On March 11, 2015, the China Food and Drug Administration promulgated the Administrative Measures for Food Recalls (hereinafter, the "Measures"). The Measures will go into effect on September 1, 2015.
The Measures categorize food recalls into three levels: if food consumption has caused or may potentially cause serious illness or death, such recall is classified as a Level One recall, which shall be activated within 24 hours upon knowledge of the safety risks and be concluded within ten working days; if food consumption has caused or may potentially cause general illness, such recall is classified as a Level Two recall, which shall be activated within 48 hours upon knowledge of the safety risks and be concluded within 20 working days; and a Level Three recall will be conducted for foods with misrepresented information in their labels and shall be activated within 72 hours upon knowledge of the safety risks and be concluded within 30 working days.
The Measures also provide that a food operator who has become aware that unsafe foods have been recalled by their manufacturers shall immediately suspend the procurement and sale of such unsafe foods, seal them, post the recall announcements issued by the manufacturers in conspicuous places and cooperate with the manufacturer's recall efforts. For unsafe foods in which non-food substances or putrid, spoiled or ill livestock is unlawfully added and thus seriously endanger human health and life shall be destroyed immediately on the spot. Food manufacturers and operators are required to faithfully record the names, trademarks, specifications, production dates, batches and quantities of unsafe food items whose production have stopped and are being recalled or disposed of. The records shall be kept for a minimum of two years.
Finally, the Measures contain the following specific provisions regarding the legal liabilities of food manufacturers and operators who violate the Measures:
- For the manufacture and operation of unsafe foods, foods subject to the three levels of recall or whose production have been halted and therefore withdrawn from the market, and f or unsafe foods in which non-food substances or putrid, spoiled or ill livestock is unlawfully added and thus seriously endanger human health and life, the operators and manufacturers shall stop operations immediately, voluntarily recall such foods, commence the recall within the required period, recall the unsafe foods according to their recall plan or dispose of the unsafe foods pursuant to applicable requirements. Otherwise, the food and drug regulatory authorities will issue warnings and impose a fine of RMB10,000 to RMB30,000.
- If a food operator aware of a food manufacturer's recall of unsafe foods but does not cooperate with the food manufacturer's recall of unsafe foods, the food and drug regulatory authorities will issue a warning and impose a fine of RMB5,000 to RMB30,000.
- For failure to perform the relevant reporting duties, such as recalling unsafe foods or gathering unsafe foods for destruction and disposal, the food and drug regulatory authorities will demand rectification and issue warnings. In case of failure to rectify, a fine of RMB2,000 to RMB20,000 will be imposed.
- For food manufacturers and operators who fail to dispose of unsafe foods pursuant to law, if they refuse or delay the disposal of unsafe foods pursuant to law after being ordered to do so by the food and drug regulatory authorities, the food and drug regulatory authorities will issue a warning and imposed a fine of RMB20,000 to RMB30,000.
- In case of failure to record the status of the halted production and operation, the recall and the disposal of unsafe foods as well as maintain such records, the food and drug regulatory authorities will order rectification and issue a warning. Refusal to rectify will result in, a fine of RMB2,000 to RMB20,000.
In addition, the Measures also stipulate that if a food producer or operator voluntarily stops the production or operation, recalls and disposes of unsafe foods to the extent of eliminating or reducing the harms or consequences, the penalties may be lighter or reduced. In case of minor legal violations and timely rectification with no further injury, no administrative penalties will be imposed.