Special Focus
Update of Regulation of Food Packaging in the Pacific Rim
Nov 2004
Catherine R. Nielsen,
Mitzi Ng Clark
As markets continue to emerge in the Pacific Rim, an increasing number of companies that produce food packaging materials are pursuing global expansion in this untapped arena. To best maximize their opportunities, corporations must adapt to a myriad of regulatory systems to ensure compliance of their products in these markets.
In October of 2002, we reported our understanding of the rules that govern the use of food packaging components in selected Pacific Rim countries. Our survey included a summary of the regulatory requirements in China, Indonesia, Malaysia, The Philippines, Singapore, South Korea, Taiwan, and Thailand. (See "The Regulation of Food Packaging in the Pacific Rim: An Overview," link below.) This article provides an update on the manner in which food packaging materials are regulated in these jurisdictions, and also includes a brief summary of the regulatory systems in Vietnam and India. As set forth below, it is clear that the laws and regulations in these countries are quite diverse, requiring an evaluation of each regulatory scheme prior to a company's entering these markets.
China
A fast-growing market for Western manufacturers, China requires food packaging materials to comply with the general provisions of the Food Hygiene Law,1 as well as hygienic standards that establish performance criteria for packaging materials. Although the Food Hygiene Law requires information on new packaging materials to be submitted to the Chinese Ministry of Health for review, the law does not appear to be fully implemented at this time. Currently, no standing committee is assigned to evaluate the safety of food packaging materials. In addition, no explicit mechanism exists by which the Ministry of Health clears new packaging materials.
Japan
Japan imposes a regulatory scheme that is comprised of government standards, as well as voluntary standards developed by industry groups. See our article, "Regulation of Food-Contact Materials in Japan" (see below for link).
India
Food packaging materials in India are regulated by the Ministry of Health and Family Welfare under the Prevention of Food Adulteration Act of 1954.2 Under the Prevention of Food Adulteration Rules, which implement the Act, food packaging materials must be kept in a clean and sanitary condition, must not be used for non-food storage purposes, and must be stored to prevent contamination.3 In addition, the rules require plastic containers used in contact with food to conform to standards promulgated by the Bureau of Indian Standards.4 These include standards for polyethylene, styrene polyethylene, polyvinyl chloride, polypropylene, and Nylon 6 polymer.5 To our knowledge, no standards exist for additives used in the manufacture of food packaging materials, nor is there a clear mechanism for clearing new packaging materials in India.
Indonesia
The Indonesian Minister of Health regulates food packaging in Indonesia under the Food Act of 1996.6 The Food Act provides that food for sale cannot be packaged in a material that has been banned and/or can release contaminants that are dangerous or prejudicial to good health.7 In addition, the information we have obtained suggests that the Indonesian government intends to identify substances that are prohibited for use in food packaging and to specify the methods for packaging certain types of food.8 As of this date, however, it does not appear that the regulations have been issued by the Ministry of Health.
Malaysia
Food packaging materials in Malaysia are regulated under the Food Act of 1983.9 Part VI of the Food Regulations of 1985,10 which implement the Food Act, sets forth the general requirements for the safe packaging of food, and prohibits food packaging from rendering food injurious to human health or contributing to its deterioration.11 The regulations also include specific prohibitions on the use of packaging that imparts lead, antimony, arsenic, or cadmium to food.12 In addition, the regulations prohibit polyvinyl chloride packaging that contains more than 1 mg/kg of vinyl chloride monomer 13 and packaging that has been used or is intended to be used for non-food products.14
Under the Malaysian Food Regulations of 1985, no provisions prescribe those substances that may or may not be used in food packaging (i.e., a "positive" or "negative" list). Thus, provided the above standards are met with respect to vinyl chloride monomer content in polyvinyl chloride packaging, and the packaging is considered safe and suitable for the intended use, the packaging may be considered safe under Malaysian law.
The Philippines
In the Philippines, food packaging materials are regulated by the Bureau of Food and Drugs (BFAD).15 The BFAD has adopted the regulatory scheme of the U.S. FDA and the Food Sanitation Law of Japan in its regulation of food packaging materials. The BFAD therefore allows the marketing of materials cleared by the U.S. FDA or covered by Japan's Food Sanitation Law, provided that such materials comply with any applicable specifications.
According to the BFAD, the Agency will accept any test rest results issued by a Japanese or FDA "accredited laboratory" to document the compliance of food packaging materials with relevant specifications. FDA does not accredit facilities that conduct testing to substantiate claims of compliance with FDA regulations. However, it is appropriate to rely on test results obtained from any reputable U.S. laboratory that can assure compliance with general good laboratory practices.
Singapore
Food packaging materials are regulated in Singapore under the Sale of Food Act and its implementing food regulations.16 Food Regulation 37 prohibits the use of any appliance, container, or vessel that is intended for use in storing, preparing, or cooking food if it contains or is capable of imparting lead, antimony, arsenic, cadmium, or other toxic substances. This includes the ban of vinyl chloride monomer at levels above 0.5 part per million and any compound known to be carcinogenic, mutagenic, teratogenic, injurious, or otherwise poisonous.
