日本 CAA 就含微生物补充剂 GMP 修订草案征求公众意见

日本食品药品监督管理局征求公众意见修订含有微生物的GMP补充剂草案

Consumer Affairs Agency (CAA) of Japan has issued a call for public comments on proposed revisions to the Good Manufacturing Practices (GMP) for supplement-form foods. These changes aim to address health concerns related to Foods with Function Claims (FFC) containing red yeast rice.

Key Highlights of the Draft Revisions

  1. Introduction of a New Definition
    The revisions introduce the term “microorganisms raw materials,” defined as raw materials produced through the cultivation or fermentation of microorganisms, including algae.
  2. New Guideline for Microorganisms Raw Materials
    Supplement-form foods containing “microorganisms raw materials” will be subject to a newly established “Guideline for the Preparation of Product Standards for Supplement-Form Food Products that Use Microorganisms Raw Materials.”
  • This guideline, an appendix to the existing GMP for Supplement-Form Foods, requires:
    • Establishing appropriate specifications for “microorganisms raw materials.”
    • Developing validated analysis methods.
    • Applying these specifications and methods to ensure quality when accepting such raw materials.
  • Implementation Timeline
    The revised guideline is scheduled for publication in 2025.

For more information, please contact REGASK.

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