The assessment of endocrine activity of chemicals is receiving much public attention. Clear criteria for their identification, however, had been missing in the past. In 2018, the guidance for the identification of endocrine disruptors (ED) came into force. It lays down the implementation of ED criteria in the context of the Biocidal Products Regulation (BPR).
A substance is considered as having ED properties if it shows adverse effects that are linked to an endocrine mode of action, such as estrogen, androgen, thyroid, and steroidogenic (EATS) modalities. The ED properties need to be assessed for both humans and non-target organisms. As a starting point, all relevant information (in-vivo, in-vitro, but also in-silico data) has to be gathered and grouped in tables. Finally, the existing knowledge on EATS-mediated adverse effects has to be addressed in a mode-of-action analysis. As a conclusion, a link between endocrine activity and observed adverse effect(s) has to be established. The new guidance is valid for all biocide applications and addresses biocidal active substances as well as co-formulants in biocidal products. Therefore, applicants have to evaluate an extensive dataset before submitting it to the competent authorities. The identification and evaluation of endocrine disruptors has also to be addressed within the scope of plant protection products regulation.
Fraunhofer ITEM with its specific expertise in toxicology supports its clients in all aspects of scientific and regulatory issues. This also comprises the compilation of data for the evaluation of the endocrine potential of biocides and plant protection products.
Fraunhofer Institute for Toxicology and Experimental Medicine