【中英文对照版】食品生产许可审查通则(2022版).docx

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1、【制定机关】 【发文字号】 【公布日期】 【施行日期】 【效力位阶】 【法规类别】市场监管总局关于发布食品 生产许可审查通则（2022版） 的公告（国家市场监督管理总局公告 2022年第33号）现发布修订后的食品生产许 可审查通则（2022版），自 2022年11月1日起施行。市场监管总局2022年10月8日食品生产许可审查通则（2022 版）第一章总则第一条为了加强食品、 食品添加剂（以下统称食品） 生产许可管理，规范食品生产 许可审查工作，依据中华人 民共和国食品安全法中华食品生产许可审查通则（2022版）General Rules for the Examination of Food

2、Production Licensing (2022 Version)国家市场监督管理总局国家市场监督管理总局公告2022年第33号部门规范性文件食品卫生Issuing authority： Instrumentalities of the State Council,All Administrations,State Administration for Market RegulationDocument Number： Announcement No. 33 2022 of the State Administration for Market RegulationDate issued

3、： 10-08-2022Effective date： 11-01-2022Level of Authority： Departmental Regulatory DocumentsArea of Law： Health and SanitationAnnouncement of the State Administration for Market Regulation on Issuing the General Rules for the Examination of Food Production Licensing (2022 Version)(Announcement No. 33

4、 2022 of the State Administration for Market Regulation)The revised General Rules for the Examination of Food Production Licensing (2022 Version) are hereby issued and shall come into force on November 1,2022.State Administration for Market RegulationOctober 8, 2022General Rules for the Examination

5、of Food Production Licensing (2022 Version)Chapter I General ProvisionsArticle 1 These General Rules are developed in accordance with the Food Safety Law of the Peoples Republic of China, the Regulation on the Implementation of the Food Safety Law of the Peoples Republic of China, the Administrative

6、 Measures for 匚cc/d DrC ic+icc I iccccicc /hcrcidf+cv referred +c oopersonnel when conducting the on-site inspection.实材料及询问相关人员等方法 实施现场核查。When necessary, an inspection team may conduct the random inspection and assessment of the applicants food safety management personnel and professional technician

7、s.必要时，核查组可以对申请人 的食品安全管理人员、专业技 术人员进行抽查考核。Article 23 The scope of an on-site inspection mainly includes production place, equipment and facilities, equipment layout and process flow, personnel management, management rules and their implementation, and the report that the food under trial production pa

8、sses the inspection.In the on-site inspection, relevant items shall be subject to inspection and scored according to food categories. If the detailed rules for examination specify or have special requirements for the relevant contents of the on-site inspection, such details or special requirements s

9、hall be verified at the same time and recorded in the Scoring Record of the On-site Inspection of Food or Food Additive Production Licensing.第二十三条现场核查范 围主要包括生产场所、设备设 施、设备布局和工艺流程、人 员管理、管理制度及其执行情 况，以及试制食品检验合格报 告。现场核查应当按照食品的类别 分别核查、评分。审查细则对 现场核查相关内容进行细化或 者有特殊要求的，应当一并核 查并在食品、食品添加剂生 产许可现场核查评分记录表 中记录。Wher

10、e an applicant applies for licensing for the first time or modifies food production licensing due to the increase of a food category, the report on the inspection of products under trial production shall be verified in accordance with the requirements of the corresponding detailed rules for examinat

11、ion and implemented standards. If an applicant applies for the modification or extension of licensing, and declares that its production conditions and the surrounding environment have changed, an on-site inspection shall be conducted based on the changes, and the inspection items not involved in the

12、 modification shall be deemed as reasonable omissions instead of scoring items.对首次申请许可或者增加食品 类别变更食品生产许可的，应 当按照相应审查细则和执行标 准的要求，核查试制食品的检 验报告。申请变更许可及延续 许可的，申请人声明其生产条 件及周边环境发生变化的，应 当就变化情况实施现场核查， 不涉及变更的核查项目应当作 为合理缺项，不作为评分项目。In an on-site according to requirements, requirements,inspection, each item shall

