WRITTEN QUESTION E-0004/00

by Bart Staes (Verts/ALE) to the Commission

(19 January 2000)

Subject: Cobalt and nickel used in dentistry

Scientific research shows that more and more people are sensitive to heavy metals such as cobalt and nickel. Cars, industry and modern farming are some of the causes of the increasing number of heavy metals in food. Recent research in France has shown a link between heavy metals (nickel, copper, cobalt and aluminium, along with sulphate) in drinking water and Alzheimer's disease. Since the human body needs only a small amount of these metals, the remainder is stored and this results in allergies.

Cobalt and nickel are frequently used in dentistry. Hypersensitive patients suffer as a result. From the public health point of view, it would be better to use healthier alternatives such as covering dentures with a complete non-corroding, wear-resistant coating. All too many dentists and laboratories argue that a coating is not necessary because there is no obligation. Nevertheless, directive 92/59/EEC(1) bans the use of products which are dangerous to the health and safety of consumers.

1. Has the Commission had any scientific research carried out into the increasing sensitivity to cobalt and nickel, in particular when they are used in dentistry? If so, what are the findings of this research? If not, is the Commission prepared to have such research carried out in view of the adverse effects on public health?

2. Is the Commission prepared to make use of cobalt and nickel in dentistry dependent on the obligatory covering of dentures with a complete non-corroding, wear-resistant coating, in view of the adverse effects on public health and the European ban on products which are dangerous to the health and safety of consumers (directive 92/59/EEC)? If not, what is the Commission's justification for the continued use of cobalt and nickel in dentistry without covering dentures with a complete non-corroding, wear-resistant coating?

(1) OJ L 228, 11.8.1992, p. 24.

Answer given by Mr Liikanen on behalf of the Commission

(16 March 2000)

1. The Commission ordered in December 1994 a study on dental amalgam and alternatives, products covered by the medical devices Directive 93/42/EEC(1), and which was performed by an ad hoc working group. Members included experts representing Member States' ministries of health, scientists from different European universities, industry representatives, medical professionals, dentists' professional associations and two experts from the United States department of Health and Human Services.

The study, aimed at assessing the potential risks that might put into jeopardy a high level of health protection for patients and consumers, focused on dental amalgam, composite resins, coating and on the biocompatibility and toxicological aspects of a number of alloys used in dentistry, in particular those based on nickel, palladium, silver, gold, cobalt.

The main conclusions of the report indicate that all dental restorative materials, including dental amalgam as well as its alternatives, i.e. alloys or resins, have the potential to cause some adverse reactions. The casting alloys have the potential to cause allergy. It is believed that dental casting alloys, whilst eliciting reactions in sensitised individuals, do not generally induce sensitisation. Allergic reactions to metal alloys, however, are rarely reported. Problems are usually resolved following the removal of the material. The prevalence of adverse effects related to dental restorative materials and patients is generally low. Available data is sparse; literature overviews and research articles indicate this to be less than 0,1 % of the general population. The risk-benefit ratio corresponds to the currently acknowledged and accepted state of the art.

The standards that support Directive 93/42/EEC represent the current state of the art. The Commission therefore considers that this Directive provides an appropriate legal framework for dental restorative materials, and that no modification of this legislation is needed at this stage. Nevertheless, the Commission will closely follow the development of scientific knowledge in this area and draw appropriate conclusions as concerns Directive 93/42/EEC.

2. Directive 92/59/EEC, on general product safety, defines in its article 2 a) safe product as any product which mldr does not present any risk or only the minimum risks compatible with the product's use, considered as acceptable and consistent with a high level of protection for the safety and health. At this stage the scientific data available do not permit the conclusion that the use in dentistry of cobalt and nickel is incompatible with the definition of safe product of the Directive, taking also into account the benefits of such use. Therefore, the Commission does not plan action at this stage concerning the use of cobalt or nickel alloys without coating. However, the Commission will carefully follow the development of the scientific knowledge in this area.

(1) OJ L 169, 12.7.1993.