Special Focus
Regulation of Food Contact Materials in Japan
Nov 2004
Catherine R. Nielsen,
Jeffrey A. Keithline
The Japanese Food Sanitation Law prohibits the sale, manufacture for sale, and use for sale of food containers, packaging materials, and utensils that contain or bear any harmful or toxic substance which may be injurious to human health. Japan does not maintain a "positive list" of materials that may be used to manufacture articles that contact food. Food contact articles are not considered food-additives under the Japanese Food Sanitation Law, and this law does not require premarket approval or review of food-contact substances prior to their use to package food.
This is not to say that Japan does not have specific requirements for food packaging. The Food Sanitation Law authorizes the Japanese Ministry of Health, Labour, and Welfare to establish specifications (also referred to as standards) for containers and packaging, as well as for raw materials used to manufacture such articles.
Three different types of specifications for containers and packaging have been established. First, general specifications apply to all containers and packaging. Second, material-specific standards have been established. Finally, certain specifications apply to the functional category of the package.
The general specifications that apply to all food containers and packaging material primarily address the use of certain metals, particularly lead, in various food contact applications. Lead must not exceed 5% in tin plating, and must not exceed 10% in metal used for the manufacture or repair of apparatus, containers, and packaging. There are also limitations on the use of lead in solder used in food packaging. In addition, the general specifications that apply to all packaging materials state that synthetic colors that are intended to be used in packaging must be specifically authorized by the Japanese Ministry of Health (i.e., listed in Appendix 2 of the Ministry's Enforcement Regulations) or must not migrate to food. The specifications also prohibit the use of di(2-ethylhexyl) phthalate (DEHP) as a plasticizer for polyvinyl chloride (PVC) used in contact with edible fats and oils or in PVC packaging for foods containing oily ingredients.
Material specific standards exist for metal cans, glass/ceramic/enamel articles, and rubber articles, including nursing apparatus. Standards also exist for synthetic polymers generally, as well as for thirteen specific resins, including PVC, polyethylene (PE), polypropylene (PP), polystyrene (PS) and foamed polystyrene, polyvinylidene chloride (PVdC), polyethylene terephthalate (PET), polymethyl methacrylate (pMMA), nylon, polymethyl pentane, polycarbonate (PC), polyvinyl alcohol (PVOH), and synthetic resins made from formaldehyde. The specifications for these materials do not generally identify substances that may be used to manufacture the materials, but rather identify end tests that must be conducted on the material to ensure that the materials meet the specifications established by the Ministry of Health. These tests include heavy metal limits, total non-volatile extractives under specified extraction conditions, as well as limitations on volatile content and residual monomer levels for some synthetic polymers. Finally, we note that no material specific standards exist for paper or wood.
Specifications also exist for specific applications such as packaging for food that is pasteurized under pressure, vending machines and packaging for food sold in vending machines, and packaging for edible ices. These specifications generally include performance testing (such as strength testing, tests to look for pin holes in the packaging, etc.) to demonstrate that the packaging can withstand the conditions under which it is used. Japan has also established requirements for packaging for milk and milk products (see related article link below).
In addition to the mandatory specifications that exist under Japanese Law, widely followed voluntary standards have been developed by various business groups in Japan. For example, the Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA) has developed voluntary specifications for materials that are recognized as suitable for use in food packaging. Other trade associations, such as the Japan Hygienic PVC Association, have established voluntary "positive lists" of materials that are appropriate for use in food-contact applications. Another example of voluntary standards for food packaging is one established by the Japan Printing Ink Makers Association. This regulation is in the form of a "negative list" and identifies materials or substances that are deemed unsuitable for use in the printing on food packaging materials.
Below, we discuss aspects of the JHOSPA specifications. If you are interested in other voluntary specifications for applications or materials not covered by the JHOSPA specifications, please contact Keller and Heckman LLP for additional information.
