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# Draft ICH M7 Guideline Available
- URL: https://www.fdaweb.com/draft-ich-m7-guideline-available/
- Published: 2022-04-07T12:00:00.000Z
- Updated: 2026-09-14T17:39:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151542

*Federal Register* notice: FDA is making available a draft ICH guidance entitled “M7(R2)Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes.” The document adds monographs for seven new compounds to the M7 Guideline which outlines considerations for assessment and control of DNA reactive (mutagenic)impurities to limit potential carcinogenic risk. The compounds are: acetaldehyde, dibromoethane, epichlorohydrin, ethyl bromide, formaldehyde, styrene, and vinylacetate. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-07/pdf/2022-07395.pdf?ref=fdaweb.com).