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).

• From: Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment
• Published: 17 April 2025
• Last updated: 2 July 2025
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  1. 2 July 2025

     Remove reference to the content being a second draft.

  2. 17 April 2025

     First published.

Documents

The use of biomarkers in genotoxicity risk assessment

Ref: 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.