European Commission 6th Annual Forum on Endocrine Disruptors – key takeaways 

As ECHA have kept us on our toes with when exactly the final guidance document will be made public, it was good to hear that the document is in a publication queue at ECHA and is expected to be published in the next few weeks! Whilst explaining the two new hazard classes for ED (Cat 1 and 2), Paul confirmed that any substance classified as a Cat 2 ED will not face any regulatory impacts under the plant protection product and biocidal product regulations (PPPR and BPR) and that substances already assessed as an ED chemical under PPPR, BPR or REACH will be transferred over to a Cat 1 under CLP.

It was disappointing to hear that no worked examples are included in the final CLP guidance document to illustrate ‘Cat 2’ or ‘no classification’. This would have been useful given Cat 2 is a new option for environmental ED regulation, and the worked examples would have been helpful to demonstrate the burden of data required to separate a Cat 1 and Cat 2 classification conclusion. A worked example of ‘no classification’ due to other toxicity and a mode of action (MoA) analysis comparing an ED and non-ED MoA would also have been very beneficial to include, especially to many essential chemicals. During the Q&A it was discussed that once the first cases of Cat 2 substances are assessed by the Committee for Risk Assessment (RAC), they will gain experience and broaden the guidance. We can therefore expect that the CLP guidance version 2.0 will contain more clarifications and support when dealing with the potential grey area between Cat 1 and 2.

Over the last 18 months, experts at Enviresearch have been providing guidance and assistance to chemical industries in implementing these new criteria under CLP. We have already delved into available draft versions of the CLP guidance from ECHA and have ongoing projects where we are helping a range of industries to navigate the new classes and diverges from the ECHA EFSA guidance (i.e., two ED hazard options). The draft CLP guidance still relies heavily on the ECHA EFSA 2018 biocides and pesticides guidance to show how to complete a weight of evidence assessment, but the main divergence from the ECHA EFSA guidance is in how you classify whether it is presumed ED or suspected ED. We have significant expertise and experience using the ECHA EFSA 2018 guidance and performing ED weight of evidence assessment for the environment. We have applied this expertise to the new CLP regulation, as there is a tight turnaround from the final guidance document being released in November 2024 and the classification being mandatory from May 2025 for all new substances. Please get in touch with Adam Doxford if you’d like any advice or support navigating this new regulation and completing an ED assessment for a substance.