The Japan Hygienic Olefin and Styrene Plastics Association
JHOSPA was established in 1973 by resin and additive makers, fabricators, converters, distributors, and food companies under the guidance of the Ministry of Health and Welfare. JHOSPA publishes a set of voluntary specifications (or guidelines) for certain polymeric materials and products for use as food containers, packaging materials, and utensils. 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.
The JHOSPA guidelines, which are entitled "Self-Restrictive Requirements on Food-Contacting Articles Made of Polyolefins and Certain Polymers," include a "positive list" of substances that may be safely used in food contact applications. The guidelines are divided into three parts: part one describes the general applicability of the guidelines; part two details the positive list of base polymers, additives, and colorants; and part three describes the end tests required for finished articles. The list of covered materials includes nearly thirty polymers, including most of the synthetic polymers that are the subject of material specific standards established by the Japanese Ministry of Health,1 as well as several other polymers including styrene/acrylonitrile copolymers (SAN), acrylonitrile/butadiene/styrene copolymers (ABS), butene-1 copolymers, and many others. The listings for polymers typically identify the permitted levels of comonomers, and some listing (but not all) identify permitted reaction control aids such as catalysts, initiators, chain transfer agents, inhibitors, etc. Some listings also identify maximum residual amounts of unreacted monomers that may be present in the finished resin.
For substances that are covered by both a JHOSPA listing and a resin specific standard established by the Japanese Ministry of Health, the end test requirements are identical. For substances that are subject only to the Ministry of Health's generic synthetic polymer standard, JHOSPA frequently imposes additional test requirements. For example, the JHOSPA test requirement for ABS requires testing to demonstrate that the total concentration of volatile substances (a rough measure of residual unreacted monomers) is less than 5000 ppm.
The positive list for additives was initially established by JHOSPA by including those additives that were already permitted in select foreign countries for use in food-contact applications. New substances are added to the list in response to petitions submitted by manufacturers. The "approved" additives are grouped into separate categories according to function: stabilizers, surface active agents, slip agents, fillers, foaming agents and adjuvants, and polymeric additives.
We understand that only members of JHOSPA have the right to file an application for establishment or revision of the JHOSPA standards, including adding a new substance to the positive list. For non-members who wish to pursue a filing, a sponsorship by a JHOSPA member is required. The Technical Committee of JHOSPA evaluates applications of new substances to be included on the positive list. A substance can be submitted for inclusion on the positive list when (i) adequate toxicity data exists and an acceptable daily intake value can be calculated; (ii) when the substance is cleared for food-contact use in the United States, the United Kingdom, Germany, the Netherlands, France, Italy, Denmark, and Belgium;2 or (iii) if the substance is a colorant, and it will not migrate to the food in terms of toxicity.
While anyone may evaluate their product and claim compliance under JHOSPA standards, it is our understanding that only members of JHOSPA can apply for a certification that a product complies with JHOSPA standards.3 If the applicant is an additive maker, the Examination Division's Certification Committee at JHOSPA verifies that the additive has an appropriate positive listing. For resin makers and fabrication companies, the Certification Committee will certify a positive listing for the substances as well as verify that the end test requirements have been met. Once a certificate has been issued to a member, the member may use the certificate associated with the product, but has the responsibility to examine and confirm the continued hygienic safety of all aspects of the product.
For more information on Japan's Food Sanitation Law, JHOSPA's voluntary standards, or JHOSPA certifications, please contact us at www.packaginglaw.com.
FOOTNOTES
1 PVC and PVdC are the subject of a Japanese material specific standard, but are not included in the JHOSPA specifications. These polymers are the subject of voluntary specifications published by other trade groups in Japan.
2 We note that the United Kingdom, Italy, Denmark and Belgium no longer establish new clearances for plastics or plastics additives. Such clearances are now adopted at the European Union level.
3 "Essential Information for Current and Prospective Members," JHOSPA pamphlet, 1996.
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