Draft Concept Paper - Development of a Stepwise Procedure for the Assessment of Substances with Endocrine Disrupting Properties According to the Plant Protection Products Regulation

This concept paper for a guidance document provides a first draft based on the outcome of a BfR workshop* on how evaluation of endocrine effects of active substances, safeners or synergists to be used in plant protection products might be conducted. Its development has become necessary in the context of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market of the European Community. Even though the criteria developed and the data set used as a basis for toxicological analysis of such substances are considered to be specific for plant protection products, it is recognized that a guidance document once developed might also have implications for other classes of substances such as biocides or chemicals under REACh. It is recommended that the proposed measures should be tested upon a certain number of plant protection products to examine their applicability and to facilitate improvement of the framework. Concerning specific scientific criteria for the assessment of endocrine disrupting properties, a tiered approach for decision making is proposed reflecting single steps of the regulatory decision process on substances with endocrine disrupting properties for their use in plant protection products. In a first step all available data are evaluated in an endpoint-based manner. In a second step mechanisms of toxicity are analysed if present. Human relevance of these mechanisms of toxicity is examined in a third step. The fourth step consists of a decision. In this context two options are proposed which may be regarded as alternatives, representing to some extent complementary procedures: An exposure-based approach and a classification-based manner. *http://www.bfr.bund.de/cm/218/establishment_of_assessment_and_decision_criteria_in_human_health_risk_assessment_for_substances_with_endocrine_disrupting_properties.pdfDE; en; efsa-focal-point@bfr.bund.d