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January 23, 2019

ECHA Publishes Substance Evaluation Conclusion for Silver

Lynn L. Bergeson Carla N. Hutton

The European Chemicals Agency (ECHA) announced on December 19, 2018, that it published several new substance evaluation conclusion documents, including one for silver.  Silver was added to the Community Rolling Action Plan (CoRAP) list in 2014 and evaluated by the Netherlands.  According to the substance evaluation conclusion and evaluation report, silver was originally selected for substance evaluation to clarify concerns about nanoparticles/ecotoxicity of different forms of the substance; environmental fate; exposure/wide dispersive use; and aggregated tonnage.  The scope of the substance evaluation was limited to the properties of and information on nanoforms of silver.  Thus the evaluation did not include a full evaluation of all elements of the registration dossiers, but was instead targeted to the characterization of the substance, environmental fate properties, environmental hazard assessment, and exposure assessment of the nanoforms of silver that are covered by the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier(s) submitted for silver.  The evaluation of the available information on silver led the Netherlands to the following conclusions:

ConclusionsTick box
Need for follow-up regulatory action at the European Union (EU) level     X
Harmonized classification and labeling (CLH)     X
Identification as substance of very high concern (SVHC) (authorization)
Other EU-wide measures
No need for regulatory follow-up action at EU level

The conclusion document notes that at present there is only a harmonized classification for silver nitrate.  According to Regulation (EC) No 1272/2008, Annex VI, silver nitrate is classified as Aquatic Acute 1 — H400 and Aquatic Chronic 1 — H410.  No M-factors are yet included.  In the registration dossier for silver nitrate, M-factors for acute and chronic of 1,000 and 100 are applied, respectively.  The conclusion document states:  “Based on the new data provided, there is no reason to classify the nanoforms of silver (EC No. 231-131-3) more stringently than silver nitrate.  In the registration dossier for the nanoforms of silver the same classification and M-factors are applied as those indicated above for silver nitrate.”  At present, the biocidal use of different forms of silver (including nanocomposite forms) and silver salts is being assessed by Sweden.  This will eventually result in CLH-proposals for each of these silver forms.  Currently, Sweden is in the process of deciding on a classification and labeling proposal for elemental silver.