食品经营许可管理办法 (track change....doc

Translated by Frank Rocco Office国家食品药品监督管理总局令Orders of China Food and Drug Administration第17号NO. 17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。The Food BusinessOperation LicenseApproval ManagementAdministration Measures hashave been considereddeliberated and adopted by at the executive meeting of the China Food and Drug aAdministration at the executive meeting and is now publicized. It will be implemented from are hereby promulgated for implementation as of October 1, 2015.局长毕井泉Director Bi jingquan2015年8月31日August 31, 2015食品经营许可管理办法 Food BusinessOperation License Approval ManagementAdministration Measures第一章总则Chapter I General Provisions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 1 These measures are formulated inIn order to regulatestandardize the food businessoperation licenseapproval activities, to strengthen supervision and management of food businessoperation, and to guarantee food safety, we formulate this Measure according to in accordance with the Food Safety Law of Thethe Peoples Republic of China，, the Administrative License Law of Thethe Peoples Republic of China and other laws and regulations.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。 Article 2 In the territory of the Peoples Republic of China, people who engagedEntity that engages in food salesselling and beveragecatering service activities should obtain a food businessoperation license according to the law.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。ThisThese measures isare applicable to the application, acceptance, examinationreview, decision, supervision and inspection of the food businessoperation licenseapproval.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 3 Food businessoperation licenseapproval should comply with the legal, transparent, fair, justice, civil -convenient, and highly-efficiencyt principles of law, openness, fairness, impartiality, convenience and efficiency.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 4 The food businessoperation licenseapproval implementshall be subject to the ”one placesite one cardlicense” principle, namely, a food business operator should obtain one food businessoperation license when fordo food businessoperation activities carried out in oneeach businessoperation premises.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 5 Food and drug supervision and management departments classifygrants food businessoperation licenses by classification in accordance withbased on the main types of food business and the risk degree of operating the projectbusiness mode of food operator and the risk level of operating item.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。 Article 6 The China Food and dDrug administration Administration is responsible for supervision and guidance theof national food businessoperation licenseapproval management.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。Local fFood and drug supervision and management departments at or abovethe county level or above areis responsible for the food businessoperation licenseapproval management ofat its own the respective administrative arearegion.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。The provinces, autonomous regions and municipalities foodFood and drug supervision and administration departments at the provincial, autonomous regional and direct municipal level canmay determine the food businessoperation approvallicense management authority of city or county food and drug supervision and Administration Departmentsmanagement department at the municipal and county level in accordance withbased on the food category and food safety risk statuscondition.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。 Article 7 The China Food and dDrug aAdministration is responsible for formulatingformulation of the review general rules of food businessoperation approvallicense examination rules.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。Local fFood and drug supervision and administrationmanagement departments at or abovethe county level or above should comply with the general rules of food business license when shall implement theexamination on food businessoperation approvallicense reviewin compliance with such food operation approval examination rules.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。 Article 8 Food and drug supervision and management departments at or abovethe county level or above should speed up the informationalization construction, announce business licenseoperation approval matters in administrative organs website, and facilitate the applicants filing businessoperation license application in the form of data telex, andin order to improve work efficiency.第二章申请与受理Chapter II Application and Acceptance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。 Article 9 The applicationEntity that applies for food businessoperation approvallicense should first obtains a business license and other legal subject qualification as a subject.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。Enterprise legal person, partnership enterprise, individual proprietorship enterprise, individual engaging in industrial and commercial householdsbusiness and so on should make the main bodyentity specified on the business license 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。Canteens of oOrgans, institutions, social organizations, private non-enterprise units and enterprises that applyies for canteen in enterprise should make the entity specified main body likein organs or public institutions legal person registration certificate, social organization registration certificate or business license and so on as the applicant.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。 Article 10 The application for food business operation approvallicense should be put forwardsubmitted in accordance with the classification of the food business main activitiesoperation business mode and the business projectsoperation item.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。Food business main activitiesoperation business mode is are divided into food salesselling operators, foodcatering service operators and unit canteens in enterprise. Food operators applying tothat applies for online operateoperation, establishes a central kitchen or engages in collectivegroup dining distribution should have such business marked in brackets after the main formatbusiness mode.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。Food businessoperation projectitems are divided into pre-packaged food salesselling (including or excluding refrigeratedcold and frozen food, not including the refrigerated and frozen food), bulk food salesselling (including or excluding refrigeratedcold and frozen food, not including the refrigerated and frozen food), special food salesselling (health food, special medicinal formula food with formula for special medical purpose, infant formula milk powder and other infant formula food) and other types of food salesselling; hot food makeproduction and salesselling of hot food, cold food makeproduction and salesselling, raw food makeproduction and salesselling, pastry make and salescake, homemade drink make and saleself-produced drinks, and other food make and sales.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。Specific species included in items such as other food salesselling and other food make and salesas well as production and selling of other food should be reported to the China Food and Drug Administration and be implemented after its approval, and then have such items clearly marked. Food that is with many varieties likein certain conditions such as hot, cold, raw, solid, liquid and so on and that is difficult to be clearly classified into certain classification canmay be classified in accordancecategorized into the classification that is with the highest level of food safety risk.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。The China Food and drug Drug administration Administration can may adjust the categoryies of food projectsoperation items in accordance withbased on the needs of supervision and administrationmanagement.