| Order of the China Food and Drug Administration | | 国家食品药品监督管理总局令 |
| (No. 17) | | （第17号） |
| The Administrative Measures for Food Distribution Licensing, 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 October 1, 2015. | | 《食品经营许可管理办法》已经国家食品药品监督管理总局局务会议审议通过，现予公布，自2015年10月1日起施行。 |
| Director: Bi Jingquan | | 局长 毕井泉 |
| August 31, 2015 | | 2015年8月31日 |
| Administrative Measures for Food Distribution Licensing | | 食品经营许可管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of regulating food distribution licensing activities, strengthening the supervision and administration of food business operations, and guaranteeing food safety, these Measures are developed in accordance with the Food Safety Law of the People's Republic of China, the Administrative Licensing Law of the People's Republic of China, and other relevant laws and regulations. | | 第一条 为规范食品经营许可活动，加强食品经营监督管理，保障食品安全，根据《中华人民共和国食品安全法》《中华人民共和国行政许可法》等法律法规，制定本办法。 |
| Article 2 Anyone that plans to engage in food sales or provide catering services within the territory of the People's Republic of China shall obtain food distribution licenses in accordance with the law. | | 第二条 在中华人民共和国境内，从事食品销售和餐饮服务活动，应当依法取得食品经营许可。 |
| These Measures shall apply to the application for food distribution licenses, the acceptance, examination and decision-making of such application, and the supervision and inspection thereof. | | 食品经营许可的申请、受理、审查、决定及其监督检查，适用本办法。 |
| Article 3 Food distribution licensing shall follow the principles of legality, openness, fairness, justice, convenience for the people, and efficiency. | | 第三条 食品经营许可应当遵循依法、公开、公平、公正、便民、高效的原则。 |
| Article 4 Food distribution licensing shall be subject to the principle of one license for one place, that is, a food distributor that engages in food distribution activities shall obtain a food distribution license for each business premise. | | 第四条 食品经营许可实行一地一证原则，即食品经营者在一个经营场所从事食品经营活动，应当取得一个食品经营许可证。 |
| Article 5 Food and drug administrations shall conduct categorized licensing of food distribution activities according to the business types of food distributors and the risk degrees of business items. | | 第五条 食品药品监督管理部门按照食品经营主体业态和经营项目的风险程度对食品经营实施分类许可。 |
| Article 6 The CFDA shall be responsible for overseeing and directing the administration of food distribution licensing across the country. | | 第六条 国家食品药品监督管理总局负责监督指导全国食品经营许可管理工作。 |
| Local food and drug administrations at and above the county level shall be responsible for administering food distribution licensing 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内的食品经营许可管理工作。 |
| The food and drug administrations of provinces, autonomous regions and municipalities directly under the Central Government may, based on food categories and food safety risks, determine the food distribution licensing administrative powers of food and drug administrations at the city or county level. | | 省、自治区、直辖市食品药品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、县级食品药品监督管理部门的食品经营许可管理权限。 |
| Article 7 The CFDA shall be responsible for preparing general rules for food distribution licensing examination. | | 第七条 国家食品药品监督管理总局负责制定食品经营许可审查通则。 |
| Local food and drug administrations at and above the county level shall carry out food distribution licensing examination in compliance with the general rules for food distribution licensing examination. | | 县级以上地方食品药品监督管理部门实施食品经营许可审查，应当遵守食品经营许可审查通则。 |
| Article 8 Food and drug administrations at and above the county level shall accelerate information technology development, and publish distribution licensing matters on the websites of administrative organs, so as to facilitate applicants in filing distribution license applications by such means as data message and enhance work efficiency. | | 第八条 县级以上食品药品监督管理部门应当加快信息化建设，在行政机关的网站上公布经营许可事项，方便申请人采取数据电文等方式提出经营许可申请，提高办事效率。 |
| Chapter II Application and Acceptance | | 第二章 申请与受理 |
| Article 9 Those who apply for food distribution licenses shall firstly obtain business licenses and other qualifications as a lawful subject. | | 第九条 申请食品经营许可，应当先行取得营业执照等合法主体资格。 |
| For an enterprise legal person, a partnership enterprise, a sole proprietorship or an individual industrial and commercial household, among others, the subject indicated on the business license shall be taken as the applicant. | | 企业法人、合伙企业、个人独资企业、个体工商户等，以营业执照载明的主体作为申请人。 |
| Where an organ, a public institution, a social organization, a private non-corporate entity, or an enterprise, among others, applies for establishing a canteen, the subject indicated on the legal person registration certificate of the organ or public institution, the registration certificate of the social organization, or business license, among others, shall be taken as the applicant. | | 机关、事业单位、社会团体、民办非企业单位、企业等申办单位食堂，以机关或者事业单位法人登记证、社会团体登记证或者营业执照等载明的主体作为申请人。 |
| Article 10 A food distribution license application shall be filed based on the business type of the food distributor and the category of the business item. | | 第十条 申请食品经营许可，应当按照食品经营主体业态和经营项目分类提出。 |
