ECHA/EFSA guidance on endocrine disruptors – challenges and experiences

13 June, 2019

knoell ecotoxicology/regulatory affairs expert Dr Martina Duft examines the best practice for implementing and dealing with the new Endocrine Disruptor (ED) criteria:

Endocrine disruptors, their definition and criteria, along with feasible options for testing and assessment have been extensively worked on and discussed in science and regulatory panels, in public and in the arena of national and global politics. Since 2002, the WHO/International Programme on Chemical Safety definition of an endocrine disruptor has been unanimously agreed upon as "an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or its progeny, or (sub)populations." Consequently, distinct adverse effects and their causal relationship to substance exposure need to be established by a proven endocrine mode of action. Only as a result of tediously detailed and fierce discussions, were the scientific criteria for their identification in the field of plant protection products (PPPs) and biocides agreed according to the same definition. Thus, the WHO definition, which does not consider potency, is now the chosen regulatory approach in the EU. 

To find out more about the new ED Guidance and Martina's view on this, have a look here.