On June 1, 2015 the European Commission’s (EC) Directorate General for Health and Food Safety (DG SANTE) invited interested participants to a one-day conference on “Endocrine disruptors: criteria for identification and related impacts”. During his opening speech, Commissioner Vytenis Andriukaitis explained to the audience of approximately 300 people that the aim of the conference was to share information and explain the next steps in the ongoing Impact Assessment (IA) (FPF reported). He stressed that the process required trust and therefore promised transparency along the way. The IA will look at four different options for EDC criteria and assess what impact these different options will have socio-economically for pesticides and biocides. Concretely, the EDC criteria will define how toxicological data on chemicals will be interpreted in EU regulation with specific provisions for EDCs. As such, the final EDC criteria will be the general definition of EDCs in the regulatory framework and will likely also be applied to other areas of EU chemicals regulation, such as food contact materials. The EU strategy on EDCs would explain this in more detail; a publication date for the strategy was not given.
Participants from Member States, the European Parliament, third countries, trade associations, public interest groups, academia and the media heard the views of various stakeholders who had commented on the Roadmap, the first step of the IA, in its public consultation (FPF reported). Open discussion was encouraged and the entire conference was recorded. All presentation slides will be made available on the conference website.
The Endocrine Society’s scientific perspective on EDCs was presented by Prof. Thomas Zoeller, University of Massachusetts at Amherst. He stressed that no threshold should be assumed for safe exposure to EDCs, meaning that the “definition of EDCs shouldn’t be solely attributable to potency”. As a consequence, potency should not play a role in the identification of what the regulator considers an EDC (i.e. should not be part of the criteria for EDCs). He further explained that the concept of thresholds is theoretical, like for genotoxic carcinogens, and can neither be proven nor disproven by empirical research because of the low doses at which effects occur. He said that in the context of EDCs and genotoxic carcinogens “the concept of a threshold […] is almost faith-based.”
Several speakers representing industry views, but also the German Federal Institute for Risk Assessment (BfR), recommended basing the EDC criteria, at least in part, on potency and therefore assuming a safe threshold for exposure to EDCs, in contrast to the mainstream opinion of independent scientists (Endocrine Society Scientific Statement, American Chemical Society).
More detailed information on the planned screening of 700 substances (FPF reported) was given by Sharon Munn of the EC Joint Research Centre (JRC). The first phase is dedicated to fine-tuning the JRC-developed methodology. All 400 registered pesticides will then be screened, followed by 100 biocides. These results will be made public in autumn, together with the finalized methodology. In a second phase, 200 selected compounds from the cosmetics and REACH regulations will be screened. It was not communicated on what basis substances will be selected; some of the screened chemicals may also be used in food contact materials.
The conference is the fourth event organized by DG SANTE on EDCs, with three Round Tables held previously (FPF reported). The IA will support regulatory decision making and is expected to be completed by the end of 2016.
EC (April 17, 2015). “Conference ‘Endocrine disruptors: criteria for identification and related impacts’.”
Ninja Reineke (June 2, 2015). ”EU Conference on hormone disruptors: What did we learn?” CHEM Trust
Health and Environment Alliance (June 11, 2015). “EU Conference on Endocrine Disrupting Chemicals.”
Diamanti-Kandarakis, E. et al. (2009). “Endocrine-disrupting chemicals: An Endocrine Society Scientific Statement.” Endocrine Reviews 30(4):293-342. (pdf)
American Chemical Society (2012). “Statement on testing for endocrine disruption. ACS Position Statement.”