13、 be scored three grades: complying with the basically complying with the and failing to comply with therequirements. The total score of all inspection items is 100 points. If an inspection item is inapplicable, it shall not be scored, and the reason for being inapplicable shall be stated in the colu

14、mn of inspection records,.现场核查对每个项目按照符合 要求、基本符合要求、不符合 要求3个等级判定得分，全部 核查项目的总分为100分。某 个核查项目不适用时，不参与 评分，在“核查记录”栏目中说明 不适用的原因。现场核查结果以得分率进行判 定。参与评分项目的实际得分 占参与评分项目应得总分的百 分比作为得分率。核查项目单 项得分无0分项且总得分率 N85%的，该类别名称及品种明 细判定为通过现场核查；核查 项目单项得分有。分项或者总 得分率85%的，该类别名称 及品种明细判定为未通过现场 核查。第二十四条根据现场核 查情况，核查组长应当召集核 查人员共同研究各自负责

15、核查 项目的得分，汇总核查情况， 形成初步核查意见。核查组应当就初步核查意见向 申请人的法定代表人（负责人） 通报，并听取其意见。第二十五条核查组对初 步核查意见和申请人的反馈意 见会商后，应当根据不同类别 名称的食品现场核查情况分别 评分判定，形成核查结论，并 汇总填写食品、食品添加剂 生产许可现场核查报告（附 件3）。第二十六条核查组应当 召开末次会议，由核查组长宣 布核查结论。核查人员及申请 人的法定代表人（负责人）应 当在食品、食品添加剂生产 许可现场核查评分记录表食 品、食品添加剂生产许可现场 核查报告上签署意见并签名、 盖章。观察员应当在食品、 食品添加剂生产许可现场核查 报告上签

16、字确认。K杳用 含且沫力n刘士/近BTThe on-site inspection result shall be determined based on the scoring rate. The scoring rate shall be the percentage of the actual score of the scoring items to the total score. If there is no single inspection item with zero points and the total scoring rate is not less than 85%

17、, the category name and category details shall be determined as having passed the on-site inspection; or if there is any single inspection item with zero points or the total scoring rate is less than 85%, the category name and category details shall be determined as having not passed the on-site ins

18、pection.Article 24 The leader of an inspection team shall, based on the on-site inspection situation, gather the inspection personnel to jointly study the scores on the inspection items undertaken by each of them respectively, and summarize the inspection situation to form preliminary inspection opi

19、nions.The inspection team shall inform the legal representative (or person in charge) of the applicant of the preliminary inspection opinions and listen to his or her opinions.Article 25 After the consultation on the preliminary inspection opinions and the applicants feedback, an inspection team sha

20、ll, according to the information on the on-site inspection of food in different categories, give a score, form the inspection conclusion, summarize the result, and enter the Report on the On-site Inspection of Food or Food Additive Production Licensing (Annex 3).Article 26 The inspection team shall

21、convene the final meeting at which the team leader shall announce the inspection conclusion. The inspection personnel and the applicants legal representative (or person in charge) shall write comments on and affix their signatures and seals to the Scoring Record of the On-site Inspection of Food or

22、Food Additive Production Licensing and the Report on the On-site Inspection of Food or Food Additive Production Licensing. The observers shall sign the Report on the On-site Inspection of Food or Food Additive Production Licensing for confirmation.Thp Rpnnrt nn thp Cn-u什a Innpntinn nf Fnnrl nr Fnnrl

23、现场核查报告一式两份，现 场交申请人留存一份，核查组 留存一份。申请人拒绝签名、盖章的，核 查组长应当在食品、食品添 加剂生产许可现场核查报告 上注明情况。参加末次会议人员范围与参加 首次会议人员相同，参会人员 应当在食品、食品添加剂生 产许可现场核查末次会议签到 表（附件4）上签名。第二十七条因申请人的 下列原因导致现场核查无法开 展的，核查组应当向委派其实 施现场核查的市场监督管理部 门报告，本次现场核查的结论 判定为未通过现场核查：（一）不配合实施现场核查的;（二）现场核查时生产设备设 施不能正常运行的；（三）存在隐瞒有关情况或者 提供虚假材料的；（四）其他因申请人主观原因 导致现场核查

