Two categories have been proposed in this draft: • Category 1 - Known and presumed endocrine disruptors: The substances are classified in this category when there are clear evidences of an adverse effect on endocrine activity. • Category 2 - Suspected endocrine disruptors: The substances are classified in this category when there is some evidence of adverse effect on the endocrine activity but not sufficiently to be classified in Category 1.
Both categories are based on relevant scientific results available from humans and/or animal studies in vivo as well as in vitro or on data from analogous substances. In addition, these new hazard classes have been considered separately for human health and for the environment, in particular for reasons of usability and workability.
The CLP criteria proposed for these new classes rest on the criteria already used for plant protection products and biocides.
This proposal is an initial draft which does not present a definitive point of view from the European Commission. Indeed, Cefic (European Chemical Industry Council) issued an opinion on the subject of the inclusion of hazard classes for endocrine disruptors. Cefic reveals that the effects of exposure to endocrine disruptors are already taken into account by hazard classes existing in CLP. Therefore, it is not considered relevant to include the hazard classes of endocrine disruptors in CLP: https://circabc.europa.eu/ui/group/a0b483a2-4c05-4058-addf-2a4de71b9a98/library/4fb1c2db-18f0-4deb-8da3-f94de5cc7b87/details.
Cefic would then like the assessment of endocrine disruptors to take place in the frame of the REACH regulation. Moreover, if this proposition is adopted, CLP would deviate from the UN GHS. According to Cefic, this topic should first be addressed globally under the UN GHS to minimise divergence.