Scientific principles for the identification of endocrine-disrupting chemicals: a consensus statement

Abstract

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.

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

“…According to the recommendation of the Joint DE-UK-Position Paper [46,47] substances, which elicit endocrine disrupting activity at doses similar or below the doses relevant for STOT-RE Cat. 1 classification, should be classified as endocrine disruptors.…”

Incidence of Breast, Prostate, Testicular, and Thyroid Cancer in Italian Contaminated Sites with Presence of Substances with Endocrine Disrupting Properties

“…An endocrine disruptor (ED) is commonly defined as an exogenous substance or mixture that interferes with the production, release, transport, metabolism, binding, action, or elimination of natural hormones, and which consequently causes adverse health effects in an intact organism, or its progeny, or (sub)population [2,3]. Like hormones, EDs can act at low dose, may have non-monotonic dose responses, will have tissue specific and time effects, will show different effects and dose responses during development relative to adults, and are likely not to have a threshold [4].…”

Incidence of Breast, Prostate, Testicular and Thyroid Cancer in Italian Contaminated Sites with Presence of Substances with Endocrine Disrupting Properties

“…An endocrine disruptor (ED) is commonly defined as an exogenous substance or mixture that interfere with the production, release, transport, metabolism, binding, action, or elimination of the natural hormones, and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)population [1][2]. Similar to hormones, EDs can act at low dose, may have non-monotonic dose responses, will have tissue specific and time effects, will show different effects and dose responses during development relative to adults, and will likely not have a threshold [3].…”