Scientific Issues Relevant to Setting Regulatory Criteria to Identify Endocrine-Disrupting Substances in the European Union

Abstract

Background:Endocrine disruptors (EDs) are defined by the World Health Organization (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 leads to using interim criteria unrelated to the WHO definition of EDs, is not relevant. Options 2 and 3 rely on the WHO definition of 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 and 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).Citation:Slama R, Bourguignon JP, Demeneix B, Ivell R, Panzica G, Kortenkamp A, Zoeller RT. 2016. Scientific issues relevant to setting regulatory criteria to identify endocrine disrupting substances in the European Union. Environ Health Perspect 124:1497–1503; http://dx.doi.org/10.1289/EHP217

Peer-reviewed and unbiased research, rather than ‘sound science’, should be used to evaluate endocrine-disrupting chemicals

“…Additional meetings and reports 22–24 have demonstrated that much of the debate on the concerns over EDC exposures represents ‘manufactured doubt’. 25 What does this mean about the controversial nature of EDCs?…”

“…This has recently been raised in the European Union, where the European Commission was found to have broken the law in their delay to propose scientific criteria for the evaluation and identification of EDCs. 24 Although draft criteria were proposed in 2013, the European Commission has instead conducted an economic assessment of the various proposed draft criteria rather than use scientific principles, judgement and justification for the selection of final criteria. Economic assessments are also widely used in other countries (eg, by the Office of Information and Regulatory Affairs in the Office of Management and Budget in the USA).…”

Case study with natural substances on the various options to identify and categorise endocrine disruptors

“…Currently, there are no criteria available for potency considerations for data in non-mammals, meaning that EC option 4 and the Industry Proposal could not be adequately considered for non-mammal data. Discussion in a workshop hosted by the German Federal Institute for Risk Assessment) [47] and a recent publication from Slama et al [48] indicate that potency criteria are not considered relevant for future identification of endocrine disruptors. However, it should be emphasized that -similar to the procedure for skin sensitizing substances -potency considerations might be helpful for the evaluation of endocrine active substances as potency aspects might help to range effects observed in relation to the potency of natural hormones.…”

Science-based regulation of endocrine disrupting chemicals in Europe: which approach?

“…Risk assessment relates the likelihood that an effect occurs to exposures experienced under different circumstances. 2 This development requires that scientific criteria for the identification of endocrine disruptors are developed, and the European Commission (EC) was obliged by law to publish such scientific criteria within the context of PPPR and BPR by 2013.…”