International Programs

Memorandum of Understanding between Food and Drug Administration Department of Health and Human Services of the United States of America and Certification and Accreditation Administration of the People’s Republic of China Regarding Registration of U.S. Food Manufacturers Exporting to China

PREAMBLE
The Participants in this Memorandum of Understanding (MOU), the Food and Drug Administration (FDA), Department of Health and Human Services (HHS) of the United States of America, and the Certification and Accreditation Administration of the People’s Republic of China (CNCA), hereinafter referred to as the "Participants,"

Recognizing that the Food Safety Law of the People’s Republic of China and Decree 145 of the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) require overseas manufacturers of certain food products offered for entry into China to be under the effective control and supervision of foreign competent authorities;

Recognizing that under Decree 145 overseas manufacturers of certain food products offered for entry into China are to be certified by the foreign competent authority exercising control and supervision over such manufacturers to be in compliance with the relevant laws and regulations of China, with respect to the food product categories identified in AQSIQ-related notices;

Recognizing that FDA is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, pursuant to the FD&C Act, is charged with protecting public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled,

Recognizing that U.S. based food manufacturers of certain food products offered for entry into China must be certified to be in compliance with the laws and regulations of China for food product categories identified in AQSIQ-related notices, and such certification is available only from third parties; and

Recognizing that the differences between the U.S. and Chinese regulatory systems as they apply to food manufacturers necessitate clarification of the registration processes in order for U.S. food manufacturers to be able to comply with AQSIQ Decree 145;

Have reached the following understandings:

I. PURPOSE

The mutual goals of FDA and CNCA, in signing this MOU, are to:

  1. Establish a registration process that provides assurances to CNCA that U.S. food manufacturers subject to AQSIQ Decree 145, and their food products subject to AQSIQ Decree 145 that the manufacturers offer for entry into China, are in compliance with the relevant standards, laws and regulations of China, as specified in AQSIQ Decree 145;
  2. Outline roles and responsibilities of each participant within this process so that each may operate according to the laws and regulations of their respective country;
  3. Clarify that the third party certification bodies acknowledged by Participants are to serve the purpose of auditing manufacturers who offer food products subject to AQSIQ Decree 145 for entry into China according to the relevant standards, laws, and regulations of China; 
  4. Provide greater clarity and certainty for all those offering food products subject to AQSIQ Decree 145 for entry into China regarding applicable processes for ensuring that the manufacturing facility and product meet the relevant food safety requirements of China; and
  5. Provide for the cooperative exchange of scientific and regulatory information, technical assistance, and research to ensure an effective registration process of food products subject to AQSIQ Decree 145 and exported from the United States and offered for entry into the People’s Republic of China.

II. AREAS OF COOPERATION AND TYPES OF ACTIVITIES

A. CNCA

CNCA intends to:

  1. Provide a list of third-party certification bodies for each food product category under the scope of AQSIQ Decree 145 as updates to the Annexes to this Memorandum;
  2. Confirm that the third-party certification bodies have relevant technical capacity and conditions to conduct China Hazard Analysis and Critical Control Point (HACCP) certification audits;
  3. Update the list of third-party certification bodies within the appropriate Annex as needed or as requested by the United States;
  4. Accept facility certification from one of the third-party certification bodies identified in Annexes to this document;
  5. Allow third-party certification bodies to attest, as indicated in Annex 1, that the U.S. manufacturer and its food products offered for entry into China, subject to AQSIQ Decree 145, meet the relevant standards, laws and regulations of China;
  6. Approve the manufacturers which meet the registration requirements according to AQSIQ Decree 145 and publish online an updated list of registered manufacturers after receipt of the list of manufacturers from FDA;
  7. Stipulate that registered manufacturers shall accept at least one audit every two years by the third-party certification body listed in the appropriate Annex;
  8. Conduct evaluations of the U.S. regulatory procedures for listing food manufacturers and the recommended registration process according to CNCA’s work plan, as needed;
  9. Evaluate acknowledged third-party certification body’s audit activities and inspect U.S. food manufacturers that have been registered with CNCA; and
  10. Request that all U.S. food manufacturers registered in China at the time this MOU is signed receive an audit against the standards, laws and regulations of China and obtain a certification from the third-party certification body listed in the appropriate Annex within two years from the date of signature of this MOU.

