| Order of the State Administration for Market Regulation | | 国家市场监督管理总局令 |
| (No. 24) | | （第24号） |
| The Measures for the Administration of Food Production Licensing, as deliberated and adopted at the 18th executive meeting of the State Administration for Market Regulation on December 23, 2019, are hereby issued, and shall come into force on March 1, 2020. | | 《食品生产许可管理办法》已于2019年12月23日经国家市场监督管理总局2019年第18次局务会议审议通过，现予公布，自2020年3月1日起施行。 |
| Director: Xiao Yaqing | | 局长 肖亚庆 |
| January 2, 2020 | | 2020年1月2日 |
| Measures for the Administration of Food Production Licensing | | 食品生产许可管理办法 |
| (issued by Order No. 24 of the State Administration for Market Regulation on January 2, 2020) | | （2020年1月2日国家市场监督管理总局令第24号公布） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of regulating the licensing for the production of food and food additives, strengthening the supervision and administration of food production, and ensuring food safety, these Measures are developed in accordance with the Administrative Licensing Law of the People's Republic of China, the Food Safety Law of the People's Republic of China, the Regulation on the Implementation of the Food Safety Law of the People's Republic of China, and other laws and regulations. | | 第一条 为规范食品、食品添加剂生产许可活动，加强食品生产监督管理，保障食品安全，根据《中华人民共和国行政许可法》、《中华人民共和国食品安全法》、《中华人民共和国食品安全法实施条例》等法律法规，制定本办法。 |
| Article 2 Whoever intends to conduct food production activities within the territory of the People's Republic of China shall obtain a food production permit in accordance with the law. | | 第二条 在中华人民共和国境内，从事食品生产活动，应当依法取得食品生产许可。 |
| These Measures shall apply to the application for the food production permit, acceptance of applications, examination, decision-making, and the supervision and inspection thereof. | | 食品生产许可的申请、受理、审查、决定及其监督检查，适用本办法。 |
| Article 3 The licensing for food production shall follow the principles of legality, openness, fairness, impartiality, convenience for the people, and efficiency. | | 第三条 食品生产许可应当遵循依法、公开、公平、公正、便民、高效的原则。 |
| Article 4 The principle of one permit for one enterprise shall apply to the licensing for food production, that is, the same food producer engaged in food production activities shall obtain a food production permit. | | 第四条 食品生产许可实行一企一证原则，即同一个食品生产者从事食品生产活动，应当取得一个食品生产许可证。 |
| Article 5 Market regulatory departments shall implement categorized licensing for food production on the basis of the degree of risk of food and in light of such factors as raw materials and production technique of food. | | 第五条 市场监督管理部门按照食品的风险程度，结合食品原料、生产工艺等因素，对食品生产实施分类许可。 |
| Article 6 The State Administration for Market Regulation (“SAMR”) shall be responsible for the supervision and guidance of food production licensing administration nationwide. | | 第六条 国家市场监督管理总局负责监督指导全国食品生产许可管理工作。 |
| Local market regulatory departments at and above the county level shall be responsible for the supervision and administration of food production licensing within their respective administrative regions. | | 县级以上地方市场监督管理部门负责本行政区域内的食品生产许可监督管理工作。 |
| Article 7 The market regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may, according to food categories and food safety risk condition, determine the administrative power for food production licensing of the market regulatory departments at city and county levels. | | 第七条 省、自治区、直辖市市场监督管理部门可以根据食品类别和食品安全风险状况，确定市、县级市场监督管理部门的食品生产许可管理权限。 |
| The market regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the licensing for the production of health food, formula food for special medical purposes, infant formula food, infant supplementary food, edible salt, and other food. | | 保健食品、特殊医学用途配方食品、婴幼儿配方食品、婴幼儿辅助食品、食盐等食品的生产许可，由省、自治区、直辖市市场监督管理部门负责。 |
| Article 8 The SAMR shall be responsible for the development of general provisions and detailed rules on the food production licensing examination. | | 第八条 国家市场监督管理总局负责制定食品生产许可审查通则和细则。 |
