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

October 07, 2016

On the occasion of an expert meeting organised by the Federal Institute for Risk Assessment (BfR), a consensus was reached on the identification of endocrine disruptors. The consensus paper was published in the scientific journal Archives of Toxicology.

Twenty-three internationally renowned scientists took part in the meeting. In addition, four observers from the European Commission, the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) were present. Among other things, the consensus paper lists the criteria for identifying endocrine disrupting substances. The scientific principles are an important precondition for creating uniform criteria at EU level as a basis for future human health assessments of substances and products with endocrine disrupting properties. The results of the meeting may therefore support the European Commission in developing regulatory criteria for the identification of endocrine disruptors in pesticides and other chemicals and products.

The current discussion focuses on substances or substance mixtures which alter the function of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or in (sub)populations. Such substances referred to as "endocrine disruptors" include, for example, industrial chemicals or active ingredients in biocides or pesticides. Some endocrine active substances naturally occur in plants, however, for example as ingredients (phytoestrogens). Since such substances in principle play a role in all regulatory areas, it was emphasised that in all regulatory domains procedures and assessment should adopt the "one substance - one assessment" principle.

An inalienable condition for legal regulation is, however, that substances with endocrine disrupting effects that adversely affect the health of an organism or its progeny can be identified with certainty within the regulatory framework. Unfortunately, endocrine disruptors are not a clearly defined group of substances which may be identified as such on the basis of their structural characteristics. Scientific criteria for identifying endocrine-disrupting substances have been the subject of controversial discussion among experts for several years.

At the end of 2014, the European Commission instructed DG Health and Food Safety, to define conclusive criteria for the regulation of endocrine disruptors, so that they could in future be used in European pesticide and biocide legislation. Due to the globally increasing concern with regard to possible adverse effects of endocrine disruptors, active substances used in biocide and pesticide products subject to approval within the EU are in future to be tested more rigorously for endocrine disrupting properties.

The expert meeting held in Berlin was attended by scientists from Europe, the USA and Japan. They discussed the foundations as well as open questions relating to the identification of endocrine disruptors. The two-day expert conference notably focused on the following questions:
  • How should endocrine disruptors be defined in the regulatory context of health assessment?
  • What are the general principles of endocrine effects from a toxicological, pharmacological and endocrinological viewpoint?
  • Which sources of uncertainty influence the identification of endocrine disrupting substances in terms of regulatory decision-making?
  • Which adverse effects caused by endocrine disruptors can already be determined using existing testing methods?
  • Which scientific research activities should be initiated to ensure better identification of endocrine disruptors?

The goal of the scientific discourse was to discuss questions and, where possible, find solutions to current scientific divergences.

BfR Federal Institute for Risk Assessment

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