Endocrine Disruptors - Regulatory and Testing Update

Endocrine Disruptors - Regulatory and Testing Update

The Akademie Fresenius Endocrine Disruptors Conference was held virtually in November 2021.
Several Smithers ecotoxicologists participated in the discussion about regulatory changes to the endocrine requirements under Biocidal Products Regulation (BPR), REACH, and Classification, Labelling and Packaging (CLP). Conference topics also covered interesting developments in endocrine disruptor testing methods. For more details about these topics, contact experts Lee Sayers or Tracey Goodband.   
Conference Highlights:
  • The EU continues to make changes according to the Chemicals Strategy for Sustainability (CSS) which impact the need for testing in order to fully evaluate the potential of a test substance to be considered an endocrine disruptor (ED) 
  • Amendments to the regulatory requirements for REACH and CLP are being planned, in addition to the changes to the BPR that have been finalized
    • Endocrine investigation is now a core requirement for BPR and will likely also be required under REACH, with substances considered to be an ED classified as Substances of Very High Concern
  • A distinction between human health and environmental impacts, with a further distinction between substances that are suspected to be ED and substances that are considered to be ED, are part of the ongoing discussion
  • Discussion of industry concerns over the developing strategies
  • The continuing efforts by OECD to harmonize and approve applicable guidance documents in the ED realm
  • Developments in thyroid evaluation in fish studies  
As with the endocrine guidance that already exists for biocides and agrochemicals, there is no clear or direct set of testing requirements, so an evaluation of each test substance needs to be performed based on existing data and known modes of actions. Also, while efforts are still being made to develop in vitro screening tests/guidelines, it is currently unclear if these will form part of the ED assessment from a regulatory point of view.

Smithers has extensive experience in endocrine testing, including long-term fish studies and amphibian work. Our experts can work with you to develop a tailored testing strategy.
For a more comprehensive discussion of these topics or your testing needs, contact us to schedule a call.

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