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Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms.

February 1st, 2023

The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. See https://echa.europa.eu/nl/view-article/-/journal_content/title/9109026-268 According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. ECHA notes that the Partner Expert Group (PEG) members "actively contributed to the update." The changes to the Guidance on information requirements and chemical safety assessment: Appendix R7-1 for nanomaterials applicable to Chapter R7a Endpoint specific guidance include (see https://echa.europa.eu/documents/10162/17224/appendix_r7a_nanomaterials_en.pdf/1bef8a8a-6ffa-406a-88cd-fd800ab163ae?t=1671617922346&_cldee=7dTbbidfLKWiyq8QJBic1wl450vIYAJ8JvUHWogQQNOZkqcjc5fObWeAvyc-hHOE&recipientid=lead-5f1702cfc0e0e71180fa005056952b31-5213ef1df15541f5b2e3297168a7a6d8&esid=8bba1ff9-12a2-ed11-8145-005056b9310e ):

- Update of the advisory note on testing and sampling strategy and sample preparation for ecotoxicological endpoints:
-- Update and revision of Section 1.1 and subsections with 1.1.1. Characterisation of test materials, 1.1.2 Sample preparation of test materials, and 1.1.3 General considerations for Fate and (Eco)-Toxicological testing; and
-- Update of Glossary Section;

- Update of Section 1 for water solubility, granulometry, n-octanol/water partition coefficient (Kow), adsorption/desorption:
-- Addition of subsection for Section 1.2.1 Water solubility with waivers and dissolution rate;
-- Addition of subsection for Section 1.2.2 Partition coefficient n-octanol/water, with waivers and dispersion stability;
-- Addition of subsection for Section 1.2.4 Dustiness; and
-- Addition of subsection for Section 1.2.5 Adsorption/Desorption with waivers and alternative methods to organic carbon-water partition coefficient (Koc).

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