Dental amalgams composed of 50% mercury, represent this element's most widespread use in the European Union and constitutes a significant environmental pollution source and a risk to human health. Consequently, the EU 2017/852 Regulation approved in 2017, has included several measures to progressively reduce the use of these amalgams and minimize their impact.

Therefore, in order to ensure that the resulting amalgam waste is collected and disposed of properly, the regulation lays down the mandatory use of amalgam separators to remove dental fillings of this material. In addition, it requires separators to guarantee the minimum retention efficiency level set out in the ISO 11143 standard (at minimum a retention of 95% of the amalgam particles).

From 1 January 2019, dental clinic operators must comply with the regulations and one way to demonstrate compliance are tests conducted by an ENAC-accredited laboratory.

Currently, there is no laboratory accredited for this activity, however, the market needs to have testing laboratories on filter amalgam separators which can certify proper operation according to the applicable law, so ENAC has stated that it is ready to receive applications for accreditation according to the UNE-EN ISO/IEC 17025 standard by any interested companies.

For further information, email Ismael García, ENAC's Department of Laboratories and Product Certification isgarcia@enac.es.