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FDA publishes the revised Draft Preventive Controls for Human Food Guidance


Feb 02, 2024

The U.S. Food and Drug Administration (FDA) has issued for public comments the revised draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance). The revision amends the Introduction and Annex 1 of the previous version of the draft guidance. Specifically:

  • The revised Introduction includes additional information to better explain the purpose of the guidance and provide general information applicable to all chapters. This includes an expanded glossary of terms that are used and defined in later chapters, and the addition of three new sections on training, references, and resources.
  • The revised Appendix 1 “Known or reasonably foreseeable hazards (“potential hazards”)” includes: 1. the addition of new sections and descriptions meant to better explain the purpose of the Appendix, how it was developed and how it should be used; 2. revisions to the product categories identified within the Appendix to better reflect food ingredients rather than finished products; 3. replacement of a series of process-related hazard tables with a discussion of those hazards; 4. an updated discussion on food allergen hazards; and 5. citations to scientific, technical and regulatory information references, particularly for less-commonly known hazards identified for different food categories. 

For further information (in English), click on the Link

Check the full text of the documents (in English), click on the Link

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