| The market regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may, according to the needs of food production licensing examination of their respective administrative regions, develop detailed rules on food production licensing examination for food with local characteristics, which shall be implemented within their respective administrative regions and be reported to the SAMR. The detailed rules on production licensing examination for food with local characteristics shall be automatically repealed after the SAMR has developed and issued detailed rules on production licensing examination for the relevant food. | | 省、自治区、直辖市市场监督管理部门可以根据本行政区域食品生产许可审查工作的需要，对地方特色食品制定食品生产许可审查细则，在本行政区域内实施，并向国家市场监督管理总局报告。国家市场监督管理总局制定公布相关食品生产许可审查细则后，地方特色食品生产许可审查细则自行废止。 |
| Local market regulatory departments at and above the county level shall, in their food production licensing examination, comply with the general provisions and detailed rules on food production licensing examination. | | 县级以上地方市场监督管理部门实施食品生产许可审查，应当遵守食品生产许可审查通则和细则。 |
| Article 9 Market regulatory departments at and above the county level shall accelerate informatization construction, promote the whole-process online handling of permit application, acceptance, examination, issuance of permits, and inquiry, among others, and publish production licensing matters on the websites of the administrative authorities to improve work efficiency. | | 第九条 县级以上地方市场监督管理部门应当加快信息化建设，推进许可申请、受理、审查、发证、查询等全流程网上办理，并在行政机关的网站上公布生产许可事项，提高办事效率。 |
| Chapter II Application and Acceptance | | 第二章 申请与受理 |
| Article 10 An applicant for a food production permit shall first obtain the business license and possess other required qualifications in accordance with the law. | | 第十条 申请食品生产许可，应当先行取得营业执照等合法主体资格。 |
| For enterprises with a legal person status, partnership enterprises, individual proprietorship enterprises, individual industrial and commercial households, and specialized farmers' cooperative organizations, among others, the subjects specified in their business licenses shall serve as the applicants. | | 企业法人、合伙企业、个人独资企业、个体工商户、农民专业合作组织等，以营业执照载明的主体作为申请人。 |
| Article 11 Applications for food production permits shall be filed according to the following food categories: grain processed products, edible oil, oil and its products, condiments, meat products, dairy products, beverages, convenient food, cookies, canned food, frozen drinks, frozen food, potatoes and puffed food, candy products, tea and tea-related products, liquor, vegetable products, fruit products, roasted seeds and nuts, nut products, egg products, cocoa and baked coffee products, sugar, aquatic products, starch and starch products, pastry, bean products, bee products, health food, formula food for special medical purposes, infant formula food, food for special dietary use, and other food. | | 第十一条 申请食品生产许可，应当按照以下食品类别提出：粮食加工品，食用油、油脂及其制品，调味品，肉制品，乳制品，饮料，方便食品，饼干，罐头，冷冻饮品，速冻食品，薯类和膨化食品，糖果制品，茶叶及相关制品，酒类，蔬菜制品，水果制品，炒货食品及坚果制品，蛋制品，可可及焙烤咖啡产品，食糖，水产制品，淀粉及淀粉制品，糕点，豆制品，蜂产品，保健食品，特殊医学用途配方食品，婴幼儿配方食品，特殊膳食食品，其他食品等。 |
| The SAMR may adjust food categories according to the needs of supervision and administration. | | 国家市场监督管理总局可以根据监督管理工作需要对食品类别进行调整。 |
| Article 12 An applicant for a food production permit shall meet the following conditions: | | 第十二条 申请食品生产许可，应当符合下列条件： |
| (1) It has places for food raw material treatment and food processing, packaging, and storage, among others, suitable for the varieties and quantities of the food that it produces, keeps the environment of these places tidy and clean, and ensures that these places maintain a prescribed distance from toxic and hazardous sites and other pollution sources. | | （一）具有与生产的食品品种、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； |
