On November 13, 2024, the European Chemicals Agency (ECHA) published an update to its guidance on the Classification, Labelling, and Packaging (CLP) regulation. The update introduces classification of endocrine disrupting chemicals and persistent substances. The updated guidance is divided into five parts, with key revisions to Part 3 on health hazards and Part 5 on additional hazards.
Part 3 of the guidance explicitly classifies endocrine disruption as a health hazard. Substances identified as endocrine disruptors are categorized into two categories, based on the strength of available evidence.
Category 1 substances are known or presumed endocrine disruptors for human health. Evidence derived from human, animal, or non-animal data must show that a substance meets all the following criteria: (1) endocrine activity, (2) adverse effects in an organism or its offspring, and (3) a biologically plausible link between the endocrine activity and the adverse effect.
Category 2 substances are suspected endocrine disruptors. This category is meant for substances where evidence of endocrine activity and adverse effect is “not sufficiently convincing to classify the substance in category 1.”
The updated Part 5 provides expanded guidance on the classification of substances that are Persistent, Bioaccumulative, and Toxic or very Persistent, very Bioaccumulative (PBT/vPvB) and Persistent, Mobile, and Toxic or very Persistent, very Mobile (PMT/vPvM).
The guidance also includes information on endocrine disruption not occuring via oestrogen, androgen, thyroid and steroidogenesis (EATS) modes of action, as well as the role of adverse outcome pathways (AOPs) in mode of action analysis.
On October 29, 2024, the European Commission hosted the 6th annual forum on endocrine disruptors, where Paul Ryan, head of ECHA’s hazard classification unit spoke about the upcoming update, as reported by Chemical Watch.
A representative from the Organisation for Economic Co-operation and Development (OECD) reported on the activities of an expert group established to review the science of endocrine disruption, according to Chemical Watch. The expert group was formed under a United Nations mandate to assess necessary updates to the Globally Harmonized System (GHS) of chemical classification. However, significant disagreements were noted within the group, such as on the technical feasibility of identifying endocrine disruption via EATS modes of action. European member countries and civil society said it is “technically possible”, while industry organizations disagreed.
On October 28, 2024, the Food Packaging Forum and ETH Zürich co-hosted the Swiss Symposium on Endocrine Disrupting Chemicals (recordings available). Leading researchers discussed the evolution of endocrine disruption science, including current challenges and future directions (FPF reported).
References
ECHA (November 13, 2024). “Guidance on CLP.”
Andrew Turley (November 5, 2024). “ECHA guidance on classifying category 2 endocrine disrupting chemicals will be limited, agency warns.” Chemical Watch News & Insight
Andrew Turley (October 31, 2024). “OECD finds experts divided over key questions for endocrine disruption.” Chemical Watch News & Insight