B. FDA

FDA intends to:

  1. Acknowledge the list of third-party certification bodies for each food product subject to the AQSIQ Decree 145 which is provided by CNCA as updates to the Annexes to this Memorandum;
  2. Issue a Competent Authority Statement to CNCA when a manufacturer and its food products that are subject to the AQSIQ Decree 145 are certified by a third-party certification body as being in compliance with the standards, laws and regulations of China according to relevant requirement specified in AQSIQ Decree 145 (for template refer to Annex 1);
  3. Evaluate relevant manufacturers’ regulatory standing with FDA through a review of regulatory compliance, inspection history and any pending regulatory action;
  4. Upon completion of the third-party certification body’s review, receive certification from the third-party body and, if certified by the third-party body to be in compliance with the standards, laws and regulations of China according to relevant requirements specified in AQSIQ Decree 145, and if found by FDA to be in good regulatory standing, include the manufacturer on FDA’s internal list of manufacturers and food products;
  5. Every quarter, or as otherwise decided between the Participants, provide CNCA with a list of manufacturers that would facilitate registration by CNCA, including any changes to previous lists of manufacturers;
  6. Provide an attestation, as indicated in Annex 1, along with the list of manufacturers and any changes to previous lists, that the manufacturer and its food products are in good regulatory standing and have received a confirmation from a third-party certification body that the manufacturer and its food products are in compliance with the standards, laws, and regulations of China according to the relevant requirements specified in the AQSIQ Decree 145;
  7. Notify CNCA of changes FDA is making to its list of manufacturers or their products when FDA is made aware of manufacturers and their products not being in compliance with the laws and regulations of China; and
  8. Issue a Competent Authority Statement to CNCA to confirm the list of registered manufacturers already registered with CNCA before this MOU is signed once those manufacturers have successfully received the attestation referenced in Annex 1 from acknowledged third-party certification bodies.

III. ADMINISTRATIVE PROCEDURES

The Participants intend that this MOU not provide for the sharing of any proprietary or confidential business information between Participants. 

The Participants intend to designate points of contact under this MOU. The Participants are expected to notify each other or the points of contact in writing.

The Participants intend that nothing in this MOU affect the acceptance of U.S. government-issued export health certificates by AQSIQ.

The Participants intend to resolve any dispute regarding the implementation or interpretation of this MOU through timely consultations.

All activities carried out pursuant to this MOU are to be conducted in accordance with the laws and regulations of the United States of America and the People’s Republic of China and are subject to the availability of personnel, resources, and available funds.  This MOU is not intended to create any binding obligations under international or domestic law.

IV. PERIOD OF UNDERSTANDING

The activities under this MOU may commence upon signature by both Participants and are expected to continue indefinitely until the MOU is modified or discontinued.  The Participants intend to evaluate the MOU every five (5) years.  The MOU may be modified by mutual written consent of the Participants and may be discontinued by either Participant upon 30 days’ written notice to the other.

Signed in duplicate in the English and Chinese languages, both texts being equally valid. 

FOR THE U.S. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES OF THE UNITED STATES OF AMERICA

________________________________
Stephen Ostroff, M.D.
Deputy Commissioner
For Foods and Veterinary Medicine

Date:    

Place:

FOR THE CERTIFICATION AND ACCREDITATION ADMINISTRATION OF THE PEOPLE´S REPUBLIC OF CHINA 

________________________________
Liu Weijun
Deputy Chief Administrator
 

Date:    

Place:

Annex 1 – Attestations

By the Third-Party Certification Body upon transmittal of a facility and product certification:

"It is hereby certified, relating to the requirements of AQSIQ Decree 145, that the manufacturer and the identified food products exported to China meet the relevant standards, laws, and regulations of China."

By FDA, upon transmittal of the manufacturer list to CNCA:

"It is hereby certified, relating to the requirements of AQSIQ Decree 145, that the manufacturers on this list are subject to the jurisdiction of the Federal Food, Drug, and Cosmetic Act and relevant FDA regulations, that each manufacturer on the list has been found by FDA to be in good regulatory standing and during the most recent facility inspection to be in substantial compliance with all applicable FDA regulations, including current good manufacturing practice requirements, and that each manufacturer and identified food products, as applicable, have been certified by an acknowledged third-party certification body to meet the relevant standards, laws, and regulations of China."

