Article 2 These Provisions shall apply to the food safety risk assessment organized by the health administrative department of the State Council in accordance with the relevant provisions of the Food Safety Law.
Article 3 The Ministry of Health is responsible for organizing food safety risk assessment, setting up a national food safety risk assessment expert committee, and timely informing the relevant departments of the State Council of the results of food safety risk assessment.
Relevant departments of the State Council put forward suggestions on food safety risk assessment according to the requirements of relevant laws and regulations and these Provisions, and provide relevant information and materials.
The relevant departments of the local people's government shall, according to the link where the risk lies, assist the relevant departments of the State Council to collect information and materials related to food safety risk assessment.
Article 4 A national food safety risk assessment expert committee shall be established according to the articles of association of the national food safety risk assessment expert committee.
The technical organization of food safety risk assessment determined by the Ministry of Health is responsible for collecting, processing and analyzing scientific data, technical information and test results related to food safety risk assessment. Food safety risk assessment technical institutions carry out risk assessment related work and accept the entrustment and guidance of the national food safety risk assessment expert Committee.
Article 5 Food safety risk assessment shall be conducted in a scientific, transparent and case-by-case manner based on food safety risk monitoring, supervision and management information, scientific data and other relevant information.
Article 6 The State Food Safety Risk Assessment Expert Committee shall independently conduct risk assessment according to these Provisions and the Articles of Association of the State Food Safety Risk Assessment Expert Committee to ensure that the risk assessment results are scientific, objective and fair.
No department may interfere with the risk assessment related work undertaken by the National Committee of Experts on Food Safety Risk Assessment and the technical institutions for food safety risk assessment.
Article 7 Under any of the following circumstances, the Ministry of Health shall, after examination and approval, issue a food safety risk assessment task to the National Committee of Experts on Food Safety Risk Assessment:
(1) Risk assessment is needed to provide scientific basis for formulating or revising national food safety standards;
(2) It is considered necessary to conduct food safety risk assessment after organizing inspection through food safety risk monitoring or receiving a report that there may be potential safety hazards in food;
(3) Relevant departments of the State Council put forward suggestions on food safety risk assessment according to Article 12 of the Regulations for the Implementation of People's Republic of China (PRC) Food Safety Law, and put forward suggestions on risk assessment projects as required (see attached table1);
(4) Other circumstances in which the Ministry of Health deems it necessary to conduct risk assessment according to laws and regulations.
Article 8 When submitting a proposal for a risk assessment project, the relevant departments of the State Council shall provide the following information and materials to the Ministry of Health:
(a) The source and nature of the risk;
(2) Relevant inspection data and conclusions;
(3) Risk scope;
(4) Other relevant information and materials.
The Ministry of Health shall organize the collection of relevant information and materials according to the needs of food safety risk assessment, and relevant departments of the State Council and local agricultural administration, quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level shall assist in the collection of food safety risk assessment information and materials as mentioned in the preceding paragraph.
Article 9 In any of the following circumstances, the Ministry of Health may make a decision not to evaluate:
(a) can be solved through existing supervision and management measures;
(2) We can draw a conclusion through inspection and product safety evaluation;
(3) International government organizations have clear information science to describe risks, which is suitable for China's dietary exposure model.
If it is difficult to make an evaluation conclusion due to lack of data and information, the Ministry of Health shall explain the reasons and basis to the relevant parties; If an international organization has an evaluation conclusion, it shall notify the relevant departments together.
Article 10 The Ministry of Health shall determine the national food safety risk assessment plan and priority assessment items according to the provisions of Article 7 of these Provisions and the recommendations of the national food safety risk assessment expert committee.
Article 11 The Ministry of Health shall assign the risk assessment task to the National Food Safety Risk Assessment Expert Committee in the form of the Risk Assessment Task Book (see Annex 2). The risk assessment task book should include the purpose of risk assessment, the problems to be solved and the output form of the results.
Article 12 The National Committee of Experts on Food Safety Risk Assessment puts forward a risk assessment implementation plan according to the assessment task and reports it to the Ministry of Health for the record.
For those who need further supplementary information, suggestions on data and information collection programs can be made to the Ministry of Health.
Article 13 The National Expert Committee on Food Safety Risk Assessment shall conduct risk assessment according to the implementation plan of risk assessment, and follow the structured procedures of hazard identification, hazard characterization, exposure assessment and risk characterization.
Article 14 The entrusted relevant technical institutions shall submit the collection, processing and analysis results of scientific data, technical information and test results related to risk assessment within the time limit required by the National Food Safety Risk Assessment Expert Committee.
Article 15 The National Expert Committee on Food Safety Risk Assessment conducts risk assessment, is responsible for the results and reports of risk assessment, and reports the results and reports to the Ministry of Health in a timely manner.
Article 16 In any of the following circumstances, the Ministry of Health may request the State Committee of Experts on Food Safety Risk Assessment to study and analyze immediately. For matters requiring risk assessment, the State Food Safety Risk Assessment Expert Committee shall immediately set up a temporary working group to formulate an emergency assessment plan.
(1) Handling major food safety accidents;
(two) food safety issues of great concern to the public need to be answered as soon as possible;
(three) the relevant departments of the State Council need to supervise and manage the work and put forward emergency assessment suggestions;
(4) Necessary for handling international trade disputes related to food safety.
Seventeenth need to carry out emergency assessment, the national food safety risk assessment expert committee in accordance with the emergency assessment plan for risk assessment, timely submit a report on the results of risk assessment to the Ministry of health.
Article 18 The Ministry of Health shall announce the results of food safety risk assessment to the public according to law.
The results of risk assessment shall be interpreted by the National Food Safety Risk Assessment Expert Committee.
Article 19 The terms in these Provisions are defined as follows:
Hazard: refers to the biological, chemical and physical factors contained in food that have potential adverse effects on health or the existence of food.
Hazard identification: According to scientific data and literature such as epidemiology, animal test, in vitro test and structure-activity relationship. , to determine whether the human body will have adverse effects on health after exposure to a certain hazard, the possibility of adverse effects, and the population and scope that may be at risk.
Hazard characteristics description: describe the adverse health effects related to hazards qualitatively or quantitatively. Animal experiments, clinical studies and epidemiological studies can be used to determine the dose-response relationship and mechanism between hazards and various adverse health effects. If possible, the safe intake level of human body should be determined for hazards with critical toxic effects.
Exposure assessment: describe the route of harm entering human body and estimate the degree of harm ingested by different people. According to the degree of harm in diet and people's dietary consumption, the total intake of harmful diet is estimated preliminarily, and the total intake of human body is estimated by considering other non-dietary ways, and compared with the safe intake.
Risk characterization: Based on hazard identification, hazard characterization and exposure assessment, comprehensively analyze the risk and degree of adverse impact of hazards on human health, and describe and explain the uncertainty in the risk assessment process.
Article 20 The provisions on the identification and qualification management of food safety risk assessment technical institutions shall be formulated separately by the Ministry of Health.
Article 21 These Measures shall be interpreted by the Ministry of Health and implemented as of the date of promulgation.