September 19, 2019

September 19, 2019

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ECHA Publishes Substance Evaluation Conclusion for Silver

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:

Conclusions Tick 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)  
Restrictions  
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.

©2019 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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