Request for re-verification of notified documents for Foods with Function Claims issued (Japan)

By | September 7, 2023

On July 3, 2023, the Consumer Affairs Agency (CAA) requested in writing that relevant organizations re-verify the scientific evidence for Foods with Function Claims (FFC), and the reverification request has already been notified to and made public by CAA (Re-Verification of Notification Documents Concerning FFC (Request)). Furthermore, CAA published the Measures for FFC based on the Food Labeling Act in Light of the Administrative Order under the Act against Unjustifiable Premiums and Misleading Representations as an important announcement on its website on July 7.

Notice Summary

On June 30, 2023, the CAA issued an administrative order based on the Act against Unjustifiable Premiums and Misleading Representations. The CAA judged that the information displayed on the food products that have been already notified to and published by the CAA as FFC, including data on the scientific evidence for their functionality, was not acceptable as reasonable evidence in order to comply with the FFC standards.

Based on this case, the CAA requested that the following be made known to all concerned organizations.

1. Re-verify the scientific evidence for the safety and functionality of the food products already notified to the CAA

2. The preparation and submission of the documents of the products must be conducted appropriately based on the latest the Guidelines for submitting a notification of FFC, FAQs on FFC and the Guidelines for Ensuring Transparency of Ex Post Facto Regulations (Ex Post Facto Checks) Based on Acts and Regulations Concerning Food Labeling, etc., for Foods with Function Claims


The measure order (issued this time by the CAA), clarify that the agency had requested the company to submit materials that provide reasonable evidence to support the functional claims displayed on the label, however, none of the subsequently submitted materials were deemed to provide such reasonable evidence to support the label for FFC. Noticeably, it is the first instance that the already submitted content of scientific evidence has been considered as insufficient since the system was launched in 2015. This makes clear that even FFC that has already been notified to the CAA will now need to be re-verified to determine whether the scientific basis for their claims is actually appropriate.

On the same day, the CAA also pointed out questionable scientific evidence of 88 other products (and their claims: DHA/EPA, monoglucosyl hesperidin, and olive-derived hydroxytyrosol) that are sharing the same ingredients and scientific evidence with the products subject to the administrative order this time, and requested that those companies of the products respond to submit convincing scientific evidence for FFC. Subsequently, on July 27, the CAA website published 15 withdrawals (from the FFC system) by food companies and a list of the other 73 products and their companies’ contact information for which no withdrawals were yet made, together with the information on the notified content (functionality) of their products. (*According to the latest information, 86 withdrawals were reported on August 29)

Re-confirm the guidelines

The notice states that appropriate verification shall be conducted based on the Guidelines for Ensuring Transparency of Ex Post Facto Regulations (Ex Post Facto Checks) Based on Acts and Regulations Concerning Food Labeling, etc., for Foods with Function Claims as well as the latest Guidelines, and FAQs on FFC. This guideline provides the basic concept regarding the scientific evidence for FFC:

FFC is not a product for which the government has conducted an examination and the Commissioner of CAA has made an individual evaluation of its functionality to be labeled

Therefore, if the notified scientific evidence supporting the labeling is found to lack rationality, the labeling may be considered inappropriate in an ex post facto check.

The guideline also includes examples of what is not considered to be appropriate scientific evidence. 

As for the guideline, a request for comments on the proposed partial revision started on July 24.

When considering the sales of FFC in the Japanese market, we highly recommend taking into account this news and ensure to provide evidence that is in line with the expectation of the CAA. When re-verifying the scientific evidence based on the above-mentioned documents for submission to the CAA, it is also recommended that you check the contents of the proposed partial revision of the guidelines (Compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement (2020) on systematic reviews and Clarification of where responsibility lies for the contents of the submission for FFC).

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