i- Yesterday FDA announced the release of revisions to the introduction and Appendix I of its “Hazards Analysis and Risk-Based Preventive Controls for Human Food” (HARPC) Draft Guidance. The guidance document is intended to assist in the implementation of the hazard analysis and preventive control for human food requirements in 21 CFR Part 117, Subpart C.
- The revised introduction includes additional general information, new sections on training (as relevant to HARPC), a list of references used in the guidance and expected to be used in future chapters of the guidance, and a compilation of additional resources.
- The revisions Appendix I, which is intended to assist in the identification of hazards, include a revised discussion of the purpose and development of the appendix, revised product categories to better reflect food ingredients instead of finished products, replacement of process-related hazard analysis tables with a discussion of the hazards, an updated discussion on food allergen hazards, and citations to other sources of information, in particular for less common hazards.
- FDA encourages any comments to be submitted within 120 days of the announcement of the availability of this revised draft in the Federal Register. That Federal Register notice is currently scheduled to be published on Friday, February 2, 2024.
FDA Revises Draft HARPC Guidance
Wednesday, January 31, 2024
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