6. Registration Processes

Foods with Nutrient Function Claims (FNFC)
Japan

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

6.1 Product Notification

N/A

6.2 Product Registration

N/A

6.3 Other Notes or Requirements

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 [2,3].

• 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 above.

Product

Same as above.

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

N/A

6.5 References

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