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Decree of the General Administration of Quality Supervision, Inspection and Quarantine
(No.142)
The Administrative Provisions on the Filing of Export Food Manufacturers, which were deliberated and adopted at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine, are hereby promulgated, and shall come into force on October 1, 2011.
Minister: Zhi Shuping
July 26, 2011
Administrative Provisions on the Filing of Export Food Manufacturers
| | 國家質量監督檢驗檢疫總局令
（第142號）
《出口食品生產企業備案管理規定》已經2011年6月21日國家質量監督檢驗檢疫總局局務會議審議通過，現予公布，自2011年10月1日起施行。
局 長 支樹平
二?一一年七月二十六日
出口食品生產企業備案管理規定
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Chapter I General Provisions
| | 第一章 總則
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Article 1 To strengthen the food safety and sanitation management of export food manufacturers and regulate the filing management thereof, these Provisions are formulated pursuant to the Food Safety Law of the People's Republic of China, the Law of the People's Republic of China on Import and Export Commodity Inspection, the Regulation on the Implementation of the Law of the People's Republic of China on Import and Export Commodity Inspection and other relevant laws and administrative regulations.
| | 第一條 為了加強出口食品生產企業食品安全衛生管理，規範出口食品生產企業備案管理工作，依據《中華人民共和國食品安全法》、《中華人民共和國進出口商品檢驗法》及其實施條例等有關法律、行政法規的規定，制定本規定。
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Article 2 The state applies the filing management system to export food manufacturers.
| | 第二條 國家實行出口食品生產企業備案管理制度。
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Article 3 These Provisions apply to the filing management of export food manufacturers within the territory of the People's Republic of China.
| | 第三條 在中華人民共和國境內的出口食品生產企業備案管理工作適用本規定。
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Article 4 The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) is responsible for the overall filing management of export food manufacturers of the whole nation.
The Certification and Accreditation Administration of the People's Republic of China (CNCA) is responsible for organizing and executing the filing management of export food manufacturers of the whole nation
The entry-exit inspection and quarantine bureaus set up by the AQSIQ at local regions (hereinafter referred to as “inspection and quarantine bureaus”) are responsible for the filing, supervision and inspection of export food manufacturers within their respective jurisdictions.
| | 第四條 國家質量監督檢驗檢疫總局（以下簡稱國家質檢總局）統一管理全國出口食品生產企業備案工作。
國家認證認可監督管理委員會（以下簡稱國家認監委）組織實施全國出口食品生產企業備案管理工作。
國家質檢總局設在各地的出入境檢驗檢疫機構（以下簡稱檢驗檢疫機構）具體實施所轄區域內出口食品生產企業備案和監督檢查工作。
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Article 5 Export food manufacturers shall set up and execute a food safety and sanitation control system focusing on hazard analysis, prevention and control, guarantee the effective running of the system, and make sure that the production, processing and storage of export foods continuously conform to the statutory requirements of China, the laws and regulations of the import countries (regions) and the safety and sanitation requirements for export food manufacturers.
| | 第五條 出口食品生產企業應當建立和實施以危害分析和預防控制措施為核心的食品安全衛生控制體系，並保證體系有效運行，確保出口食品生產、加工、儲存過程持續符合我國有關法定要求和相關進口國（地區）的法律法規要求以及出口食品生產企業安全衛生要求。
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Chapter II Items for Filing and Filing Procedures
| | 第二章 備案內容與程序
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Article 6 Where an export food manufacturer fails to fulfill the statutory obligation of filing or fails to pass the filing examination, its products may not be exported.
| | 第六條 出口食品生產企業未依法履行備案法定義務或者經備案審查不符合要求的，其產品不予出口。
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Article 7 For filing purposes, an export food manufacturer shall submit a written application and the following documents or certifications, and be responsible for the authenticity of the filing materials:
| | 第七條 出口食品生產企業備案時，應當提交書面申請和以下相關文件、證明性材料，並對其備案材料的真實性負責：
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1. Business license, organization code certificate, and identity certificate of the legal representative or authorized person in charge;
| | （一）營業執照、組織機構代碼證、法定代表人或者授權負責人的身份證明；
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2. A self-declared commitment that it satisfies the sanitation requirements for export food manufacturers and the requirements of the import country (region), and a self-inspection report;
| | （二）企業承諾符合出口食品生產企業衛生要求和進口國（地區）要求的自我聲明和自查報告；
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3. Working conditions (plane charts of the production area and workshops), producing and processing techniques of products, critical processing links, use of raw materials, supplementary materials and food additives, eligibilities of the sanitation and quality control personnel and specialized technical personnel, and other basic information about it;
| | （三）企業生產條件（廠區平面圖、車間平面圖）、產品生產加工工藝、關鍵加工環節等信息、食品原輔料和食品添加劑使用以及企業衛生質量管理人員和專業技術人員資質等基本情況；
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4. Basic information about the establishment and implementation of the food safety and sanitation control system;
| | （四）建立和實施食品安全衛生控制體系的基本情況；
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5. A food production permit or any other administrative license that shall be obtained according to law;
| | （五）依法應當取得食品生產許可以及其他行政許可的，提供相關許可證照；
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6. Other certifications, internal laboratory eligibilities and other relevant situations.
| | （六）其他通過認證以及企業內部實驗室資質等有關情況。
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Article 8 An inspection and quarantine bureau directly under AQSIQ shall, within 5 days after an export food manufacturer applies for filing, make a preliminary examination on the filing materials submitted by the enterprise. If the materials are complete and in statutory forms, the application shall be accepted; if the materials are not complete or in statutory forms, it shall notify the enterprise of all items that need to be supplemented or corrected at one time.
To facilitate export, an inspection and quarantine bureau directly under AQSIQ may authorize its branch offices to accept a filing application and organize the appraisal thereof.
| | 第八條 直屬檢驗檢疫機構應當自出口食品生產企業申請備案之日起5日內，對出口食品生產企業提交的備案材料進行初步審查，材料齊全並符合法定形式的，予以受理；材料不齊全或者不符合法定形式的，應當一次告知出口食品生產企業需要補正的全部內容。
為便利企業出口，直屬檢驗檢疫機構可以根據工作需要，委托其分支機構受理備案申請並組織實施評審工作。
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Article 9 An inspection and quarantine bureau directly under AQSIQ shall, within 10 days after accepting a filing application, form an appraisal group to examine the conformity of the filing materials submitted by the applicant with the relevant requirements.
If it needs to make an on-site inspection on an export food manufacturer, the inspection shall be completed within 30 days. If it fails to complete the documentary examination or on-site inspection within the prescribed time due to the enterprise's fault, any extension of time shall not be counted in the prescribed time limit.
Appraisers must pass the examination of the CNCA or the inspection and quarantine bureaus directly under AQSIQ.
| | 第九條 直屬檢驗檢疫機構自受理備案申請之日起10日內，組成評審組，對出口食品生產企業提交的備案材料的符合性情況進行文件審核。
需要對出口食品生產企業實施現場檢查的，應當在30日內完成。因企業自身原因導致無法按時完成文件審核和現場檢查的，延長時間不計算在規定時限內。
從事評審的人員應當經國家認監委或者直屬檢驗檢疫機構考核合格。
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Article 10 Under any of the following circumstances, an inspection and quarantine bureau directly under AQSIQ shall make an on-site inspection on an export food manufacturer:
．．．．．． | | 第十條 有下列情形之一的，直屬檢驗檢疫機構應當對出口食品生產企業實施現場檢查：
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