| By business types, food distributors are categorized into food sellers, catering service providers, and entities' canteens. Where a food distributor applies for engaging in food distribution through the network, establishing a central kitchen, or engaging in collective food delivery, it shall be noted in brackets after the business type. | | 食品经营主体业态分为食品销售经营者、餐饮服务经营者、单位食堂。食品经营者申请通过网络经营、建立中央厨房或者从事集体用餐配送的，应当在主体业态后以括号标注。 |
| Business items in food distribution are categorized into the sales of pre-packed foods (including or excluding refrigerated or frozen foods), sales of unpacked foods (including or excluding refrigerated or frozen foods), sales of special foods (health foods, formula foods for special medical purposes, infant formula milk powder, and other infant formula foods), and sales of other types of foods; and the production and sales of hot foods, cold foods, raw foods, pastry foods, self-made beverage, and other types of foods, among others. | | 食品经营项目分为预包装食品销售（含冷藏冷冻食品、不含冷藏冷冻食品）、散装食品销售（含冷藏冷冻食品、不含冷藏冷冻食品）、特殊食品销售（保健食品、特殊医学用途配方食品、婴幼儿配方乳粉、其他婴幼儿配方食品）、其他类食品销售；热食类食品制售、冷食类食品制售、生食类食品制售、糕点类食品制售、自制饮品制售、其他类食品制售等。 |
| The specific categories included in other types of foods for sale or other types of foods for production and sale shall be reported to the CFDA for approval before implementation, and be clearly indicated. Foods with multiple states such as hot, cold, raw, solid and liquid and can hardly be clearly categorized may be categorized based on the state with the highest risk-based food safety level. | | 列入其他类食品销售和其他类食品制售的具体品种应当报国家食品药品监督管理总局批准后执行，并明确标注。具有热、冷、生、固态、液态等多种情形，难以明确归类的食品，可以按照食品安全风险等级最高的情形进行归类。 |
| The CFDA may adjust the categories of business items in food distribution as required for supervision and administration. | | 国家食品药品监督管理总局可以根据监督管理工作需要对食品经营项目类别进行调整。 |
| Article 11 A food distribution license application shall meet the following conditions: | | 第十一条 申请食品经营许可，应当符合下列条件： |
| (1) It shall have places for food raw material treatment and food processing, sales, and storage, among others, which shall be commensurate with the varieties and quantities of the foods distributed by it, keep the environment of these places tidy and clean, and ensure that these places maintain a prescribed distance from toxic and hazardous sites and other pollution sources. | | （一）具有与经营的食品品种、数量相适应的食品原料处理和食品加工、销售、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 shall have distribution equipment or facilities commensurate with the varieties and quantities of the foods distributed by it, and have corresponding equipment or facilities for disinfection, changing clothes, sanitation, day-lighting, illumination, ventilation, anti-corrosion, anti-dust, anti-fly, rat proof, mothproof, washing, disposal of waste water, and storage of garbage and waste. | | （二）具有与经营的食品品种、数量相适应的经营设备或者设施，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； |
| (3) It shall have full-time or part-time food safety managers and have rules and regulations for ensuring food safety. | | （三）有专职或者兼职的食品安全管理人员和保证食品安全的规章制度； |
| (4) It shall have a reasonable equipment layout and technical flowchart to prevent cross pollution between foods to be processed and ready-to-eat foods and between raw materials and finished products and to prevent foods 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 as prescribed by laws and regulations. | | （五）法律、法规规定的其他条件。 |
| Article 12 To apply for a food distribution license, the following materials shall be submitted to the local food and drug administration at or above the county level at the place where the applicant is located: | | 第十二条 申请食品经营许可，应当向申请人所在地县级以上地方食品药品监督管理部门提交下列材料： |
| (1) A written application for the food distribution license. | | （一）食品经营许可申请书； |
| (2) Photocopies of the business license or other certification documents on the subject qualification of the applicant. | | （二）营业执照或者其他主体资格证明文件复印件； |
| (3) Documents on the layout of major equipment and facilities suitable for food distribution activities, and operating procedures, among others. | | （三）与食品经营相适应的主要设备设施布局、操作流程等文件； |
| (4) Rules and regulations that ensure food safety such as those on food safety self-inspection, employee health management, purchase inspection records, and handling of food safety incidents, among others. | | （四）食品安全自查、从业人员健康管理、进货查验记录、食品安全事故处置等保证食品安全的规章制度。 |
| To engage in food sales by using automatic vending equipment, the applicant shall also submit the product conformity certificate on automatic vending equipment, the specific place for placing the equipment, the distributor's name, domicile and contact information, the methods for publicizing the food distribution license, and other materials. | | 利用自动售货设备从事食品销售的，申请人还应当提交自动售货设备的产品合格证明、具体放置地点，经营者名称、住所、联系方式、食品经营许可证的公示方法等材料。 |
| Where the applicant authorizes any other person to apply for a food distribution license, the agent shall submit the power of attorney and the agent's identity certification document. | | 申请人委托他人办理食品经营许可申请的，代理人应当提交授权委托书以及代理人的身份证明文件。 |
| Article 13 An applicant shall faithfully submit relevant materials and report the true information to the food and drug administration, be responsible for the authenticity of application materials, and affix his or her signature or seal to the written application and other materials. | | 第十三条 申请人应当如实向食品药品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 14 A local food and drug administration at or above the county level shall, respectively for the following circumstances, handle a food distribution license application filed by an applicant: | | 第十四条 县级以上地方食品药品监督管理部门对申请人提出的食品经营许可申请，应当根据下列情况分别作出处理： |
