First published in EFSA Supporting Publications: :
23 September 2015
21 September 2015
Technical Report Post 11
Regulation (EC) No 1107/2009 introduced new criteria for the approval of pesticide active substances, including hazard based exclusion criteria with regard to certain classification criteria, environmental concerns, and endocrine disrupting properties. The Regulation specifies criteria for substances with carcinogenic, mutagenic or toxic for reproduction properties (CMR), Persistent Organic Pollutants (POPs) and substances that are persistent, bioaccumulable and toxic (PBTs) including those very persistent and very bioaccumulable. The Regulation also calls for specific scientific criteria for the determination of endocrine disrupting properties, and pending the adoption of these criteria, enacts the so-called ‘interim criteria’, based on classification considerations and ‘toxic effects on the endocrine organs’. Since 2014, EFSA has published 15 Conclusions on new active substances and 26 on applications for renewal that explicitly summarise the assessment of potential endocrine effects under Regulation (EC) No 1107/2009. For 24 active substances, including 3 microbial pesticide active substances, the available information has not led to the detection of specific concerns, however in the case of two substances EFSA has recommended additional studies to confirm this conclusion. Hazard or risk based concerns have been identified from the available information for 15 substances. An overview of the outcome of the assessments of the interim criteria and the concerns identified regarding endocrine disrupting properties in EFSA Conclusions on the Pesticides Peer Review is presented. The number of substances assessed to date is insufficient to conduct a statistical analysis however a wide range of options is already evident. For some substances the interim criteria were not met, but EFSA highlighted evidence extracted from the regulatory studies or scientific publications suggesting possible concerns, and recommended the need for additional studies to finalise the assessment of the potential endocrine mediated adverse effects. With this approach, the EFSA Conclusions offer risk managers, stakeholders and citizens a transparent assessment of the available evidence, offering information that can be used to support the decision making process.