Assessment of endocrine disrupting properties in EFSA Conclusions on the Pesticides Peer Review

Question Number
EFSA-Q-2015-00519
Issued
21 September 2015
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Abstract

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.

Summary

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 in accordance with the provisions of Regulation (EC) No 1272/2008, and ‘toxic effects on the endocrine organs’.

The EFSA Conclusions present the properties of the substance, in particular the toxicological and ecotoxicological profiles, including the assessment of potential endocrine effects, based on the available data. 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. These concerns are related to the application of the interim criteria, the identification of relevant adverse effects which could be related to endocrine mechanisms or both.

An overview of the outcome of the assessments and the concerns identified regarding endocrine disrupting properties in EFSA Conclusions on the Pesticides Peer Review is presented. Expressing the results of the scientific assessments on potential endocrine related effects is very complex, and some EFSA conclusions have been republished with editorial modifications for clarifying the results. Considering the interest in this area and the EFSA role in risk communication the EFSA Pesticides Unit has compiled in this document the recent assessments offering an overview of over thirty pesticides active substances.

The number of substances assessed to date is insufficient to conduct a statistical analysis however a wide range of options is already evident. Although the number of substances is still too limited for allowing a statistical assessment, some differences between the application of the criteria and the outcome of the detailed scientific assessment presented in the EFSA conclusions have been identified, as could be expected for regulatory interim criteria. A number of active substances meet the interim criteria for the identification of endocrine disrupting properties and possible endocrine-mediated adverse effects were observed in mammals, while in one case the first interim criterion is met although the scientific evidence suggests that it is unlikely the substance to be endocrine disruptor in mammals (false positive). In addition, for some substances the interim criteria were not meet, but EFSA considers  that some adverse effects, identified from the regulatory studies or scientific publications, could be linked to endocrine mediated mechanisms (false negatives), and therefore EFSA highlighted possible concerns and recommended the need for additional studies to finalise the assessment of the endocrine 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.

Published
23 September 2015