Regulation of Food Packaging Materials in the People's Republic of China
Food-packaging materials in China are regulated under the Food Safety Law of the People's Republic of China (P.R.C.). The Food Safety Law became effective on June 1, 2009, and now governs all issues of food quality and food safety in China. Article 36, together with Article 62 of the Food Safety Law, prohibits the importation, use, or purchase of food-related products (e.g., food packaging materials, utensils, equipment, etc.) not complying with an applicable Chinese Food Safety Standard. This provision further requires that food producers establish product verification systems detailing the specification and supplier information for food-related products, which are to be maintained for two years. Violations can result in substantial penalties, including fines on the order of five to 10 times the value of commodities whose value exceeds 10,000 Renminbi (RMB), and 2,000 to 50,000 RMB for commodities of lesser value[1].
China has developed hygienic standards for a number of polymeric materials that are commonly used to produce food-contact articles, including polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyethylene terephthalate, nylon, and polycarbonate. Standards are promulgated by the Chinese Ministry of Health (MOH), and enforcement is carried out by the General Administration for Quality Supervision, Inspection and Quarantine (AQSIQ). Generally, the standards for resins establish physical and chemical requirements for the material (e.g., weight loss upon drying, combustion residue, and extractions using n-hexane), while application-specific standards set migration limits and performance criteria for finished containers and packaging.
China is in the process of revising many of its existing Food Safety Standards (e.g., hygienic standards, testing standards, etc.) relating to food packaging materials, some of which are well out of date, to ensure harmonization with the new Food Safety Law. For example, China's Hygienic Standard for Food Packaging Paper (GB 11680-1989) has been in place since 1989 and is currently being revised by a designated working group. In the meantime, however, existing standards are considered enforceable. In recent months, substantial attention has been focused on China's "Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials" (GB 9685-2008), which currently provides a positive list of additives permitted for use in food containers and packaging materials, including polymers, coatings, and adhesives, as well as paper and paperboard. The Standard was amended, effective June 1, 2009, to permit the use of 959 food additives in the manufacture of food packaging.
Notwithstanding this expansion of GB 9685, Chinese authorities are aware that there are numerous substances in current use in China that, while safe for their intended use, are not explicitly cleared under an applicable Food Safety Standard. Accordingly, in May of 2009, industry was informally advised that MOH would consider "provisional approval" of a number of unapproved materials currently in use in China for purposes of granting a temporary status for such substances. The draft "Interim Measures on Administrative Permission of New Species of Food Related Products" was published for comment on May 6, 2009, with the intent to provide for the clearance of products currently in use in China. However, these procedures remained unofficial as of the June 1, 2009, effective date for the Food Safety Law and GB 9685.
To prevent market disruptions by effectively prohibiting such substances from further use, MOH and five other Chinese agencies issued a June 5, 2009, Joint Announcement indicating that there would be a one-year transitional period, lasting until June 1, 2010, before enforcement actions began. The June 5 Announcement was ambiguously worded, but indicated that during the transitional period industry would be expected to conduct "self-examination" and reporting of materials in current use. This transition policy was intended to avoid a crush of approval applications for substances in use but not listed under an applicable Food Safety Standard in China. While the specific contours of the self-reporting and notification procedures remained uncertain, some read the June 5 Announcement as inferring that continued marketing would be permitted for those products currently in use in China for which an application for approval via the Ministry's forthcoming "self-reporting" procedures would be submitted. These procedures are described in more detail below.
Procedures for Clearing Unapproved Food-Contact Substances and Materials Currently in Use in China
MOH issued, on December 4, 2009, a "Circular on the Conduct of Food Packaging Material Clean-up Operations," to various Chinese agencies regarding the production and use of unapproved food-contact materials. According to the Circular, companies were to assess the compliance of the food-contact materials currently in use in China and file submissions with MOH to seek explicit approval for food-contact materials without a suitable status. The Circular set out the procedure for clearing the use of additives and resins currently marketed in China but not actually approved[2]. MOH is expected to publish two lists after a review of the submissions by the Ministry's technical experts. The first list will be titled, "List of Substances Which Can Be Used in Food Packaging Materials" (the so-called "positive list"),[3] and the second list will be titled, "List of Substances Which are Prohibited for Use in Food Packaging Materials" (the so-called "negative list")[4].
According to the December 4 Circular, "serious actions will be taken against entities or personnel who continue to use the substances on the ‘List for Substances Which Are Prohibited for Use in Food Packaging Materials' in food packaging materials and containers manufactured or sold after the list is announced."
On February 12, 2010, the Chinese authorities issued final MOH Guidance Documents with the forms and instructions for obtaining clearances for these materials. The Guidance set forth the data requirements and the June 1, 2010 deadline for applications for approval of food packaging materials currently in use in China. While MOH may consider approving applications without all applicable data, this will be determined on a case-by-case basis.
These procedures have now concluded with MOH having received more than 3,000 petitions for various food-contact substances, including more than 500 new resins. The Ministry has indicated that approvals will be noted on its website and will be released in batches. Substances with clearly demonstrated safety will likely be the first to receive consideration. In this regard, some expect MOH to attach substantial weight to the existence of regulatory clearances for a given food-contact substance in the United States, the European Union (EU), and Japan.
While procedures for clearing new, i.e., not in current use, food-contact substances are supposed to be forthcoming, it is unclear when they will be issued. Until then, no submissions for new food packaging materials are being accepted.
[1] See Article 85 of the Food Safety Law.
[2] The Circular provides details regarding submissions for food-contact resins, and for "new species of food-related products," which is intended to cover all other food-contact products (i.e., "food packaging materials and containers;" "tools and equipment for food production and operation;" "additives for food containers, packaging materials, equipment and tools;" "detergents for food;" and "disinfectants for food").
[3] While the list of approved substances is referenced here as a "positive list," it will not serve as an exhaustive positive list, but rather a list of approved substances. In addition to the food-contact materials and substances cleared in the current consolidated list (GB 9685-2008), the first positive list will include substances that are grandfathered according to the procedures noted in the recent Circular.
[4] We note that, with regard to the negative list, MOH has not provided any information on the form of submission for materials that should be banned for food-contact uses; further, no explicit criteria have been established for determining which substances should be banned for these uses.