|October 4, 2013|
Previously published on September 2013
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, companies must adapt to a myriad of regulatory systems to ensure compliance of their products in these markets. Adding complexity to the matter is the fact that no "common market" system, like the European Union or MERCOSUR in South America, has standardized food packaging regulations in Pacific Rim countries.
We summarize below the systems governing the regulation of food packaging materials in selected Pacific Rim countries. Our survey includes a summary of the regulatory requirements in China, Taiwan, Japan, South Korea, India, Indonesia, Thailand, The Philippines, Malaysia, Singapore, Vietnam, and Hong Kong. (To go directly to the section on a particular country, just click on that country.) As set out below, the laws and regulations in these jurisdictions are quite diverse, requiring an evaluation of each regulatory scheme prior to a company's entering these markets. Thus, the regulatory system of the individual country must be evaluated prior to introducing a packaging component or finished package into commerce in the Pacific Rim.
Food-packaging materials in China are regulated under the "Food Safety Law of the People's Republic of China," which went into effect on June 1, 2009. This law prohibits the importation, use, or purchase of food-related products, including food packaging materials, not complying with an applicable Chinese Food Safety Standard promulgated by the Chinese Ministry of Health (MOH).
China has developed hygienic standards for a number of polymeric materials that are commonly used to produce food-contact articles. Generally, the standards for resins establish physical and chemical requirements for the material, while application-specific standards set migration limits and performance criteria for finished containers and packaging. The "Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials" (GB 9685-2008) include a positive list of additives permitted for use in food containers and packaging materials. The approval of new food packaging materials is governed by the Management Rules for the Administrative Approval of New Varieties of Food Related Products (the Rules), which went into effect June 1, 2011.
For more detailed information on the regulation of food packaging materials in China, see the PackagingLaw.com article, Regulation of Food Packaging Materials in the People's Republic of China.
The Department of Health (DOH) is responsible for the management of food safety in Taiwan. Food packaging materials in Taiwan are regulated under the Act Governing Food Sanitation (the Act), which was first promulgated in 1975, and applicable food standards promulgated by DOH. The most recent version of the Act was promulgated on June 22, 2011. It prohibits the use of food-contact materials that are toxic, tend to cause unfavorable chemical reactions, or are otherwise harmful to health.1 The Act also includes registration and licensing requirements for food containers and packaging. 2
Taiwan's "Sanitary Standard for Food Utensils, Containers and Packages," updated August 2013, provides that food packaging must comply with specific material testing requirements, most of which relate to the level of heavy metals that may be present in the finished article. The standard applies to finished food-contact articles, rather than raw materials used to manufacture finished articles. In addition, the standard prescribes migration testing limits for plastics, the specific test conditions of which vary on a polymer-by-polymer basis. Importantly, the standard is not a "positive list" for polymeric resins; therefore, polymers not included in the standard may still be used, provided they meet all other applicable requirements. An additional requirement imposed by the standard is that coloring agents in food containers and packages that could potentially migrate into the food must comply with regulations in the "Scope and Application Standards of Food Additives."
On January 1, 2010, four DOH agencies—the bureaus of Food Safety, Food and Drug Analysis, Pharmaceutical Affairs, and Controlled Drugs—were incorporated into a new agency, the Taiwan Food and Drug Administration (TFDA).
The Japanese regulatory framework for food packaging materials combines government regulations based on the Food Sanitation Law of 1947, together with industry standards that have been voluntarily established by industry trade associations. In terms of the requirements under the Japanese Food Sanitation Law, this legislation sets forth a general safety standard that covers not only food, but also food additives, food packaging materials and equipment, detergents for vegetables and fruits, eating utensils, and toys for young children. With respect to food-contact materials, the legislation prohibits the sale of equipment or packages containing toxic or harmful substances that may be deleterious to human health. The legislation also includes an enforcement component, which governs the inspection of domestic food-business facilities, import notification requirements, monitoring and testing requirements, and penalties.