24、无法正常开展 的。第二十八条核查组应当 自接受现场核查任务之日起5 个工作日内完成现场核查，并 将食品、食品添加剂生产许 可核查材料清单（附件5） 所列的相关材料上报委派其实 施现场核查的市场监督管理部 门。Additive Production Licensing shall be made in duplicate, with one copy delivered to and kept by the applicant on site and one copy kept by the inspection team.If an applicant refuses to affix his

25、 or her signature or seal, the leader of the inspection team shall indicate the relevant information on the Report on the On-site Inspection of Food or Food Additive Production Licensing.The scope of attendees in the final meeting shall be the same as that of the attendees of the first meeting, and

26、the attendees shall sign their names on the List of Attendees in the Final Meeting of the On-site Inspection of Food or Food Additive Production Licensing (Annex 4).Article 27 Where an on-site inspection cannot be conducted due to any of the following reasons of the applicant, the inspection team sh

27、all report such failure to the market regulatory department that has appointed it to conduct the on-site inspection, and issue a conclusion that the applicant fails to pass the on-site inspection:1. The applicant fails to cooperate in the on-site inspection.2. The production equipment and facilities

28、 cannot be put into normal operation during the on-site inspection.3. The applicant conceals the relevant information or provides false materials.4. The on-site inspection cannot be carried out normally due to any other subjective reason of the applicant.Article 28 The inspection team shall, within

29、five working days from the date when it accepts the on-site inspection task, complete the on-site inspection, and submit the relevant materials set out in the List of Materials on the Inspection of Food or Food Additive Production Licensing (Annex 5) to the market regulatory department that has appo

30、inted it to conduct the on-site inspection.第二十九条因不可抗力 原因，或者供电、供水等客观 原因导致现场核查无法开展 的，申请人应当向审批部门书 面提出许可中止申请。中止时 间原则上不超过10个工作日， 中止时间不计入食品生产许可 审批时限。因自然灾害等原因造成申请人 生产条件不符合规定条件的， 申请人应当申请终止许可。申请人申请的中止时间到期仍 不能开展现场核查的，或者申 请人申请终止许可的，审批部 门应当终止许可。第三十条因申请人涉嫌 食品安全违法被立案调查或者 涉嫌食品安全犯罪被立案侦查 的，审批部门应当中止食品生 产许可程序。中止时间不计入

31、食品生产许可审批时限。立案调查作出行政处罚决定为 限制开展生产经营活动、责令 停产停业、责令关闭、限制从 业、暂扣许可证件、吊销许可 证件的，或者立案侦查后移送 检察院起诉的，应当终止食品 生产许可程序。立案调查作出 行政处罚决定为警告、通报批 评、罚款、没收违法所得、没 收非法财物且申请人履行行政 处罚的，或者立案调查、立案 侦查作出撤案决定的，申请人 申请恢复食品生产许可后，审 批部门应当恢复食品生产许可 程序。Article 29 Where an on-site inspection cannot be conducted due to force majeure, or any ot

32、her objective reason such as power supply and water supply, the applicant shall file a written application for the suspension of licensing with the approval department. The suspension period shall not exceed ten working days in principle, and shall not be included in the time limit for the approval

33、of food production licensing.Where the applicants production conditions fail to meet the prescribed conditions due to a natural disaster or any other reason, the applicant shall apply for the termination of licensing,Where an on-site inspection cannot be conducted upon the expiration of the suspensi

34、on period applied for by the applicant or the applicant applies for the termination of licensing, the approval department shall terminate the licensing.Article 30 Where an applicant is under formal investigation on suspicion of involvement in any food safety-related violation of law or is under crim

35、inal investigation on suspicion of involvement in any food safety-related crime, the approval department shall suspend the food production licensing procedure. The suspension period shall not be included in the time limit for the approval of food production licensing.Where, after formal investigatio

36、n, an administrative punishment decision is made to restrict production and operation activities, order production or business suspension, order closure, restrict from employment, suspend or revoke the license, or the case is transferred to the procuratorate for prosecution after case investigation,