The Food Control Division of the Agri-Food and Veterinary Authority of Singapore (AVA), the regulatory body exercising jurisdiction over food packaging materials,17 has indicated that no pre-market approval is required for the import and sale of food packaging materials. Moreover, the Division does not object to the use of materials that are designed for food packaging purposes, provided the materials do not impart harmful substances to the packaged food. According to the Division, manufacturers and importers should conduct their own safety assessments to ensure that the packaging materials are safe for their intended use. International standards, including those established by the U.S. Food and Drug Administration, may be used in this assessment.
South Korea
In South Korea, the Food Sanitation Act requires that food-contact materials be free of substances that are harmful to human health. While South Korea does not maintain a positive or negative list of additives that may or may not be used in food packaging, it does maintain regulations that govern the final food packaging material. These regulations provide that food packaging must be made from one of thirty-eight synthetic polymer resins. Among the polymers listed are polyethylene, polystyrene, polyethylene terephthalate, ethylene vinyl acetate, and ethylene vinyl alcohol. In addition, on May 18, 2004, the Korea Food and Drug Administration (KFDA) added a listing for 2,2-bis(4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether (i.e., BADGE) and its hydrolysis products. Regenerated cellulose, natural and synthetic rubber, paper, metal, wood, glass, and ceramic also may be used in food packaging. The synthetic polymer listings do not identify processing aids, catalysts, or adjuvants that may or may not be used in the manufacture of each polymer; however, colorants used in food packaging must be listed as food additives in the Food Sanitation Act.
For polymers not covered by the regulations, manufacturers must obtain pre-market approval from KFDA. A submission to KFDA must include the name and contact information for the manufacturer of the material, the product name, identification of the chemical name for the product, a description of its manufacturing process and its intended use, product and migration specifications, and tests methods that are use to ensure compliance with these specifications. According to KFDA, the typical time period for the review process is 30 days.
Taiwan
Food packaging materials in Taiwan are regulated under the Act Governing Food Sanitation.18 The Law prohibits the use of food-contact materials that are toxic, tend to cause unfavorable chemical reactions, or are otherwise harmful to human health.19 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.20 We have been informed, however, that no such public notice has been published with regard to food packaging components, and that, currently, there is no list that identifies substances that are permitted or prohibited for use as components of food packaging materials.
Sanitary Standard Number 8, titled, "Sanitary Standard for Food Utensils, Containers, and Packages," requires that food packaging comply with specific material testing requirements, most of which relate to the level of heavy metals that may be present in the finished food-contact article.21 This standard also prescribes migration test limits for various plastics, the conditions of which vary on a polymer-by-polymer basis; these test requirements appear to be nearly identical to Japanese national standards.
Thailand
Food packaging in Thailand is regulated by the Thai Food and Drug Administration.22 According to the Ministry of Health's Notification No. 111 (B.E. 2531), titled, "Qualities or Standards of Plastic Containers, Usage of Plastic Containers, and Prohibition of Usage of Articles as Food Containers," plastic materials may be used to package food, so long as they are clean, emit no substance that contaminates food in a quantity that may be hazardous to human health, contain no microorganisms that cause disease, and transfer no color that contaminates food.23 The Notification also establishes specifications for plastic containers according to the type of plastic used.24 For example, testing for the presence of heavy metals is required for all polymers.25 For a number of polymers, the Notification also requires testing to determine their hexane extractable level and the volatility of substances such as toluene, ethyl benzene, and styrene.26
Vietnam
On November 1, 2003, the Vietnam Ministry of Health implemented the Ordinance on Food Hygiene and Safety, which governs the production, trade, and consumption of food in Vietnam.27 Item 1, Article 17, of the Ordinance provides that food packaging must meet the requirements for food hygiene and safety, which the Ordinance defines as "any necessary conditions and measures to assure that food will not cause harm to human health." 28 In addition, Item 1 states that food packaging must protect foods from contamination, ensure that food quality is maintained during the shelf-life of the food, and facilitate the labeling of the food.29
Item 2 of Article 17 requires packaging used in direct contact with food to be experimented and tested for food hygiene and safety.30 Such testing must be conducted in accordance with Decree Number 867, which places restrictions on the use in food packaging of ceramics, glass, synthetic plastic, and alloys. Specifically, the decree sets forth permitted and non-permitted levels of impurities for these materials, as well as testing methods for specific sub-groups of materials.
With regard to plastic materials used in food packaging, such materials must comply with Regulation No. 3339/2001/QD-BYT ("Hygiene Safety Regulation on Plastic Materials Used in Foodstuff Packaging").31 This regulation sets forth general requirements for plastic packaging materials, as well as a positive list of permitted levels of monomers; this positive list includes specific migration limits for specified monomers, and prescribes specific material testing requirements for polyethylene, polypropylene, polyethylene terephthalate, and polyvinyl chloride. The regulation also requires that additives and colors meet the standards implemented by the Ministry of Health for these substances. However, there does not appear to be a positive list for additives and colors, or an explicit mechanism by which new packaging materials are cleared in Vietnam.
