中国食品生产监管简介Introduction to China Food Production Administration 国家质检总局食品生产监管司 Department of Supervision on Food Production, AQSIQ 2010-8-30

1、实施食品生产许可Implementation of Food Production Licensing 2002年，国家质检总局开始对加工食品实施食品生产许可制度。 2009年，食品安全法明确规定国家对食品生产实行许可制度，从事食品生产应当依法取得食品生产许可。 In 2002, AQSIQ started implementing food production licensing system on processed food. The Food Safety Law implemented in 2009 has further clarified the implementation of food production licensing system of the country.

（1）食品生产许可基本要求 Basis Requirements of Food Production Licensing 在中华人民共和国境内，企业从事食品生产活动应当具备场所、生产设备或者设施、设备布局和工艺流程、食品安全专业技术人员和管理人员、食品安全管理制度5个方面的基本条件。 In China, enterprises engaged in food production activities shall be equipped with 5 basic requirements, i.e. production site, production equipment and health protection, production technique and layout, technician and management staff, and management system. The basic standard in judging these requirements is that they shall adapt to the varieties and quantities of the food applying for the production license.

（1）食品生产许可基本要求 Basis Requirements of Food Production Licensing 1) 要有与申请生产许可的食品品种、数量相适应的食品原料处理和食品加工、包装、贮存等场所，保持该场所环境整洁，并与有毒、有害场所以及其他污染源保持规定的距离； Having places for treating food raw materials and food processing, packaging, storage, etc. which adapt to the varieties and quantities of the food applying for the production license; keeping the environment of the said places tidy and clean, and ensuring that they are at a prescribed distance from toxic and hazardous sites and other pollution sources;

（1）食品生产许可基本要求 Basis Requirements of Food Production Licensing 2) 要有与申请生产许可的食品品种、数量相适应的生产设备或者设施，有相应的消毒、更衣、盥洗、采光、照明、通风、防腐、防尘、防蝇、防鼠、防虫、洗涤以及处理废水、存放垃圾和废弃物的设备或者设施； Having the equipment or facilities, which adapt to the varieties and quantities of the food applying for the production license, and having the corresponding equipment or facilities for disinfection, changing clothes, toilet, day-lighting, illumination, ventilation, anti-corrosion, anti-dust, anti-fly, rat proof, mothproof, washing, disposal of waste water, and storage of garbage and waste；

（1）食品生产许可基本要求 Basis Requirements of Food Production Licensing 3) 要有与申请生产许可的食品品种、数量相适应的合理的设备布局、工艺流程，防止待加工食品与直接入口食品、原料与成品交叉污染，避免食品接触有毒物、不洁物； Having reasonable equipment layout, technical flowchart which adapt to the varieties and quantities of the food applying for the production license; so as to prevent cross pollution between the food to be processed and ready-to-eat food, and between raw materials and finished products, and to prevent the food from contacting with toxic substances or unclean articles；

（1）食品生产许可基本要求 Basis Requirements of Food Production Licensing 4) 要有与申请生产许可的食品品种、数量相适应的食品安全专业技术人员和管理人员； Having professional food safety technicians and managerial personnel which adapt to the varieties and quantities of the food applying for the production license；

（1）食品生产许可基本要求 Basis Requirements of Food Production Licensing 5) 要有与申请生产许可的食品品种、数量相适应的保证食品安全的培训、从业人员健康检查和健康档案等健康管理、进货查验记录、出厂检验记录、原料验收、生产过程等食品安全管理制度。 Having training that ensures the food safety, health management such as health examination of employees and health profile, purchase check and inspection record, ex-factory check record, acceptance of raw materials, production process and other food safety management system which adapt to the varieties and quantities of the food applying for the production license.

