Endocrine disruption is a specific form of toxicity, where natural and/or anthropogenic chemicals, known as “endocrine disruptors” (EDs), trigger adverse health effects by disrupting the endogenous hormone system. There is need to harmonize guidance on the regulation of EDs, but this has been hampered by what appeared as a lack of consensus among scientists. This publication provides summary information about a consensus reached by a group of world-leading scientists that can serve as the basis for the development of ED criteria in relevant EU legislation. Twenty-three international scientists from different disciplines discussed principles and open questions on ED identification as outlined in a draft consensus paper at an expert meeting hosted by the German Federal Institute for Risk Assessment (BfR) in Berlin, Germany on 11–12 April 2016. Participants reached a consensus regarding scientific principles for the identification of EDs. The paper discusses the consensus reached on background, definition of an ED and related concepts, sources of uncertainty, scientific principles important for ED identification, and research needs. It highlights the difficulty in retrospectively reconstructing ED exposure, insufficient range of validated test systems for EDs, and some issues impacting on the evaluation of the risk from EDs, such as non-monotonic dose–response and thresholds, modes of action, and exposure assessment. This report provides the consensus statement on EDs agreed among all participating scientists. The meeting facilitated a productive debate and reduced a number of differences in views. It is expected that the consensus reached will serve as an important basis for the development of regulatory ED criteria.
Bibliographical noteFunding Information:
This workshop was made possible by funds provided by the German Federal Institute for Risk Assessment which is gratefully acknowledged. We thank Dame Anne Glover, Scientific Advisor to former European Commission President Jose Manuel Barroso, for moderating the discussions at the workshop. We wish to acknowledge helpful comments on an initial draft of the document from the following, who were unable to participate in the meeting: Frank Barile (St John’s University, Queens, New York, USA), Bas Blaauboer (Utrecht University, Utrecht, The Netherlands), Thomas Colnot (CiS Toxicology, Osorno, Chile), Wolfgang Dekant (University of Wuerzburg, Wuerzburg, Germany), Jose Domingo (Universitat ‘Rovira i Virgili’, Reus, Spain), Michael Flüh (Directorate-General for Health and Food Safety, European Commission, Brussels, Belgium), Gio Batta Gori (The Health Policy Center, Bethesda, Maryland, USA), Sam Kacew (University of Ottawa, Ottawa, Canada), Hans Marquardt (Hamburg University Medical School, Hamburg, Germany), Olavi Pelkonen (University of Oulu, Oulu, Finland), Kai Savolainen (Finnish Institute of Occupational Health, Helsinki Finland), and Nico Vermeulen (Vrije Universiteit, Amsterdam, The Netherlands). We gratefully acknowledge the work of the rapporteurs of the meeting, Anke Joas, Iris Gutierez and Judy Choi (all BiPro, München). We would like to thank David Dix (US EPA) and Hiroaki Aoyama (IET, Japan) for their presentations and their valuable contributions. We also would like to thank the observers from the European Commission (Laura Fabrizi and Peter Korytar), from EFSA (Hubert Deluyker) and ECHA (Peter Lepper) and from the BfR (Bernd Schäfer, Ulrike Bernauer, Michael Oelgeschlaeger and Silvia Vogl) for their participation.
© 2016, The Author(s).