国家质量监督检验检疫总局令

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第 192 号

《出口食品生产企业备案管理规定》已经2017年10月10日国家质量监督检验检疫总局局务会议审议通过,现予公布,自2018年1月1日起施行。

局 长  支树平        

2017年11月14日      

出口食品生产企业备案管理规定

第一章 总  则

第一条 为加强出口食品生产企业食品安全卫生管理,规范出口食品生产企业备案管理工作,依据《中华人民共和国食品安全法》、《中华人民共和国进出口商品检验法》及其实施条例等有关法律、行政法规的规定,制定本规定。

第二条 国家实行出口食品生产企业备案管理制度。

第三条 在中华人民共和国境内的出口食品生产企业备案管理工作适用本规定。

第四条 国家质量监督检验检疫总局(以下简称国家质检总局)主管全国出口食品生产企业备案工作。

国家认证认可监督管理委员会(以下简称国家认监委)负责统一组织实施全国出口食品生产企业备案管理工作。

国家质检总局设在各地的出入境检验检疫部门(以下简称检验检疫部门)具体实施所辖区域内出口食品生产企业备案和监督检查工作。

第五条 出口食品生产企业应当建立和实施以危害分析和预防控制措施为核心的食品安全卫生控制体系,该体系还应当包括食品防护计划。出口食品生产企业应当保证食品安全卫生控制体系有效运行,确保出口食品生产、加工、储存过程持续符合我国相关法律法规和出口食品生产企业安全卫生要求,以及进口国(地区)相关法律法规要求。

第二章 备案程序与要求

第六条 出口食品生产企业未依法履行备案法定义务或者经备案审查不符合要求的,其产品不予出口。

第七条 出口食品生产企业申请备案时,应当向所在地检验检疫部门提交以下文件和证明材料,并对其真实性负责:

(一)营业执照、法定代表人或者授权负责人的身份证明;

(二)企业承诺符合相关法律法规和要求的自我声明和自查报告;

(三)企业生产条件、产品生产加工工艺、食品原辅料和食品添加剂使用以及卫生质量管理人员等基本情况;

(四)建立和实施以危害分析和预防控制措施为核心的食品安全卫生控制体系的基本情况;

(五)依法应当取得其他相关行政许可的,提供相应许可证照。

第八条 检验检疫部门应当自出口食品生产企业申请备案之日起5日内,对出口食品生产企业提交的备案材料进行初步审查,材料齐全并符合法定形式的,予以受理;材料不齐全或者不符合法定形式的,应当一次性告知出口食品生产企业需要补正的全部内容。

第九条 检验检疫部门应当自受理备案申请之日起20日内,组织专家完成评审工作,并出具专家评审报告。专家评审主要采取文件评审方式,对进口国(地区)有特殊注册要求或者风险程度较高的企业,可以实施现场评审。

前款规定的专家评审时间不计算在检验检疫部门备案审查和决定期限内。

第十条 对依法取得资质的认证机构出具的危害分析和关键控制点(HACCP)认证结果或者其它等效的食品安全卫生控制体系认证结果,评审时应当予以采信。

出口食品生产企业声明已经建立以危害分析和预防控制措施为核心的食品安全卫生控制体系并有效运行的,评审时可以结合企业信用记录适当采信。

第十一条 检验检疫部门应当自收到专家评审报告之日起20日内进行审查,并作出是否准予备案的决定。准予备案的,自作出决定之日起10日内,向企业颁发《出口食品生产企业备案证明》(以下简称《备案证明》);不予备案的,应当书面告知企业并说明理由。

第十二条 国家认监委和直属检验检疫部门应当公布从事专家评审工作的人员名单,并通过持续培训,不断提高评审人员的专业水平和能力。

第十三条 《备案证明》有效期为5年。

出口食品生产企业需要延续《备案证明》有效期的,应当在其有效期届满30日前,向所在地检验检疫部门提出延续申请。检验检疫部门应当在《备案证明》有效期届满前作出是否准予延续的决定。

第十四条 出口食品生产企业的企业名称、法定代表人、营业执照等备案事项发生变更的,应当自发生变更之日起15日内,向所在地检验检疫部门申请办理变更手续。

出口食品生产企业生产地址搬迁、新建或者改建生产车间以及食品安全卫生控制体系发生重大变更等情况的,应当在变更前向所在地检验检疫部门报告,并重新办理备案。

第十五条 出口食品生产企业应当建立食品安全卫生控制体系运行及出口食品生产记录档案,记录和凭证的保存期限不得少于食品保质期满后6个月;没有明确保质期的,保存期限不得少于2年。

