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          ECHA Proposes Adding 3 New Substances to SVHC List

          from CIRS by

          On September 1, 2025, the European Chemicals Agency (ECHA) initiated a public consultation under the EU REACH Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) regarding proposals to list three substances as Substances of Very High Concern (SVHCs). Stakeholders may submit scientific or technical comments by October 16, 2025.

          The latest list of SVHCs can be searched here via our free tool ChemRadar.

          The proposed substances are:

          Name
          EC Number
          CAS Number
          Reason for proposing
          4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts--Toxic for reproduction (Article 57c)
          4,4'-methylenediphenol210-658-2620-92-8Toxic for reproduction (Article 57c)
          n-hexane203-777-6110-54-3Specific target organ toxicity after repeated exposure (Article 57(f) - human health)

          Obligations for Companies When Products Contain SVHCs

          1. Provide Safety Data Sheets (SDS) to downstream users when SVHCs are sold individually.
          2. Provide SDS if SVHCs are present in mixtures at concentrations ≥0.1%.
          3. Provide detailed information free of charge within 45 days to downstream users or consumers if SVHCs exceed 0.1% (w/w) in articles.
          4. Notify ECHA within six months if an article contains >0.1% (w/w) of a single SVHC and the annual export volume exceeds 1 ton.
          5. Submit SCIP notifications for articles containing SVHCs >0.1% since January 5, 2021, in compliance with the EU Waste Framework Directive (WFD).

          CIRS Insights

          SVHCs typically include CMR 1A/1B substances (carcinogenic, mutagenic, or toxic to reproduction), PBTs (persistent, bioaccumulative, and toxic), vPvBs (very persistent and very bioaccumulative), and substances with equivalent hazards (e.g., endocrine disruptors). These substances are often considered potential candidates for the REACH Authorization List. Once listed as SVHCs, the likelihood of their eventual inclusion in the Authorization List increases significantly.

          About CIRS

          CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to EU REACH, CLP, GHS, TSCA, and K-REACH. Our chemical compliance services in the EU cover:

          If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

          Further Information

          ECHA

            

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