rec_22

(22) Only pre-dosed encapsulated dental amalgam should be allowed for use, and the use of amalgam separators in dental facilities in which dental amalgam is used or dental amalgam fillings or teeth containing such fillings are removed should be made mandatory, in order to protect dental practitioners and patients from mercury exposure and to ensure that the resulting waste is collected and disposed of in accordance with sound waste management and under no circumstances released into the environment. In this respect, the use of mercury in bulk form by dental practitioners should be prohibited. Amalgam capsules such as those described in European standards EN ISO 13897:2004 and EN ISO 24234:2015 are considered to be suitable for use by dental practitioners. Furthermore, a minimum level of retention efficiency for amalgam separators should be set. Compliance of amalgam separators should be based on relevant standards, such as European standard EN ISO 11143:2008. Given the size of economic operators in the dentistry sector affected by the introduction of those requirements, it is appropriate to provide sufficient time to adapt to the new requirements.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.