While Japan does not currently have a "positive list" of substances that are permitted for use in articles that contact food, or require premarket approval or review of food-contact substances prior to their use in the marketplace, the Food Sanitation Law authorizes the establishment of specifications for food containers and packaging and the raw materials used to manufacture such articles. The Japanese Ministry of Health, Labour, and Welfare (MHLW)—under the Pharmaceutical and Food Safety Bureau, Department of Food Safety, Standards and Evaluation Division—is responsible for developing such specifications. To date three different types of specifications for containers and packaging materials have been established: (1) general specifications that apply to all containers and packaging; (2) material-specific standards; and (3) certain specifications that apply to the end-use application for the packaging.
In addition to the governmental standards and specifications described above, many voluntary standards are in place in Japan that serve as a vehicle for marketing various food packaging materials that may not be considered under the governmental framework. These voluntary standards are widely respected in Japan. In some instances, companies will require suppliers to have their products sanctioned by the appropriate trade association prior to purchase.
For more detailed information, see the PackagingLaw.com article, The Regulation of Food Packaging Materials in Japan.
South Korea's Food Sanitation Act establishes the legal basis for food safety-related work conducted by the Ministry of Health and Welfare (MHW) and the Ministry of Food and Drug Safety (MFDS).3 With respect to food packaging, the Act includes a general requirement that food-contact materials be free of substances harmful to human health. More specific regulations, standards, and specifications impacting food packaging materials are established and enforced by MFDS.
In April 2013, the Food Additive Standards Division of MFDS published updated standards for food packaging, titled, "Korea Standards and Specifications for Utensils, Containers and Packaging for Food Products." The updated standards replace Chapter 7 of the Korean Food Code, "Standards and Specifications for Equipment and Container/Packaging." The updated standards are not incorporated in the latest publication of the Korean Food Code in 2009, but are published separately.
The new standards and specifications have four sections: general rules; common standards and specifications, including manufacturing standards and usage specifications; specifications for individual materials; and general test methods. The subsection on manufacturing standards bans the use of di-(2-ethylhexyl)phthalate (DEHP) unless no possibility exists that it will migrate into food, and imposes a limit of 100 mg/kg of lead, cadmium, mercury, and hexavalent chromium in utensils, containers, and packaging.
The subsection on manufacturing standards also includes a prohibition of printing inks on the food-contact side of utensils, containers, and packaging, and specifies that printing inks applied to the non-food-contact side must be sufficiently dry to comply with certain migration limits. Further, in the case of benzophenone, this substance must not migrate at levels greater than 0.6 mg/L. In the case of inks used to print the non-food-contact side of flexible printing, residual toluene from ink compounds should be no greater than 2 mg/m2. With respect to colorants, only those permitted as food additives are allowed, unless the colorant is melted glaze, glass, or enamel, or unless it can be shown that there is no migration of the colorant into the food. A ban on di-n-butylphthalate (DBP), benzyl-n-butylphthalate (BBP), and bisphenol A (BPA) in infant feeding bottles (including bottle nipples) is set out in the usage specifications subsection of the standards.
The section on specifications for individual materials is divided into subsections on: synthetic resins; cellophane; rubber; paper or processed paper; metal; wood; glass, ceramic, porcelain enamel and pottery; and starch. Definitions are provided for each substance, along with residue and migrant specifications. The standards and specification also set out test methods that can be used to demonstrate compliance with the specifications. The subsection on synthetic resins identifies 38 synthetic resins—including PET, polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), butylenesuccinate-adipate copolymer (PBSA), and epoxy resin.
The section on general test methods includes analytical tests for determining the level of certain individual metals, directions for preparing migration test solutions for specific food-contact materials, an analytical test to determine the migration level of colorants, and a test to measure BPA. Testing guidelines are developed by the National Institute of Food and Drug Safety Evaluation (NIFDA), a research institute that conducts risk assessments and advises MFDS. MFDS authorizes foreign laboratories to conduct testing and to issue required certifications. As of the publication of this article, the only U.S. laboratory authorized to conduct food-related testing on food packaging is the Oregon Department of Agriculture, Portland, Oregon.
