SETAC Europe 35th Annual Meeting

Navigating New Challenges and Divergences in Endocrine Disruptor Assessments Under European Regulations

Abstract: The recent release of ECHA's updated Classification, Labelling and Packaging (CLP) guidance introduces endocrine disruptor (ED) hazard classification. Although this updated CLP guidance works in conjunction with ED guidance already available for pesticides and biocides from ECHA EFSA (2018), the addition of ED hazard classification into CLP creates new challenges at every stage of the regulatory process. As CLP regulation does not require any new testing to be conducted to conclude a hazard classification for a substance, this updated guidance highlights the crucial role of Weight-of-Evidence (WoE) assessments in determining a chemical's ED properties. This is because of the CLP’s dependence on available data, which when sourced from the open literature can vary significantly in reliability and quality. Consequently, there's a pressing need for robust WoE methodologies and tools, especially for data-poor chemicals that lack regulatory studies or naturally interact with the endocrine system. Challenges with this updated CLP guidance also arise where it diverges from the ECHA EFSA (2018) guidance for pesticides and biocides. While the updated CLP guidance relies heavily on the pesticide and biocide guidance in some places, there are some major divergences between their approaches and classification of ED. For example, CLP introduces a new classification option of suspected ED, in addition to known or presumed ED in the pesticide and biocide guidance, but there is no clear guidance or worked examples provided on how to differentiate these options. The strength of evidence needed to distinguish between categories 1 and 2 will likely vary chemical to chemical, as data sufficiency will impact the WoE assessment. Additionally, the updated CLP guidance supports different tools and encourages classification based on New Approach Methodologies (NAMs) and other predictive data to be included in the WoE, as additional testing is not required. In this poster presentation these approaches to assessing ED under CLP, compared to the pesticide and biocide regulations, will be explored, with a focus on the use and role of WoE within each.

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Author(s):

Chloe Eastabrook Enviresearch United Kingdom This Author Is the Presenter

Gareth Le Page Enviresearch United Kingdom

Charles Hazlerigg Enviresearch United Kingdom