（2）企业申请食品生产许可程序 Procedure of Enterprises Application for Food Production License 1) 拟设立食品生产企业申请食品生产许可的，应当向生产所在地许可机关，即所在地质量技术监督部门提交食品生产许可申请。 One who plans to set up a food production enterprise and so to apply for the food production license shall submit the application to the licensing authority in its production place, i.e. Bureau of Quality and Technical Supervision:

（2）企业申请食品生产许可程序 Procedure of Enterprises Application for Food Production License 2) -许可机关收到食品生产许可申请后，应当做出是否受理的决定； -不予受理的，应当说明理由。 -Upon receive of the application, the licensing authority shall decide whether the application is accepted or rejected. -Reasons shall be given should the application is rejected.

（2）企业申请食品生产许可程序 Procedure of Enterprises Application for Food Production License 3) 许可机关受理申请后，依照有关规定组织对申请的资料和生产场所进行核查。 Once the licensing authority accepts the application for food production license, it shall organize an examination on the submitted materials and the production site in accordance with the related provisions.

（2）企业申请食品生产许可程序 Procedure of Enterprises Application for Food Production License 4) -许可机关应当在法律法规规定的期限内，根据核查结果，作出许可决定。 -生产条件符合要求的，依法作出准予生产的决定；生产条件不符合要求的，依法作出不予生产许可的决定。 -The licensing authority shall work within the timeline in accordance with laws and regulations to examine the result and make decision on the licensing. -Should it fulfill the requirements, a decision to approve the production shall be made according to laws. Should it fail the requirements, a decision to disapprove the production shall be made according to laws.

（2）企业申请食品生产许可程序 Procedure of Enterprises Application for Food Production License 5) 拟设立的食品生产企业必须在取得食品生产许可证书并依法办理营业执照工商登记手续后，方可根据生产许可检验的需要组织试产食品，并申请生产许可检验。 Production enterprises shall first obtain the food production license and process for the business license in accordance with laws, then only can they organize for pilot production based on the requirements of inspection for production license, hence apply for the production license inspection.

（2）企业申请食品生产许可程序 Procedure of Enterprises Application for Food Production License 6) -检验结论合格的，许可机关根据检验报告确定食品生产许可的品种范围。 -检验结论为不合格的，可以按照有关规定申请复检，经复检仍不合格的，不予确定该类食品的生产许可范围。复检结论为全部食品品种不合格的，应当按照有关规定注销食品生产许可。 -Determination of scope of food production license. Should it pass the inspection, the licensing authority shall determine the range of food varieties for the food production license based on the inspection report, and state it on the second sheet of the food production license. Should the inspection fail, the enterprise may apply for a re-inspection after correction. -Should the re-inspection still unsatisfactory，no scope of food production shall be determined in the license, and no such statement shall be recorded on the second sheet of the license. Should all foods were concluded fail in the re-inspection, the license shall be cancelled in accordance with the relevant provisions.

（3）食品生产许可机构 Food Production Licensing Authority 1)．行政部门职责Duties of the Administrative Department （1）国家质检总局在职责范围内负责全国食品生产许可管理工作。AQSIQ shall assume its responsibility within its scope of duty in managing the national food production licensing. Bureau of Quality and Technical Supervision in the 31 provinces, autonomous regions and municipalities shall ensure the implementation of license scope of varieties in their respective administrative region in accordance with the related laws and regulations and the related requirements of AQSIQ. （2）县级以上地方质量技术监督部门在职责范围内负责本行政区域内的食品生产许可管理工作。Bureau of Quality and Technical Supervision above county level shall assume their responsibilities within the scope of duty in their respective administrative region in managing the licensing of food production.

（3）食品生产许可机构 Food Production Licensing Authority 2) 生产许可证审查中心职责 Duties of the Examination Center of Production Licensing 生产许可证审查中心参与食品生产许可核查人员管理、全国食品生产许可信息统计汇总等工作。 The Examination Center of Production Licensing is responsible to implement the production licensing of the AQSIQ on examination organizing, materials compilation, production license numbering, public notification on production licensing information and compilation of statistics of the national food production license.

（3）食品生产许可机构 Food Production Licensing Authority 3) 检验机构职责 Duties of the inspection authority 检验机构收到样品后，应当按照规定要求和标准进行检验，并准确、及时地出具检验报告。 Upon receive of the sample, the inspection authority shall carry out inspection in accordance with the requirements and standard, and accurately and timely issue the inspection report.

