As of 1 May 2025, Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation) has been amended by Delegated Regulation (EU) 2023/707 to introduce new hazard classes for endocrine disruptors. These classes apply independently to human health (ED HH) and the environment (ED ENV).
In accordance with the amended CLP Regulation and the associated ECHA guidance (May 2024), a substance is to be classified as an endocrine disruptor where it meets the following three criteria:
Evidence of an adverse effect
The substance causes a change in morphology, physiology, growth, development, reproduction or lifespan of an organism, system, population or subpopulation that results in impairment of functional capacity, reduced ability to compensate for additional stress, or increased susceptibility to other influences.
Evidence of an endocrine mode of action
The substance alters the function(s) of the endocrine system. This may involve interference with hormone synthesis, secretion, transport, binding, action, or elimination, affecting the regulation of biological processes controlled by hormones.
Biologically plausible causal relationship
There is a scientifically plausible and consistent link between the endocrine mode of action and the adverse effect observed.
Where all three conditions are fulfilled, the substance qualifies for classification as an endocrine disruptor under the CLP Regulation.
Two categories are defined:
Category 1: The substance is known or presumed to be an endocrine disruptor in humans or the environment. This category is assigned when there is clear evidence of all three criteria.
Category 2: The substance is suspected to be an endocrine disruptor. This category is assigned when there is some evidence of endocrine activity and/or adverse effects, but the available information is not sufficient to meet the criteria for Category 1.
These provisions align with the internationally recognised WHO/IPCS definition of an endocrine disruptor and establish a harmonised approach to hazard identification within the EU.
Ekotox Centres provide support for classification into the new hazard classes, as well as assistance with meeting subsequent obligations in accordance with the CLP and REACH Regulations.