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 three years.

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 repeated re-examinations.

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 years.

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.