The government of India is in the process of reforming the regulatory framework pertaining to food and food-contact materials. The Food Safety and Standards Act of 2006 (FSSA, No. 34 of 2006) serves as the foundation for integrating and consolidating the pre-existing food laws and standards into a single, science-based regulatory scheme. This new scheme is intended to encompass the manufacture, storage, distribution, sale and import of food, as well as to ensure the safety of materials that may contact food intended for human consumption.
The FSSA established the Food Safety and Standards Authority of India (FSSAI). FSSAI has been tasked with developing science-based standards and methodology for the evaluation of food and food-contact materials, preparing guidelines for the accreditation and certification of testing laboratories, and providing guidance on emerging risks and response measures with respect to food safety. Draft regulations, titled "Food Safety and Standards," were published on October 20, 2010, and updated in early August 2011. The regulations are divided into six individual legislative titles. The Packaging and Labeling Title includes packaging requirements. These requirements are broad in nature, and reflect a recurring theme that food-contact materials shall not render the food unsafe for consumption.
For more detailed information on the regulation of food packaging materials in India, see the PackagingLaw.com article, Regulation of Food-Contact Materials in India.
Food, including food packaging, is regulated under Law 18/2012 in Indonesia. Known as the new Food Law, it replaced the Food Act of 1996 (Law 7/1996). Law 18/2012 requires that the food supply be sufficient, safe, high quality, diverse, affordable, and not conflict with religion, beliefs, and culture. In this regard, it imposes a broad range of pre-market and post-market controls to try to ensure food safety.
Indonesia's new Food Law defines "Food Packaging" as "material used to enclose and/or wrap Food that is in contact both directly as well as indirectly." The use of food packaging that is hazardous to human health or releases pollutants that are hazardous to human health is banned in Part Six, which specifically addresses food packaging.
The National Agency of Drug and Food Control (BPOM) Regulation No. HK.03.1.23.07.11.6664 on Food Package Control includes lists of permitted and prohibited food-contact materials. The lists include adhesives, ceramic materials, polystyrene, rubber and elastomers, glass, ion exchange resins, metal and metal alloys, paper and board materials, plastics, and coatings. The positive list includes maximum migration limits. A National Standard, SNI 7626.1, on testing food-contact substances migrating from food packaging was issued in 2011 by the National Standardization Agency of Indonesia (BSI).
In Thailand, food packaging is regulated by the Food Act, B.E. 2522 (1979), which prohibits the production, importation, and distribution of impure, adulterated, substandard, and otherwise banned foods. Notably, the Food Act defines "impure" foods to include "food in containers made of materials which are likely to be dangerous to health."4
The Ministry of Public Health (MPH) is responsible for the overall execution of the Food Act and is authorized to issue ministerial regulations to carry out the provisions of the Act. The Thai Food and Drug Administration (FDA), a department in MPH, has specific responsibility for regulating food packaging materials. This includes reviewing and granting approvals for packaging materials.
Under Ministerial Notification No. 92, B.E. 2528 (1985), a variety of requirements are specified with respect to food containers. Namely, the Notification provides that food containers must be clean and free of germs, not emit any heavy metals or other substances that contaminate food at levels that may be harmful to health, and not emit any color to food. Other requirements include specific standards for food containers made of plastic, and a ban on reusing certain types of food containers.
Ministerial Notification No. 295, B.E. 2548 (2005), which applies specifically to plastic food containers, includes the same general requirements as Notification No. 92, along with the additional requirement that plastic food containers cannot contain pathogenic microorganisms. It also specifies that plastic containers for milk and milk products must be made from polyethylene, ethylene, 1-alkene copolymerized resin, polypropylene, polystyrene, or polyethylene terephthalate. In addition, the Notification includes specifications for plastic containers according to the type of plastic used. More specifically, these standards include a limitation with respect to levels of certain heavy metals (i.e., lead, cadmium, and arsenic), monomers, and additives. Colored plastic containers are not permitted, except on a case-by-case basis.
