Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment

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Article
EFSA Journal
EFSA Journal 2013;11(3):3132 [84 pp.].
doi
10.2903/j.efsa.2013.3132
Panel members at the time of adoption
Jan Alexander, Diane Benford, Qasim Chaudhry, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Bernadette Ossendorp, Simon More, Alicja Mortensen, Birgit Noerrung, Joe Perry, Iona Pratt, John Sofos, Josef Schlatter, Kristen Sejrsen
Acknowledgements

The SC wishes to thank the members of the working group on Endocrine Active Substances: Jan Alexander, Jacques Auger, Diane Benford, Susy Brescia, Gisela Degen, Anthony Hardy, Karen Ildico Hirsch-Ernst, Peter Hoet, Susanne Hougaard Bennekou, Robert Luttik, Peter Matthiessen, Wim Mennes, Peter Pärt, Daniel Pickford, Thomas Platzek, Josef Schlatter, Emanuela Testai and Theo Vermeire for the preparatory work on this scientific output; the representatives of the European Commission and EU Agencies: Gabriele Schoening, Niklas Andersson, Jean-Marc Vidal, Dorota Jarosinska, Sharon Munn, Daskaleros Panagiotis, Michael Walsh; the hearing experts: Susan Jobling, Trine Husøy and EFSA staff: Bernard Bottex, Miriam Jacobs, Djien Liem, Reinhilde Schoonjans and Sarah Trattnig for the support provided to this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00760
Adopted
28 February 2013
Published in the EFSA Journal
20 March 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Upon request of the European Commission, the Scientific Committee (SC) of the European Food Safety Authority reviewed existing information related to the testing and assessment of endocrine active substances (EASs) and endocrine disruptors (EDs). This work was conducted by a working group of experts in endocrinology, risk assessment and toxicology, together with observers from other EU agencies, namely EMA, ECHA and EEA. To distinguish between EDs and other groups of substances with different modes of action, it was concluded that an ED is defined by three criteria: the presence of i) an adverse effect in an intact organism or a (sub)population; ii) an endocrine activity; and iii) a plausible causal relationship between the two. As scientific criteria for adversity have not been generally defined, specific criteria for endocrine disrupting effects could not be identified. Hence, expert judgement is required to assess on a case-by-case basis the (eco)toxicological relevance of changes at the molecular to individual and/or (sub)population level following exposure to an EAS. The SC concluded that a reasonably complete suite of standardised assays for testing the effects of EASs is (or will soon be) available for the oestrogenic, androgenic, thyroid and steroidogenic modalities in mammals and fish, with fewer tests for birds and amphibians. Shortcomings in current tests and for other endocrine modalities and species were reviewed. Critical effect, severity, (ir)reversibility and potency aspects are part of the hazard characterisation of EDs. To inform on risk and level of concern for the purpose of risk management decisions, risk assessment (taking into account hazard and exposure data/predictions) makes best use of available information. Levels of concern are not determined exclusively by risk assessment but also by protection goals set by the risk management.

Keywords
Endocrine active substance (EAS), endocrine disruptor (ED), hazard assessment, test methods, (eco)toxicological risk assessment, adverse effects
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Number of Pages
84