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Administrative Measures for Food Recalls [Revised]
食品召回管理办法 [已被修订]
【法宝引证码】

Order of the China Food and Drug Administration 

国家食品药品监督管理总局令

(No. 12) (第12号)

The Administrative Measures for Food Recalls, as deliberated and adopted at the executive meeting of the China Food and Drug Administration (“CFDA”), are hereby issued and shall come into force on September 1, 2015. 《食品召回管理办法》已经国家食品药品监督管理总局局务会议审议通过,现予以公布,自2015年9月1日起施行。
Director: Bi Jingquan 局 长 毕井泉
March 11, 2015 2015年3月11日
Administrative Measures for Food Recalls 食品召回管理办法
Chapter I General Provisions 

第一章 总 则

Article 1 In order to strengthen the administration of food production and business operation, reduce and avoid the damage of unsafe food, and protect the physical health and life safety of the public, these Measures are developed in accordance with the provisions of the Food Safety Law of the People's Republic of China and the regulation on its implementation as well as other relevant laws and regulations.   第一条 为加强食品生产经营管理,减少和避免不安全食品的危害,保障公众身体健康和生命安全,根据《中华人民共和国食品安全法》及其实施条例等法律法规的规定,制定本办法。
Article 2 These Measures shall apply to the cessation of food production and business operation, recall and disposal of unsafe foods as well as the supervision and administration thereof within the territory of the People's Republic of China.   第二条 在中华人民共和国境内,不安全食品的停止生产经营、召回和处置及其监督管理,适用本办法。
“Unsafe foods” means the foods prohibited from production and business operation in accordance with the laws and regulations on food safety and other foods that may damage human health as proved by evidence. 不安全食品是指食品安全法律法规规定禁止生产经营的食品以及其他有证据证明可能危害人体健康的食品。
Article 3 Food producers and dealers shall, in accordance with the law, be the primary persons responsible for food safety, establish and improve the relevant management rules, collect and analyze food safety information, and perform the obligations to cease the food production and business operation, recall and disposal of unsafe foods in accordance with the law.   第三条 食品生产经营者应当依法承担食品安全第一责任人的义务,建立健全相关管理制度,收集、分析食品安全信息,依法履行不安全食品的停止生产经营、召回和处置义务。
Article 4 The CFDA shall direct the supervision and administration of the cessation of food production and business operation, recall and disposal of unsafe foods nationwide.   第四条 国家食品药品监督管理总局负责指导全国不安全食品停止生产经营、召回和处置的监督管理工作。
Local food and drug administrations at or above the county level shall oversee and administer the cessation of food production and business operation, recall and disposal of unsafe foods within their respective administrative regions. 县级以上地方食品药品监督管理部门负责本行政区域的不安全食品停止生产经营、召回和处置的监督管理工作。
Article 5 Food and drug administrations at or above the county level shall organize the establishment of food safety expert databases consisting of experts in related fields such as medical science, toxicology, chemistry, food, and law, so as to provide professional support for the cessation of food production and business operation, recall and disposal of unsafe foods.   第五条 县级以上食品药品监督管理部门组织建立由医学、毒理、化学、食品、法律等相关领域专家组成的食品安全专家库,为不安全食品的停止生产经营、召回和处置提供专业支持。
Article 6 The CFDA shall summarize and analyze the information on the cessation of food production and business operation, recall and disposal of unsafe foods nationwide, and improve the measures for the supervision and administration of food safety according to the risk factors related to food safety.   第六条 国家食品药品监督管理总局负责汇总分析全国不安全食品的停止生产经营、召回和处置信息,根据食品安全风险因素,完善食品安全监督管理措施。
Local food and drug administrations at or above the county level shall collect, analyze and process the information on the cessation of food production and business operation, recall and disposal of unsafe foods within their respective administrative regions, and oversee their performance of responsibilities of food producers and dealers. 县级以上地方食品药品监督管理部门负责收集、分析和处理本行政区域不安全食品的停止生产经营、召回和处置信息,监督食品生产经营者落实主体责任。
Article 7 Food industry associations are encouraged and supported to strengthen industrial self-discipline, develop industry rules, and direct and promote food producers and dealers' lawful performance of obligations to cease the production and business operation, recall, and disposal of unsafe foods.   第七条 鼓励和支持食品行业协会加强行业自律,制定行业规范,引导和促进食品生产经营者依法履行不安全食品的停止生产经营、召回和处置义务。
The public is encouraged and supported to conduct social supervision of such activities as the cessation of food production and business operation, recall and disposal of unsafe foods. 鼓励和支持公众对不安全食品的停止生产经营、召回和处置等活动进行社会监督。
Chapter II Cessation of Food Production and Business Operation 

