About this Publication on Dental fillings: a concern for your health?

1. Source for this Publication
   
2. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)
   
3. Background to this SCENIHR opinion
   
4. Specific questions asked by the European Commission to the SCENIHR
   

1. Source for this Publication

This publication is a summary of the opinion “The safety of dental amalgam and alternative dental restoration materials for patients and users” produced in 2015 by the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) of the European Commission.

Levels 1 & 2 were written by the GreenFacts editorial team and the DG Health and Consumers of the European Commission. This publication is produced by GreenFacts under a contract from the DG Health and Consumers of the European Commission.

2. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)

The Committee provides opinions on emerging or newly-identified health and environmental risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies.

For further information on the SCENIHR, see:
http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm 

3. Background to this SCENIHR opinion

Dental amalgam and its substitutes are regulated under Council Directive 93/42/EEC concerning medical devices, according to which they must comply with the essential requirements laid out in the directive, in particular in relation to the health and safety of the patients.

In January 2005, the Commission adopted a proposal for a Community Strategy concerning Mercury in order to reduce mercury levels in the environment and human exposure. Pursuant to Action 6 of the Strategy, the use of dental amalgam should be evaluated with a view to considering whether additional regulatory measures are appropriate.

In view of the above, the Commission requested the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of dental amalgam and alternative dental restoration materials. According to the SCENIHR opinion adopted in May 2008, dental amalgam is a safe material to use in restorative dentistry for patients. No health risk other than allergic reaction in certain individuals can be associated with the use of dental amalgam. The alternatives are not without clinical limitations and toxicological risks, and less is known about these alternatives for which available scientific data are more limited.

4. Specific questions asked by the European Commission to the SCENIHR

The SCENIHR is asked the following questions:

1. Is there any new scientific evidence that justify reasons for concern from the health point of view in the use of dental amalgam as dental restoration material?
2. In view of the above, is the use of dental amalgam safe for patients and users, i.e. dental health professionals? Are certain populations particularly at risk, e.g. pregnant women or children? Is it possible to recommend certain practices to minimize patient's and user's exposure to dental amalgam?
3. Is there new scientific evidence on the safety and performance of alternative materials?
4. Is it possible to recommend alternative materials and certain practices related to these materials to reduce potential risks for patients and users?
5. In case there is not enough scientific data to answer these questions, the SCENIHR is asked to formulate recommendations for research that could help to provide the necessary data

Read the summary...