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Recurring issues in EFSA toxicology peer reviews – outcome of experts meeting

This technical report recently published by EFSA reflects the outcome of the mammalian toxicology experts’ meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No. 1107/2009. The main issues identified were related to the quality and level of details of the renewal assessment reports and the adherence to the new data requirements, in particular regarding in vitro metabolism studies, phototoxicity and photomutagenicity testing. General issues regarding the assessment of metabolites and impurities, the assessment of the potential for endocrine disruption, the proposals for classification and labelling and the assessment of literature search were also discussed. Conclusions and further recommendations on these issues are reported.

Some key points from the experts:

  • Guidance on in vitro metabolism is needed in order to satisfy the data requirement as no validated test methods are available. EFSA considers that in the meantime such studies should be conducted according to available protocols
  • Photomutagenicity testing is not required for the time being, unless further guidance is provided. EFSA to collect the existing scientific knowledge in view of defining appropriate testing strategies related to phototoxicity and photomutagenicity and their follow-up
  • The in vivo UDS test should not be considered for the follow up of positive results in the in vitro gene mutation assay. An in vivo Comet assay or a transgenic rodent gene mutation assay is recommended. However, concerns are raised over the financial cost of the latter assay and the limited number of testing laboratories able to undertake such assays
  • Toxicokinetic data are required to demonstrate target organ exposure in in vivo genotoxicity assays, data are usually available for the parent compound but often not for metabolites.

The EFSA report is available at: http://www.efsa.europa.eu/en/supporting/pub/1074e

For advice on toxicology, risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, enquiries@jsci.co.uk

Published 18th August 2016
Categories Agrochemicals, Links, News
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