第十六条 出口食品生产企业应当于每年1月底前向其所在地检验检疫部门提交上一年度报告。

出口食品生产企业发生食品安全卫生问题的,应当及时向所在地检验检疫部门报告,并提交相关材料、原因分析和整改计划。检验检疫部门应当对整改情况进行现场监督检查。

第三章 监督管理

第十七条 国家认监委对检验检疫部门实施的出口食品生产企业备案工作进行指导和监督。

检验检疫部门应当依法对所辖区域内的出口食品生产企业进行监督检查。发现违法违规行为的,应当及时查处,并将处理结果上报国家认监委。

第十八条 检验检疫部门应当按照出口食品生产企业备案编号规则对予以备案的出口食品生产企业进行编号管理。

第十九条 检验检疫部门应当在风险分析的基础上,结合企业信用记录,对出口食品生产企业进行分类管理,确定不同的监督检查方式,并根据监督检查结果进行动态调整。

监督检查可以采取报告审查、现场检查和专项检查等方式进行。

第二十条 检验检疫部门可以将对出口食品生产企业的监督检查和对相关认证活动的监督检查结合进行。

第二十一条 检验检疫部门应当公布本辖区出口食品生产企业备案名录。国家认监委统一公布全国出口食品生产企业备案名录,并报国家质检总局。

检验检疫部门在监管中获悉食品安全风险信息,根据工作职责需要向地方农业、食药、质监等监管部门通报的,应当及时通报。

第二十二条 检验检疫部门应当建立出口食品生产企业备案管理档案,及时审查汇总企业年度报告、监督检查情况、违法违规行为等信息,并纳入企业信用记录。

第二十三条 认证机构对其出具的危害分析和关键控制点(HACCP)认证结果或者其它等效的食品安全卫生控制体系认证结果承担相应法律责任。

获得前款规定认证的出口食品生产企业存在严重问题,认证机构未及时进行处理的,自发现之日起1年内不予以采信认证机构相关认证结果。

认证机构因违法行为被查处的,自发现之日起2年内不予以采信其相关认证结果。

第二十四条 出口食品生产企业存在违法违规行为的,检验检疫部门可以约谈企业相关负责人。

第二十五条 出口食品生产企业有下列情形之一的,检验检疫部门应当责令其限期整改,整改期间不受理企业相关食品的出口报检:

(一)出口食品因企业自身安全卫生方面的问题在1年内被进口国(地区)主管当局通报3次以上的;

(二)出口食品经检验检疫时发现存在安全卫生问题的;

(三)不能持续符合备案条件,出口食品存在安全卫生隐患的。

第二十六条 出口食品生产企业有下列情形之一的,检验检疫部门应当撤销《备案证明》,予以公布,并向国家认监委报告:

(一)出口食品发生重大安全卫生事故的;

(二)出口食品生产、加工过程中有非法添加非食用物质、违规使用食品添加剂或者采用不适合人类食用的方法生产、加工食品等行为的;

(三)出租、出借、转让、倒卖、涂改《备案证明》的;

(四)不接受检验检疫部门监督管理,或者在接受监督管理时隐瞒有关情况、提供虚假材料,且拒不改正的;

(五)存在本规定第二十五条所述情形,经整改后仍不能符合要求的;

(六)依法应当撤销《备案证明》的其他情形。

第二十七条 出口食品生产企业有下列情形之一的,检验检疫部门应当注销《备案证明》,予以公布,并向国家认监委报告:

(一)《备案证明》有效期届满,未申请延续的;

(二)出口食品生产企业依法终止或者申请注销的;

(三)《备案证明》依法被撤销的;

(四)依法应当注销《备案证明》的其他情形。

第四章 法律责任

第二十八条 出口食品生产企业有下列情形之一的,责令改正,给予警告:

(一)未按照本规定保存相关档案或者提交年度报告的;

(二)发生食品安全卫生问题,未按照本规定及时向所在地检验检疫部门报告的;

(三)未按照本规定办理变更或者重新备案的。

第二十九条 出口食品生产企业违反《中华人民共和国食品安全法》、《中华人民共和国进出口商品检验法》及其实施条例等有关法律、行政法规规定的,依照相关规定追究其法律责任。

