China’s State Administration for Market Regulation (“SAMR”) recently issued Measures for the Administration of Lists of Serious Illegal and Dishonest Acts (the “Measures”). These Measures, which took effect on September 1, 2021,[1] were promulgated to standardize the management of lists maintained by market regulation authorities of parties that have committed serious violations of law in the areas of food safety, drugs, medical devices, and cosmetics, among others.
With respect to food safety, the Measures lay out a number of serious unlawful acts that could cause a party to be included in publicized lists on the National Enterprise Credit Information Publicity System. Such illegal acts include:
- engaging in food production or distribution activities without obtaining a food production and operation permit;
- producing food using non-food grade raw materials;
- adding chemical substances, other than food additives, or other substances to food that may harm human health;
- producing food designed specifically for infants, young children, or other specific populations with nutritional ingredients that do not conform to food safety standards;
- producing health foods, formula foods for special medical purposes, or infant formula that have not been registered in accordance with regulations, or that have not been manufactured in accordance with the technical requirements of registered product formulas and production processes;
- producing or distributing food or food additives containing pathogenic micro-organisms, residues of pesticides, veterinary medicines, biotoxin, heavy metals, or pollutants and other substances harmful to human health that exceed the limits set out in food safety standards;
- other illegal acts that violate food safety laws and administrative regulations that seriously endanger the health and safety of human health and life.
Parties included in such lists are subject to severe administrative penalties, including heavy fines, revocation of permits (e.g., product and facility licenses) and business licenses, and suspension or closure of businesses.
The Measures also include provisions for notification of parties and hearing and objection procedures, as well as procedures for application for administrative reconsideration and removal from the lists.
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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:
John Balzano, Julia Post, Muyun Hu, Annie Wang, and Kaixin Fan
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[1] Available at http://gkml.samr.gov.cn/nsjg/fgs/202108/t20210801_333255.html.