WRITTEN QUESTION E-2053/99

by Kyösti Virrankoski (ELDR) to the Commission

(3 November 1999)

Subject: Plastics used in dentistry

Is the Commission aware that the American-made PVC bite plane used in orthodontic treatment for children and young people contains the compound DOP (di-octylphthalate) which is harmful to health?

The PVC product softened with DOP dissolves in the mouth, and in animal experiments it has been shown to cause weight loss, enlargement of the liver and nervous and skeletal abnormalities. It has also been shown to stunt growth.

The DOP compound contained in PVC has been identified beyond doubt in Finland in two expert analyses at VTT (the State Technical Research Institute plastics laboratory) and TTK (Tampere Technical University plastics technology).

In Finland the medical administration has banned the use of film wrappers containing softeners in the packaging of fatty foodstuffs because of the solubility of the softener. The same compound hazardous to health is also used in toys and childcare items for children under the age of 3. The Council of State in Finland has also formally banned the use of phthalates suspected of being harmful as softeners in the above-mentioned products with effect from the beginning of November.

In the USA, the risks of phthalate softeners have been made clear and the major toy manufacturers have stopped using softeners in toys which may be placed in the mouth.

Bite planes are kept in the mouth for two or three years, for around 10 to 12 hours per day. In Finland it is estimated that some 50 000 patients have these potentially dangerous bite planes in their mouths. On this basis we may estimate that millions of people in the EU Member States are using this kind of appliance.

Because this is an important matter for public health, I should like to know what measures the Commission proposes to take in this connection.

Even if the potentially dangerous raw material currently in use were to be prohibited in bite planes, no treatment problems would arise, since a completely stable and harmless alternative has been discovered.

Answer given by Mr Byrne on behalf of the Commission

(16 December 1999)

Orthodontic devices are covered by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1). They are manufactured as custom made devices from intermediate products, such as plastics, specifically intended by the manufacturer for this purpose. The intermediate products must meet the provisions for medical devices as contained in the directive, including the essential requirements. The essential requirements detail the requirements which a medical device must meet, including a risk/ benefit analysis and specific elements related to bio-compatibility and toxicity of the materials.

The Commission is aware that a variety of materials are used in orthodontic treatment including a number of plastics. Typically, in orthodontic applications materials such as ethyl vinyl acetate (EVA) and poly-methyl-methacrylate( PMMA) are used. Plastics containing phthalates may be used in dentistry for certain applications such as checking the bite or for relining dentures but it is assumed that such 'soft' materials would have a limited utility for long term orthodontic work.

The Commission does not currently have specific information concerning the risk presented by di-octyl phthalate (DOP) in orthodontic applications. Phthalates used as plasticizers in polyvinyl chloride (PVC) toys and childcare articles are other than DOP. Nevertheless, the Commission has proposed, that all relevant phthalates that could be used as plasticizers in PVC toys, of which di-octyl phthalate is one, should be banned for use in toys intended to be put in the mouth by small children.

The Commission will seek further information, from amongst others the Finnish authorities, and ask the scientific committee's advice if it appears necessary.

(1) OJ L 169, 12.7.1993.