Guidance

Use of biomarkers in genotoxicity risk assessment

Covers in vivo biomarkers of genotoxicity that can be used for human carcinogenicity risk assessment. COM guidance statement (G10).

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This guidance statement focuses on the detection of biomarkers of genotoxicity, that is the induction of DNA damage, mutation or both in humans.

Biomarkers can provide valuable information to aid chemical risk assessment processes and are used as investigative tools in human studies that aim to evaluate carcinogenic hazards and risk.

Updates to this page

Published 17 April 2025
Last updated 2 July 2025 show all updates
  1. Remove reference to the content being a second draft.

  2. First published.

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