Promulgation of Implementation Rules of Food Safety Law 2019

As revealed by the State Council Notice No. 721 ^[1] on Oct. 31st, China released the new implementation rules of the Food Safety Law (2019) (English version by ChemLinked) to satisfy the updated food supervision requirements. The new implementation rules will come into being on December 1st, 2019.  

Main Content

• Stringent food safety supervision

1. People's governments above county level shall establish a united authoritative supervision mechanism.

2. Details the requirements of random inspection and inter-district supervision & inspection, etc.

3. Perfect the report and reward system

4. Establish the blacklist system for business operators who severely break the law and set up a punishment mechanism for discredited enterprises

• Optimized food safety standards and risk monitoring mechanism

1. Intensify the application of risk monitoring results

2. Standardize the formulation of food safety local standards

3. Ensure the filing scope of enterprises’ standards (QB)

4. Improve the scientificity of food safety management

• Further detailed entity’s responsibilities

1. Nail down the responsibilities of enterprises

2. Standardize food storage and transportation

3. False advertising is prohibited

4. Optimize the management system of special foods

• Detailed penalties and liabilities to enterprises that break the law purposely, the punishment will target legal representatives, principal persons in charge, directors and other responsible persons.

*Note: the interpretation of this new implementation rule and its connection to Food Safety Law ^[2] will be released soon. The English version of this implementation rule will also be updated later.

Some significant items are listed here

Special food

• Special food cannot be mixed and sold with common food or drug. (Article 39)

• It is prohibited to formulate food safety local standards for health food, FSMP and infant formula. (Article 12)

Infant formula

• Except health food, food products are prohibited from using any heath food functional claims or similar terminology. Infant formula containing optional ingredients listed in GB standards are not allowed to be named after this optional ingredient. (Article 38)

Health food

• If the production of health food involves pretreatment such as raw material extraction and purification, the health food manufacturers shall be capable of such ingredient pretreatment (Article 35)

FSMP

• FSMP manufacturers shall conduct lot by lot inspection on the final products according to the testing items required in national food safety standards. (Article 36)

• Specific Full Nutritional Formula Food of FSMP shall be sold through medical Institutions or drug retail enterprises. (Article 36)

• The advertisement for Specific Full Nutritional Formula Food of FSMP shall be regulated as prescription medicine, and that of other FSMP shall be supervised as OTC (Article 37)

Food importation

• Based on risk management requirements, the National Entry-Exit Inspection and Quarantine Department can designate specific ports for the importation of related food products. (Article 46)

• Food products without national food safety standard cannot be imported until relevant national or international standards have passed review by Chinese authority (summarized based on Article 47)

• If the registered oversea food manufacturers are found non-compliant, they shall be rectified within the time limit, and its product importation will be suspended during the rectification period. If the enterprises still fail to meet the registration standard, the competent authority will remove the manufacturer registration qualification and announce the results to the public (article 50)

• National Entry-Exit Inspection and Quarantine Department will issue risk alerts when overseas food safety incidents have the potential to impact domestic food safety or imported food, food additives and food-related products are proven to pose serious food safety risks. In these circumstances the following measures may be taken:

1. Cargo returned or destroyed

2. Further importation restricted

3. Suspension or prohibition of further importation

Food supervision

• The State Council will formulate the directory and corresponding testing methods of non-edible chemical substances and other substances that may pose risk to health and which are likely to be added in food (Article 63)

History Revision

• 2015: China CFDA opens Food Safety Law Draft Implementation Rules for public feedback

• 2016: State Council Released Revised Draft Implementation Rules of Food Safety Law for Public Consultation

• 2017: CFDA Revise Food Safety Law Implementation Rules (Draft-WTO notification)