Guidelines for Notification of Foods with Function Claims partially revised (Japan)

By | November 8, 2023

On September 29, 2023, the Consumer Affairs Agency (CAA) announced the partial revision of the Guidelines for Notification of Foods with Function Claims (FFC) ([For food-related business operators] About notification of FFC). As outlined in the partial revision draft for Guidelines for Notification of FFC (Summary), the major points of the revision are compliance with the “PRISMA*(the Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement (2020) “ in the systematic review and the indication of the implementation date.

*PRISMA is a globally recognized evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.

Main revisions

 (See underlined parts in red in Table 1 and Table 2 of the “Old / New Comparison”.)

(1) Compliance with the PRISMA Statement (2020) for systematic reviews

-Revision of the PRISMA Statement Checklist (2020) (changes to each checklist item)
-Addition of PRISMA statement abstract checklist (2020)

(2) Clarification of responsibility for the content of the notification

-Adding the item, the content has been confirmed by the notifier (or its representative of the company), in the Checklist for preparation of notification documents for FFC

(3) Other technical matters

Pre-registration of research plans shall be conducted in accordance with Appendix 2, Section 2.3 (2) B (A) a of Points to Consider When Preparing Application Forms for Foods for Specified Health Uses in Permission for Labeling of Foods for Specified Health Uses, etc.
-When the results of clinical studies (human trials) using the final product are used as the scientific basis for the functionality of FFC, the registration code for FFC for the public database  must be indicated.
-The notification documents must specifically state the rational reasons that led to the judgment that the product’s functionality is approved for labeling based on the assessment of certainty (or reliability) from the perspective of “totality of evidence” (meaning comprehensive evaluation of evidence, regardless of outcome).

The Q&A for FFC has also been revised, and the questions about the following contents have been added:
Pre-registration of research plans
When the content is updated, the title should include the updated content so that it can be understood
-Workflows when creating a research review for the first time and when updating it

The Operation that aims to announce or return the notification by an authorized organization within a period not exceeding 30 days was abolished by this revision.

Implementation date and transitional measures

(1) Regarding the compliance of systematic reviews with the “PRISMA Statement (2020)”, (I) new notifications are to be submitted on or after April 1, 2025, and (II) existing notifications shall be submitted “as needed”. There is no transitional period for (2) clarification of responsibility for the content of the notification and (3) other technical matters. Regarding the existing transitional measures for notification, the Summary of the Opinions and Views on the Opinions in the public comments also mentioned “as needed”. In the future, more systematic reviews will be reexamined for many products by official bodies (including existing notifications), so it is advisable to carefully confirm the contents of the revisions.

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