The claimants manufactured a dental bleaching product. It contained hydrogen peroxide at levels in excess of the limit. It sought to distribute it under licence as a medical product on prescription. The defendant sought to control its distribution under the cosmetics directive. It was held that the two regimes were distinct, and the medicines directive was specifically disapplied to cosmetics. The central purpose of the product was to improve the appearance of teeth, and that fell squarely within the cosmetics directive, and the product had been properly regulated.
Lord Slynn of Hadley, Lord Steyn, Lord Hope of Craighead, Lord Clyde, Lord Hutton
Times 02-Jul-2001, [2001] UKHL 32, (2001) 61 BMLR 10, [2001] 3 CMLR 1
Bailii, House of Lords
Council Directive 93/42/EEC the Medical Devices Directive
England and Wales
Updated: 03 September 2021; Ref: scu.84471
