With strict regulations around the use of tooth whitening products in EU countries, Martin Foster, dentolegal consultant, discusses how to stay within the law.
In the mix
Since 31 October 2012, the maximum legally permitted level of hydrogen peroxide contained in, or effectively released from, tooth whitening products that can be used in EU countries has been set at 6%. The use of such products is subject to certain conditions, including use only by, or under the direct supervision of, a dental practitioner. Importantly, such products cannot legally be used on patients below the age of 18 years.
The relevant current legal provisions in the UK are contained within the Cosmetic Products Enforcement Regulations 2013 (commonly known as the EU Cosmetics Regulations). The policing and enforcement of these is under the remit of the Health and Safety Executive and Trading Standards Officers across the country.
The regulations permit preparations containing hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide (including carbamide peroxide and zinc peroxide), to be used for tooth whitening, with the maximum effective concentration of hydrogen peroxide allowed under the law being 6%.
A preparation that contains 10% carbamide peroxide will release 3.6% hydrogen peroxide. Commonly used products that contain up to 16% carbamide peroxide will therefore fall within the permitted range, as the level of hydrogen peroxide released will not exceed 6%.
The GDC view
The General Dental Council (GDC) reminded registrants in its 2016 position statement on tooth whitening that products that produced concentrations exceeding 6% hydrogen peroxide were prohibited.
The GDC also stated that products containing or releasing between 0.1% and 6% hydrogen peroxide cannot be used in any person under 18 years of age, “except where such use is intended wholly for the purpose of treating or preventing disease”.
Getting it straight
The inclusion of this phrase in the GDC statement may seem to suggest that there could be an exception to the general prohibition regarding the use of hydrogen peroxide products on those under the age of 18. However, this does not bear up to close scrutiny.
Although achieving an improvement in the appearance of discoloured teeth through the use of a whitening agent is clearly desirable, it is a procedure carried out primarily for cosmetic reasons and is not the treatment of “disease” per se.
The law recognises no “therapeutic exception” with respect to cosmetic preparations. As a consequence, the justification of acting in the patient’s best interests is not a defence that allows the clinician to break the law.
Straying outside the law
Acting in contravention of the regulations by using a tooth whitening preparation for a patient under 18 (or indeed treating an adult patient with a preparation that exceeds the permitted concentration) will constitute a criminal act. It may result in a criminal prosecution, and a conviction will carry with it all of the wider implications that flow from this.
The GDC statement on tooth whitening makes it clear that the commission of a criminal offence by a registrant will be considered relevant to any assessment of a practitioner’s fitness to practise.
If the clinician is an employee, his or her employer could also be investigated and prosecuted, which in turn could result in additional disciplinary and professional difficulties for the clinician.
The current legal situation can be a source of frustration for any clinician seeking the best treatment options for a child patient. While the GDC obviously expects registrants to act in the best interests of the patient, it equally expects registrants to obey the law.
Given situations may arise where illegal tooth whitening treatment for a younger patient would avoid the need to consider potentially more invasive or destructive treatment options, there is a real dilemma with this issue. It is ethical to act in the patient’s best interests but it is unethical to break the law.
The decision here is in the hands of the clinician. Whitening is ironically, a rather grey area in terms of ethical responsibilities, but the law is very black and white: the use of products contrary to the regulations is illegal.
While there may be perfectly justifiable reasons for using these materials clinically, and the dentist may be acting in good faith and serving the patient’s best interests, the legal system will not see this as a defence. The GDC further sets out in its position statement that any registrant it receives a complaint about regarding a breach of the regulations can expect the matter to be referred to the relevant Trading Standards Department.
Any decision to break the law in order to provide tooth whitening is a matter for the judgement of the clinician, but it is crucial to keep in mind that a breach of the regulations will constitute a criminal offence, irrespective of the intention behind this.
Dental Protection can support members in relation to the expectations of the GDC or with advice on any other aspects of this topic – our experts are always at the end of the phone to help answer queries from members on the range of practical and ethical dilemmas that can arise.
To get in touch with one of our experts for more advice on tooth whitening, call 08005611010 or visit dentalprotection.org.