[Updated] Japan Finalizes the Health Supplement Rules After Kobayashi Incident

Editor's note: This article was originally published on July 8, 2024, and was updated on August 26, 2024, as per the latest developments. The updated contents are marked in red below.

On June 27, 2024, Japan’s Consumer Affairs Agency (CAA) unveiled a draft amendment to the Food Labeling Standards, seeking for public comment till July 26, 2024. The key changes focus on Food with Function Claims (FFC), involving labeling requirements and detailed provisions for the notification process. The proposal was finalized on August 23, 2024, and came into force upon issuance.

FFC is subject to the notification system in Japan. Enterprises can claim their products' functional ingredients and expected health benefits by providing sufficient scientific evidence supporting the safety and efficacy of the ingredients. However, following the outbreak of the Kobayashi Pharmaceutical red yeast rice incident, the government has decided to amend the Food Labeling Standards to enhance the credibility of notification system. The key amendments are analyzed below.

Labeling

The current regulations stipulate that the term "機能性表示食品 (Food with Function Claims)" must be displayed on the front panel of the product's container or packaging. However, the following changes are highlighted in the amendment:

1. Placement of "機能性表示食品" label

The "機能性表示食品" label must be prominently displayed on the upper portion of the front panel, rather than anywhere on the front.

2. Display of the notification number (newly added)

The product's notification number must also be shown in close proximity to the "機能性表示食品" label.

Notification process

1. Definition

CAA modifies the definition of FFC. In the original definition, it adds and emphasizes when subsequent scientific evidence indicating the claimed functional benefits of the ingredient are no longer considered appropriate for health maintenance or improvement, the Commissioner of the CAA may determine that the product can no longer be labeled as an FFC.

2. Schedule

As revealed by the current Food Labeling Standards, enterprises must notify to CAA at least 60 days prior to sale. However, the amendment indicts that the deadline may be brought forward to 120 days prior to sale in certain circumstance.

That is, if a functional ingredient involved is totally new in FFC product, and the CAA determines that additional time is required to verify that the content of the proposed labeling does not violate relevant laws and regulations, the notification shall be submitted at least 120 days before the intended launch date.

3. Notification content

The amendment also includes two new appendices on FFC, regulating the notification method and compliance content. The following are noteworthy points:

Content	Appended Table 26 Notification Method	Appended Table 26 Compliance Content
Labeling	The notifier shall submit documentation containing the required labeling information specified in Articles 3(2) or 18(2) of Food Labeling Standards, along with sample labeling.	/
Basic information of food-related enterprises, such as enterprises’ name and contact information	The notifier shall submit the location of manufacturing or processing facility. In the case of imported products, the location information refers to the importer's business office. In the case of milk, the location information refers to the milk processing plant.	/
Information of safety and functionality	The notifier shall submit scientific basis for: Recommended daily intake amount; Any precautions regarding consumption; Safety and functional efficacy of the claimed ingredient(s).	Any new scientific findings regarding the safety and functionality of the functional ingredients covered by notification shall be promptly report to CAA.
Information of production/manufacturing and quality control	The notifier shall submit documents detailing the following items: Information regarding their production, manufacturing, and quality control systems; Qualitative and quantitative test results for the functional ingredients in the notified product, as well as the testing methods used;	Appropriate records shall be kept on the specifications, including the ingredient source confirmation method and frequency, for raw materials containing functional ingredients; The following items should be confirmed regarding the specification of the food to be notified. Compliance with Food Sanitation Act Appropriate upper and lower limits for the functional ingredient content; Appropriate specifications for other safety-critical ingredients; Regular analysis of the functional ingredients is conducted even after notification.
Information of the collection system for health hazards reports	The notifier shall submit a document containing the specified information regarding the health hazard response system. Such as, the contact information and available business hours of the department that will respond to inquiries from consumers, healthcare professionals, and others regarding health hazard information.	If the health hazard information is provided by someone other than a physician, and no medical examination has been conducted, the notifier shall take appropriate actions, such as recommending that the information provider seek medical examination by a physician.
Other necessary matters	The notifier must submit a document with specified details about the notified food product, including its name, category, reasons for the selected category, proof for not causing excessive nutrient intake, and the planned launch date, etc.	The notifier must conduct a self-inspection and evaluation of their compliance with the notification information, then report the results to CAA. The deadline for the first report is one year after the notification number for the specified function claims food was assigned. Subsequent reports are due annually thereafter.

Implementation

This amendment is planned to come into effect on September 1, 2024. However, the following provisions shall come into effect on April 1, 2025:

Matters listed in items 1 - 4 and item 6 in Appended Table 26 Notification Method.
Matters listed in item 4 in Appended Table 26 Compliance Content.

Notably, the labeling of processed foods and fresh foods manufactured, processed, or imported before August 31, 2026 can continue to follow the previous requirements.