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Positive List System for Food Apparatus / Containers and Packaging

In accordance with partial revision of the Food Sanitation Act promulgated on June 13, 2018, a “positive list” system which allows only substances that have been evaluated for safety to be used in food apparatus, containers and packaging came into effect on June 1, 2020.

Food Apparatus / Containers and Packaging

Article 4 of the Food Sanitation Act determines the following:

Apparatus

The term "apparatus" as used in this Act shall mean tableware, kitchen utensils, and other machines, implements, and other articles which are used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering, or consuming food or additives and which come into direct contact with food or additives; provided, however, that this term shall not include machines, implements, and other articles used for harvesting food in agriculture and fisheries.
(Example) cups, rice bowls, chopsticks, spoons, knives, chopping boards, manufacturing machinery, transport equipment

Containers and packaging

The term "containers and packaging" as used in this Act shall mean articles which contain or wrap food or additives and are offered "as is" when delivering food or additives.
(Example) Boxes, bags, and wrapping paper

Overview of the Positive List System for Food Apparatus / Containers and Packaging

The Positive List System is a system of regulations that requires creation of a list of substances that are allowed to be used (Positive List) and prohibits, in principle, substances other than those that are permitted to be used.
"Synthetic resin” given as a material covered by the Positive List System in Article 1 of the Food Sanitation Act.

Range of application

• Containers and packaging made of synthetic resin
• Synthetic resin refers to a layer of synthetic resin formed on the food contact surface of other materials of equipment and container packaging (e.g. Milk carton, etc.).

Synthetic resins do not include rubber, which is an elastic material that does not have thermoplastic properties.

• Substances that form the basis of synthetic resins (base polymers)
• Substances intended to remain in the final product to alter the physical or chemical properties of synthetic resins (additives).

• Materials that are not intended to remain in the final product

(Example) Catalysts or polymerization aids used to support polymerization reactions of base polymers
　　　Impurities in the impurities and additives in raw monomers of base polymers

* Substances not covered by the Positive List System are managed by conventional risk management.

https://www.mhlw.go.jp/content/11130500/000595368.pdf#page=154

Positive List

Applicable substances are stipulated in Standards for Food, Additives, Etc. (Notice No. 370 of Ministry of Health and Welfare Notice of 1959).
　https://www.mhlw.go.jp/content/11130500/000625490.pdf
　(Appendix 1, Table 1: Base Polymer, Table 2: Additives)

In accordance with Ministry of Health, Labor and Welfare Notice No. 195 of 2020, the quantity of synthetic resin that does not impair human health is defined as "0.01mg/kg in food." If the synthetic resin is not used in the areas where it comes into contact with food, and is processed not to elute more than the specified quantity or does not mix it with food when immersed is regarded as safe to use with substances other than those given on the Positive List.

Transitional measures

Transitional Measures period: 5 years (until May 31, 2025)

If apparatus or containers and packaging sold, manufactured or imported for sale, or being used before June 1, 2020, or the same (*) apparatus or containers and packaging used for business operation manufactured or imported for sale before 5 years from said date, synthetic resins used in it as raw materials are regarded as those given in Appendix 1 (Health and Welfare Notice No. 370 of 1959).

* the meaning of “the same”

If used within the applicable range determined for the use of substances used in apparatus or containers and packaging which had manufactured prior to the effective date.

Manufacturing Control

According to the regulation in Article 50-3 of the Food Sanitation Act (Article 52: from June 1,2021), standards for maintaining a sanitary environment for manufacturing containers and packaging and other necessary public health measures are established and observing the standards for general sanitation and manufacturing control are required.
Businesses operators that do not use substances covered by the Positive List System need to comply standards for general sanitation management only.

Manufacturing Control Standards

1. General sanitation management (Article 66-5, Paragraph 1 of Regulations for Enforcement of the Food Sanitation Act (Japanese))
   Concerns maintaining a sanitary environment inside and outside facilities and other general sanitation management: (Content) Records and preservation of records concerning personnel, facilities and equipment management, manufacturing, etc.
   
2. Manufacturing control (Article 66-5, Paragraph 2 of Regulations for Enforcement of the Food Sanitation Act (Japanese))
   Concerns initiatives for proper management of manufacturing necessary to prevent the occurrence of food sanitation hazards 　　
   (Content) Design and quality checks of safe products, etc.

The above standard was established in accordance with "Guidelines for ensuring Safety in the Manufacturing of Food Apparatus / Containers and Packaging (Circular No.14 of 0710 issued by Seishoku, July 10, 2017)".

https://www.mhlw.go.jp/content/11130500/000595368.pdf#page=164

Applicable Business Operator

• Operator of business that manufactures apparatus (including parts)
• Manufacturer of container/packaging immediately before it is delivered to a business operator who manufactures food or additives
• If the manufacture of the apparatus or container/packaging is outsourced, the primary manufacturer and subcontractor who receives consignment for manufacture or other apparatus or containers/packaging from the primary manufacturer of apparatus or container/packaging.

Communication among business operators

Article 50-4 of the Food Sanitation Act (Article 53 from June 1,2021) stipulates that a business operator who manufactures or sells apparatus or container/packaging that is subject to the Positional List System is obligated to explain to the other party who purchase the products that the product being handled is in compliance with the Positive List System. In addition, any business operator who handles raw materials for apparatus or container/packaging must endeavor to provide necessary explanations when the manufacturer of the apparatus or container/packaging requests confirmation of compliance with the Positive List System.

Information to communicate

• Information that helps confirm compliance of materials to the Positive List
  ( it is not necessary to disclose individual substances).
  (Example) Specifications at the conclusion of a contract between business operators, quality assurance certificates at the time of delivery, and confirmation certificates of industry associations

Effective date

Date of enforcement

As of June 1, 2020

• * This does not apply to apparatus and container/packaging manufactured or imported for sale or used for commercial purposes prior to the effective date.
  

Notification system of apparatus and container/packaging manufacturers

The business notification system will come into effect on June 1, 2021, after which it will be required to notify the local health center where the business is located.
The same range of application applies to business operators obligated to provide notification as the business for which the manufacturing control is required.
For a detailed explanation of business notification, please click here.

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Amendment of the Food Sanitation Act

Institutionalization of Sanitation Management in Accordance with HACCP

Establishment of Business Notification System and Review of Business License System

Foods Containing Designated Ingredients, etc.

Recall Information Notification System for Food and Other Products

Positive List System for Food Apparatus / Containers and Packaging

Improving Safety Assurance of Imported Foods

Strengthening Preventative Measures against Widespread Cases of Food Poisoning