Special Focus
Japan's Food-Packaging Regulations: Industry Takes Meaningful Role
Oct 2002
Catherine R. Nielsen
Japan's regulation of food-packaging materials comprises government standards complemented by a widely followed set of voluntary standards that were developed by an industry group.
The Japanese regulatory framework for food and food-related materials is based on the 1947 Food Sanitation Law.1 This law is very broad, covering not only food, but also food additives, housewares, food packaging materials, and non-food items such as toys and detergents.
Unlike the definition of a "food additive" under Section 201(s) of the Federal Food, Drug, and Cosmetic Act in the United States, Japan's definition of a "food additive" does not include components of packaging materials. Rather, the term "additive" refers to substances used in or on food, in the process of manufacturing of food or for the purpose of the processing or preserving of food, by adding, mixing, infiltrating, or other means.2 Furthermore, the provisions of the Food Sanitation Law generally prohibit the sale, manufacture, or import with intent to sell of any package that is toxic, or that may have a harmful effect on food or human health through contact.3
Any person wishing to import a food, additive, apparatus, or container or package intended for sale or for use in business must notify the Minister of Health and Welfare.4 The ministry may prescribe specifications to meet the safety standard; where specifications have been established, products must meet the specifications prescribed by the Japanese authorities.5 Generally speaking, where no Japanese safety standard is in place, evaluation under a regulation implemented by the U.S. Food and Drug Administration, clearing the use of a substance in food-contact applications, is taken as adequate assurance that the substance complies with the safety and suitability provisions of the Japanese law.
As stated above, the Food Sanitation Law grants the Minister of Health and Welfare the authority to specify standards for packaging materials intended for food-contact applications. To date, the ministry has promulgated specific regulations for 12 plastic packaging materials: polyvinyl chloride, polyethylene, polypropylene, polystyrene, polyvinylidene chloride, polyethylene terephthalate, polymethyl methacrylate, nylon, polymethyl pentene, polycarbonate, polyvinyl alcohol, and plastics using formaldehyde as manufacturing materials. These regulations set forth end-test specifications for the particular plastic resin; they do not list permissible additives for use in manufacturing these resins.
In addition, the Food Chemistry Division of Japan's Ministry of Health and Welfare has issued "Current Regulatory Requirements Related to Utensils and Containers made of Synthetic Resins in Contact with Food."6 This amendment provides end-test specifications for those utensils and containers made with synthetic resins, including polyvinyl chloride, polyethylene, polypropylene, polystyrene, polyvinylidene chloride, and polyethylene terephthalate.
Voluntary Standards
Aside from the general safety standard and the particular end-tests and specifications under the Food Sanitation Law noted above, a "positive list" of additives that are used to manufacture various plastic materials for food-contact applications is provided in a widely followed set of voluntary standards that were developed by the Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA).
This list, developed by industry, originally came into existence in 1973. Accompanying guidelines, titled "Self Restrictive Requirements on Food-Contacting Articles Made of Polyolefins and Certain Polymers," occasionally mirror, and sometimes reference, the comparable FDA Food Additive Regulations, although the JHOSPA guidelines tend to be more restrictive than FDA regulations in some respects (e.g., incidental reaction control agents are often part of the resin specification). JHOSPA's voluntary guidelines cover 27 basic polymers used to manufacture plastic food-contact materials, organized by categories of base polymers, additives, and colorants, and described by chemical name.
Although voluntary from a strictly legal viewpoint, the standards are widely recognized and followed in Japan. Consequently, a listing by JHOSPA may be a requirement for satisfying certain customers in the Japanese market. A company that would like to include its "new substance" on the positive list must first become a regular member of the JHOSPA industry group.
Once a member of JHOSPA, a firm must meet one of three criteria in order to submit an unlisted substance for inclusion on the positive list:
- the non-effective dose to a test animal is known and the acceptable daily intake (ADI) value can be calculated;
- the substance has been cleared for food-contact use in the United States, the United Kingdom, Germany, the Netherlands, France, Italy, Denmark, or Belgium; or
- the substance is a colorant, and it will not migrate to food.7
To make a submission, a member is requested to submit a completed application form, in duplicate, to the Technical Committee. The submission should include the chemical identity of the substance, quality standards and test method for the standards, data demonstrating effectiveness of the substance for its intended use, migration/extraction test data, a description of the migration test methods, toxicity data (acute toxicity test, subacute toxicity test, and chronic toxicity tests), and any calculations necessary to draw a correlation between the toxicity testing and actual use.
No fee is required at the time of the filing. However, if the Technical Committee finds the need for examination of the toxicological data by a specialized expert or third party, the committee will ask for the submitter's consent and will charge any related expenses to the applicant.
If an application is being made for inclusion on the positive list based on a regulation in one of the countries listed, the regulation is interpreted under the most restrictive conditions of use; extraction data will be required in the submission using the most severe use condition prescribed in the foreign regulations; and the testing should be conducted according to the test specifications prescribed by JHOSPA.8 If a substance has been regulated in one of the allowable foreign countries as a direct food additive, it may be submitted for inclusion on the positive list as long as it is technically effective in manufacturing and processing the food-contact articles.9
In summary, Japan imposes an overarching safety and suitability requirement for food-contact substances under the statutory framework for food additives. An assurance from a manufacturer demonstrating, perhaps by way of regulation in the United States, the safety and suitability of its product for use in food-contact applications may be sufficient for marketing in Japan. In addition, industry has established a positive list of substances listing those substances allowable in food-contact applications. In some cases, a customer may require inclusion on this list.
FOOTNOTES
1Law No. 233, Dec. 24, 1947, last amendment: Law No. 101, May 24, 1995.
2See Chapter 1, Article 2 of the Food Sanitation Law.
3See Chapter 4, Articles 8-9 of the Food Sanitation Law.
4See Chapter 5, Article 16 of the Food Sanitation Law.
5See Chapter 4, Article 10 of the Food Sanitation Law.
6Latest amendment: Ministry Notification No. 109 (July 20, 1980).
7See JHOSPA "Rules for Positive List," Chapter 1 (March 1992).
8See id. at Attachment 2.
9See id. at page 3.
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