On 24 April 2015, the "Food Safety Law of People’s Republic of China" (the Law) was passed by the 14th Meeting of the Chinese Executive Committee and it came into force on 1 October 2015. This is an important revision since the previous version was published in 2009. In the revised version, 50 new articles are added among other revisions, adding up to a total of 10 chapters with 154 articles.
The Law focuses on the strictest possible supervision of the whole process of the production, sales, food and beverage service, etc., and intensifies the responsibility and liability of the production and operating entities. Meanwhile, it has also established the most strict punishment system such as criminal liability investigation; consolidation of the liability of the responsible person of the local government and supervision authority, etc. Further, the Law raises the punishment for activities not complying with the food safety regulations in order to prevent such activities happening again. If the illegal activities are considered crimes, the person responsible has criminal liability. If a person is sentenced to prison or found guilty of another severe crime, the person will not be allowed to participate into food-related work for the rest of his/her life.
Key aspects of the Law:
1. Six situations need to be assessed
In order to discover potential food safety risks as early as possible, the Law includes a chapter concerning the inspection and evaluation of the food safety risk and the following six situations need to be evaluated:
- The food, food additives and related food products may have potential safety risks after the inspection, or according to relevant reports;
- In order to provide a scientific basis for the development or revision of national standards for food safety;
- In order to determine the key areas of the supervision and management and necessary to have the risk assessment;
- Discovering new potential hazard factors to food safety;
- Need to determine whether a certain factor constitutes a food safety hazard;
- Other circumstances which the health administrative department under the State Council believes justify a risk assessment.
The Law states that the national food safety standards must be formulated and promulgated by the administrative department of public health under the State Council together with the food and drug supervision and administration department under the State Council. The national food safety standards must cover food, food additives, food related products in the pathogenic microorganisms, pesticide residues, veterinary residues, biological toxins, heavy metals and other pollutants and other substances harmful to people’s health; variety, use range and dosage of food additives; the labels of staple and supplementary food exclusively for infants and other particular groups of people must also bear indications of the main nutrient ingredients and contents thereof; requirements for labeling, marking, and manual requirements relating to food safety, such as health, nutrition and so on; hygienic requirements for food production and operation processes; quality requirements relating to food safety; methods and procedures for food safety or related to food safety; other needs to be formulated as standards for food safety.
2. Infant formula milk powder
The Law explicitly stipulates that raw food material, food additives, product formula, product labels, etc., of infant formula must be notified to the provincial FDA. The product formula of infant formula milk powder must be registered with the CFDA (China Food and Drug Administration). Formula research reports and other documents that can demonstrate the scientificalness and safety of the formula must all be submitted in connection with registration. The Law also emphasizes that the sub-packaging of infant formula is forbidden and that the manufacturer must not use the same formula to produce infant formula milk powder of different brands.
3. Health food
The Law stipulates that the labels and menus of health food muat not include disease prevention or treatment function and must have the statement of "this product cannot replace medicine". Moreover, it states that the Inventory of Health Food Raw Material will be prepared and published by the CFDA. After the publication of the inventory, the raw materials not listed in the inventory or the newly imported health food must be registered with the CFDA. Other health food must be notified to the provincial FDA. Imported supplementary vitamins, minerals and so on must be notified to the CFDA. The detailed guidance is pending for now.
4. Food for special medical use
Taken into consideration that the food for special medical use is quite different from the normal food, which has a higher safety requirement, and that doctor’s advice will be needed, such food must be registered prior to use. Documents such as product formula, manufacturing technique, label, menu and documents that can demonstrate the safety, nutritional sufficiency and clinical effect for special medical use of the product must all be submitted during the registration at the CFDA.
5. Food from online shopping
The Law stipulates that the third party online platform must require retailers to register with real ID and with the clear understanding of their food safety responsibility. The related certificates must be acquired by the online retailers and the certificates must be reviewed by related supervision departments. If customers’ rights are influenced after purchasing certain food through the third party platform, compensation may be claimed by customers from online food retailers or food manufacturers first. If the third party platform is not able to provide the exact contact information of the online food retailer or the food manufacturer, the compensation must be paid by the third party platform directly to the customer.
Beside the above revise, the fine amounts for the punishment of relevant illegal activities have been increased dramatically; the highest amount for the punishment can be as high as 30 times the price of the products.
The Law came into force on 1 October 2015. We recommend relevant companies to take the revise into consideration and to be ready to comply with the Law.