EFSA has published a technical report that gives an overview on the assessments of potential endocrine effects performed under Regulation No.1107/2009 since 2014 (15 Conclusions on new active substances and 26 on applications for renewal).
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 (based on the classification for reproductive and carcinogenic effects), the identification of relevant adverse effects which could be related to endocrine mechanisms or both.
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.
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.