第十一条申请食品经营许可，应当符合下列条件： Article 11 The applicationentity that applies for food businessoperation approvallicense should meet the following requirements:（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；(1)Have raw material processing, food processing, sales, storage and other places that compatible with food varieties and number, keep it clean, tidy and maintain a specified distance from toxic, hazardous sites and other pollution sources;having appropriate premises for raw material disposition, food processing, trading and storage that are sufficient for the intended variety and quantity of foods to be operated; keeping the premises tidy and clean; and ensuring that prescribed distances have been maintained between such premises and toxic or hazardous locations and/or other sources of contamination;（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；(2)Have operating equipment or facilities that compatible with food varieties and number, have corresponding disinfection, changing clothes, toilet, natural and artificial light, ventilation, prevention of spoilage, protection against dust, elimination of flies and rodents, washing of equipment, sewage discharge and the containment of garbage and other wastes;having appropriate trading equipment and facilities that are sufficient for the variety and quantity of foods to be operated; and having appropriate equipment and facilities for disinfection, changing clothes, lighting, illumination, ventilation, anti-corrosion, dust-proofing, fly-proofing, rat-proofing, insect-proofing, cleaning, sewage disposal, and garbage disposal and storage;（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；(3)Have full-time or part-time food safety management personnel, rules and regulations to ensure food safety;having full-time or part-time food safety management personnel and having rules and regulations that ensures food safety;（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；(4)Have reasonable equipment layout and process flow to prevent the cross contamination between to-be processed food and direct edible food, raw materials and finished product, avoid food contacting with poison, unclean substances;having reasonable equipment layout and operating procedures; avoiding cross-contamination between foods to be processed and ready-to-eat foods and raw materials and finished products; preventing contact between foods and toxic or unclean substances; and（五）法律、法规规定的其他条件。(5)Other conditions stipulated by the laws orand regulations.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： Article 12 The applicationEntity that applies for food businessoperation approvallicense should submit the following materials to food and drug supervision and management departments at or above the county level or above where the applicant is located:（一）食品经营许可申请书；(1)Application letter for food businessoperation approvallicense;（二）营业执照或者其他主体资格证明文件复印件；(2)Photocopies of business license or other subject qualification certificatescertification documents as subject;（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；(3)The main equipment, facilities layout, operating procedures and other documents should adapt to food business;dDocuments regarding main facilities layout and operating procedure appropriate for food operation;（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。(4)Self-inspection of food safety, employeespersonnel health management, purchaseincoming food inspection records, food safety incidents disposaldisposition and other regulations that ensure food safety.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。Using automatic vending equipment engaged in food sales, the applicant should also submit certificate of vending equipment products, the specific location, the operator name, address, contact way, publicity of food business license and many other materials.Applicant that engages in food selling by using automatic product selling equipment shall submit the product qualification certificate of the automatic product selling equipment, information of the specific location of such equipment, the operators name, address, contact information, publication method of the food operation license, and other certification materials.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。If the applicant entrusts an agent to apply for the food operation approval Tthen such agent should submit the authorized attorneyauthorization letter and the agents identity certificateits identification document of the agent if the applicant entrusted an application to handle food business license.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 13 The applicant should truthfullyhonestly submit relevant materials and reflect real situationcondition to the food and drug supervision and administration departments, be responsible for the authenticity of the application materials, and sign or seal on the materials on the applicationsuch as the application letter.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： Article 14 food Food and drug supervision and administration departments at or above the county level or above should deal with food businessoperation approvallicense application that proposedis submitted by the applicants according tounder the following circumstancesconditions:（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。(1)The If the application items that neednt obtainis free from the food businessoperation approvallicense should informthen the applicant of not acceptingshall be immediately informed of the non-acceptance decision.（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。(2)Immediately make a decision of not accepting and inform the applicant to apply to relevant administrative authority If the application items do not fall within the food and drug administration departments competence.If the application item is beyond the authority scope of the food and drug supervision and management department according to law, such department shall immediately decide not to accept the application and inform the applicant that the applicant shall submit the application to relevant administrative authority.（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。(3)If therere are some errors in the application materials that can be corrected on the spot, the applicant should be allowed to correct itthem on the spot, and the applicant shall sign or seal at the correction place, thenas well as indicate mark the date of correction.（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。(4)TheIf the application materials are incomplete or inconsistent with the statutory form, then the applicants should be informed of all the contents that need to be supplemented and corrected on the spot or within 5five working days. Those informing on the spot should return materials to applicants;If the applicant is informed of the same on site then the application materials shall be returned to the applicant. those informing in 5 working days should collect the application materials and issue the receipt certificates.If the applicant is informed within five working days then the application materials shall be accepted and receipt of application materials shall be issued. Those not informing until overdue should see it as acceptance since the date of receiving application materialsIf the applicant is not informed on time then the application shall be deemed as accepted on the day of receiving the application materials.（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。(5)Application materials are complete, meet the statutory form or the applicants submit all corrected materials in accordance with the requirements, it should accept the application for food business license.If the application materials are complete and comply with statutory forms, or the applicant has submitted all the rectified materials in accordance with requirements then such application for food operation approval shall be accepted.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。 Article 15 food Food and drug supervision and management departments at or above the county level or above that decides to accept the application proposedsubmitted by applicants should issue an acceptance notice. of acceptance; If such department decides not to accept it shouldthe application then such department shall issue a notice of rejecting to non-acceptance in which, states the reasons for rejection, and inform the applicant of the rights to apply for an administrative reconsideration or to bring an administrative litigationlawsuit.第三章审查与决定Chapter III Review and Decision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。 Article 16 Food and drug supervision and management departments at or above the county level or above should review the application materials submitted by the applicant. If substantial contents of the application materials need to be verified then such department shall, should verify the real content of application materials, should carry out on-site verificationinspection. Who onlyIf the applicant solely applyies for pre-packaged food salesselling (excluding frozen and cold