EUROPE – EFSA: Recurring issues in mammalian toxicology

During the EFSA peer review of pesticide active substances under Regulation (EC) No. 1107/2009, several aspects in the area of mammalian toxicology were identified by EFSA that needed discussion with experts from National Authorities in order to enhance the harmonisation of the risk assessment of active substances.

A new discussion was held at the Pesticide Peer Review Meeting 17 of October 2019. The following topics were addressed:

  • Experience gained and feedback on the assessment of endocrine disrupting (ED) properties with the EFSA/ECHA guidance (2018) – Points for a potential update of the guidance,
  • Possibility to apply to pesticides the new ECHA guidance on impurities in biocides (to be published),
  • Issues related to the assessment of isomers (EFSA guidance 2019),
  • Issues related to the assessment of relevant metabolite in groundwater as regards genotoxicity,
  • Assessment of genotoxicity in chemical mixtures,
  • Use of in silico method for predicting genotoxicity endpoints,
  • Toxicological assessment of metabolites found as residues (EFSA guidance 2016),
  • Possibility to use Benchmark Dose (BMD) when a NOAEL cannot be set in toxicological studies,
  • Top dose selection in (chronic) toxicology studies.

EFSA also presented an update on the following ongoing projects:

  • Use of in vitro interspecies comparative metabolism studies,
  • Update of the OECD guidance notes on dermal absorption (ENV/JM/MONO(2011)36),
  • Development of integrated approaches to testing and assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment,
  • Development of adverse Outcome Pathway (AOP) for substances having ED properties.

Other issues (such as the use of historical control data in toxicology studies) were raised by experts and are reported for consideration in future discussions.


To download: 

EFSA Technical Report – Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology (26 March 2020)


See also our previous articles: 

EUROPE – EFSA: Recurring issues in mammalian toxicology (2018)

EUROPE – EFSA: Recurring issues in mammalian toxicology (2016)


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