A report commissioned to review one of the largest teeth whitening products online.

Background

The Product is a ‘cosmetic product’ within the meaning of the Cosmetic Products (Safety) Regulations 2008 (the “Regulations”).

The Regulations restrict the maximum concentration of hydrogen peroxide (and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide) to no more than 0.1%.

It is an offence for any person to supply a cosmetic product which is subject to restrictions and/or conditions unless those restrictions and/or conditions are satisfied.

Application

The Product’s packaging does not provide the concentration of hydrogen peroxide in the Product. However, many websites provide that the kit uses 16% carbamide peroxide which is equivalent to 5.8% hydrogen peroxide.

If the Product does contain hydrogen peroxide in this concentration, it should not be sold in the UK.

The Regulations implement the EC Directive which concerns the safety of cosmetic products, and thus this same prohibition will apply throughout Europe.

Controversy

Historically there has been a suggestion by those in the industry that teeth whitening products are not cosmetic products and thus are not subject to the Regulations. This school of thought was/is of the view that teeth whitening products are ‘medicinal devices’ and therefore subject to different regulation.

However, in 2001, a case which went to the House of Lords clarified the position and made it clear that the intended purpose of teeth whitening products is to change or restore appearance and, that being so, it was correct to place it within the scope of the Cosmetic Regulations.

This case therefore confirmed that it is illegal in the UK to supply a product for the purpose of teeth whitening, if the product contains or releases more than 0.1% hydrogen peroxide.

What are the implications of the new directive on teeth whitening? Council Directive 2011/84/EU has now been published, and the UK must adopt and publish the provisions necessary to comply with this Directive before 30 October 2012.

The Directive does not change the position in relation to the maximum concentration of hydrogen peroxide permitted in teeth whitening products. This remains at no more than 0.1%.

What it does do is increase the maximum authorised concentration permitted if sold to dental practitioners. Dental practitioners may use products of this increased concentration on their patients.

The Directive means that the Product may legitimately be sold to dental practitioners. However, it remains that it is illegal to sell the Product direct to the consumer.

Recent enforcement

Trading Standards has recently taken action in relation to a dental supply company to prevent the company from supplying teeth whitening products that contain or release more than 0.1% hydrogen peroxide. Trading Standards have stated that their interest lies in pursuing supply companies at present time.

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