第三十条 国家认监委和检验检疫部门的工作人员在实施备案和监督管理工作中,滥用职权、徇私舞弊、玩忽职守的,依法给予行政处分;构成犯罪的,依法追究刑事责任。

第五章 附  则

第三十一条 出口食品生产企业需要办理国外(境外)卫生注册的,应当按照本规定取得《备案证明》,依据我国和进口国(地区)有关要求,向其所在地检验检疫部门提出申请,并由国家认监委统一对外推荐。

检验检疫部门在监管中发现获得国外(境外)卫生注册的企业不能持续符合进口国(地区)注册要求,或者其《备案证明》已被依法撤销、注销的,应当报国家认监委取消其对外推荐注册资格。

第三十二条 本规定中检验检疫部门实施行政许可的期限以工作日计算,不含法定节假日。

第三十三条 本规定所称的出口食品生产企业不包括出口食品添加剂、食品相关产品的生产、加工、储存企业。

第三十四条 供港澳食品、边境小额和互市贸易出口食品,国家质检总局另有规定的,从其规定。

第三十五条 本规定由国家质检总局负责解释。

第三十六条 本规定自2018年1月1日起施行。国家质检总局于2011年7月26日公布的《出口食品生产企业备案管理规定》同时废止。

Order of the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China

No. 192

The “Regulations on the Administration of Filing of Export Food Production Enterprises” was deliberated and adopted at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine on October 10, 2017. It is hereby promulgated and will come into force on January 1, 2018.

Director Zhi Shuping

November 14, 2017

Provisions on the Record Management of Export Food Production Enterprises

Chapter I General Provisions

Article 1 In order to strengthen the food safety and hygiene management of export food production enterprises and standardize the filing management of export food production enterprises, in accordance with the “Food Safety Law of the People’s Republic of China”, “The Import and Export Commodity Inspection Law of the People’s Republic of China” and its implementation regulations and other relevant laws , administrative regulations, formulate these regulations.

Article 2 The state implements a record management system for export food production enterprises.

Article 3 These regulations apply to the record management of export food production enterprises within the territory of the People’s Republic of China.

Article 4 The General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (hereinafter referred to as the General Administration of Quality Supervision, Inspection and Quarantine) is in charge of the filing of export food production enterprises across the country.

The Certification and Accreditation Administration of the People’s Republic of China (hereinafter referred to as the CNCA) is responsible for the unified organization and implementation of the filing management of export food production enterprises across the country.

The entry-exit inspection and quarantine departments (hereinafter referred to as inspection and quarantine departments) established by the AQSIQ in various places implement the filing, supervision and inspection of export food production enterprises within their respective jurisdictions.

Article 5 An export food production enterprise shall establish and implement a food safety and hygiene control system centered on hazard analysis and preventive control measures, which shall also include a food defense plan. Export food production enterprises should ensure the effective operation of the food safety and sanitation control system, and ensure that the production, processing and storage of export food continue to comply with relevant laws and regulations of my country and the safety and sanitation requirements of export food production enterprises, as well as the relevant laws and regulations of the importing country (region).

Chapter II Filing Procedures and Requirements

Article 6 If an export food production enterprise fails to fulfill the statutory obligation of filing according to law or fails to meet the requirements after filing and review, its products will not be exported.

Article 7 When an export food production enterprise applies for filing, it shall submit the following documents and certification materials to the local inspection and quarantine department, and be responsible for its authenticity:

(1) Business license, identity certificate of legal representative or authorized person in charge;

(2) The self-declaration and self-examination report that the enterprise promises to comply with relevant laws, regulations and requirements;

(3) The basic information of the enterprise’s production conditions, product production and processing technology, use of food raw and auxiliary materials and food additives, and health quality management personnel;

(4) Basic information on the establishment and implementation of a food safety and sanitation control system centered on hazard analysis and preventive control measures;

(5) If other relevant administrative licenses should be obtained according to law, provide the corresponding licenses.

Article 8 The inspection and quarantine department shall conduct a preliminary review of the filing materials submitted by the export food production enterprise within 5 days from the date when the export food production enterprise applies for filing. If the materials are complete and conform to the statutory form, it shall be accepted; If it is in statutory form, the export food production enterprise shall be notified of all the content that needs to be supplemented and corrected at one time.

Article 9 The inspection and quarantine department shall organize experts to complete the evaluation work and issue an expert evaluation report within 20 days of accepting the filing application. Expert review mainly adopts the method of document review, and on-site review can be implemented for enterprises with special registration requirements in importing countries (regions) or with high risk levels.

