Special Focus
The Regulation of Food Packaging In the Pacific Rim: An Overview
Oct 2002
Catherine R. Nielsen
As an increasing number of companies that produce food-packaging materials seek to open new markets for their products, the countries of the Pacific Rim are more frequently becoming their focus. As a result, corporate regulatory compliance officers must adapt to the realities of the global arena, establishing compliance of their products in untapped markets of Asia and Australia.
Adding complexity to the matter is the fact that no "common market" system, like the European Union or MERCOSUR in South America, exists in Pacific Rim countries. Thus, the regulatory system of each country must be evaluated individually before introducing a packaging component or finished package into commerce in the region.
An examination of the requirements imposed by Pacific Rim countries reveals that, in many, it is sufficient that food packaging does not transfer any substance to food that could render the food injurious to health or otherwise unfit for human consumption. In many instances, if a particular packaging product has an appropriate U.S. Food and Drug Administration or European Union status allowing its use in food-contact applications in the United States or Europe, the packaging may be deemed suitable for similar applications in the foreign jurisdiction in question.
By relying both on foreign government resources and on contacts in various Pacific Rim countries, we have developed an understanding of the rules that govern the use of food-packaging components in a number of these countries. Set forth below is a brief summary of the regulatory systems in selected Pacific Rim countries.1
China
In this vast market, food containers and food-packaging materials must comply with both the general provisions contained in the Food Hygiene Law and any relevant hygiene control standards.
The general provisions of the Food Hygiene Law relate to the production and marketing of food in China, and are designed to ensure food safety and prevent harm to human health. Article 12 of the law requires that containers, packaging, utensils, and equipment used for food conform to any hygiene standards and the hygiene control regulations. Article 13 requires that raw materials used for making containers, packaging, utensils, and equipment used for food meet hygiene requirements and be safe for the use, and that the finished products should be easy to clean and disinfect.
With respect to the production of food-packaging materials, in addition to the requirement that any raw materials used be permitted by the hygienic standards, China requires that food-contact packaging be free of harmful substances, such as metals; further, recycled materials are not generally permitted to be used in the manufacture of packaging for food.
The relevant hygiene control requirement for packaging components is the Hygienic Standards for Adjuvants and Processing Aids in Food Containers and Packaging Materials. The standard sets forth a list of raw materials permitted for use in packaging. The specific regulated materials are categorized by intended use, including those used as antioxidants, preservatives, lubricants, vulcanizing agents, solvents, and colorants. The Hygienic Standards also limit the scope of use of the materials and the maximum amounts that may be used in China.
For example, pigment blue, listed under the category of "colorant," is only permitted for use in plastics or paints, at a maximum level of 0.25 percent of the product. The Hygienic Standards do not encompass polymers that are used as the base material of a plastic packaging material (such as polyethylene or polypropylene); interestingly, no other separate standard apparently exists that addresses polymers' specific use.
Where a material is not listed in an applicable hygienic standard, information on the material and its intended use should be filed with the "Standards Office" for its review. According to our sources, appropriate supporting documentation would include chemical identity, chemical structure, and relevant information regarding the clearance and use of the material in other jurisdictions. The Standards Office will establish a panel of experts to evaluate the submission; this panel may conduct experiments and testing to determine the suitability of the material for the use.
If the Standards Office determines the packaging component is suitable for the use, it will issue an "assessment letter," together with all relevant supporting documentation, providing its recommendations to the Ministry of Hygiene for further review and subsequent approval, if appropriate. If approval is granted by the Ministry of Hygiene, the Standards Office will then classify the approved substance under the relevant hygienic standards. We surmise that such applications may not be necessary for polymeric materials, as these do not appear to be the subject of any separate standards or listings applying to their use.
Notably, the Standards Office does not have a standing committee of experts responsible for assessing food-packaging materials. As such, the "approvals" of such applications are expected to take longer than submissions on food additives intended for direct addition to food.
Indonesia
Food packaging is regulated in Indonesia by the Minister of Health under the comprehensive law concerning foodstuffs and agricultural products, the Food Act of 1996. While the regulations implementing this law were to become effective in 2000, as of October 2000, no regulations had been established. More recent information on the status of the regulations is not readily available.
However, the Food Act of 1996 establishes that any person producing food for sale is prohibited from using any packaging material that has been banned or that can release contaminants that are dangerous or prejudicial to good health. In addition, our information suggests that the Indonesian government intends to identify the materials that are forbidden for use in packaging (i.e., to establish a "negative" list), and to specify the methods for packaging certain foods.
New types of packaging materials may be used for food packaging only after receiving the approval of the Indonesian government, and packaging materials with unknown human health effects require safety testing.
Japan
An important market for western manufacturers, Japan imposes a regulatory scheme that combines elements of both government and industry regulation.
Malaysia
Food is regulated in Malaysia by the Food Act of 1983, which is implemented by the Food Regulations of 1985. Part VI of the regulations (which contains regulations 27 to 36A) specifically applies to packaging for food.
The Food Regulations set forth the general requirements for safe packaging of food, but also include specific prohibitions on the use of containers. For example, Malaysia prohibits the use of packaging that imparts lead, antimony, arsenic, or cadmium to food; the use of packaging made of polyvinyl chloride that contains more than 1mg/kg of vinyl chloride monomer is prohibited; and no package may be used that had been used or intended to be used for any non-food product.