37、 the food production licensing procedure shall be terminated. If, after formal investigation, an administrative punishment decision is made to give a warning, circulate a notice of criticism, impose a fine, or confiscate illegal income or illegal property, and the applicant executes the administrati

38、ve punishment decision, or a decision to withdraw the case is made upon formal investigation or criminal investigation, the approval department shall resume the food production licensing procedure after the applicant applies for the resumption of food production licensing.第四章审查结果与整改第三H*一条 审批部门应 当根据申

39、请材料审查和现场核 查等情况，对符合条件的，作 出准予食品生产许可的决定， 颁发食品生产许可证；对不符 合条件的，应当及时作出不予 许可的书面决定并说明理由， 同时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。现场核查结论判定为通过的婴 幼儿配方食品、特殊医学用途 配方食品申请人应当立即对现 场核查中发现的问题进行整 改，整改结果通过验收后，审 批部门颁发食品生产许可证； 申请人整改直至通过验收所需 时间不计入许可时限。第三十二条作出准予食 品生产许可决定的，审批部门 应当及时将申请人的申请材料 及相关许可材料送达申请人的 日常监管部门。第三十三条现场核查结 论判定为通过的，申请人

40、应当 自作出现场核查结论之日起1 个月内完成对现场核查中发现 问题的整改，并将整改结果向 其日常监管部门书面报告。因不可抗力原因，申请人无法 在规定时限内完成整改的，应 当及时向其日常监管部门提出 延期申请。第三十四条申请人的日 常监管部门应当在申请人取得 杳r止前忤mm。不曰肉为却Chapter IV Examination Results and RectificationArticle 31 The approval department shall, according to the examination of application materials, the on-site i

41、nspection, and other information, make a decision to grant food production licensing and issue a food production permit to the eligible applicant; and if the application fails to meet the relevant conditions, the approval department shall promptly make a written decision to disapprove licensing, exp

42、lain the reasons for disapproval, and at the same time, inform the applicant of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.An applicant for infant formula food or formula food for special medical purposes that is determined as p

43、assing the on-site inspection in the conclusion shall immediately rectify the problems found during the on-site inspection. After the rectification result passes the acceptance check, the approval department shall issue a food production permit; and the time required by the applicant for making rect

44、ification until it passes the acceptance check shall not be included in the time limit for licensing.Article 32 Where a decision to grant the food production licensing is made, the approval department shall promptly serve the application materials of the applicant and the relevant licensing material

45、s upon the applicants routine regulatory department.Article 33 Where the on-site inspection conclusion is that the applicant passes the on-site inspection, the applicant shall, within one month after the on-site inspection conclusion is made, rectify the problems found in the on-site inspection and

46、report the rectification results in writing to the routine regulatory department.If the applicant is unable to complete the rectification within the prescribed time limit due to force majeure, the applicant shall file an application for extension with its routine regulatory department in a timely ma

47、nner.Article 34 The applicants routine regulatory department shall, within three months after the applicant obtains the food production licensing,证企业开展一次监督检查。对 已实施现场核查的企业，重点 检查现场核查中发现问题的整 改情况；对申请人声明生产条 件未发生变化的延续换证企 业，重点检查生产条件保持情 况。第五章附则第三十五条 申请人的试 制食品不得作为食品销售。第三十六条特殊食品生 产许可审查细则另有规定的， 从其规定。第三十七条省级市场监

48、 督管理部门可以根据本通则， 结合本区域实际情况制定有关 食品生产许可管理文件，补充、 细化食品、食品添加剂生产 许可现场核查评分记录表食 品、食品添加剂生产许可现场 核查报告。第三十八条 本通则由国 家市场监督管理总局负责解 释。第三十九条本通则自 2022年11月1日起施行。原 国家食品药品监督管理总局 2016年8月9日发布的食品 生产许可审查通则同时废止。conduct the supervision and inspection of the enterprise obtaining the permit. For an enterprise that has been subjected to an on-site inspection, the inspection shall focus on whether the problems found in the on-site inspection have been rectified; for an enterprise that renews the permit but declares no change of production conditions, the inspection shall focus on the maintenance of production con