Food packaging in Thailand also may potentially be required to comply with new standards that have been proposed by the Thai Industrial Standards Institute (TISI). TISI, the national standards body of Thailand, develops both mandatory and voluntary Thai Industrial Standards (TlSs). Currently, the only mandatory TIS impacting food is TIS 51-2530 (1987) for canned pineapple. However, TISI has proposed a series of mandatory national standards pertaining to food-contact materials and articles. Some would replace existing voluntary standards, such as Draft TIS 1027-25XX "Plastic Bags for Food" (covering only plastic bags made from pure resin, and replacing TIS 1027-2534(1991). Others, such as Draft TIS XXXX-25XX "Plastics Food Containers for Microwave Oven Part 1: For Reheating," represent new standards. The proposed standards are only available in Thai.
In the Philippines, food packaging materials are generally regulated by the Food and Drug Administration (FDA), which was established by the Food, Drugs and Devices, and Cosmetic Act of 1963 (Republic Act No. 3720). The "Food Safety Act of 2013," which was signed into law on August 23, 2013, is intended to strengthen the Philippine food safety regulatory system. The law divides food safety responsibilities between: the Department of Agriculture (DA), which includes the National Food Authority; the Department of Health (DOH), which includes the FDA and the Center for Food Regulation and Research; the Department of the Interior and Local Government (DILG), and Local Government Units (LGUs). The law also creates the Food Safety Regulation Coordinating Board, the purpose of which is to coordinate food safety regulation functions between DA, DOH, DILG and LGUs.
Under the Food Safety Act of 2013, food in containers with any poisonous or deleterious substance is considered adulterated. DA and DOH are responsible for setting mandatory food safety standards, with the stipulation that Codex standards shall be adopted "except when they are in conflict with what is necessary to protect consumers and scientific justification exists for the action taken." The law mandates that DA and DOH to jointly issue the implementing rules and regulations within ninety (90) days after the Act enters into force, which will occur 15 days after its publication in two newspapers of general circulation.
With respect to food packaging, the Food Safety Act of 2013 specifies that DOH is responsible for ensuring the safety of all food processing and product packaging activities. Food business operators are required to identify the individual or company from whom they have received packaging materials, food, and other supplies.
General safety requirements for food packaging materials are included in several government orders and circulars. For example, the Revised Guidelines on Current Good Manufacturing Practice in Manufacturing, Packing, Repacking, or Holding Food (Administrative Order No. 153), issued May 7, 2004, states, "There shall be appropriate quality control operations procedures to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable."
Under BFAD Circular No. 2006-016 (Undated List of Food Additives),5 any food packaging material that "results or may reasonably be expected to result, or indirectly, in its becoming a component or otherwise affecting the characteristics of any food," and is safe under the conditions of its intended use, falls under the definition of a food additive. The Circular includes a list of permitted food additives, together with guidelines governing their use in food that is distributed in the Philippines. In addition, the Circular states that, "[a] food additive and functional classes adopted by the Codex Alimentarius Commission (CAC) shall be automatically included as an addendum to the Appendix for Food Additives." The Philippine FDA also has stated in correspondence to individual firms that the Agency recognizes clearances for food-contact substances in the U.S. and Japan.
Food packaging materials in Malaysia are regulated under the Food Act of 1983. Part VI of the Food Regulations of 1985, 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. The regulations also include specific prohibitions on the use of packaging that imparts lead, antimony, arsenic, cadmium, or other toxic substances to food. In addition, the regulations prohibit polyvinyl chloride packaging that contains more than 1 mg/kg of vinyl chloride monomer, or results in more than 0.05 mg/kg of vinyl chloride monomer in food.6 Packaging that is damaged or that has been used or is intended to be used for non-food products also is banned.7
The Malaysian Food Regulations of 1985 do not prescribe 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.
In Singapore, the manufacture, import, and sale of food products—including food packaging materials—is governed by the Sale of Food Act, 1973 (revised in 2002) and its implementing regulations. Two of these regulations—Food Regulations and Sale of Food (Food Establishments) Regulations—specifically address food packaging. Part III, No. 37 of the Food Regulations ("Containers for food") 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 any other toxic substance. This includes a ban on products containing 0.05 ppm vinyl chloride monomer, as well as products known to be carcinogenic, mutagenic, or poisonous.
