European Union Finalizes CLP Guidance for Endocrine Disruptors

November 21, 2024

ECHA identifies four new hazard categories for endocrine-disrupting chemicals in its updated guidance on the classification, labelling, and packaging of substances and mixtures (CLP). 

On November 13, the European Chemicals Agency (ECHA) published an updated version of its Guidance on the Application of the CLP Criteria to address the new hazard classes for endocrine disruption (ED) and PMT/vPvM[1] properties. The guidance identifies four new hazard categories for endocrine-disrupting chemicals, including “known or presumed” (Category 1) and “suspected” (Category 2) endocrine disruptors for human health or the environment. The guidance describes the criteria for classification, and advocates for the use of a weight-of-evidence approach informed by expert judgment and considering all available relevant information.

For the ED hazard classes, the criteria involve an evaluation of endocrine activity, adverse effects, and a biologically plausible link via mode-of-action analyses. Assessment of endocrine activity may involve mechanistic information from in vitro and in vivo studies, as well as results from in silico models. The guidance provides example ED classifications for human health and environmental hazards based on estrogen, androgen, thyroid, and steroidogenic (EATS) and non-EATS modalities.

For existing substances placed on the European Union (EU) market before May 1, 2025, classification and labeling for the new endpoints is mandatory starting November 2026. For mixtures placed on the EU market before May 1, 2026, classification and labeling for the new endpoints is mandatory starting May 1, 2028. The mandatory deadlines are earlier for new substances and mixtures placed on the market after May 1, 2025, and May 1, 2026, respectively.

For more than two decades, Gradient scientists have been at the forefront of the topic of endocrine-disrupting chemicals, including:

• Drafting technical documents to support the United States Environmental Protection Agency (US EPA) Endocrine Disruptor Screening Program;
• Conducting weight-of-evidence reviews related to ED activity and adversity;
• Overseeing product portfolio prioritization and vulnerability assessments;
• Testing planning and oversight; and
• Incorporating ED into product stewardship programs.

Timeline to Adopt New EU Hazard Classes

To discuss preparing for the requirements of this regulation, please feel free to contact Gradient.

Contact:

Ari S. Lewis, M.S.
Principal

Tim Verslycke, Ph.D.
Principal

Charlotte Marsh, M.S., CPPS
Senior Toxicologist