Assessment of endocrine disruptors under European regulations

Abstract The European Union intends to implement a horizontal and coherent approach for the identification of endocrine disruptors (ED) across all relevant legislations, based on the broadly accepted definition given by the World Health Organisation in its International Programme on Chemical Safety. With regard to this, the European Commission is currently undertaking a “fitness-check” across all relevant European legal frameworks to analyze whether ED are adequately addressed in each regulation and to propose measures to close identified gaps. However, different regulatory approaches exist in different parts of European legislation for substances identified as ED. The pesticides applied in agriculture (i.e., plant-protection products (PPPs)) and biocides regulations contain a similar provision requiring ED identification through scientific criteria, but the approach differs slightly between the two pieces of legislation. For PPPs, substances with particularly hazardous properties are excluded from market authorization. This includes also intended ED in invertebrates, despite the fact that these substances provide a relatively specific toxicity and, therefore, typically a rather low toxicity for vertebrate taxa. For biocides, intended ED in invertebrates are excluded from these exclusion or “cut-off criteria.” The European Regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals’ legislation specifically mentions ED as substances that can be identified as Substances of Very High Concern, if they are of equivalent level of concern when compared with carcinogenic, mutagenic, or toxic for reproduction; persistent, bioaccumulative, and toxic; or very persistent and very bioaccumulative substances. The use and import of ED in products and articles can also be restricted, if a concern for human health and/or the environment is identified. In contrast, all pharmaceuticals, including ED, are assessed based on risk. However, the risk assessment should reflect the specific mode of action of the substance tested. Consequently, the most sensitive taxa should be tested, and the test should cover the most sensitive life stage and the most sensitive endpoint.