Statement from the Dental Directory
I can confirm that based upon legal advice, The Dental Directory has stopped with immediate effect, the sales of all Tooth Whitening products.
It is fair to say that the ‘’Blind Eye’’ policy adopted by Trading Standards for the past 4/5 years on Tooth Whitening regarding the implementation of the Consumer Protection Act 1987 – The Cosmetic Products (Safety) Regulations 2008 has been withdrawn.
The background to this is, in January 2011, a member of the public made a complaint to Hull Trading Standards that a Home Whitening product containing a concentration of 10.0% Hydrogen Peroxide had been prescribed to her, by a dentist. Under the current Regulations, the maximum strength permitted is 0.01% Hydrogen Peroxide. I can tell you that all current brands available in the market contain considerably higher concentrations of Hydrogen Peroxide.
Because, the Dental Directory had sold the Home kit to the dentist in Hull, we have received various visits and correspondence from Essex Trading Standards commencing in late March and continuing throughout April and May, regarding the sale of all Tooth Whitening products. During one of these visits, we were issued with an immediate Suspension Order under the Consumer Protection Act 1987 – The Cosmetic Products (Safety) Regulations 2008 on the two WY 10 Professional Home Kits.
During the past day or so, we have received additional correspondence from Trading Standards which has resulted in my colleague, the Company Secretary being cautioned and he will be interviewed by Trading Standards under this caution. This has prompted us, to decide to stop selling all Tooth Whitening products.
I profoundly apologise for any inconvenience this may cause you however, it has been made clear to us, that it is highly likely that Hull Trading Standards will be taking this matter forward to Court.
I attach the research note drafted by our Kennedy’s our retained lawyers relating to the immediate past history of Tooth Whitening, the legal position and I guess most importantly, the individuals who can under the Regulations be prosecuted – this as you will see, includes dentists.
I will clearly, keep you informed of all future actions that Trading Standards may take.
The Dental Directory
TOOTH WHITENING LEGAL RESEARCH NOTE
1. This draft note sets out the legal and regulatory framework in respect of the supply of tooth whitening products.
The Legal Framework
2. Tooth whitening products have been the subject of much discussion in Europe in terms of whether they are classified as “cosmetic products” and therefore subject to the maximum concentration of hydrogen peroxide of 0.1% under the Cosmetic Directive 76/768/EC (CD), or whether they are “medical devices” and therefore subject to the regime under the Medical Devices Directive 93/42/EEC (MD). Many European companies who market tooth whitening products with more than 0.1% hydrogen peroxide have classified their products as medical devices under the MD which provides that products with a CE Mark may be legally marketed anywhere in the EU. The courts in Germany have confirmed this approach and in Spain the government require that they are marketed with some restrictions as dental devices.
3. The position in the UK is however different. In 2001, the case of Optident Limited and Ultradent Productions Inc v Secretary of State for Trade and Industry for Healthconfirmed that a whitening gel with a hydrogen peroxide content of 3.4% is a cosmetic product and the marketing of it as a medical device in Great Britain, despite its CE mark was not allowed. Following this decision, tooth whitening products are considered as cosmetic products and subject to the domestic legislation which regulates such products. As a directive, the CD is not directly enforceable in the UK and has been transposed into UK law by the Cosmetic Products (Safety) Regulations 2008 (the Regulations).
4. Under the terms of the Regulations, it is illegal for a person to supply tooth whitening products which contain more than 0.1% hydrogen peroxide or for any associated products which release greater than 0.1% hydrogen peroxide to be supplied. Equally, the same Regulations, can be applied to Dentists who undertake Tooth Whitening treatments using commercially sourced combined products.
5. The Regulations are enforced in the UK by the Consumer Protection Act 1987 which renders a contravention of the Regulations a criminal offence. Accordingly, if a person supplies or applies a tooth whitening product which exceeds the maximum permitted concentration of hydrogen of 0.1%, an offence will have been committed. Each offence is punishable by a maximum fine of £5,000 and/or a maximum term of imprisonment of six months.
6. The Consumer Protection Act 1987 provides a defence of due diligence. This means a defence is available to a person if it is able to provide that it took all reasonable precautions and exercised all due diligence to avoid the commission of the offence.
Can individuals be held personally liable under the legislation?
