HL Deb 11 October 1999 vol 605 cc52-3WA
Lord Colwyn

asked Her Majesty's Government:

Why the Department of Trade and Industry and the Department of Health applied to the Court of Appeal to reverse the judgment of Mr. Justice Laws that tooth whiteners should be classified as medical devices. [HL4069]

Lord Sainsbury of Turville

The Department of Trade and Industry and the Department of Health appealed as both departments believed that his conclusion that tooth whitening products were medical devices which should bear a CE Marking and be regulated under the Medical Devices Regulations 1994 was incorrect. Both departments believe these products to be cosmetics and this view was upheld by a unanimous decision of the Court of Appeal.

Lord Colwyn

asked Her Majesty's Government:

What were the total costs involved in the judgment by the Court of Appeal in favour of the Department of Trade and Industry and the Department of Health against Optident; and what were the total amount of damages being sought by Optident against the Department of Trade and Industry and the Department of Health for alleged loss of sales whilst the legal status of tooth whitening agents was uncertain. [HL4070]

Lord Sainsbury of Turville

Legal costs have not been finalised. At present Treasury Solicitors costs are estimated to be in the region of £30,000. However, the Court of Appeal ordered Optident to pay the departments' costs and therefore the departments will hope to recover the majority of the legal costs incurred.

Optident have not quantified their claim for damages. The damages claim is unlikely to be quantified unless the decision of the Court of Appeal is overturned.

Lord Colwyn

asked Her Majesty's Government:

Whether it is in the public interest that, following the Department of Trade and Industry and Department of Health appeal, United Kingdom patients will now be denied the choice of a tooth whitening approach to discoloured teeth and obliged to consider options that are more expensive and destructive of tooth tissue. [HL4071]

Lord Sainsbury of Turville

The Department of Trade and Industry has a Community obligation to ensure that cosmetic products supplied in the UK comply with the Cosmetics Directive. This includes the duty to prohibit the sale of cosmetics which contain or emit concentrations of hydrogen peroxide in excess of the limits permitted by that directive.

Lord McColl of Dulwich

asked Her Majesty's Government:

What advice has been given by the Department of Trade and Industry to the Trading Standards Department about tooth whiteners; and whether they intend to modify that advice. [HL3947]

Lord Sainsbury of Turville

All 202 Trading Standards Departments (TSDs) have been informed of the Court of Appeal's Judgment of 1 July 1999 regarding tooth whitening products.

The advice that has been given to TSDs, based upon the law as now stated by the Court of Appeal, is that tooth whitening products are cosmetics, regulated by the Cosmetic Products (Safety) Regulations 1996 and that it is irrelevant whether they bear the CE Marking under the Medical Devices Directive.

TSDs have also been advised that they may wish to seek their own legal advice on the implications of the Court of Appeal's judgment. The DTI have also suggested to TSDs that they should consider enforcement action, including prosecution, in any case where there is sufficient evidence of supply of tooth whitening products in contravention of the 1996 Regulations after the 1 July clarification of the law by the Court of Appeal.

As stated above, the department has modified its advice following the County Appeals Judgment on 1 July. The department does not intend to modify that advice further for the time being.