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 patients. Dental amalgam has been used for over 150 years for the treatment of dental cavities and is still used, in particular, for the treatment of large cavities due to its excellent mechanical properties and durability. Dental amalgam is a combination of alloy particles and mercury and contains about 50% of mercury in the elemental form. Overall, the use of alternative materials such as composite resins, glass ionomer cements, ceramics and gold alloys, is increasing, either due to their aesthetic properties or alleged health concerns in relation to the use of dental amalgam. On 28 January 2005, the Commission adopted the Communication to the Council and the European Parliament on a Community Strategy Concerning Mercury.^The Strategy addresses most aspects of the mercury life cycle. Its key aim is to reduce mercury levels both in relation to human exposure and the environment. It identifies twenty priority actions to be undertaken, both within the EU and internationally. The Strategy was welcomed by Council Conclusions on 24 June 2005 as well as by a European Parliament Resolution on 14 March 2006. 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. The Commission services consulted two Scientific Committees on the use of dental amalgam, the Committee for Environmental and Health Risks (SCHER) and the Committee for Emerging and Newly Identified Health Risks (SCENIHR). The opinions of both Committees were not conclusive regarding the appropriateness of additional regulatory measures to restrict the use of dental amalgam.^Concerning the environmental aspects, the SCHER opinion concluded that on the basis of the information available, it was not possible to "comprehensively assess the environmental risks and indirect health effects from use of dental amalgam in the Member States of the EU 25/27", and identified a number of gaps that need to be addressed.