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EFSA Benchmark dose modelling approach updated

Updated Scientific Committee guidance on how EFSA’s Scientific Panels apply the benchmark dose (BMD) in their scientific assessments was published last week. A workshop to support its implementation will take place on 1-2 March 2017 and be live video streamed on EFSA’s website. The BMD approach extends the use of dose-response data from studies in experimental animals to better characterise and quantify potential risks from chemicals in the food chain. In use at EFSA since 2009, the experience gained from its application and recent methodological developments led EFSA’s experts to update their guidance, including the following highlights:

  • Revised section on how to apply the BMD approach in practice, with model averaging now recommended as the preferred method for BMD calculations.
  • Default models for BMD analysis have been reviewed and a new criterion introduced.
  • A new flow chart and template provide a step-by-step guide for performing and reporting a BMD analysis.

In JSC’s experience some member states have been reluctant so far to consider the BMD approach in agrochemical dossiers. It is hoped that this further guidance will lead to improved regulatory acceptance of the approach given that it is widely accepted as a more advanced method compared to the NOAEL approach for deriving health based guidance values. The updated guidance is available here: https://www.efsa.europa.eu/en/efsajournal/pub/4658 .

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 6th February 2017
Categories Agrochemicals, Links, News
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