Silver

Silver and silver compounds have been registered under EU REACH. All these dossiers are now in the maintenance phase.

Substance Evaluation nanosilver

In 2014, silver was listed on the CoRAP (Community Rolling Action Plan) list for Substance Evaluation for concerns related to environmental behavior and ecotoxicity of nanoforms. The final decision was issued in June 2016 and requested information on ecotoxicity, physico-chemical properties and uses of nanosilver. Furthermore, if any of the ecotoxicity tests indicated a higher toxicity for the nanoform than for ionic silver, information on environmental fate of nanosilver had to be provided. The dossier has been updated in July 2017 with the information on ecotoxicity, physico-chemical properties and uses of nanosilver. Since the ecotoxicity tests did not indicate a higher toxicity for the nanoform than for ionic silver, further fate testing was not needed. The conclusions of the Substance Evaluation drafted by the Netherlands have been available since November 2018.  Substance evaluation – CoRAP.

Silver metal – harmonized classification

The classification of silver was adopted on 19 June 2024.

In June 2022, the European Chemicals Agency’s Risk Assessment Committee (RAC) adopted its opinion  on silver, which recommended a harmonised human health classification for reproductive toxicity (category 2 – fertility (H361F)) and Specific Target Organ Toxicity – Repeated Exposure (STOT RE category 2 (brain)) for nano-silver, silver metal (massive and powder forms) and a harmonised environmental classification for aquatic acute 1 and aquatic chronic 1 for silver powder and silver nano.

EPMF is disappointed that the RAC chose not to make a differentiation between silver metal (massive and powder) and nanosilver, despite scientific evidence presented to the RAC as part of the opinion making process. Our industry remains convinced that, based on scientific studies, a differentiation should be drawn between the behaviour of different forms of silver for human health endpoints and silver metal (massive and powder) should not have received the same harmonised classification for reproductive effects, nor for STOT RE than nanosilver. The EPMF position is available here.

The RAC opinion has been published on 8^th February 2023 on the ECHA website. It has been used by the Commission and EU Member States in developing an adaptation to Annex VI of the Classification, Labelling and Packaging (CLP) Regulation (22^nd ATP). The 22^nd ATP has been published on 30^th September.  The change in the harmonised classification of silver takes effect 1^st May 2026 with a Repro cat. 2 and STOT RE cat. 2 classification for human health.

The EPMF has contributed to several studies to generate data on silver metals and compounds.

• An Extended One-Generation Reproductive Toxicity (EOGRT) study with silver acetate was finalised and implemented in the REACH dossier.
• In line with the EU Biocidal Products Regulation (BPR), a 2-year carcinogenicity study with silver acetate was conducted. This has been finalised and will be implemented in the REACH dossier in 2026.
• Also in line with the EU BPR, an endocrine disruptor testing programme is ongoing for both human health and the environment. The results of these studies will be implemented in 2026.

Silver prioritisation process in the Water Framework Directive

Water Framework Directive (WFD) aims to protect inland surface waters and groundwater against pollution. The European Commission proposed to revise the list of pollutants affecting surface water and groundwater and to include silver on the Priority Substances list. The more detailed EPMF position with scientific findings can be found here.

Registration and Timeline

Silver and Silver Compounds Inventory
(Including Classifications and ID Cards)