The Sale of Food (Food Establishments) Regulations require food processing establishments to be licensed. These regulations also mandate licensees to ensure that food is packed with food packaging materials that are fit for their intended use and "not likely to contaminate the food."8
The Agri-Food and Veterinary Authority (AVA) is the statutory body in Singapore responsible for enforcing the Sale of Food Act (Chapter 283) and its implementing regulations. The Food Control Division of AVA has indicated that pre-market approval is not required for the import and sale of food packaging materials, and that these materials may be used without Division objection if they do not impart harmful substances to the food. Nonetheless, the Division has suggested that manufacturers and importers of food packaging materials conduct safety assessments of their products to ensure they are safe for their intended uses, and that international standards—including those established by the U.S. FDA—may be used to support these assessments.
Vietnam's Food Safety Law (No. 55/2010/QH12) became effective July 1, 2011. The legislation replaced the Ordinance on Food Hygiene and Safety. Article 18 of the Food Safety Law specifies that food packages must be made of safe materials that do not release poisonous substances, or impart off odors or flavors into the food. Food-contact materials also are required to conform to relevant technical regulations, including the Ministry of Health's regulations on food packages and containers. Finally, a conformity declaration for food packages and containers must be registered with competent state agencies prior to marketing.
On April 25, 2012, Decree No. 38/2012/ND/CP concerning implementation of some articles of the Food Safety Law was signed by the Prime Minister. These articles include the following: 1) Declaration of Conformity to Technical Regulations or Food Safety Regulations; 2) Safety requirements for genetically modified foods; 3) Granting and withdrawing food safety certificates for establishments that meet food safety requirements; 4) State inspection on food safety for imported and exported foods; 5) Labeling of food products; and 6) Delegation of responsibilities for state management of food safety to the relevant Ministries, including Health (MOH), Agriculture and Rural Development (MARD), and Industry and Trade (MOIT). These ministries are currently developing Circulars and Technical Regulations to enforce sections of Decree No. 38/2012/ND/CP.
Among the National Technical Regulations impacting food packaging materials are: QCVN 12-1:2011/BYT, "Safety and hygiene for synthetic resin implement, container and packaging in direct contact with foods;" QCVN 12-2:2011/BYT, "Safety and hygiene for rubber implements, container and packaging in direct contact with foods;" and QCVN 12-3:2011/BYT, "Safety and hygiene for metallic containers in direct contact with foods." On April 22, 2013, Vietnam issued draft Technical Regulation G/SPS/N/VNM 44 on requirements governing the quality hygiene, and safety of glass, porcelain or enameled implements, containers, and packaging in direct contact with food.
Food packaging materials in Hong Kong are subject to the Public Health and Municipal Services Ordinance, which prohibits the migration of packaging components that may render food injurious to health. The Public Health and Municipal Services Ordinance (Cap. 132) and its subsidiary legislation established the legal framework for food safety control in Hong Kong and has remained in effect even after the transfer of Hong Kong from the United Kingdom to China. Therefore, food packaging materials imported into Hong Kong are currently not required to comply with the Chinese Standards. The Centre for Food Safety, which is responsible for implementing policies on food safety control, recommends that imported food be accompanied by a health certificate issued by the relevant health authority of the country of origin, certifying that the food product is fit for human consumption. For packaging materials, a determination of safety and suitability for its intended purpose in the U.S. or another country is a sufficient basis to assert safety for use in Hong Kong.
1 Article 15 of Act Governing Food Sanitation.
2 Article 14 of Act Governing Food Sanitation.
3 MFDS was previously known as the Korean Food and Drug Administration (KFDA). KFDA was elevated to the ministerial level and renamed in March 2013.
4 Thai Food Act B.E. 2522 (1979), Chapter 4, Section 26 (5).
5 Between 1982 and 2009, the Philippine FDA was known as the Bureau of Food and Drugs (BFAD).
6 Malaysia Food Regulations of 1985, Part VI (30).
7 Malaysia Food Regulations of 1985, Part VI (31) and (35).
8 Sale of Food (Food Establishments) Regulations, No. 9 ("Packaging of food").