China Food Laws Year in Review 2021 - From the Year of the Ox to the Year of the Tiger
2021 was an unpredictable year with many unknowns. Although the pandemic continues to cloud our vision for what the future will bring, the Chinese authorities took many steps to further develop its food laws and promote its long-term agenda to build a “Healthy China.” We saw the country revise and update food regulations and standards, require virtually all overseas manufacturers who export food to China to register their facilities, and strong signals supporting the development of new food technologies. In this article, we summarize the important regulatory changes that occurred in 2021, followed by an outlook of what we may expect to see in 2022.
Mandatory facility registration has been expanded from specific high-risk imported food categories to all imported foods following “the strictest administration” policy. Specifically, starting from January 1, 2022, virtually all overseas manufacturers exporting food products to China are required to be registered with the Chinese General Administration of Customs (GAC) under GAC Decree 248 of 2021[1] with additional regulatory requirements imposed on imported foods under GAC Decree 249.[2] Under the new regulatory framework formed under the above two decrees, imported foods, per their risk level, are categorized into “specified foods” (18 types) and “other foods.” Manufacturers of “specified foods” must be registered via the recommendation of its home country, whereas for “other foods,” manufacturers can file their registration applications on their own or through an agent. Notably, GAC Decree 248 also requires labeling the facility registration number on the inner and outer packaging of foods exported to China. More details can be found on China’s food facility registration requirements in Keller and Heckman’s China Regulatory Matters (CRM) newsletters.[3]
Food labeling attracted much regulatory attention in 2021. The National Health Commission (NHC) released the second draft of GB 28050-20xx National Food Safety Standard- General Standard for the Nutrition Labeling of Prepackaged Foods[4] for public consultation, echoing the government’s long-term agenda to build a “Healthy China,” with a focus on reduction of fat, salt, and sugar in food. Compared with the current GB 28050, the draft version newly subjects sugar and saturated fat to mandatory declaration in the nutrition information table. A warning statement, “Children and teenagers should carefully choose foods with high salt, high fat, and high sugar,” is also required on the food label. The front-of-pack nutrition labeling (FOPNL) is added in this draft as well; however, it remains voluntary.
Management of special foods remains among the primary tasks of the Chinese food authorities. Special foods, as defined in China’s Food Safety Law, refer to health foods, infant and young children formula, and foods for special medical purpose (FSMP). A Chinese label must be directly printed on the package of a special food exported to China per GAC Decree 249. In other words, a sticker is no longer allowed to display the Chinese labeling information on the above food products.
Further, in China, health foods are subject to “two-track” management, i.e., pre-market registration and notification. Several draft documents were released in 2021 focusing on the management of health foods subject to notification, including the positive lists of ingredients and function claims for nutrition supplements.[5] China’s State Administration for Market Regulation (SAMR) also moved forward with publishing the long-awaited implementing regulations[6] in their draft form, further guiding the application of health foods subject to registration (also known as “Blue Hat” approval). At present, one of the hurdles to file a “Blue Hat” approval application is the absence of corresponding efficacy testing protocols. The consultation of these drafts suggests those documents may be finalized in the coming months.
Mandatory food safety national standards for some food products, e.g., infant formula and cheese,[7] were finalized and released in 2021. Also amended were the standards for the limits on pesticide and pathogen residues in food. Notably, GB 2760-2014 Standard for the Use of Food Additive[8] is under revision. The latest draft includes food additives that have been newly approved or with modified use specifications since the current version of GB 2760 was published in 2014.
In 2021, NHC reviewed and approved eight new food ingredients and 35 new food additives in five batches.[9] Meanwhile, China National Center for Food Safety Risk Assessment (CFSA) is planning to update the List of Edible Strains Permitted for Use in Foods and List of Edible Strains Permitted for Use in Infants and Young Children Foods[10] by incorporating 16 newly approved edible strains for general food use and seven edible strains for use in infant and young children’s foods.
Alternative proteins
have been attracting wider attention, from the authorities, to stake holders in the industry. The Chinese Ministry of Agriculture and Rural Affairs (MARA), for the first time, includes cultivated meats in its blueprint for food security as a part of its 14th Five-Year Plan.[11] Such an action marks an important milestone to the cell-based industry, as it signals the government’s support for the long-term development of relevant technology. In China, the requirements for the approval of cell-based foods are not entirely straightforward at the moment; however, we have seen some discussion at the legislative level exploring whether cell-based foods can be treated as novel foods.
Regulatory progress has been made with plant-based foods as well. In November 2021, China issued a draft voluntary national standard,[12] detailing terms, definitions, and classification of veggie meat analogues, following the release of a voluntary group standard for plant-based foods[13] by the Chinese Institute of Food Science and Technology (CIFST) in August 2021.
Law enforcement on food industry remains high on the government’s agenda to secure food safety. In 2021, Chinese administrative agencies took a more critical look at food claims and advertisements. Companies have been fined for false and misleading food advertising under Chinese food labeling rules, e.g., making nutrition claims without meeting pertinent thresholds under GB 28050.[14] SAMR announced its plans to strengthen the management of specific foods, such as solid beverages,[15] soy sauce, and vinegar.[16] For example, SAMR is cracking down on conventional foods in the form of solid beverages or tea bearing health claims or sensitive words.
