Answer given by Mr Dalli on behalf of the Commission

17.12.2010

The Commission is aware that some organisations are calling for a ban on dental amalgam. It should be noted though that other organisations take the opposite view, such as in the recently adopted Resolution of the Council of European Dentists on dental amalgam, according to which, dental amalgam continues to be the most appropriate filling material for many dental restorations.

According to the scientific opinion adopted by the Scientific Committee for Emerging and Newly Identified Health Risks (SCENIHR) in May 2008, dental amalgam is an effective restorative material and may be considered as the material of choice for certain restoration. Some local adverse effects are occasionally seen with dental amalgam fillings, including allergic reactions, but the incidence is low and normally readily managed.

According to SCENIHR, all dental materials may be associated with very low rates of local adverse effects with no evidence of systemic disease. Alternative materials are not without clinical limitations and toxicological hazards. Whereby dental amalgam are well known compounds on which extensive studies have been carried out, information is still missing on the full composition and exposure to certain alternative materials.

Based on current scientific knowledge, the Commission sees no sufficient justification to propose measures restricting the use of dental amalgam for human safety reasons. Any legislative proposal stipulating restrictive measures would need to be built on reliable data and evidence as well as on a robust impact assessment.

The Commission will monitor scientific developments in this field and will re-examine its position in case further evidence becomes available.