6. Registration Processes

General Foods
Japan

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

6.1 Product Notification

Not applicable.

6.2 Product Registration

Not applicable.

6.3 Other Notes or Requirements

Product Notification

None.

Product Registration

None.

6.4 Manufacturing Site Registration

Not applicable.

6.4.1 Standard/Rules for Manufacturing Site

Article 50 of the Food Sanitation Act (Act No. 233 of 1947) requires food manufacturers to implement hygiene control measures in accordance with HACCP [1]. This requirement is applied not only to food products manufactured in Japan but also to those imported from outside of Japan. The main requirements are to follow the 7 principles and 12 steps listed below. The guidance documents for HACCP by 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)
  

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

None.

6.5 References

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