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There is currently continued confusion relating to the legal position of dentists using tooth whitening techniques which involve the use of bleach.
Background
There have been concerns regarding the use of strong concentrations of hydrogen peroxide in the hairdressing and beauty industries, both in terms of the risks to the public and to the workers in these sectors. A number of EU Directives sought to regulate the situation over the past few years, commencing with the European Council Directive on Cosmetic Products 76/768/EEC. The most recent Directive was in 2004 and was brought into force in Ireland under the European Communities (Cosmetic Products) Regulations, 2004 (as amended) (the “Irish Regulations”).
While the Irish Regulations stipulate that oral hygiene products should not contain more than 0.1% of hydrogen peroxide, there is no specific guidance regarding the exact recommended quantities of bleaching products to be used in tooth whitening procedures. This issue has not yet been considered specifically in Ireland and, as a result, it is useful to look at the UK position for guidance as it may be of persuasive force in Ireland. The House of Lords in 2001 held that the Government had the right to consider bleaching products as falling under the EU Cosmetic Directive and therefore within the terms of the UK's Cosmetic Products (Safety) Regulations 1996 which are equivalent to the 2004 Irish Regulations.
The legal situation in the UK arises in part as a result of action taken against the Department of Trade and Industry and the Department of Health by a manufacturer and distributor of a bleaching product which contained carbamide peroxide. Whilst the company in question was successful in its initial case against the two government departments, the Judgement was subsequently overturned on Appeal and the Appeal Court decision, in turn, was upheld by the House of Lords in 2001. The situation at present is therefore that it is illegal in the UK to supply a product for the purpose of tooth whitening, if that product contains or releases more than 0.1% hydrogen peroxide.
Although it has yet to be tested, Dental Protection's advice is that the Judgement is likely to cover all bleaching products that release more than 0.1% hydrogen peroxide, regardless of whether they are administered chairside or provided to a patient to take home. This produces a particular dilemma for dental practitioners who may be concerned that patients are being denied a treatment that is both safe and effective. Dental Protection is not an arbiter of clinical opinion; nevertheless, there appears to be a considerable weight of authoritative scientific opinion to support the use of these techniques, particularly when considering the destruction of healthy tooth structure which is necessary with many of the alternative techniques.
Are there changes forecast?
Dental Protection welcomes the proposed amendment to the European Cosmetics Directive, which brings future changes to legislation one step closer. The European Council has adopted a Directive on tooth whitening, which strengthens consumer protection whilst allowing dentists to legally supply products for tooth whitening, which release or contain up to 6% hydrogen peroxide.
Once a new European Directive is in place, the Irish Government is obliged to amend the Regulations to reflect this. As soon as those new Regulations come into force it will be possible for products over 0.1% but less than 6% hydrogen peroxide to be supplied to patients provided that the patient has been examined by a dentist and the first treatment has been performed by the dentist or under his or her direct supervision.
Until the Irish Government amends the law, it will remain illegal to supply products for the purpose of tooth whitening that contain or release more than 0.1% hydrogen peroxide. The position statement on Tooth Whitening, set out below remains unaltered and members who may wish to provide tooth whitening are asked to familiarise themselves with the position statement.
Under current Irish Law, regulations provide that oral hygiene products should not contain more than 0.1% hydrogen peroxide. A new EU Directive was passed in September 2011. Under this new Directive, for products containing between 0.1% and 6% hydrogen peroxide, a clinical examination and first treatment by a dentist will be required to ensure the absence of risk factors or oral pathologies, after which the patient will be able to continue treatment by him or herself
The use of these products by persons younger than 18 years will not be allowed and products containing in excess of 6% hydrogen peroxide are prohibited.
Ireland has a duty to enforce the Directive from no later than October 2012.
The changes in the EU Directive may trigger increased marketing by some dental suppliers and members are advised that although the EU Directive has been amended this does not have an immediate effect on the law in the Ireland which remains unchanged on this subject. Consequently the advice set out in the position statement below, also remains unchanged. Dental Protection members who wish to be sent an email alert when the changes in the Regulations occur, should register for e-communications on the website.
Enforcement
The Irish Medicines Board can initiate its own investigations without being restricted to the need to react to specific complaints. This can, in theory, also apply to the use of certain cosmetic products (or to unsafe levels of these products) by dentists. It is likely to be proactive in enforcing compliance with the new tooth whitening directive once it comes into force in Ireland later this year.
Is there anything dentists can do?
Dental Protection's view is that the best position a healthcare professional can take is to act in a patient’s interests at all times.
We have continued to work with the various agencies and to lobby for change in the current legal status so that tooth whitening is available. This is important because for many patients the alternative is a more destructive and irreversible treatment approach which does not sit easily with current concepts of minimally invasive dentistry.
Dental Protection's advice
- Take individual therapeutic decisions in respect of each patient.
- Avoid advertising the use of tooth whitening products as this may constitute intent to supply the goods beyond an individual therapeutic decision.
- Take advice if you have concerns or are approached by the National Consumer Agency.
- If you have concerns about providing tooth whitening products then consider delaying treatment until the legal situation is resolved, rather than proceeding to provide more destructive techniques. Most elective procedures can be deferred.
- Ensure that patients are fully informed as to the risks and benefits of both bleaching procedures, and the more interventive alternatives, including a discussion about the current legal status of tooth whitening procedures.
- 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.
Summary
Any member of Dental Protection who is challenged in relation to the use of bleaching techniques in their treatment of patients can contact Dental Protection for advice, assistance and support.