16 October 2018

Legal acts

Legal acts

and repealing Regulation (EC) No 1102/2008
Article 10

Dental amalgam
From January 1, 2019

1. From 1 January 2019, the dental amalgam is used only in the form of an encapsulated dose. Dentists are not allowed to use mercury in non-encapsulated form.
From July 1, 2018

2. From 1 July 2018 dental amalgam may not be used in the treatment of deciduous teeth, in the dental treatment of children under 15 years of age and pregnant or nursing women, except when the dentist deems it absolutely necessary due to special medical needs of the patient.
Until 1 July 2019

3.On 1 July 2019, each Member State shall draw up a national plan regarding the measures it intends to implement to gradually reduce the use of dental amalgam. Member States shall make their national plans publicly available on the internet and forward them to the Commission within one month of their adoption.
From January 1, 2019

4. From 1 January 2019, operators of dental offices where dental amalgam is applied or in which dental amalgam fillings are removed or teeth containing such fillings provide their offices with amalgam separators for the purpose of retaining and collecting amalgam particles, including particles found in used water.

These entities shall ensure that:

(a) amalgam separators put into service from 1 January 2018 ensured retention of at least 95% of the amalgam particles;
On January 1, 2021

(b) from 1 January 2021, all amalgam separators in use ensured that the amalgam particles were retained at the level specified in point (a). and).

Amalgam separators must be maintained according to the manufacturer’s instructions to ensure the highest practicable level of amalgam retention.

5. Amalgam amalgam caps and separators conforming to European standards or with other national or international standards ensuring an equivalent level of quality and retention are deemed to meet the requirements set out in paragraph 1 and 4.

6.Deachers of dentists ensure that their amalgam waste, including amalgam residues, its particles, fillings once with teeth, or parts thereof, contaminated with dental amalgam, was performed and collected by an authorized plant or company specializing in waste management.

In no case may dentists release – directly or indirectly – such amalgam waste into the environment.

EU regulation on mercury