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Parliamentary questions
4 July 2008
Answer given by Mr Verheugen on behalf of the Commission

1. According to the Scientific Committee on Emerging and Newly Identified Health Risks (Scenihr) final opinion adopted on 6 May 2008, there is no scientific evidence to support a connection between dental amalgam and conditions such as Alzheimer’s, autism and developmental disorders in children. The Scenihr opinion is strictly limited to the effect of mercury containing dental amalgam on patients and dental professionals.

Regarding the environmental risk and indirect health effect of dental amalgam, according to the opinion of the Scientific Committee on Health and Environmental Risks (SCHER), also published on 6 May 2008, the main environmental concern of dental amalgams is methyl mercury. The indirect exposure of humans to methyl mercury from dental amalgams is well below tolerable limits, thus indicating a low risk for serious health effects based on predicted contribution of amalgam uses to body burdens of methyl mercury. However, it should be noted that this screening assessment covers exclusively the release of mercury from dental clinics wastewater.

The SCHER based its opinion on an evaluation of reports prepared by Germany, Denmark and Sweden on the environmental risk and indirect health effect from the use of dental amalgam in these countries, on information on risks related to mercury available from the other Member States of the European Union, on contributions received through the call for information published on the website of the Directorate-General responsible for Health (DG SANCO) from 26 April to 4 June 2007 and on available academic review.

The Scenihr and the SCHER required additional information and comments from stakeholders and the general public prior to the final adoption of these two scientific opinions. Scientists based in Freiburg contributed to the two public consultations. All contributions received during the calls for information and the public consultations on the two preliminary scientific opinions were taken into consideration by the Scientific Committees prior to the adoption of their final opinions.

In view of the above and based on existing data and science, the Commission cannot conclude that a connection between dental amalgam and the conditions described by the Honourable Member has been established.

2. According to Scenihr, the available academic studies on human population, including some very recent epidemiological studies, do not allow to conclude that the mercury in dental amalgam has a causative role in disease. The opinion does not mention that additional long term studies would be necessary to reach that conclusion.

3. In 2002, the Commission has been notified — under the information procedure laid down by Directive 98/34/EC(1) — of the envisaged Danish measure referenced under 2002/0421/DK(2). The Commission raised questions with regard to the Danish measure, but did not oppose it formally. However, the measure taken by Denmark was exclusively based on environmental considerations under specific environmental circumstances. The fact that the Commission did not oppose the Danish measure in 2002 does not imply any recognition of health risks for patients caused by mercury in dental amalgam. In line with Directive 98/34/EC, the Danish authorities communicated to the Commission the final adopted text of their measure.

The Commission has been notified in February 2006 — under the information procedure laid down by Directive 98/34/EC — of two envisaged Swedish measures on mercury, referenced under 2006/0081/S and 2006/0102/S(3). The Commission reacted against the planned Swedish measures and as a result Sweden postponed its entry into force of the planned measures for 12 months, since elements of the measures were covered by a proposal for a directive amending Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury — in the meantime adopted(4). As the draft measures appeared to contradict certain provisions of Community law, the Commission also sent a detailed opinion to Sweden which mentioned notably the issue of dental amalgams. To date, the Swedish authorities have not yet communicated the final adopted text of their measures to the Commission.

4. According to Scenihr, dental amalgam is an effective restorative material and may be considered the material of choice for some restorations; the alternative materials are not without clinical limitations and toxicological hazards. Whereby dental amalgams are well known compounds on which extensive studies have been carried out, information is still missing on the full composition of and exposure to certain alternative materials.

With respect to dental amalgam and populations at risk, there is no evidence that infants or children are at risk of adverse effects arising from the use of dental amalgam, the most recent studies failing to find any association between the use of amalgam and impaired neuropsychological development in children. There is a lack of information about effects in pregnant women. However, according to the Scenihr opinion, there is no evidence to suggest that pre-existing amalgam restorations pose any risk to the health of such women or the developing foetus. It is recognised that dental personnel may be at greater risk with respect to mercury exposure than the general population; however, the incidence of reported adverse effects is very low.

According to the communication from the Commission on the precautionary principle adopted in 2000(5), the recourse to the precautionary principle is justified when potentially dangerous effects have been identified, scientific evidence does not allow the risk to be determined with sufficient certainty, and the potentially dangerous effect may be inconsistent with the high level of protection chosen for the Community. In view of the above, the Commission does not intend to propose the application of the precautionary principle to dental amalgam. This position is subject to review in case of new scientific evidence.

5. The Commission has naturally carefully considered the Parliament's wish for a legislative proposal aimed at limiting the use of dental amalgam to be presented before the end of 2007. However, such a measure would have to be justified on the ground of health or environmental risks.

For the reason stated under 4, the Commission is not in possession of sufficient justification to propose measures limiting the use of dental amalgam, based on the current state of science and knowledge. The Commission will monitor scientific developments in this field and will re-examine the need to take necessary measures in case further scientific evidence becomes available.

6. On the basis of available information and science, the Commission considers it is thus inappropriate to ban dental amalgams for the following reasons: dental amalgam is an effective restorative material and may be considered the material of choice for some restorations in posterior teeth; according to the overwhelming majority of the scientific community, no health risk for patients other than allergic reactions in certain individuals can be associated to the use of dental amalgam, potential risks of alternatives have not yet been fully examined. The Commission will re-examine its position in case new data on the potential health and environmental risks of dental amalgam become available.

(1)Directive 98/34/EC of 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.
(2)For further information, see weblink: http://ec.europa.eu/enterprise/tris/pisa/app/search/index.cfm?fuseaction=advanced&lang=de
(3)For further information, see weblink: http://ec.europa.eu/enterprise/tris/pisa/app/search/index.cfm?fuseaction=advanced&lang=de
(4)Directive 2007/51/EC of Parliament and of the Council of 25 September 2007 amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury, OJ L 257, 3 October 2007.
(5)COM(2000)1 final.

OJ C 999, 01/01/2009
Last updated: 4 August 2008Legal notice