EFSA has assisted the European Commission in providing a draft opinion on aspects of genotoxicity, including the following conclusions and confirmations:

  • Negative results in an in vivo unscheduled DNA synthesis (UDS) assay (which is no longer recommended as a follow-up study) are not sufficient to refute in vitro evidence of genotoxicity.
  • Negative results in the in vivo bone marrow micronucleus test are only valid if exposure to the bone marrow is confirmed. Direct and indirect evidence should be assessed in a weight-of-evidence manner.
  • Genotoxicity data as a whole should be considered using a weight-of-evidence approach. Health-based guidance values may be established if in vivo genotoxicity can be discounted, but more data are needed if genotoxic concerns remain.

European Food Safety Authority (2017). Reflection on interpretation of some aspects related to genotoxicity assessment. http://www.efsa.europa.eu/sites/default/files/engage/170724.pdf


The above items were taken from the September 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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