On January 17, 2025, Japan’s Consumer Affairs Agency (CAA) issued Proposal No.235080079 (hereinafter the Proposal), detailing notification methods and required documents for Foods with Function Claims (FFC). The proposal is open for public comments until February 17, 2025, allowing stakeholders to provide feedback on the requirements. Comments can be submitted through the e-GOV website.
In August 2024, the CAA approved revisions to the Food Labeling Standards, which included updates to labeling requirements and the notification process. Among these revisions, Appended Table 26 was introduced to address FFC notification requirements.The Proposal builds upon Appended Table 26 by specifying additional requirements for notification materials and clarifying procedures for new and modified notifications.
Key updates:
1. Submission form
The provisions in Appended Table 26 must be completed and submitted using the following forms:
Appended From | Contents |
Appended Form(Ⅰ) | Checklist for preparing notification documents for FFC |
Appended Form(Ⅱ) | Safety evaluation sheet |
Appended Form(Ⅲ)‐1 -1 | Information on manufacturing and quality control (tablets, capsules, etc., using naturally extracted materials as raw ingredients) |
Appended Form(Ⅲ)‐1 ‐2 | Information on manufacturing and quality control (other processed foods) |
Appended Form(Ⅲ)‐2 | Information on production, harvesting, fishing, and quality control (fresh foods) |
Appended Form(Ⅲ)‐3 | Information on the analysis of raw materials and final products |
Appended Form(Ⅲ)‐4 | Information on the analysis of final products using extracts or similar components as functional ingredients |
Appended Form(Ⅴ)-1- 1 | Checklist for the scientific basis of functionality |
Appended Form(Ⅴ)-1 -2 | Submitter's involvement in the explanatory materials regarding the functionality to be claimed (systematic review). |
Appended Form(Ⅴ)-2 | Documentation explaining rational reasons for using a human testing method different from the one for Foods for Specified Health Uses (FOSHU) |
Appended Form(Ⅴ)-3 | Supplementary documentation regarding the scientific evidence of the functionality to be claimed |
Appended Form(Ⅴ)-4 | Documents explaining the functionality to be claimed (systematic review) |
Appended Form(Ⅴ)-5 | Database search results |
Appended Form(Ⅴ)-6 | Literature search flowchart |
Appended Form(Ⅴ)-7 | List of adopted references |
Appended Form(Ⅴ)-8 | List of excluded references |
Appended Form(Ⅴ)-9 | List of unreported studies |
Appended Form(Ⅴ)-10 | Reference list |
Appended Form(Ⅴ)-11a or b | Quality evaluation sheets for individual studies (human trials) |
Appended Form(Ⅴ)-12 a or b | Quality evaluation sheets for individual studies (observational studies) |
Appended Form(Ⅴ)-13 a or b | Quality evaluation sheet for overall evidence |
Appended Form(Ⅴ)-14 | Summary sheet (qualitative research review) |
Appended Form(Ⅴ)-15 | Summary sheet (meta-analysis) |
Appended Form(Ⅴ)-16 | Evaluation sheet for the results of the systematic review |
Appended Form(Ⅴ)-17 | Evaluation sheet for the relevance between systematic review results and the functionality to be claimed |
Appended Form(Ⅴ)-18 | Evaluation sheet for the relevance between systematic review results and the functionality to be claimed |
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2. New notification
Submitters must notify the CAA when introducing a new functional food product for sale.
Products differing only in flavor, shipping specifications (e.g., size), or content quantity do not require separate notifications. However, all display information and distinctions must still be included in the overarching notification.
If the notified functional ingredients or their combinations have not been previously published by the CAA and there are concerns about compliance with relevant regulations, additional time may be required for document review.
3. Notification updates
If there are minor changes, additional information, or corrections to previously notified content, the notifier must promptly report these to the CAA. However, significant changes requiring notification include:
Alterations to ingredient ratios or manufacturing methods that affect product identity.
Modifications to functional ingredients or their scientifically supported functionality.
Changes to the functional ingredient content per recommended daily intake.
Adjustments to the recommended daily intake itself.
Updates to the product name.