EUROPE-EFSA : Statement on the coverage of bats by current risk assessment

EFSA has published a scientific statement that considers whether the current risk assessment performed for birds and ground dwelling mammals exposed to pesticides is also protective of bats.

Bats are not specifically mentioned under the current risk assessment for pesticides methodology however they are an important group of mammals, frequently foraging in farmland and potentially exposed to pesticides. Bats help to regulate arthropod populations.

EFSA PPR Panel addressed three main issues:

– whether bats are toxicologically more or less sensitive than the most sensitive birds and mammals;

– whether oral exposure of bats to pesticides is greater or lower than in ground dwelling mammals and birds;

– whether there are other important exposure routes relevant to bats.

Based on the evidence compiled, the PPR Panel concludes that bats are not adequately covered by the current risk assessment approach, and that there is a need to develop a bat-specific risk assessment scheme. Based on the current assessment, this should include a focus on:

(a) oral exposure via residues in insects and grooming,

(b) dermal exposure and

(c) exposure of pups via milk.

It is important to highlight that any risk assessment scheme should consider the total body burden from all exposure routes as bats foraging in the field will be exposed to residues in insects, and via dermal and inhalation routes.

In general, there was scarcity of data to assess the risks for bats exposed to pesticides. Recommendations for research are made, including identification of alternatives to laboratory testing of bats to assess toxicological effects.


To download: 

Scientific statement on the coverage of bats by the current pesticide risk assessment for birds and mammals (EFSA Journal 2019;17(7):5758)


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EUROPE: Combined template to be used for assessment reports and proposals for classification

A revised template to be used for Assessment Reports according to Regulation (EC) No 1107/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272/2008 has been published by the Commission (SANCO/12592/2012 rev. 1.2).

This revised template was agreed by the PAFF Standing Committee on 6 October 2017. It should be used for combined assessment and CLH reports prepared for active substances covered by Commission Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 and for active substances for which an application for the approval has been submitted as from 6 October 2017.

To download: template to be used for for assessment reports and Proposals for classification

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EUROPE: MCRA 8.1, EFSA new tool for consumer cumulative risk assessment

EFSA has developped MCRA sofware tool that allows cumulative risk assessment for consumers.


In 2013, EFSA’s Panel on Plant Protection Products and their Residues published a general methodology for classifying pesticides into cumulative assessment groups (CAGs).


In 2015, the software – known as the Monte Carlo Risk Assessment (MCRA) tool – has been developed to process CAGs containing up to 100 active substances.


Luc Mohimont, from EFSA’s Pesticides Unit, said:

“This is an exciting and significant development. Progress has been made in developing an approach for carrying out reliable exposure assessments of multiple pesticides, which takes us a step closer to our ultimate goal: to carry out comprehensive risk assessments of the combined effects on humans of pesticides, rather than just individual chemicals.”


In a pilot study, consumer exposure assessments are now being performed with MCRA tool on groups of pesticides that may affect the thyroid and nervous systems. The results of these assessments will be published by the end of 2016, and will be considered by EFSA when it produces two scientific reports on cumulative risk assessments for the thyroid and the nervous systems in 2017.

Over the coming years, CAGs will be defined for other organs, tissues and systems. Data is already being collected to define groups of pesticides that affect the liver, kidneys, eyes, and the reproductive and developmental systems.

Experience gained in the initial assessments will be used to optimise the tool to ensure its fitness for purpose in the context of regulatory decisions on applications concerning maximum residue levels (MRLs) of pesticides in food.


Useful link:

EFSA Report (2016): MCRA made scalable for large cumulative assessment groups