November 22, 2024 by Becky Brown
New hazard classes have been introduced under Classification and Labelling (CLP) regulations to cover endocrine disruption (ED), Persistence, Bioaccumulation and Toxicity (PBT) and Persistence, Mobility and Toxicity (PMT) and, last week, the new guidance for complying with the new classification for endocrine disruption (ED) criteria was published.
For ED, substances are to be classified separately for human health and the environment. Substances will be classified based on available data as confirmed or suspected ED, not ED, or not enough information to classify.
Owen Green (toxicologist) and Becky Brown (ecotoxicologist) were part of the partner expert group commenting on the preparation of the ED part of the guidance. Despite extensive input from a range of stakeholders the guidance remains sufficiently open that identification of ED substances could be controversial in many cases with category 2 classification being applied where there are uncertainties. Uncertainties might include scenarios where the strength of evidence for a biologically plausible link to endocrine activity is not considered insufficient, where the available data are of restricted reliability or are conflicting, or where there are not enough data for classification as category 1.
We foresee other issues with applying the new guidance as follows:
- High numbers of substances for evaluation;
- For some substances there will be insufficient substance specific data to classify, whereas for others there will be large datasets of conflicting information;
- Read across to a worst-case substance (a strategy routinely used for risk assessment purposes under REACH) could lead to unsubstantiated ED concerns;
- There is a lack of guidance regarding classification of substances which are UVCBs (substances of unknown or variable composition, complex reaction products or of biological materials),
wca has been working with partners to develop strategies for ED classification for industrial chemicals including UVCB substances. The approaches are aimed at prioritisation, tiered assessments and gathering data for read across strategies focused on potential endocrine mechanisms. If you would like to learn more about our approaches or need help classifying your substances for ED please don’t hesitate to contact us.
Image credit: iStock.com/GlobalP