Malaysia does not currently maintain a list of substances that may be used as components in food packaging (i.e., a "positive" list). As such, provided the above standards are met with respect to heavy metal transfer and vinyl chloride content (for PVC packaging), and the packaging is otherwise safe and suitable for the application, such use may be considered cleared under Malaysian law.
The Philippines
The Bureau of Food and Drugs regulates food-contact materials in the Philippines. The BFAD "adopts" the U.S. Food and Drug Administration's regulations and Japan's Food Sanitation Law regulations pertaining to permissible food-contact materials, and allows the marketing of materials permitted under these regulations provided that they comply with any relevant specifications.
Food-contact materials need not comply with both the Japanese Food Sanitation Law and U.S. FDA regulations; compliance with one country's requirements is sufficient for the marketing of food-contact materials in the Philippines.
In addition, the BFAD considers acceptable any test results issued by a Japanese or FDA "accredited laboratory" to substantiate claims of compliance with specifications. As FDA does not accredit laboratories for performing tests to substantiate claims of compliance with FDA regulations, it is appropriate to rely on test results from any reputable U.S. lab that can assure compliance with general good laboratory practices.
Singapore
Food-packaging materials are regulated in Singapore under the Sale of Food Act and Regulation 37 of the food regulations. According to the Food Control Authority of Singapore, no premarket approval is required for the import and sale of food-packaging materials; thus, the Food Regulations do not contain a positive list of components that are permitted for use in the manufacture of food packaging.
The Food Control Authority has indicated that it has no objection to the use of food-packaging materials when they are designed for packaging food, and there is no likelihood for these materials to impart any harmful substance into the packaged food. Manufacturers and importers are responsible for conducting their own safety assessments on the materials to ensure that the packaging materials are safe when used as intended. The Food Control Authority recommends relying on international standards, such as those established by the U.S. Food and Drug Administration, when conducting the assessments.
Food Regulation 37, the only regulation that specifically applies to packaging, bans the use of "any appliance, container, or vessel that is intended for use in the storage, preparation or cooking of food, and is ... capable of imparting lead, antimony, arsenic, cadmium, or any other toxic substances to any food stored, prepared, or cooked in it." Regulation 37 also prohibits the use of food packaging that contains more than 0.5 parts per million vinyl chloride monomer, or any compound known to be carcinogenic, mutagenic, teratogenic, injurious, or otherwise poisonous.
South Korea
South Korea's Food Sanitation Act prohibits the use of a material for food packaging that contains or is contaminated by toxic or poisonous substances that may be harmful. South Korea does not maintain a positive or negative list of additives that may or may not be used in food packaging.
Instead, South Korea maintains regulations that govern the final food-packaging material, which provide that food packaging must be made from one of 35 synthetic polymer resins. Among the polymers listed are polyethylene, polystyrene, polyethylene terephthalate, and ethylene vinyl acetate. The synthetic polymer listings to do not identify the processing aids, catalysts, adjuvants, etc., that may or may not be used in the manufacture of each polymer.
South Korea also allows the use of seven other materials in food packaging: regenerated cellulose, natural and synthetic rubber, paper, metal, metal pipe, wood, and glass and ceramic. The final packaging product must meet safety standards for the specific material. The safety standards include limits on heavy metals; total volatiles; impurities, by-products, or unreacted raw materials; and total values of residues after evaporation.
Taiwan
Food-packaging materials are regulated in Taiwan under the Food Sanitation Law. Article 15 of the law states that food packaging may not be used if it is toxic, tends to cause unfavorable chemical reactions, or is otherwise harmful to health.
Article 14 of the law indicates that food-packaging components-like food additives-that are designated by the central competent authority in a public notice shall not be used without being registered and licensed. We have been informed that no such public notice has been published with respect to food-packaging components, and that currently there is no list identifying specific substances that are permitted or prohibited for use as components of food packaging.
Sanitary Standard Number 8, "Sanitary Standard for Food Utensils, Containers, and Packages," indicates that certain food packaging must comply with specific material testing requirements, most of which relate to the levels of heavy metals in the material. For plastics, it appears that migration testing is required as well; these test requirements appear akin to FDA's regulatory end tests, established to confirm that a material produced in conjunction with a regulatory clearance is of a sufficient quality. The specific test conditions (solvents, conditions, and standard for passage) vary on a polymer-by-polymer basis.
Thailand
In a 1988 publication, the Thai government addressed the use of plastic containers to hold food. According to No. 111 (B.E.2531), "Qualities or Standards of Plastic Containers, Usage of Plastic Containers, and Prohibition of Usage of Articles as Food Containers," plastic containers used to hold food are required to be clean, emit no substance that contaminates food in a quantity that may be hazardous to health, contain no microorganisms that cause disease, and transfer no color that contaminates the food.
The notice also establishes specifications with which plastic containers must comply depending on the type of plastic used. For example, heavy metal testing is required for polymers, as well as testing to determine the hexane extractable level and the residues from substances volatile in normal heptane.
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As this summary demonstrates, the laws and regulations of the Pacific Rim countries that relate to food-packaging materials are diverse. While most countries impose a general safety requirement, there is no common approach to regulation beyond that similarity.
Until a common market is established-or until globalization forces harmonization-companies choosing to introduce food-packaging components into the Pacific Rim will need to continue to evaluate each country's requirements prior to entering the market.
FOOTNOTES
1As this article is only a summary of the most general legal requirements, we recommend conducting further investigation into the requirements prior to introducing a product into any Pacific Rim country.
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