China’s State Administration for Market Regulation (“SAMR”) recently issued Administrative Measures for the Supervision and Inspection of Food Production and Distribution (the “Measures”), which took effect on March 15, 2022.[1]  The Measures implement manufacturing and distribution requirements in China’s Food Safety Law and build upon the 2016 version of the measures on routine inspections of food production and distribution facilities.

The Measures provide that provincial-level market supervision bureaus (“MSBs”) that regulate food locally may, in accordance with SAMR’s list of key points for supervision and inspection of food production and distribution,[2] formulate a list of priority inspection items for their respective areas.  Inspectors of food producers should focus on, the qualifications of food producers, production environmental conditions, production process control, product inspection, storage and delivery control, labeling, food recall, and handling of food safety incidents.  For contract manufacturing arrangements, the Measures direct inspectors to focus on recordkeeping of foods entrusted for production and the entrusting party’s (e.g., the brand owner’s) supervision of the entrusted party’s food production.  The Measures provide key points for the inspection of food retailers, producers and sellers of special foods, centralized trading market operators, and catering services.

The Measures direct local MSBs to conduct inspections of all food producers and sellers within their region at least once every two years.  Inspectors are permitted to conduct sampling inspections of the food produced, review and copy account books and other relevant materials, seal or seize food and equipment that have evidence of not meeting food safety standards, and seal facilities that illegally engage in food production and distribution activities.

Unlike the prior version from 2016, the Measures provide detailed direction on inspection of food labeling. Specifically, when inspections reveal defects in food labeling or instructions, MSBs shall order the parties concerned to make corrections; when food producers have instituted remedial measures and can ensure food safety, such food products may continue to be sold as long as the remedial measure are clearly conveyed to consumers.  In determining whether food labels or instructions are defective, factors such as safety, the subjective fault of the parties, and consumers’ understanding shall be considered.  Citing Article 125 of the Food Safety Law, the Measures provide a list of circumstances under which labels are to be deemed defective, including when the translation of foreign languages is inaccurate, when the size and height of foreign language characters are larger than the Chinese characters, and when the ingredient list sequence is not standardized.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, and Kaixin Fan

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[1] Available at https://gkml.samr.gov.cn/nsjg/fgs/202112/t20211231_338736.html.

[2] Available at https://gkml.samr.gov.cn/nsjg/spscs/202203/t20220311_340370.html.

Photo of John Balzano John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with…

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.

Photo of Julia Post Julia Post

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development…

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development matters, including informed consent requirements, biospecimen procurement and research use, and other good clinical practice. She advises clients regularly on product life-cycle management issues, including patent linkage frameworks and marketing exclusivity in the U.S. and China.

Julia works with pharmaceutical, medical device, food, and cosmetics clients on complex regulatory compliance matters and helps them develop their advocacy strategies before U.S. and China regulators, at both national and local levels. She regularly assists companies and trade associations on policy issues, including the development and submission of comments on legislative and regulatory proposals. Julia works closely with local counsel throughout the Asia-Pacific region to assist clients with their marketing approval and compliance strategies.

Prior to joining the Food, Drug, and Device practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

Julia has an active pro bono practice at Covington, with a particular focus on reproductive justice matters and representation of third-party caregivers and children in custody cases.