Regulating endocrine disruptors: Interfaces between legislations & related challenges
Endocrine Disruptors (EDs), their definition and criteria, together 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, most recently specifically in the EU. Since 2002, the WHO International Programme on Chemical Safety definition of ED 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. New scientific criteria were agreed upon.
To enable authorities and applicants to properly implement and deal with the new criteria in practice, in June 2018 ECHA and the European Food Safety Authority (EFSA) published a longawaited joint guidance document. Overall, several pieces of legislation are relevant to ED chemicals in the EU. The Plant Protection Products Regulation (PPPR, 1107 /2009(EC)), the Biocidal Products Regulation (BPR, 528/2012(EC)), REACH (1907 /2006 (EC)) and the Cosmetics Regulation (1223/2009 (EC)) are the main focus, but food contact materials, toys and pharmaceuticals are among other potentially affected areas. Recently also some crucial interfaces between REACH and the In Vitro Diagnostic Medical Device Regulation (IVDR) have become evident.