| (1) Where the application matters do not need to be subject to food distribution licensing in accordance with the law, the administration shall immediately inform the applicant of the denial of the application. | | （一）申请事项依法不需要取得食品经营许可的，应当即时告知申请人不受理。 |
| (2) Where the application matters do not fall under the scope of functions of the food and drug administration in accordance with the law, the administration shall immediately make a decision to deny the application, and notify the applicant to file an application with the relevant administrative organ. | | （二）申请事项依法不属于食品药品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) Where there is any error in the application materials that can be corrected on the spot, the applicant shall be allowed to correct the error on the spot, affix the required signature or seal to the place of correction, and note the date of correction. | | （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) Where the application materials are incomplete or not made in the statutory forms, the administration shall notify the applicant at one time of all required supplements and corrections on the spot or within five working days. If the administration 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 receive the application materials and issue the certificate on the receipt of application materials. If the administration fails to notify the applicant within the prescribed time limit, the application shall be deemed accepted as of receipt of 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) Where the application materials are complete and made in the statutory forms, or the applicant has submitted all the supplements and corrections as required, the administration shall accept the application for a food distribution license. | | （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，应当受理食品经营许可申请。 |
| Article 15 Where a local food and drug administration at or above the county level decides to accept an application filed by an applicant, it shall issue a notice of acceptance notice; and if it decides not to accept the application, it shall issue a notice of denial, explain the reason for denial, and notify the applicant of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law. | | 第十五条 县级以上地方食品药品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-making | | 第三章 审查与决定 |
| Article 16 A local food and drug administration at or above the county level shall examine the license application materials submitted by an applicant. If the substantial contents of the application materials need to be verified, on-site verification shall be conducted. On-site verification is not required if the applicant only applies for the sales of pre-packed foods (excluding refrigerated and frozen foods) and the modification of the food distribution license does not change facilities and the layout. | | 第十六条 县级以上地方食品药品监督管理部门应当对申请人提交的许可申请材料进行审查。需要对申请材料的实质内容进行核实的，应当进行现场核查。仅申请预包装食品销售（不含冷藏冷冻食品）的，以及食品经营许可变更不改变设施和布局的，可以不进行现场核查。 |
| On-site verification shall be conducted by qualified personnel. Not less than two persons shall be assigned for verification. They shall produce their valid certificates, fill out on-site verification forms for the food distribution license, keep on-site verification records, and if no mistake is found upon examination by the applicant, the verification personnel and the applicant shall affix their signatures or seals to the verification form and records. If the applicant refuses to affix his or her signature or seal, the personnel conducting verification shall indicate the situation. | | 现场核查应当由符合要求的核查人员进行。核查人员不得少于2人。核查人员应当出示有效证件，填写食品经营许可现场核查表，制作现场核查记录，经申请人核对无误后，由核查人员和申请人在核查表和记录上签名或者盖章。申请人拒绝签名或者盖章的，核查人员应当注明情况。 |
| A food and drug administration may authorize a food and drug administration at a lower level to conduct on-site verification of an accepted application for the food distribution license. | | 食品药品监督管理部门可以委托下级食品药品监督管理部门，对受理的食品经营许可申请进行现场核查。 |
| The personnel conducting verification shall complete the on-site verification of business premises within ten working days as of acceptance of the on-site verification task. | | 核查人员应当自接受现场核查任务之日起10个工作日内，完成对经营场所的现场核查。 |
Article 17 Unless an administrative license decision can be made on the spot, a local food and drug administration at or above the county level shall make a decision to grant an administrative license or not within 20 working days as of acceptance of an application. If the time limit needs to be extended due to any particular reason, with the approval of the person in charge of the administrative organ, the time limit may be extended by ten working days, and the applicant shall be informed of the reason for the extension.
．．．．．． | | 第十七条 除可以当场作出行政许可决定的外，县级以上地方食品药品监督管理部门应当自受理申请之日起20个工作日内作出是否准予行政许可的决定。因特殊原因需要延长期限的，经本行政机关负责人批准，可以延长10个工作日，并应当将延长期限的理由告知申请人。
．．．．．． |
|
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 【￥800.00】 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
|
| | | |
| | | |