Environmental Health Perspectives
25 April 2016
Scientific Issues Relevant to Setting Regulatory Criteria to Identify Endocrine Disrupting Substances in the European Union
Rémy Slama, 1 Jean-Pierre Bourguignon, 2 Barbara Demeneix, 3 Richard Ivell, 4 Giancarlo Panzica, 5 Andreas Kortenkamp, 6 and Thomas Zoeller 7
Background: Endocrine Disruptors (EDs) are defined by WHO as exogenous compounds or mixtures that alter function(s) of the endocrine system and consequently cause adverse effects in an intact organism, or its progeny, or (sub)populations. European regulations on pesticides, biocides, cosmetics, and industrial chemicals require the European Commission to establish scientific criteria to define EDs.
Objectives: We address the scientific relevance of four options for the identification of EDs proposed by the European Commission.
Discussion: Option 1, which does not define EDs and implies to use interim criteria unrelated to the WHO definition of EDs, is not relevant. Options 2 and 3 rely on the WHO definition for EDs, which is widely accepted by the scientific community, with option 3 introducing additional categories based on the strength of evidence (suspected EDs and endocrine active substances). Option 4 adds potency to the WHO definition, as a decision criterion. We argue that potency is dependent on the adverse effect considered, is scientifically ambiguous and note that potency is not used as a criterion to define other particularly hazardous substances such as carcinogens and reproductive toxicants. The use of potency requires a context that goes beyond hazard identification and corresponds to risk characterization, in which potency (or, more relevantly, the dose-response function) is combined with exposure levels.
Conclusions:
There is scientific agreement regarding the adequacy of the WHO definition of EDs. The potency concept is not relevant to the identification of particularly serious hazards such as EDs. As is common practice for carcinogens, mutagens and reproductive toxicants, a multi-level classification of ED based on the WHO definition, and not considering potency, would be relevant (corresponding to option 3 proposed by the European Commission).
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1
Inserm and Univ. Grenoble Alpes, IAB joint research center, Team of Environmental Epidemiology, Grenoble, France;
2
Pediatric Endocrinology, CHU Liège and Neuroendocrinology Unit, GIGA Neurosciences, Univ. Liège, Belgium;
3
UMR CNRS/MNHN 7221, Dept. RDDM, Muséum National d’Histoire Naturelle, 75005 Paris, France;
4
School of Biosciences & School of Veterinary Medicine and Science, University of Nottingham, UK;
5
Dept. Neuroscience, University of Torino, and Neuroscience Institute Cavalieri Ottolenghi (NICO), Orbassano, Italy;
6
Brunel University London, Institute of Environment, Health and Societies, Uxbridge, UK;
7
University of Massachusetts, Biology Department, Amherst, Massachusetts, USA
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