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Draft revised EFSA guidance on dermal absorption published for comment

A draft of the revised EFSA Guidance Document on Dermal Absorption was published for public comment in late December 2016.

The revisions to the document were made following the evaluation of new human in vitro dermal absorption studies provided to EFSA by the European Crop Protection Association (ECPA) and the Bundesinstitut für Risikobewertung(BfR). The main changes are as follows:

  • Revised default values of 10% (concentrate) and 50% (dilution) for water based/dispersed and solid formulations. The current defaults of 25% and 70% remain for organic solvent based formulations.
  • The 25% rule for read-across between similar formulations now ranges from 100% to 5% depending on the initial concentration range of the constituent.
  • The treatment of variability in studies is changed. If variability is >25% of the study mean, the proposed action is to add a multiple of the standard deviation with the multiple used dependent on the number of replicates.
  • A further revision detailing the dermal absorption value to be used for dried leaf deposits (worker exposure risk assessment) is expected following the publication of ongoing research.

Written comments should be submitted by 24 February 2017. Further information can be found on the EFSA website: http://www.efsa.europa.eu/en/press/news/161222

For advice on 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 9th January 2017
Categories Agrochemicals, Links, News
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