Updated June 2022

In Japan food contact materials are regulated by national legislation as well as by industry voluntary rules. The 1947 enacted Food Sanitation Act regulates foods, food additives, apparatus and packages/containers and also allows for further specifications. It is supported by the Food Safety Basic Act. Further, Notification No. 370 by the Ministry of Health, Labor and Welfare (MHLW) establishes specifications and standards for foods, food additives and other materials. Apart from regulating food contact materials, the Japanese regulation contains an article which attributes responsibility to manufacturers for harm caused by their substances even if they comply with the legislation (Food Sanitation Law Enforcement Regulations, Chapter 1, Art.16). Each company within the food packaging supply chain must share compliance information with the downstream users (Food Sanitation Act, Art. 52-53).

The legislation also outlines the rules under which migration testing has been carried out in order to ensure that an article will meet the specification[1]. As such, metal cans, glass/ceramic/enamel articles, rubber and polymer articles have material-specific standards and are complemented by specifications on 15 particular resins [1]. It further sets limits for some contaminants, such as lead, antimony and polyvinylchloride (PVC) containing bis(2-ethylhexyl) phthalate (Food Sanitation Law, Chapter 1, Art.17.3.2.1). Dairy and dairy-based products are subject to specific regulations (Ordinance of Specifications and Standards for Milk and Milk Products, Ministry of Health and Welfare Ordinance No.52), as they are thought to be intended for vulnerable populations such as infants and the elderly[1].

In 2020 under an amendment of the Food Sanitation Act (Article 18(3)) the MHLW published a positive list of substances used in synthetic resins for utensils, containers and packaging. The ministry created an exception for unlisted substances that were sold or manufactured in Japan before 2020. These unlisted substances can remain on the Japanese market until May 2025. As of March 2022, MHLW had no plans to extend the grace period. However, a substance not included on the list can still be used if it is not used in part of the utensil, container, or packaging that comes into contact with food, or if the substance does not migrate to a concentration more than 0.01 mg/kg of food.

The UCP is divided into two tables each with multiple sections. Table 1 contains polymer plastics, polymer coatings, and trace monomers. While Table 2 includes synthetic polymers, purified naturally derived substances, organic low molecular substances, individual food additives, unrefined natural substances, natural high molecular substances, inorganic substances, and substances used for coatings. The substances listed in each section include the name in Japanese and English, CAS registry number, what types of food it can come into contact with, permitted conditions of use, and any extra notes about the particular substance.

In April 2022, the MHLW published a draft restructured positive list for synthetic resins in food contact. Japan is simplifying the categories of substances by merging the synthetic polymers and additives tables while dropping the table for minor monomers. Instead of the current division of substances the proposed regulation would divide substance into base materials or additives, and would remove the sections for polymer trace monomers, unrefined natural substances, natural high molecular polymers, inorganic substances, and substances used for coatings.

Companies with a branch in Japan can get a voluntary certificate of compliance with the positive list for the substances they use. When all chemicals used in a material comply, companies can further receive a certificate of compliance for the material itself.

While Japan does not have a positive list of substances authorized for other food contact materials, voluntary industry rules include a positive list of food contact materials, including those authorized by Title 21 of the U.S. C.F.R., the European Union additive list, those allowed as direct food additives, and substances listed on national legislation in the UK, Germany, Italy, Holland, Belgium and France. Under this voluntary rule, information on substances can be submitted which is assessed by the industrial safety association committees[1]. These standards are widely respected and compliance is often required by end-of-chain producers[1].

References

  1. Mori, Y., Rules on food contact materials and articles in Japan, in Global legislation for Food Packaging Materials, R.V. Rinus Rijk, Editor. 2010, Wiley-VCH: Weinheim. p. 291-319.
  2. David Ettinger and Eric Gu, What you need to know about Japan’s new positive list system [https://chemicalwatch.com/139250/-what-you-need-to-know-about-japans-new-positive-list-system]

Read more

Ozaki, A, et al. (May 2022). “Validation Study on Migration Test for Plastic Food Utensils, Containers, and Packaging.” Journal of the Food Hygienic Society of Japan.

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