The expert review time stipulated in the preceding paragraph is not included in the inspection and quarantine department filing review and decision period.

Article 10 The hazard analysis and critical control point (HACCP) certification results issued by legally qualified certification bodies or other equivalent food safety and hygiene control system certification results shall be accepted during the review.

If the export food production enterprise declares that it has established a food safety and hygiene control system with hazard analysis and preventive control measures as the core and is operating effectively, it can be properly accepted in combination with the enterprise’s credit record during the review.

Article 11 The inspection and quarantine department shall conduct an examination within 20 days of receiving the expert review report, and make a decision on whether to approve the filing. If the filing is approved, within 10 days from the date of making the decision, issue the “Export Food Production Enterprise Recording Certificate” (hereinafter referred to as the “Filing Certificate”) to the enterprise; if the filing is not approved, the enterprise shall be notified in writing and explain the reasons.

Article 12 The National Certification and Accreditation Administration and the inspection and quarantine departments directly under it shall publish the list of personnel engaged in expert evaluation, and continuously improve the professional level and ability of the evaluation personnel through continuous training.

Article 13 The “Filing Certificate” is valid for 5 years.

If an export food production enterprise needs to extend the validity period of the “Filing Certificate”, it shall submit an application for renewal to the local inspection and quarantine department 30 days before the expiration of the validity period. The inspection and quarantine department shall make a decision on whether to approve the renewal before the expiration of the “Filing Certificate”.

Article 14 If the enterprise name, legal representative, business license and other filing items of an export food production enterprise change, it shall apply to the local inspection and quarantine department for modification procedures within 15 days from the date of the change.

In case of relocation of the production site, new or rebuilt production workshops, and major changes in the food safety and hygiene control system of the export food production enterprise, it shall report to the local inspection and quarantine department before the change, and go through the filing process again.

Article 15 Export food production enterprises shall establish food safety and sanitation control system operation and export food production record files, and the storage period of records and certificates shall not be less than 6 months after the expiry of the food shelf life; if there is no clear shelf life, the storage period shall not be less than 2 years.

Article 16 An export food production enterprise shall submit the previous annual report to the inspection and quarantine department where it is located before the end of January each year.

If any food safety and sanitation problem occurs in an export food production enterprise, it shall report to the local inspection and quarantine department in a timely manner, and submit relevant materials, cause analysis and rectification plan. The inspection and quarantine department shall conduct on-site supervision and inspection of the rectification situation.

Chapter III Supervision and Management

Article 17 The National Certification and Accreditation Administration shall guide and supervise the filing work of export food production enterprises implemented by the inspection and quarantine department.

The inspection and quarantine department shall supervise and inspect the export food production enterprises within its jurisdiction according to law. If violations of laws and regulations are discovered, they shall be investigated and dealt with in a timely manner, and the results shall be reported to the CNCA.

Article 18 The inspection and quarantine department shall manage the numbering of the export food production enterprises that have been filed in accordance with the numbering rules for the recordation of export food production enterprises.

Article 19 The inspection and quarantine department shall, on the basis of risk analysis and in combination with enterprise credit records, conduct classified management of export food production enterprises, determine different supervision and inspection methods, and make dynamic adjustments based on the supervision and inspection results.

Supervision and inspection can be carried out in the form of report review, on-site inspection and special inspection.

Article 20 The inspection and quarantine department may combine the supervision and inspection of export food production enterprises with the supervision and inspection of relevant certification activities.

Article 21 The inspection and quarantine department shall publish the record list of export food production enterprises in its jurisdiction. The National Certification and Accreditation Administration uniformly publishes the national record list of export food production enterprises and reports it to the General Administration of Quality Supervision, Inspection and Quarantine.

If the inspection and quarantine department learns of food safety risk information during supervision and needs to report it to local agriculture, food and drug, quality supervision and other supervision departments according to its job duties, it shall report it in a timely manner.

Article 22 The inspection and quarantine department shall establish record management files for export food production enterprises, review and summarize information such as the enterprise’s annual report, supervision and inspection situation, and violations of laws and regulations in a timely manner, and include them in the enterprise’s credit record.

Article 23 The certification body shall bear corresponding legal responsibility for the hazard analysis and critical control point (HACCP) certification results or other equivalent food safety and hygiene control system certification results issued by it.

