Answer given by Mr Verheugen on behalf of the Commission
The Commission has recently considered the issue of dental amalgams and their possible effects on health in light of the most up-to-date scientific knowledge. On 6 May 2008 the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted an opinion(1) on the safety of dental amalgam and alternative dental restoration materials for patients and users. According to SCENIHR, there is no evidence for a causal relationship between dental amalgam and autism. In addition, SCENIHR does not consider that the current use of dental amalgam poses a risk of systemic diseases, including Alzheimer's disease.
According to this scientific opinion, the main sources of mercury in the environment are natural ones (e.g. emissions from volcanoes, combustion of fossil fuels) or linked to certain industrial activities. In addition, it was noted that the exposure to mercury depends on various factors, including in particular the accumulation of some mercury compounds in the aquatic food chain, but also on ambient mercury levels (determined by geographical location and life-style choices), the diet, the possibility of occupational exposure for those who work in mercury-related industries and practices, and the use of mercury containing medical or cosmetic products, including amalgam.
According to the SCENIHR, the main exposure to mercury in individuals with amalgam restorations occurs during the placement or removal of the fillings. However, according to SCENIHR, the exposure levels in individuals with amalgam fillings are between 5 and 30 times lower than those permitted for occupational exposure.
SCENIHR concluded that dental amalgam is a safe material to use in restorative dentistry with respect to patients. Dental health is an extremely important component of general healthcare and the benefits of amalgam to individuals presenting dental caries far outweigh the very low level of risk associated with allergies.
With regard to alternative materials, SCENIHR stated that although there are well recognised cytotoxicity and mutagenicity profiles for some of the chemical substances used in alternative materials, there is no evidence for any adverse clinical effects associated with such substances, apart from a very low incidence of allergies.
As a general principle, the relative risks and benefits of using dental amalgam or the various alternatives should be explained to patients to assist them to make informed decisions. In both cases, as with any other medical or pharmaceutical intervention, caution should be exercised when considering the placement of any dental restorative material in pregnant women.
For preparing its opinion, SCENIHR took into consideration the academic and scientific literature available during the time of the development of the opinion, as well as the contributions received through the call for information and public consultation published on the website of the Directorate-General for Health and Consumers (DG SANCO). During these two procedures, all interested parties had the opportunity to provide their comments and/or any further relevant information regarding the opinion.
In light of the above and after taking account of the SCENIHR’s opinion that, on the basis of the available data and current knowledge, there is no risk of systemic disease linked to the use of dental amalgam, the Commission cannot justify action to ban such use. However, it will be prepared to reconsider its position if any new data are published which provide grounds for a new risk assessment of dental amalgam.
The Commission has not received any notification from Luxembourg on a possible new ban on the use of dental amalgam in application of the procedure provided for by Directive 98/34/EC of the Parliament and of the Council(2).
According to SCENIHR, there is few if any advantages to carrying out further research on aspects of the safety of dental amalgam restorations. The lack of data on the toxicity, exposure and health effects of the alternative materials does imply, however, that more experimental, clinical and epidemiological research is required to guarantee patient safety in the future. Research on dental amalgams and on materials for their replacement has been supported since the 3rd framework programme. Recently, two projects received Commission support under the 6th framework programme.
Directive 98/34/EC of the Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations. OJ L 204, 21.7.1998.