Chapter I. General

Article 1. These regulations are formulated for the purpose of implementing the Food

Safety Law of the People’s Republic of China (hereinafter referred to as the Food Safety

Law).

Article 2. Local people’s governments at or above the county level shall reinforce their food safety supervision and administration capability building, so as to provide assurance to food safety supervision and administration work. The coordination and cooperation mechanism of food safety supervision and administration departments shall be established and perfected, food safety information network shall be integrated and perfected so that the access to technical information of food safety information institutions and food inspection institutions can be shared.

Article 3. Institutions under the State Council, such as the Ministry of Industry and

Information Technology and the Ministry of Commerce, shall prepare the development

program and industrial policies for food sector, promote industrial structure optimization and

upgrading, guide trust building in food sector, and encourage its healthy development.

Chapter II. Food Safety Risk Monitoring, Assessment, and Food Safety Standard

Article 4. National food safety risk monitoring program, as provided for in Article 11 of

Food Safety Law, shall be jointly developed according to the requirements of food safety risk

assessment, food safety standard preparation or revision, and Administration for Quality

Supervision, Inspection, and Quarantine (AQSIQ), State Administration for Industry and

Commerce (SAIC), State Food and Drug Administration (SFDA) of the State Council, and the

Ministry of Commerce (MOFCOM).

Article 5. The health administrative department of the people’s government of each

province, autonomous region, and municipalities directly under the Central Government

shall organize its local AQSIQ, SAIC, food and drug administrative department, and

commerce department to, pursuant to Article 11 of Food Safety Law, develop the food

safety risk monitoring program for the local jurisdiction area and shall submit it to MOH for

filing.

AQSIQ, SAIC, SFDA, and MOFCOM shall be briefed on this filing by MOH.

Article 6. The Ministry of Agriculture (MOA), AQSIQ, SAIC, SFDA, and MOFCOM shall

collect food safety risk information and, when necessary the Ministry of Health (MOH), shall

jointly adjust the food safety risk monitoring program in a timely manner.

Article 7. Apart from making adjustments to the food safety risk monitoring program in

accordance with Article 12 of Food Safety Law, MOH shall, when necessary, adjust this

program depending on the disease information as reported by medical institutions.

Article 8. A medical institution, when having received patients for food-borne disease

and food poisoning, or suspected cases, shall report the disease information timely to the

health administrative department of the county or district people’s government.

After receiving the report, the local health administrative department shall summarize

and analyze the disease information and shall, in a timely manner, report to its superior

health administrative department and, if need be, it may report directly to MOH. Disease

reporting regulations shall be prepared by MOH.

Article 9. Food safety risk monitoring work shall be undertaken by a technical institution

as chosen jointly by MOH, SAIC, and SFDA.

The technical institution charged with food safety risk monitoring shall, in accordance

with the food safety risk monitoring program, perform monitoring in a systematic and

constant way, ensure that the monitoring data are true, accurate, and objective, and shall

submit the monitoring data and analysis results to MOH and the department assigned the

monitoring tasks.

In order to collect samples and relevant data, food safety risk monitoring personnel may

enter the premises where farm food products are grown or developed or where food is

processed, circulated or catering service provided; the samples shall be paid for.

Article 10. MOH shall collect and summarize food safety risk monitoring data and

analyze the results and shall notify AQSIQ, SAIC, and SFDA, and MOFCOM.

Article 11. MOH shall arrange for food safety risk assessment in case of any one of the

following circumstances:

(1) Where risk assessment is needed in order to provide scientific references to the

development or revision of national food safety standard;

(2) Where risk assessment is needed in order to identify the key fields and key species of

supervision administration and to assess the effectiveness of supervision administration

measures;

(3) Where new factors are identified that may jeopardize food safety;

(4) Where it is needed to determine whether a certain factor poses a food safety danger;

(5) Where it is needed to determine whether a food is safe or not;

(6) Where risk assessment is required pursuant Article 44 and 63 of Food Safety Law;

and

(7) Other situations where MOH deems necessary to conduct a risk assessment.

Article 12. MOH shall notify MOA in a timely manner of food safety risk monitoring and risk

assessment results.

MOA shall notify MOH in a timely manner of the quality and safety risk monitoring and risk

assessment results of farm food products.

Where MOH, as may be needed for the purpose of food safety risk assessment, requires

that MOA furnish safety assessment reports on pesticides, fertilizers, plant growth

regulators, animal medicines, fodders, and fodder additives, MOA shall provide such

information in a timely fashion.

Article 13. MOH shall, jointly with MOA, AQSIQ, SAIC, SFDA and MOFCOM, prepare a

program and implementation plan for national food safety standard. Public comments and

suggestions shall be invited for the preparation of the program and implementation plan for

national food safety standard.

Article 14. MOH shall select technically qualified institutions to develop the draft of national

food safety standard; it is recommended that the draft of the national food safety standard

be developed jointly by research institutions, educational institutions, academic institutions,

trade societies.

MOH shall publicize the draft of national food safety standard to society for comments and

suggestions.

Article 15. The National Food Safety Standard Review Committee under Article 23 of Food

Safety Law shall consist of experts selected by MOH and representatives MOA, AQSIQ, SAIC,

and SFDA as well as representatives from the Ministry of Industry and Information

Technology and MOFCOM.

The National Food Safety Standard Review Committee is responsible for reviewing the

appropriateness and practicability of the draft of national food safety standard and its

coherence with relevant national standards. The work procedures of the National Food Safety

Standard Review Committee shall be prepared by MOH.

Article 16. The health administrative department of the people’s government of each

province, autonomous region, and municipality directly under the Central Government shall

report on enterprise standards, as may be submitted for filing by local enterprises pursuant

to Article 25 of Food Safety Law, to its local peer AQSIQ, SAIC, and SFDA.

Article 17. MOH shall, jointly with the agriculture administrative department, AQSIQ , SAIC,

and state food and drug supervision department of the State Council as well as the Ministry

of Commerce, follow up and assess the implementation of national food safety standard and

shall, according to the assessment findings, arrange for a timely revision of this standard.