The Implementing Rules on the PRC Food Safety Law ("Food
Safety Rules") became effective on 20 July 2009, the date of
their promulgation by the PRC State Council.
Reporting Obligation of Medical Institutions
Taking into consideration the involvement of medical
institutions in food safety incidents, Article 8 of the Food Safety
Rules requires medical institutions to report cases of suspected or
confirmed food poisoning or food-related illness immediately to the
local health department.
Effective Term of Licenses
Pursuant to Article 29 of the Food Safety Law, the food
producers and food business operators are required to obtain the
food production license, food circulation license or catering
services license. Article 20 of the Food Safety Rules provides that
such licenses constitute the premise of the registration of the
food producers or business operators with competent Administration
of Industry and Commerce and the effective term of such licenses is
Remedy for Recalled Food
Article 53 of the Food Safety Law stipulates that the recalled
defective food may be disposed by remedy, harmless treatment or
destruction. Article 33 of the Food Safety Rules requires that the
measure of remedy is only applicable under the circumstance that
the food is recalled due to the non-compliance of the labels, marks
or specifications with relevant food safety standards.
Re-examination of Food
Further to requirements for the re-examination of food in
Article 60.3 of the Food Safety Law, Article 34 of the Food Safety
Rules makes the findings of the re-examination institution final
and binding. This eliminates the inconvenience and burden of
Absence of National Food Safety Standard
Pursuant to the Food Safety Law, national standards formulated
by the Ministry of Health are the most crucial criteria for
determining the safety of food. However, because the national
standards cannot cover all circumstances that may endanger public
health, Article 38 of the Food Safety Rules requires that, in the
absence of applicable standards, the Exit and Entry Administration
Bureau must notify the Ministry of Health if it finds anything in
imported food that threatens public health.
Effective Term of Registration of Foreign Food Producers
Article 65 of the Food Safety Law requires overseas food
producers that export food to the PRC to register with the Entry
and Exit Administration Bureau, and Article 39 of the Food Safety
Rules stipulates that the registration is effective for four
Imported Food Additives
The Food Safety Rules also cover imported food additives.
Article 40 of the Food Safety Rules applies the requirement that
imported pre-packaged food products bear labels and specifications
in Chinese (Art. 66, Food Safety Law) to imported food additives.
Non-complying additives will be confiscated, and a fine of up to
RMB 50,000 or five times the value of the products may be imposed,
depending on the actual value of the imported food additives. (Art.
58, Food Safety Rules)
Time Limit for Reporting Food Safety Incidents
The Food Safety Law requires the unit where the food safety
incident occurs to report it to the local health department.
Article 43 of the Food Safety Rules requires that the report be
made within two hours of the incident. Failure to comply may
subject the unit to the administrative penalties in Article 88 of
the Food Safety Law, including an order of correction, warning,
administrative fines, cessation of production and operation and, in
serious cases, revocation of relevant licenses or permits. (Art.
60, Food Safety Rules)
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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