Since labeling is one of the topics that is frequently reported for non-compliance, SAMR clarified the scenarios of “labeling defects” (e.g., font size failing to meet the requirement) in the Measures for the Supervision, Inspection and Administration of Food Production, and Operation,[17] under which the scope of labeling defects generally includes labeling issues that may not pose a threat to food safety and are not misleading to consumers, e.g., inaccurate translation of foreign language and using a non-standardized ingredient name. Per the Measures, food with labeling defects can continue to be sold in the market provided that manufacturers take measures to correct the defect and ensure food safety. Remedial measures, however, should be demonstrated to the consumer.
Outlook for 2022
According to NHC’s 2022 Work Plan,[18] it will continue focusing on the revision of major national food safety standards, such as the one for the maximum residue limits of contaminants and pathogens in foods, use of food additives, and food hygiene specifications and corresponding inspection methods.
Further, regulations and standards whose amendments have already been published for some rounds of consultation are expected to be finalized in 2022 with a grace period for the industry, e.g., GB 7718-2011 General Standard for the Labeling of Prepackaged Foods[19] and GB 28050-2011, as well as the Measures on Supervision and Management of Food Labeling.[20] One hopes that the labeling rules from these different sources reconcile and the industry enjoys a smooth transition in practice.
We will continue to keep you updated on the latest legal developments throughout the year. In the meantime, if you need any support navigating China’s food laws and regulations, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Li (li@khlaw.com), Yin Dai (dai@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Overseas%20Facilities%20Registration%20Regulation%20-%20Decree%20248_Beijing_China%20-%20People%27s%20Republic%20of_04-11-2021.pdf
[2] https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Decrees%20248%20and%20249%20-%20January%201%20Implementation%20Date_Beijing_China%20-%20People%27s%20Republic%20of_12-08-2021
[3] https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Overseas%20Facilities%20Registration%20Regulation%20-%20Decree%20248_Beijing_China%20-%20People%27s%20Republic%20of_04-11-2021
[4] https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi0nICPzcn5AhVmM1kFHTKiCdoQFnoECCAQAQ&url=http%3A%2F%2Fwww.agrichina.org%2Fadmin%2Fkindeditor-4.1.2%2Fattached%2Ffile%2F20130321%2F20130321195042_3280.pdf&usg=AOvVaw0FGIUAxNhZ2pLVmZsYCkPq
[5] http://www.gov.cn/zhengce/zhengceku/2021-09/16/content_5637606.htm
[6] List of Health Function Claims for Non-nutrient Supplements (2022 Edition), Technical Guidelines for Inspection and Evaluation of Health Food Functions (2022 Edition), Inspection and Evaluation Methods of Health Food Functions (2022 Edition), Guidelines for Human Clinical Trial (2022 Edition), https://www.samr.gov.cn/hd/zjdc/202201/t20220113_339092.html
[7] http://www.nhc.gov.cn/sps/s7891/202103/0bdb6c4318724644b40e3f3f894aa88f.shtml
[8] https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Standard%20for%20Food%20Additive%20Use%20-%20GB2760-2015_Beijing_China%20-%20Peoples%20Republic%20of_4-28-2015.pdf
[9] NHC Announcement No.9/2020, http://www.nhc.gov.cn/sps/s7892/202101/59f6380209494ea6b67a49648e59fd84.shtml;
NHC Announcement No.2/2021, http://www.nhc.gov.cn/sps/s7892/202102/b03cdbca10464f2890d1b5d50d7bbb48.shtml;
NHC Announcement No.5/2021, http://www.nhc.gov.cn/sps/s7892/202104/ae8afd8de4c84419b57fe7147d6f5206.shtml; NHC Announcement No.6/2021, http://www.nhc.gov.cn/sps/s5853/202107/6502707e8eba433a8ae53ac78c020a8b.shtml; NHC Announcement No.9/2021, http://www.nhc.gov.cn/sps/s7892/202110/0c1d177c19384989acfd24a37a8b8692.shtml
[10] https://www.cfsa.net.cn/Article/News.aspx?id=CB3E2B99ED5BE4E99CFE17D109A97B3D7F73BCD83D0DF579
[11] 14th Five-Year Plan for National Agricultural and Rural Science and Technology Development (2021-2025), http://www.gov.cn/zhengce/zhengceku/2022-01/07/5666862/files/175b7109359a41ca9d1e03ed0f0fd46c.pdf
[12] http://www.cnlic.org.cn/ZhinNengBuShi/ShiPinChanYeBu/202111/t20211102_64418.html
[13] http://www.cifst.org.cn/uploads/file/20210824/1629777389439490.pdf
[14] https://cfws.samr.gov.cn/detail.html?docid=2c9bf29c7a13ac58017a2f4cd92b66a9
[15] https://gkml.samr.gov.cn/nsjg/spscs/202201/t20220107_338958.html
[16] https://gkml.samr.gov.cn/nsjg/spscs/202106/t20210629_331737.html
[17] https://gkml.samr.gov.cn/nsjg/fgs/202112/t20211231_338736.html
[18] http://www.nhc.gov.cn/sps/s3594/202110/219af8b595e448c1967a5b03ce5c497e.shtml
[19] https://sppt.cfsa.net.cn:8086/db?type=2&guid=9058ADC5-AFC3-4586-9798-D0170F6F879C
[20] https://www.samr.gov.cn/hd/zjdc/202007/t20200727_320262.html