Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Tooth Bleaching Products - Medical Devices or Cosmetic Products? ***

Dr. Jutta Lange (Abschlußjahr: 2005)

The basis used by the German Courts in coming to a judgement is, in any case, the LMBG, which constitutes the implementation of the EC Cosmetics Directive to German Law. However, the wording of the definition here is not exactly identical with that of the CD 76/768/EEC.The Administrative Court of Düsseldorf firstly deal with the disease term and comes to the decision that intrinsic discolouration, which is clearly visible to the naked eye, constitutes a disease. In establishing the predominant intended purpose, the Court comes to the conclusion, on the basis of the assessment criteria of concentrations of active substances and indications for use in the instructions for use, that there is a predominantly medical intended purpose and the products are therefore not cosmetics, but medical devices. The author cannot accept these arguments. Neither can the disease term that was taken as a basis be applied to all intrinsic discolouration, nor do the assessment criteria lead to a predominantly medical intended purpose.
The Higher Administrative Court of NRW, in coming to its decision, primarily deals with the cosmetic purpose on the basis of the criterion “external”. The Court comes to the conclusion that, based on the “internal mode of action” of the products, there is no “external application”, and therefore also no cosmetic intended use is present. Furthermore, the Court substantiates its judgement with the unsuccessful efforts at an alteration in the Cosmetics Directive. This would show that the products are not supposed to be cosmetics. In the authors opinion, the wording of the German definition was falsely interpreted by the Court, and the wrong conclusion drawn from the arguments.

The English Courts, the Supreme Court of Judicature and the House of Lords, are revising the arguments of the Royal Court of Justice (1st instance). Firstly, it is emphasised that the word “and” in the definition “the teeth and the mucous membranes of the oral cavity“ is meant in a disjunctive sense, and not in a conjunctive sense. After all, the listing after “human body“ is also meant disjunctively. It is thus sufficient if the products are intended solely to be used on the teeth. The first instance argument, that the expression “changing appearance” in the context of “cleaning, perfurming,...”, as well as the list of examples of cosmetic products in Annex I CD would show that the effect of cosmetic products is “temporary, superficial and reversible”, is irrelevant, as it is not the effect that would be concerned, but the intended purpose. The argument that tooth-bleaching agents are supposed to be intended for “to ameliorate a troublesome condition...” does not contradict the use of cosmetics. Many cosmetic products, such as, for example, face creams, are intended for the purpose of dealing with troublesome conditions. That the product has been “implanted” when bleaching non-vital teeth (this is excepted in the 5th recital of the CD) can likewise not be accepted by the Courts, as the product has been washed out again prior to filling the teeth. Thus, the appeal Courts come to the conclusion that the definition of a cosmetic product is fulfilled. With regard to a medical purpose, the Courts also argue that the products would not be used to treat or alleviate a disease, but to treat the consequences of a disease. Tooth discolouration rather concerns a social handicap. In addition, it is evident from the labelling, the instructions for use and the advertising material that the purpose of the products is supposed to be the bleaching of dark teeth. Consequently, the tooth-bleaching agents are cosmetic products. The author can only go along with the argumentation of the Supreme Court of Judicature and the House of Lords.

Finally, the author comes to the conclusion that tooth-bleaching agents are cosmetic products. This opinion is also represented by the EU Commission. On 20. October 2004, at a joint meeting in Brussels of the national and EU Commission experts from the authorities for medical devices and those for cosmetics, it was decided that tooth-bleaching products are exclusively intended for the bleaching of teeth and do not possess any medical intended purpose, and therefore are cosmetic products. The EU and national entities decided to initiate harmonisation efforts for tooth-bleaching products within the EU, with the aim of being able to classify such upon the revised EC Directive 76/768/EEC coming into force. This process could still last another two to four years. The reason for this is the lack of consensus regarding the maximum permitted concentration of peroxides and placing warnings on the products.