China Issues New Food Safety "Draft" Risk Assessment Regulations
On June 8, 2009, China's Ministry of Health published a draft regulation to implement the risk assessment aspects of China's new Food Safety Law (FSL), which was scheduled to go into effect June 1, 2009. The goal of the regulation is to standardize food safety risk assessments.
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Comments by Chinese interested parties were due June 20, 2009. (According to the U.S. Foreign Agricultural Service (FAS), this regulation has not yet been submitted to the World Trade Organization for comment.)
Highlights of the Draft Food Risk Assessment Regulations
The following are highlights of an unofficial English translation of the draft regulation, "Regulation for the Administration of Food Safety Risk Evaluation," as provided by FAS.
Risk assessments1. A food safety risk assessment refers to the scientific evaluation of the potential negative impact on human health caused by food and biological, chemical and physical hazards in food additives. It includes hazard identification, hazard description, exposure evaluation and a description of the risk.
Situations requiring risk assessments. Food safety risk assessments could be conducted (with approval by the Ministry of Health (MOH)) in the following situations: (i) to provide evidence for developing or amending national food safety standards; (ii) to analyze food safety surveillance results or review reports that show potential food safety risks; (iii) if one of several specified ministries asks that a food safety risk assessment be conducted; and (iv) situations where MOH identifies a need for an assessment.
Emergency risk assessments. Under the following situations, MOH could request an emergency risk assessment: (i) to deal with significant food safety accidents; (ii) for highly concerning food safety problems which need quick responses; (iii) if needed by regulatory agencies and proposed for emergency evaluation; (iv) if needed to deal with international trade disputes; and (v) for other food safety affairs that should be solved through risk assessment.
Ministry of Health would coordinate. The MOH would be responsible for organizing food safety risk evaluation; establishing national food safety risk assessment expert panels; issuing risk assessment tasks; taking appropriate surveillance actions, inspection, notification and supervision based on the food safety risk assessment results.
Assessment committee. The national food safety risk assessment committee would conduct the risk evaluation but could also authorize related technical agencies to undertake collection, handling and analysis of scientific data, technical information and test results.
Assessments based on science, etc. Food safety risk assessments would be based on surveillance information, scientific data and other related information; and follow principles of science and transparency and be conducted on a case-by-case basis.
Situations requiring no risk assessment. The MOH could decide not to conduct an assessment if: (i) there is illegal behavior during the production process that can be solved by taking action in accordance with the law; (ii) the food safety risk is low or problems can be solved by taking simple risk management measures and it is not necessary to conduct a full evaluation; (iii) there is an international risk assessment conclusion, and the conclusion is suitable for the Chinese dietary exposure mode.
1The translation of the draft regulation also uses the term evaluation.
(See ITT's Online Archives or 06/18/09 news, 09061815, for BP summary of other draft regulations associated with China's Food Safety Law.
See ITT's Online Archives or 05/27/09 news, 09052715, for BP summary of China's first regulation implementing the Food Safety Law which was on the Ministry of Health's role in food safety, domestic licensing, a national food safety standard, etc.)
FAS GAIN report, "China, Agricultural Situation Draft Regulation on Risk Assessments" (No. CH9055, dated 06/19/09) available at http://www.fas.usda.gov/gainfiles/200906/146357839.pdf
Original version of the regulation (in Chinese) available at: http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohwsjdj/s3593/200906/41100.htm