Endocrine Disruption in 2022 and a look ahead to what’s coming in 2023

2022 was the year we expected to see the most significant updates to Endocrine Disruption assessments for REACH and BPR in over 5 years. We look back what 2022 brought and take a look ahead to the changes we can expect to see in 2023.

Concentration limit for Co-formulants in Biocidal products: All co-formulants (non-active substances) will now be subject to an endocrine disruption assessment. However, the concern is only for those identified as ED if they are present either individually at >0.1% or collectively are >0.1% of the product. This update will align the BPR more with REACH.

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The Rapid Androgen Disruption Activity Reporter (RADAR) test: RADARdeveloped by French biotech company Laboratoire WatchFrog has now been published as an OECD test guideline for identifying substances acting on androgen receptors. This screening test uses transgenic Japanese medaka fish embryos and fits into Level 3 of the OECD conceptual framework.

Learn more. 

Fresenius Endocrine Disruption, November 2022: We attended an informative and interesting Fresenius conference on Endocrine disruption where our own Charles Hazlerigg presented how modelling can be used to assess population relevance of endocrine active chemicals. In PPP and biocides, the identification of endocrine substances includes the caveat that for non-target animals, adverse effects should be relevant at the (sub)population level. Charles presented 2 case studies of how conservative population modelling can be used in active substance renewals, in the spirit of the guidance as a hazard assessment.

Looking forward to 2023

ECHA have indicated that CLP’s new hazard classes for endocr

ine disruption is scheduled to enter into force in Q1/Q2 2023. The new classes are for Known or Presumed Endocrine Disrupters (category 1), and Suspected Endocrine Disruptors (category 2) depending on how sufficiently convincing the evidence is. There is significant concern and uncertainty on what will constitute ‘sufficiently convincing’, and therefore guidance will be required. Concerns on whether non-animal testing could be accepted as evidence for classification has been addressed in an update to the draft to include that for Cat1, evidence may be from non-animal data providing an equivalent level of detail as human and animal data.

There will also need to be some consideration of how these new known/presumed EDs and Suspected EDs classes will be considered in biocides and PPPs which already have their own data requirements and regulatory guidance.

While the EU is developing these new hazard classes in CLP (along with PBT, vPvB and PMT and vPvM substances), the EU is also pushing for the UN to include them in the Globally Harmonized System (GHS) to maintain global harmonisation.

Proposed REACH revisions are expected to be published early 2023, with commission adoption aimed for Q4 2023, and are likely to include requirements for data on EDCs, using a tiered approach starting with in vitro screening tests before in vivo testing is triggered. Chemical Watch speculates that registrants will first generate ED data under REACH, which will then be used in the weight-of-evidence assessment for CLP purposes, and that will inevitably lead to the classification of many substances as EDCs.

Chemical watch article

For more information on how you can navigate the ever-evolving world of Endocrine Disruption or to discuss your requirements, contact us today to see how we can support you.