El 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
- 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. - 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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