（4）全国食品生产许可情况 National Food Production Licensing - 2010年上半年质检部门共为8948家企业发放9790张食品生产许可证，为9732家企业换发10357张食品生产许可证，注销2100张食品生产许可证书。 - 截至2010年6月底，全国持有效食品生产许可的企业总数约13万家。 - In 2009, the national and provincial Bureau of Quality and Technical Supervision issued 25428 food production licenses to 23269 enterprises and renewed 22109 food production licenses to 21120 enterprises, and cancelled or suspended 8041 food production licenses. - As of the end of 2009, a total of 120 thousand enterprises posses the valid food production license.

2、食品生产企业监督检查 Supervision And Inspection on Food Enterprises 为督促食品生产加工企业落实质量安全主体责任、规范食品生产加工企业质量安全监督检查工作、保障食品质量安全，国家质检总局制定了《食品生产加工企业落实质量安全主体责任监督检查规定》（2009年第119号公告）AQSIQ promulgated the “Regulations on Inspection and Supervision of Food Production and Processing Enterprises as Main Body in Implementing Quality Safety Responsibility” in order to supervise the enterprises in continually fulfilling the production requirements in accordance with laws after obtaining the food production license. The regulations clarify that Department of Quality Inspection above provincial level shall listen to the enterprises report, review the enterprises records, query the enterprises employees, examine the production site, inspect the enterprises products and the food raw materials and food additives used and the food related products, examine the stakeholders approach, carry out inspection and supervision on the enterprises related to laws, regulations and standards according to laws.

企业质量安全主体责任 Enterprises’ prime responsibilities in quality and safety 1 企业应保持资质的一致性 Actual production shall be identical with certificate 2 企业应建立进货查验记录制度 Purchase check and inspection record system 3 企业应建立生产过程控制制度 Production processing control system 4 企业应建立出厂检验记录制度 Exit-factory check record system 5 企业应建立不合格品管理制度 Unqualified products management system

企业质量安全主体责任 Enterprises’ prime responsibilities in quality and safety 6 企业生产加工食品的标识标注内容应符合法律、法规、规章及食品安全标准规定 Labels and notes in factory shall comply with relevant laws, rules and standards in relation to food safety 7 企业应建立销售台帐 Sales record system shall be established 8 企业标准执行应符合相关法律法规规定 Enterprises’ own standards shall be in line with relevant laws and codes 9 企业应建立不安全食品召回制度 Recalling system shall be established 10 企业从业人员健康和培训应符合相关法律法规规定 Health check of staffs and training shall be upon relevant rules and regulations

企业质量安全主体责任 Enterprises’ prime responsibilities in quality and safety 11 企业接受委托加工食品应符合相关法律法规规定 Enterprises shall follow relevant rules when receiving OEM orders 12 企业应建立消费者投诉受理制度 Complain system shall be set up 13 企业应主动收集食品安全风险监测和评估信息，快速反应并建立和保存记录 Proactive collecting information for safety evaluation and rapidly reacting, and filing records 14 企业应按规定妥善处置食品安全事故 Properly handling accidents related to food safety

3、其他工作/Other Tasks 1）对食品添加剂、食品相关产品实施生产许可； 2）召回； 3）按规定权限组织调查处理生产加工环节质量安全突发事件 和事故； 4）组织国家专项监督抽查； 5）参与国家风险监测计划的制定与实施等。 1) Implementation of licensing for food packaging, container, tools and food additives. 2) Organize special sample survey based on food risk information. 3) Investigate on food safety accidents in the food production processes. 4) Intervene the implementation of national surveillance and assessment project. 5) Letters and public messages handling.

谢谢大家/Thank you！ 国家质检总局食品生产监管司/AQSIQ 聂大可/Die Dake 电话/Tel：86-10-82262212 传真/Fax：86-10-82260724 邮箱/Email：niedk@aqsiq.gov.cn