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Teeth Whitening Legislation

http://www.dentalprotection.org/uk/positionstatements/toothwhitening/#sthash.0IFOnXos.dpuf

Teeth Whitening

The law relating to teeth whitening changed on 31 October 2012. The new law increases the percentage of hydrogen peroxide allowed in tooth whitening or bleaching products to 6%, subject to conditions which include first use by a dental practitioner or under their direct supervision. Until 31 October the previous law remained in force and this position statement relates to treatment provided after 31 October 2012.

Dental Protection welcomes the change in the law, which will allow practitioners to act in their patients’ best interests whilst remaining within the law. The legislation relating to tooth whitening is laid down by the European Union and the change to the law follows many years of lobbying by dental groups. The new law 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 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 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 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.

It is appropriate for the dentist to carry out an examination before embarking on a course of tooth whitening, to determine whether tooth whitening is a suitable treatment option for the patient. 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

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 that 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 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 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 the 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 following an examination of the patient. Dental Protection advises members to make a detailed contemporaneous record of the examination and 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 (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.

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

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. Thus hygienists and therapists can administer the first use of tooth whitening, if an equivalent level of safety is ensured.

Before undertaking any procedure, a registrant must ensure that they are trained and competent.

The Regulations do set out that the treatment is under the “direct supervision” of the dentist but do not define “direct supervision”. In Maintaining Standards the GDC used the term “direct personal supervision” to indicate when the dentist was to be on the premises. If a member is issuing a prescription to a hygienist or a therapist they need to be confident that an equivalent level of safety is ensured.

Under the GDC’s Scope of Practice only dentists, therapists and hygienists can provide tooth whitening. Therapists and hygienists must have a prescription from the dentist before providing this treatment.

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 or hygienist/therapist, 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 oral examination and the consent process is thorough and carefully documented.

Advertising

Prior to the change in the law, Dental Protection had advised members to avoid advertising the use of tooth whitening products as this may constitute intent to supply the goods beyond an individual therapeutic decision. The change in the law from 31 October 2012 means that 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 hyrogen 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. Any advertisements should comply with the GDC guidance Principles of Ethical Advertising and the Advertising Standards Authority Codes. Members who wish to use ‘discount deal’ sites should ensure that they follow the GDC 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 that 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 should not be used on patients aged under 18. This means that 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 a 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 legal and ethical dilemma for members who consider, for example, that it would be in the best interests of a particular patient under 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 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 – 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. In providing treatment in breach of the Regulations, members should recognise that they could leave themselves vulnerable to a complaint being made to local Trading Standards Officers, see below Breach of the Regulations.

Over 6%

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. Members may consider, for example, the extensive published evidence that products containing or releasing more than 6% hydrogen peroxide may lead to a higher incidence of side effects including sensitivity, which in turn are responsible for a significant number of complaints relating to these procedures. Furthermore, this evidence suggests that the use of these higher concentrations, whether administered in the surgery or at home, may ultimately confer no long-term benefits in aesthetic terms when compared to the alternative products that remain within the proposed new 6% limit.

If a member considers that 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 Trading Standards Officers.

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 local Trading Standards Officers.
  • 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 - 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

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. If a practitioner breaches the Regulations they leave themselves open to investigation and prosecution. The Local Authority has a duty to enforce safety provisions within its area and can initiate its own investigations without being restricted to the need to react to specific complaints.

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. The officer may inspect any goods and enter a dental practice for the purposes of ascertaining whether there has been any contravention of any safety provision.

Obstructing a Trading Standards Officer in exercising his duty can constitute an offence in itself. If admission is refused an officer can apply to the Magistrates for a warrant (Section 30 (2) Consumer Protection Act 1987) to enter the premises.

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 Trading Standards Officers with the same circumspection as s/he would a police interview. In this situation members are advised to contact Dental Protection for further advice.

Reporting of Adverse Effects

The EU as part of the agreement to change the Directive demanded that there should be reporting of adverse effects. Dental Protection understands that the BDA intends to place an undesirable effects survey on their website. If members are treating a patient who experiences an adverse effect they are advised to keep a record of this, so that anonymised information can be provided for the survey.

Indemnity and 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 do remain some unwelcome anomalies, especially where patients aged under 18 are concerned and Dental Protection will continue to make representations in this regard.

However, 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 GDC, 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

Please Note: Den Lab Limited is not member of or affiliated to any dental association; all of our listed products are sold under the legal requirements set out in the above statement. All customers should seek the advice of the dentist before purchasing any of our products. The sale of carbamide peroxide is made on the understanding that you are purchasing as a dentist or have the authorisation of a dentist to purchase and use peroxide gel in the teeth whitening process.

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