* * *
Our survey of the regulatory systems of Pacific Rim countries reveals the broad diversity of laws and regulations that relate to food packaging materials. While most of the countries we surveyed impose a general safety requirement, no collective approach to regulating food packaging materials exists beyond this requirement. Until a common market is established, corporations must evaluate the regulatory system of each country individually before introducing food packaging components into the Pacific Rim.
FOOTNOTES
1 See Food Hygiene Law of the People's Republic of China (No. 59 Order of the President) (1995), at http://www.can-way.com/en_fa_w.htm (last visited Sept. 15, 2004).
2 See the Prevention of Food Adulteration Act (1954) (India) at http://mohfw.nic.in/pfa.htm (last visited September 16, 2004).
3 See Part IX, the Prevention of Food Adulteration Rules (1955) (India) at http://mohfw.nic.in/pfa.htm (last visited September 16, 2004).
4 See Part IX(49)(v), the Prevention of Food Adulteration Rules (1955) (India) at http://mohfw.nic.in/pfa.htm (last visited September 16, 2004).
5 See id.
6 See Foreign Service Agricultural Service, United States Department of Agriculture, INDONESIA FOOD & AGRICULTURAL IMPORT REGULATIONS AND STANDARDS COUNTRY REPORT (2000).
7 Id.
8 Id.
9 See Food Act 1983 (Malaysia), at http://www.moh.gov.my/fqc/reference/Food%20Act/index.htm (last visited September 15, 2004).
10 See Food Regulations 1985 (Malaysia), at http://www.moh.gov.my/fqc/reference/Food
%20Regulations/index.htm (last visited September 15, 2004).
11 See Regulation 27, Food Regulations 1987 (Malaysia), at http:///www.moh.gov.my/fqc/reference/Food
%20Regulations/Regulation27.htm (last sited September 15, 2004).
12 See Regulation 28, Food Regulations 1987 (Malaysia), at http:///www.moh.gov.my/fqc/reference/Food
%20Regulations/Regulation27.htm (last visited September 15, 2004).
13 See Regulation 29, Food Regulations 1985 (Malaysia), at http://www.moh.gov.my/fqc/reference/Food
%20Regulations/Regulation30.htm (last visited on September 15, 2004).
14 See Regulation 31, Food Regulations 1985 (Malaysia), at http://www.moh.gov.my/fqc/reference/Food
%20Regulations/Regulation30.htm (last visited on September 15, 2004).
15 For further information on BFAD, see http://www.doh.gov.ph/bfad3/index.htm (last visited September 15, 2004).
16 See Foreign Agriculture Service, United States Department of Agriculture, SINGAPORE FOOD AND AGRICULTURAL IMPORT REGULATIONS AND STANDARDS, COUNTRY REPORT (2003).
17 For further information on the AVA, see http://www.ava.gov.sg/JAVASCRIPT/m2-intro.html (last visited September 15, 2004).
18 See Act Governing Food Sanitation (1975) (Taiwan), at http://www.doh.gov.tw/dohenglish/Laws/
Laws_Item.asp?No=24&ClassNo=L03 (last visited September 15, 2004).
19 See Article 15, Act Governing Food Sanitation (1975) (Taiwan), at http://www.doh.gov.tw/dohenglish/Laws/
Laws_Item.asp?No=24&ClassNo=L03 (last visited September 15, 2004).
20 See supra note 18.
21 See Sanitary Standard for Food Utensils, Containers, and Packages (1999) (Taiwan) at http://www.doh.gov.tw/dohenglish/Laws/Laws_Content.asp
?No=159&ClassName=&ClassNo=L03 (last visited September 16, 2004).
22 For further information regarding the Thai Food and Drug Administration, see http://www.fda.moph.go.th/aboutthaifda43.htm (last visited September 15, 2004).
23 See Notification No. 111 (B.E. 2531) (Thailand), at http://www2.fda.moph.go.th/law/Law_Book_1.asp?
productcd=3&lawid=300018_110&lawname=NOTIFICATION%20NO.111
(B.E.2531)&language=e&Contents=1&v_call=lawlink
&historylink=/law&arg_language=e (last visited September 15, 2004).
24 See id.
25 See id.
26See id.
27See Foreign Service Agricultural Service, United States Department of Agriculture, VIETNAM FOOD & AGRICULTURAL IMPORT REGULATIONS AND STANDARDS, VIETNAM'S ORDINANCE ON FOOD HYGIENE AND SAFETY (2003).
28See id.
29See id.
30See id.
31See Ministry of Health Decision No. 3339/2002/QD-BDT (2001) (Vietnam).
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