If the export food production enterprises that have obtained the certification stipulated in the preceding paragraph have serious problems, and the certification agency fails to deal with them in a timely manner, the relevant certification results of the certification agency will not be accepted within one year from the date of discovery.

If the certification body is investigated and dealt with for illegal activities, its relevant certification results shall not be accepted within 2 years from the date of discovery.

Article 24 If an export food production enterprise has violations of laws and regulations, the inspection and quarantine department may interview the relevant person in charge of the enterprise.

Article 25 Where an export food production enterprise falls under any of the following circumstances, the inspection and quarantine department shall order it to rectify within a time limit, and during the rectification period, the export inspection declaration of the enterprise’s relevant food shall not be accepted:

(1) The export food has been notified by the competent authority of the importing country (region) for more than 3 times within one year due to the company’s own safety and hygiene problems;

(2) Safety and sanitation problems are found during the inspection and quarantine of exported food;

(3) Unable to continuously meet the filing conditions, and there are potential safety and hygiene hazards in the exported food.

Article 26 In any of the following circumstances, the inspection and quarantine department shall revoke the “Filing Certificate”, publish it, and report to the CNCA:

(1) A major safety and sanitation accident occurs in exported food;

(2) During the production and processing of exported food, illegal addition of non-edible substances, illegal use of food additives, or production and processing of food by methods that are not suitable for human consumption, etc.;

(3) Lease, lend, transfer, resell, or alter the “Filing Certificate”;

(4) Not accepting the supervision and management of the inspection and quarantine department, or concealing relevant information or providing false materials when accepting supervision and management, and refusing to make corrections;

(5) The circumstances mentioned in Article 25 of these regulations exist, and the requirements are still not met after rectification;

(6) Other circumstances under which the “Filing Certificate” should be revoked according to law.

Article 27 In any of the following circumstances, the inspection and quarantine department shall cancel the “Filing Certificate”, publish it, and report to the CNCA:

(1) The validity period of the “Filing Certificate” has expired and no application for renewal has been made;

(2) The export food production enterprise terminates according to law or applies for cancellation;

(3) The “Filing Certificate” is revoked according to law;

(4) Other circumstances under which the “Filing Certificate” should be canceled according to law.

Chapter IV Legal Responsibilities

Article 28 Where an export food production enterprise falls under any of the following circumstances, it shall be ordered to make corrections and given a warning:

(1) Failing to keep relevant files or submit annual reports in accordance with these regulations;

(2) Failure to report to the local inspection and quarantine department in a timely manner in accordance with these regulations in case of food safety and hygiene problems;

(3) Failing to go through modification or re-filing in accordance with these regulations.

Article 29 If an export food production enterprise violates the “Food Safety Law of the People’s Republic of China”, “The Import and Export Commodity Inspection Law of the People’s Republic of China” and its implementation regulations and other relevant laws and administrative regulations, it shall be investigated for legal responsibility in accordance with relevant regulations.

Article 30 If the staff of the CNCA and the inspection and quarantine department abuse their powers, engage in malpractices for personal gain, or neglect their duties in the implementation of filing and supervision and management work, they shall be given administrative sanctions according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.

Chapter V Supplementary Provisions

Article 31 If an export food production enterprise needs to apply for foreign (overseas) health registration, it shall obtain a “Filing Certificate” in accordance with these regulations, and apply to the local inspection and quarantine department in accordance with the relevant requirements of my country and the importing country (region), and It is recommended by the National Certification and Accreditation Administration.

If the inspection and quarantine department discovers during the supervision that the enterprise that has obtained foreign (overseas) health registration cannot continue to meet the registration requirements of the importing country (region), or its “Filing Certificate” has been revoked or canceled according to law, it should report to the CNCA to cancel its foreign registration. Eligibility for registration is recommended.

Article 32 The time limit for the implementation of administrative licensing by inspection and quarantine departments in these regulations is calculated in working days, excluding legal holidays.

Article 33 The export food production enterprises referred to in these regulations do not include the production, processing and storage enterprises of export food additives and food-related products.

Article 34 For Hong Kong and Macao food, food for small border and mutual market trade, if there are other regulations stipulated by the AQSIQ, such regulations shall prevail.

Article 35 The AQSIQ is responsible for the interpretation of these regulations.

Article 36 These regulations shall come into force on January 1, 2018. The “Regulations on the Administration of Filing of Export Food Production Enterprises” announced by the AQSIQ on July 26, 2011 will be abolished at the same time.

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