| (2) It has production equipment or facilities suitable for the varieties and quantities of the food that it produces, and has the corresponding equipment or facilities for disinfection, changing clothes, sanitation, day-lighting, illumination, ventilation, anti-corrosion, anti-dust, anti-fly, rat proof, mothproof, washing, waste water treatment, and storage of garbage and waste; where health food production processes include raw material extraction, purification, and other pretreatment processes, the applicant needs to have raw material pretreatment equipment or facilities suitable for the varieties and quantities of the food that it produces. | | （二）具有与生产的食品品种、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；保健食品生产工艺有原料提取、纯化等前处理工序的，需要具备与生产的品种、数量相适应的原料前处理设备或者设施； |
| (3) It has full-time or part-time professional food safety technicians and food safety management personnel and rules and regulations for ensuring food safety. | | （三）有专职或者兼职的食品安全专业技术人员、食品安全管理人员和保证食品安全的规章制度； |
| (4) It has a reasonable equipment layout and technical flowchart to prevent cross-contamination between the to-be-processed food and ready-to-eat food, and between raw materials and finished products, and to prevent the food from contacting toxic substances or unclean articles. | | （四）具有合理的设备布局和工艺流程，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； |
| (5) Other conditions prescribed by laws and regulations. | | （五）法律、法规规定的其他条件。 |
| Article 13 An applicant for a food production permit shall submit the following materials to the local market regulatory department at or above the county level at the place where it is located: | | 第十三条 申请食品生产许可，应当向申请人所在地县级以上地方市场监督管理部门提交下列材料： |
| (1) An application form for the food production permit. | | （一）食品生产许可申请书； |
| (2) A layout diagram of the food production equipment and a food production technical flowchart. | | （二）食品生产设备布局图和食品生产工艺流程图； |
| (3) A list of the major food production equipment and facilities. | | （三）食品生产主要设备、设施清单； |
| (4) The information on full-time or part-time professional food safety technicians and food safety management personnel, as well as food safety management rules. | | （四）专职或者兼职的食品安全专业技术人员、食品安全管理人员信息和食品安全管理制度。 |
| Article 14 An applicant for a production permit for health food, formula food for special medical purposes, infant formula food, or other special food shall also submit the production quality management system documents and relevant registration and recordation documents suitable for the food that it produces. | | 第十四条 申请保健食品、特殊医学用途配方食品、婴幼儿配方食品等特殊食品的生产许可，还应当提交与所生产食品相适应的生产质量管理体系文件以及相关注册和备案文件。 |
| Article 15 Those intending to engage in the production of food additives shall obtain a food additive production permit in accordance with the law. | | 第十五条 从事食品添加剂生产活动，应当依法取得食品添加剂生产许可。 |
| An applicant for a food additive production permit shall have the places, production equipment or facilities, food safety management personnel, professional technicians and management rules suitable for the varieties of food additives that it produces. | | 申请食品添加剂生产许可，应当具备与所生产食品添加剂品种相适应的场所、生产设备或者设施、食品安全管理人员、专业技术人员和管理制度。 |
| Article 16 An applicant for a food additive production permit shall submit the following materials to the local market regulatory department at or above the county level at the place where it is located: | | 第十六条 申请食品添加剂生产许可，应当向申请人所在地县级以上地方市场监督管理部门提交下列材料： |
| (1) An application form for a food additive production permit. | | （一）食品添加剂生产许可申请书； |
| (2) A layout diagram of food additive production equipment and a production technical flowchart. | | （二）食品添加剂生产设备布局图和生产工艺流程图； |
| (3) A list of major food additive production equipment and facilities. | | （三）食品添加剂生产主要设备、设施清单； |
| (4) The information on full-time or part-time professional food safety technicians and food safety management personnel, as well as food safety management rules. | | （四）专职或者兼职的食品安全专业技术人员、食品安全管理人员信息和食品安全管理制度。 |
| Article 17 The applicant shall truthfully submit the relevant materials and report the real situation to the market regulatory department, be responsible for the veracity of the application materials, and affix signature or seal to the application form and other materials. | | 第十七条 申请人应当如实向市场监督管理部门提交有关材料和反映真实情况，对申请材料的真实性负责，并在申请书等材料上签名或者盖章。 |
