An overview of the EU regulation on endocrine disruptors

Abstract

TPS 641: Policies, interventions, communication, Exhibition Hall, Ground floor, August 28, 2019, 3:00 PM - 4:30 PM Background: Many substances have been shown to affect the endocrine system and consequently cause adverse effects in living organisms or populations. The European Union (EU) identified this issue of endocrine disruptors (EDs) in the 1990s and has since then developed regulations specifically referring to EDs. Aim We reviewed the EU regulations that relate to EDs. Main conclusions Minimising overall exposure of humans and the environment to EDs was defined as an aim in the 7th Environmental Action Program and 2018 EU framework on EDs. Attaining this goal requires a) a cross-sectorial (“horizontal”) definition of EDs; b) a guidance document explaining how to apply the definition using test results and scientific literature to identify EDs; c) tests covering all ED modalities (e.g. estrogenic or thyroid-related modalities); d) legal requirements to make these tests compulsory in application dossiers submitted by an industry willing to market a new substance; e) a management logic for substances and products that turn out to contain EDs. Currently, a legal definition of EDs only exists for biocides and plant protection products (pesticides), the sectors with the most advanced EDs regulation in the EU. However, even for pesticides, the regulation is imperfect, in that a definition and a management logic exist (zero exposure to EDs in pesticides) but without appropriate ED tests covering all ED endpoints being compulsory in application dossiers. These omissions make ED identification very difficult in practice. The lack of efficient consideration and regulation of EDs is more pronounced in other sectors where human ED exposure is also very likely, such as food additives and food contact materials (including non-plastic food contact material), cosmetics, toys, consumer goods and workers’ protection, where EDs are sometimes even not defined. We present recommendations regarding test development, test requirements and management of EDs across sectors.