Japan Proposes Amendments to Functional Food Labeling Regulations

On February 27, Japan’s Consumer Affairs Agency issued Proposal No. 235080082, proposing amendments to the regulations on the labeling of specified health foods. The key revisions include:

  1. New Management Measures for Monacolin-Containing Health Foods – Strengthening production, manufacturing, and quality control requirements for this category of specified health foods.
  2. GMP Standards for Foods Using Natural Extracts – Introducing Good Manufacturing Practice (GMP) standards for tablet and capsule-type foods made from natural extracts. Compliance with these standards will become a prerequisite for labeling approval and part of official post-market supervision. Additionally, specific examples of approved disease risk reduction claims for health food labeling will be formulated.
  3. Mandatory Observational Study Data for Labeling Approval – Defining observational study data as a required scientific basis for labeling approval and specifying content requirements for such studies.

The public comment period for this proposal will remain open until March 28, 2025.
(Source: Agriculture and Food Products Technical Trade Measures Information Platform of Guangdong Province)

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