6. Registration Processes

Foods with Function Claims (FFC)
Japan

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

General Food

N/A

Category

A notification for FFC is required. The authority in charge is CAA.

Process:

1. Notifier to complete an online registration and obtain an ID and password.
2. Notifier to complete an online submission of notification document to the CAA.
3. CAA to conduct an administrative check of the submitted document, and address questions to notifiers or requests for modifications of documentation.
4. CAA to inform the notifier of the completion of the check and issue a notification number via the online system.
5. Notifier can start selling the notified product after 60 days of completion of the notification.

A notification document shall include the following information:

• Name and contact information of the notifier
• Evidence of safety (history of consumption and/or scientific data)
• Evidence of function claim (clinical study data conducted using the notified final product or results of research review conducted on the functional ingredient)
• Manufacturing process and quality control
  • Manufacturer’s name and location
  • Copy of a notification of Factory Identity Code (if applicable)
  • Details of hygiene and quality management implemented in the manufacturing facility
  • Copy of a certificate of GMP or an equivalent scheme (if applicable)
  • Details of the system to prevent shipping of out-of-specification products.
  • Details of the source material of the functional ingredient
  • Product specification including the rationale for the specification and COAs
  • Qualitative and quantitative analysis method of the functional ingredient
• Post-market data collection system for adverse events
• Information about the notified product 
• Product package sample of the notified product
• Mode of action of the functional ingredient

Duration:

The timeline for the CAA's administrative check of notified documents depends on the CAA's workload, but typically 40-50 days. If the CAA has any questions and/or requests additional information/data, it may take longer.

Cost:

No governmental fees are required. 

Product

Same as above.

6.2 Product Registration

General Food

N/A

Category

No, but a product notification is required to be an FFC product, as described in Section 6.1.

Product

Same as above.

6.3 Other Notes or Requirements

Product Notification

The CAA is currently in the process of revising the "Guideline for the Notification Procedures of Foods with Function Claim”. It is anticipated that stricter scientific requirements will be imposed for research review and that the new requirements by the revised guideline will be applied to notifications made on and after 1 April 2025 [2].

Product Registration

N/A

6.4 Manufacturing Site Registration

N/A

6.4.1 Standard/Rules for Manufacturing Site

General Food

The Food Sanitation Act (Act No. 233 of 1947) requires food manufacturers to implement hygiene control measures in accordance with HACCP [3]. This requirement is applied not only to food products manufactured in Japan but also to food products imported into Japan. The main requirements are to follow the 7 principles and 12 steps listed below. The guidance documents for HACCP by the type of food business can be found on the MHLW's website [4,5].

• Step 1: Forming a HACCP team
• Step 2: Product Description
• Step 3: Identify the intended use
• Step 4: Creating a manufacturing process list
• Step 5: On-site confirmation of manufacturing process list
• Step 6: Analysis of hazards (Principle 1)
• Step 7: Determining important control points (CCP) (Principle 2)
• Step 8: Setting management standards (Principle 3)
• Step 9: Setting the monitoring method (Principle 4)
• Step 10: Setting improvement measures (Principle 5)
• Step 11: Setting the verification method (Principle 6)
• Step 12: Keep records (Principle 7)

Category

Same as the Product requirement below.

Product

A) Supplement-Form Processed Foods

For supplement-form processed foods of FFC, in addition to the above requirement, the CAA strongly encourages food business operators to implement the Japanese GMP for food supplements, the US cGMP, or their equivalent in their manufacturing facilities [1]. Currently, these 2 Japanese organizations have been accredited as certification bodies of GMP:

• The Japan Health and Nutrition Food Association (JHNFA) [6]
• The Japanese Institute for Health Food Standards (JIHFS) [7]

B) Non-Supplement-Form Processed Foods

Same as General Foods. However, it is not subject to the GMP requirement. 

C) Fresh Foods

Same as General Foods. However, it is not subject to the GMP requirement. 

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

None.

6.5 References

1. Guideline for the Notification Procedures of Foods with Function Claim
https://www.caa.go.jp/policies/policy/food_labeling/foods_with_function_claims/assets/foods_with_function_claims_220401_0002.pdf (in Japanese)

2. Overview of the Draft Amendment for Guideline for the Notification Procedures of Foods with Function Claim
https://public-comment.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000256887 (in Japanese)

3. Food Sanitation Act (Act No.233 of 1947)
https://www.japaneselawtranslation.go.jp/ja/laws/view/3687 (in English)
 
 4. Guidance Documents for Hygiene Control Methods based on HACCP
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000179028_00002.html (in Japanese)
 
5. Guidance Documents for Hygiene Control Methods according to the principles of HACCP
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000179028_00005.html (in Japanese)

6. The Japan Health and Nutrition Food Association (JHNFA) 

https://www.jhnfa.org/

7. The Japanese Institute for Health Food Standards (JIHFS) 

http://www.jihfs.jp/