| Article 18 An applicant for the production of several categories of food shall, according to the administrative power for food production licensing determined by the provincial market regulatory department, submit application materials to one of the acceptance departments at its discretion. The acceptance department shall inform the market regulatory departments with the corresponding approval authority in a timely manner, and organize joint examination. | | 第十八条 申请人申请生产多个类别食品的，由申请人按照省级市场监督管理部门确定的食品生产许可管理权限，自主选择其中一个受理部门提交申请材料。受理部门应当及时告知有相应审批权限的市场监督管理部门，组织联合审查。 |
| Article 19 The local market regulatory department at or above the county level shall handle the applicant's application for a food production permit respectively according to the following circumstances: | | 第十九条 县级以上地方市场监督管理部门对申请人提出的食品生产许可申请，应当根据下列情况分别作出处理： |
| (1) If a food production permit is not required for the subject matter of application in accordance with the law, it shall notify the applicant of non-acceptance of the application immediately. | | （一）申请事项依法不需要取得食品生产许可的，应当即时告知申请人不受理； |
| (2) If the subject matter of application does not fall under the scope of functions of the market regulatory department according to the law, it shall make a decision on non-acceptance of the application immediately, and notify the applicant to apply to the relevant administrative authority. | | （二）申请事项依法不属于市场监督管理部门职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请； |
| (3) If the application materials contain any error that can be corrected on the spot, it shall allow the applicant to make correction on the spot, and the applicant shall affix signature or seal to the correction and indicate the date of correction thereon. | | （三）申请材料存在可以当场更正的错误的，应当允许申请人当场更正，由申请人在更正处签名或者盖章，注明更正日期； |
| (4) If the application materials are incomplete or do not conform to the statutory form, it shall notify the applicant of all necessary supplements and corrections at one time on the spot or within five working days. If it notifies the applicant on the spot, it shall return the application materials to the applicant; and if it notifies the applicant within five working days, it shall collect the application materials and issue a written receipt of the application materials. If it fails to notify the applicant within the prescribed time limit, the application shall be deemed to have been accepted on the date of receipt of the application materials. | | （四）申请材料不齐全或者不符合法定形式的，应当当场或者在5个工作日内一次告知申请人需要补正的全部内容。当场告知的，应当将申请材料退回申请人；在5个工作日内告知的，应当收取申请材料并出具收到申请材料的凭据。逾期不告知的，自收到申请材料之日起即为受理； |
| (5) If the application materials are complete and conform to the statutory form, or the applicant has submitted all required supplements and corrections, it shall accept the application for a food production permit. | | （五）申请材料齐全、符合法定形式，或者申请人按照要求提交全部补正材料的，应当受理食品生产许可申请。 |
| Article 20 Where the local market regulatory department at or above the county level decides to accept the application filed by the applicant, it shall issue a notice on acceptance; and if it decides not to accept the application, it shall issue a notice on non-acceptance, give the reasons for non-acceptance, and notify the applicant of the right to apply for administrative reconsideration or institute an administrative lawsuit in accordance with the law. | | 第二十条 县级以上地方市场监督管理部门对申请人提出的申请决定予以受理的，应当出具受理通知书；决定不予受理的，应当出具不予受理通知书，说明不予受理的理由，并告知申请人依法享有申请行政复议或者提起行政诉讼的权利。 |
| Chapter III Examination and Decision | | 第三章 审查与决定 |
| ．．．．．． | | ．．．．．． |
|
Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.
1. To become a premium member, please call 400-810-8266 Ext. 171.
2. Binding to the account with access to this database.
3. Apply for a trial account.
4. To get instant access to a document, you can Pay Amount 【￥900.00】 for your single purchase. | |
您好：您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户；您可通过网上支付进行单篇购买，支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
|
| | | |
| | | |