7. As detailed above, the prohibition against the supply of tooth whitening products with a hydrogen peroxide content of above 0.1% applies to the “person” that supplies the product. This “person” can either be a person or a company. As it was the Company that supplied the Products, any offence should be brought against the Company in the first instance; however, the Consumer Protection Act 1987 provides that individuals can be held criminally responsible under certain circumstances.
8. The Consumer Protection Act 1987 provides that if a company is found responsible for an offence, a director, manger, secretary or other similar office of the company, or a person purporting to act in such a capacity, can be held criminally responsible where the offence was committed with the “consent”, “connivance” of, or was attributable to any “neglect” on the part of that individual. Looking at these terms in turn, “consent” means knowing and not doing anything about the risks, and “neglect” means an unreasonable breach of the duty of care. If an individual has consented, connived or been neglectful it could be held personally liable.
9. The Regulations are enforced by the local authority. Trading Standards Officers as part of the local authority are empowered to take enforcement action. The national co-ordinating authority for local authority regulation (called LACORS at the time but since very recently known as Local Government Regulation) advised Trading Standard Officers in 2004 to take a low key approach to the enforcement of the Regulations. This was amidst a background of discussions held and consultations undertaken by the European Commission in 2005. One such consultation undertaken by the Scientific Committee on Consumer Products (SCCP) concluded that the use of tooth whitening products containing between 0.1% and 6% is safe if it follows consultation with the dentist. Despite this, no resolution was made at European level to increase the maximum levels of hydrogen peroxide in the CD.
10. The advice from LACORS condoning a low key approach to enforcement was subsequently withdrawn in September 2006. LACORS advised that in the absence of any resolution to the matter at European level, that the levels of hydrogen peroxide stated in the CD should be taken as the correct level for safe supply in tooth whitening products and that these levels are the ones to be adhered to by those in trade or business who supply these items.
11. LACORS reaffirmed this advice in a letter dated 7 February 2007 which was sent to the General Dental Council and the British Dental Association. In this letter LACORS noted that a resolution at European Commission level was not imminent. The letter further provides that all suppliers are to be treated “equally, be they retail, mail-order or dentist”. LACORS referred to clarification received from the Department of Trade and Industry (now re-named as the Department of Business Innovation and Skills) that contrary to the prevailing view within the dental profession, dentists are covered in the same way as any other professional under the Regulations and are not exempt from enforcement action in respect of the supply of tooth whitening products above the limits specified in the CD.
12. There has not been a reversal of this decision and it remains the case that low key enforcement in respect of tooth whitening products is not advised and no longer condoned.
Discussions at UK Parliament and the European Commission
13. In 2008, the European Commission presented an amending directive to the experts committee on cosmetic products. This proposed to allow tooth whitening products containing a maximum amount of 0.1% hydrogen peroxide to be freely available to consumers, as they are today. Tooth whitening products containing up to 6% hydrogen peroxide would be available to consumers after assessment and first application by a dental practitioners. The remainder of the kit could then be taken home and used by the consumer as directed by the dental practitioner. This proposal was the result of six scientific papers being submitted from the SCCP which, in short, provided that allowing a greater percentage of hydrogen peroxide in tooth whiteners would not be detrimental to the health of consumers. However, the Commission did not take this forward and despite there being numerous various amendments to the CD the maximum level of hydrogen peroxide in oral hygiene products remains at 0.1%.
14. We have carried out a search for any more recent activity at UK or European level which suggests that a change in the law is imminent or supports an argument that enforcement action is not appropriate. The most recent activity occurred In January 2009, where Paul Beresford Conservative MP lobbied the previous government at a House of Commons debate to press the European Commission to change the CD. This debate centred upon the supply of tooth whitening products by dental professionals. He referred to confusion on the part of dental professionals arising from the varied approach adopted by Trading Standards Officers in that some officers have visited dental surgeries and accepted the use of such products as part of dental procedures, but not for over the counter sales, and others who continue to threaten to prosecute dentists for using more than 0.1% concentration. In response, Gareth Thomas, Minister for both the Department for Business Enterprise and Regulatory and Department for International Development said that he would continue to apply pressure to the European Commission to amend the CD as per Paul Beresford’s suggestions. However, further to this debate in January 2009 the issue has gone quiet and has not since been raised in either UK Parliament or at the European Commission. It does not appear to exist on the present Coalition Government’s agenda.
Kennedys Law LLP
20 April 2011
Statement from the Dental Directory