Regulations
Dentists who breach the Regulations may be subject to Fitness to Practice proceedings under the Dentists Act 1985 in addition to any action taken by the Irish Medicines Board or Environmental Health Officers of the HSE.
The maximum penalty for breaching the Regulations is a sentence of imprisonment not exceeding six months or a fine not exceeding €3,000 or both. For the purposes of the Regulations, every contravention of the Regulations shall be deemed a separate contravention and shall carry the same penalty as for a single contravention.
Both the Irish Medicines Board and Environmental Health Officers are authorised to inspect, seize and detain cosmetic products. The Irish Medicines Board has advised that its intention is to adopt a risk-based approach to market surveillance and both the Board and Environmental Health Officers of the HSE will co-ordinate activities in this area with initial focus on products sold directly to consumers and illegal products that contain in excess of 6% hydrogen peroxide.
If a member feels s/he is at risk of being prosecuted for a breach of the Regulations, s/he should treat any proposed interview with an officer of the Irish Medicines Board/HSE with the same circumspection as s/he would an interview with An Garda Síochána. In this situation members are advised to contact Dental Protection for further advice.
Reporting of adverse effects
The EU demands that there should be reporting of adverse effects. The Dental Council, in its tooth whitening guidance to the dental profession, states that all serious undesirable events must be reported to the Irish Medicines Board.
Indemnity and assistance
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 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.