第二章 停止生产经营

Article 8 Where any food producer or dealer finds that any of the foods it produced or sold is unsafe, it shall immediately cease the production or sale of such food, and by making a notice or an announcement, notify the relevant food producer or dealer to cease production and business operation and notify consumers to stop consuming it, and take necessary measures to prevent and control food safety risks.   第八条 食品生产经营者发现其生产经营的食品属于不安全食品的,应当立即停止生产经营,采取通知或者公告的方式告知相关食品生产经营者停止生产经营、消费者停止食用,并采取必要的措施防控食品安全风险。
Where the food producer or dealer fails to suspend the production or business operation of any unsafe food in accordance with the law, the food and drug administration at or above the county level may order it to cease the production or business operation of the unsafe food. 食品生产经营者未依法停止生产经营不安全食品的,县级以上食品药品监督管理部门可以责令其停止生产经营不安全食品。
Article 9 Where the sponsor of a centralized food market, the lessor of food booths or the organizer of a food exhibition finds that the food sold by any food dealer is unsafe, it shall take effective measures in a timely manner to ensure that the relevant dealer ceases the business operation of such unsafe food.   第九条 食品集中交易市场的开办者、食品经营柜台的出租者、食品展销会的举办者发现食品经营者经营的食品属于不安全食品的,应当及时采取有效措施,确保相关经营者停止经营不安全食品。
Article 10 Where the provider of a third-party online food distribution platform finds that the food sold by any online food dealer is unsafe, it shall, in accordance with the law, stop the online trading platform services and take other measures so as to ensure that the online food dealer ceases the business operation of such unsafe food.   第十条 网络食品交易第三方平台提供者发现网络食品经营者经营的食品属于不安全食品的,应当依法采取停止网络交易平台服务等措施,确保网络食品经营者停止经营不安全食品。
Article 11 Where any unsafe food produced or distributed by a food producer or dealer is not sold to consumers and under the control of any other producer or dealer, the food producer or dealer shall immediately recover such unsafe food and take necessary measures to eliminate risks.   第十一条 食品生产经营者生产经营的不安全食品未销售给消费者,尚处于其他生产经营者控制中的,食品生产经营者应当立即追回不安全食品,并采取必要措施消除风险。
Chapter III Recall 

第三章 召 回

Article 12 Where a food producer knows that any food it produced and distributed is unsafe by such means as self-examination, complaints and reporting of the general public, and notification of dealers and regulatory authorities, it shall voluntarily recall such food.   第十二条 食品生产者通过自检自查、公众投诉举报、经营者和监督管理部门告知等方式知悉其生产经营的食品属于不安全食品的,应当主动召回。
Where any food producer should have voluntarily recalled any unsafe food, the food and drug administration at or above the county level may order it to recall such food. 食品生产者应当主动召回不安全食品而没有主动召回的,县级以上食品药品监督管理部门可以责令其召回。
Article 13 Based on the seriousness and urgency degree of food safety risks, food recall is divided into three levels:   第十三条 根据食品安全风险的严重和紧急程度,食品召回分为三级:
(1) Level I recall: Where the food has caused or may cause serious health damage or death after consumption, the food producer shall initiate the recall within 24 hours after knowing of the food safety risks, and report the recall plan to the local food and drug administration at or above the county level. (一)一级召回:食用后已经或者可能导致严重健康损害甚至死亡的,食品生产者应当在知悉食品安全风险后24小时内启动召回,并向县级以上地方食品药品监督管理部门报告召回计划。
(2) Level II recall: Where the food has caused or may cause ordinary health damage after consumption, the food producer shall initiate the recall within 48 hours after knowing of the food safety risks, and report the recall plan to the local food and drug administration at or above the county level. (二)二级召回:食用后已经或者可能导致一般健康损害,食品生产者应当在知悉食品安全风险后48小时内启动召回,并向县级以上地方食品药品监督管理部门报告召回计划。
(3) Level III recall: Where the food label or mark has false indications, the food producer shall initiate the recall within 72 hours after knowing of the food safety risks, and report the recall plan to the local food and drug administration at or above the county level. If there is any flaw in the label or mark, and no health damage is caused after the food is consumed, the food producer shall make corrections and may voluntarily recall the food. (三)三级召回:标签、标识存在虚假标注的食品,食品生产者应当在知悉食品安全风险后72小时内启动召回,并向县级以上地方食品药品监督管理部门报告召回计划。标签、标识存在瑕疵,食用后不会造成健康损害的食品,食品生产者应当改正,可以自愿召回。
Article 14 The food producer shall recall unsafe foods based on the recall plan.   第十四条 食品生产者应当按照召回计划召回不安全食品。
The local food and drug administration at or above the county level may, after receiving the recall plan of a food producer, organize experts to assess the recall plan when necessary. If it deems in the assessment conclusion that the recall plan shall be amended, the food producer shall immediately make amendment, and recall the food according to the amended recall plan.
......
 县级以上地方食品药品监督管理部门收到食品生产者的召回计划后,必要时可以组织专家对召回计划进行评估。评估结论认为召回计划应当修改的,食品生产者应当立即修改,并按照修改后的召回计划实施召回。
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