Annex 2 – Acknowledged Third-Party Certification Bodies
for Dairy and Infant Formula Products

序号
No.
名称
Name
地址
Address
联系电话
Tel
1Agricultural Marketing Service, United States Department of Agriculture1400 Independence Ave SW, Washington DC, 20250,+1 202-720-4392
2中国质量认证中心
China Quality Certification Centre (CQC)
北京市丰台区南四环西路188号9区
Section 9, No.188, Nansihuan(the South Fourth Ring Road) Xilu (West Road), Beijing, China
+86 10-83886666
3方圆标志认证集团有限公司
China Quality Mark Certification Group Co., Ltd
北京市海淀区增光路33号
No.33, Zengguang Road, Haidian District, Beijing, China
+86 10-68477287
4北京中大华远认证中心
Beijing Zhongda Huayuan Certification Center (ZDHY)
北京市东城区阜外大街乙22号415室
B22, Fuwai Street, West District, Beijing
+86 10-68396415
5北京五洲恒通认证有限公司
Beijing Continental Hengtong Certification Co., Ltd( CHTC )
北京市丰台区角门18号枫竹苑二区1号楼3层303室
Room 303,Mingliuweilai Mansion, No.18 in Jiaomen, Fengtai District, Beijing, China
+86 10-63180681
6上海天祥质量技术服务有限公司
Intertek Testing Services Ltd., Shanghai
上海市徐汇区宜山路889号齐来工业城2号楼6楼
6/F., Building 2, Comalong Industrial Park, No.889,Yishan Road, Shanghai
+86 21-61194005

Annex 3 – Acknowledged Third-Party Certification Bodies for Seafood Products

序号
No.
名称
Name
地址
Address
联系电话
Tel
1National Marine Fisheries Service, National Oceanic and Atmospheric Administration, United States Department of Commerce1315 East West Highway, Silver Spring, MD 20910+1 301-427-8300
2中国质量认证中心
China Quality Certification Centre (CQC)
北京市丰台区南四环西路188号9区
Section 9, No.188, Nansihuan (the South Fourth Ring Road) Xilu (West Road), Beijing, China
+86 10-83886666
3方圆标志认证集团有限公司
China Quality Mark Certification Group Co., Ltd
北京市海淀区增光路33号
No.33, Zengguang Road, Haidian District, Beijing, China
+86 10-68708523
4上海质量体系审核中心
Shanghai Audit Center of Quality System (SAC)
上海市长宁区武夷路258号
No.258 Wuyi Road Shanghai
+86 21-52387700 (总机 Operator),
52389950
5广东中鉴认证有限责任公司
Guangdong Certification Co., Ltd
广东省广州市越秀区广州大道中路227号4楼
No.227, Middle Road, Guangzhou Avenue, Yuexiu District, Guangzhou, Guangdong Province
+86 20-87369002/9003/9001
6东北认证有限公司
Northeast Audit CO., LTD.(NAC)
沈阳市沈河区文艺路21-1号
No. 21-1, Wenyi Road, Shenhe District, Shenyang, Liaoning
+86 24-83961668
7杭州万泰认证有限公司
HANGZHOU WIT ASSESSMENT CO LTD
杭州市滨江区江虹路1750号信雅达国际创意中心1幢1301-1308、1401-1402、1405-1408室
13-14 Floor, Sunyard International, No.1750 Jianghong Road, Binjiang District, Hangzhou, China
+86 571-87901296,
87711527
8北京新世纪检验认证股份有限公司
Beijing New Century Inspection & Certification Co., Ltd. (BCC)
北京市西城区国英园1号楼11层1101室
11/Fl, Guoying Yihao, Nanxiaojie, Xizhimen’nei, Xicheng District, Beijing
+86 10-58561802
9北京中大华远认证中心
Beijing Zhongda Huayuan Certification Center (ZDHY)
北京市东城区阜外大街乙22号415室
B22, Fuwai Street, West District, Beijing
+86 10-68396633,
68396647
10华夏认证中心有限公司
China Certification Center
北京市海淀区卧虎桥甲六号
No.6 Wohuqiao, Haidian District, Beijing
+86 10-62335102
11深圳市环通认证中心有限公司
Universal Certification Centre Co., Ltd. (UCC )
广东省深圳市福田区侨香路裕和大厦六层全层
6TH FLOOR, Yuhe Building, Qiaoxiang Road, Futian District, Shenzhen
+86 755-83355888
12北京中安质环认证中心
ZhongAn Authentication Center
北京市朝阳区东三环南路58号富顿中心1号楼22层
Fulton Center, No.58, East Sanhuan Road, Chaoyang District, Beijing
+86 10-58673519; 18311490788
12兴原认证中心有限公司
Xingyuan Quality Certification Center (XQCC)
北京市海淀区上地三街9号金隅嘉华大厦C座711室
Room 711, Building C, Jinyu Jiahua Plaza, No. 9, Shangdi San Avenue, Handian District, Beijing
+86 10-62981683,
62981193
13北京世标认证中心有限公司
World Standards For Certification Center (WSF)
北京市海淀区德胜门西大街15号远洋风景家园8栋2单元701、702室
Room 701 and 702, Unit 2, Building 8, Yuanyangfengjing, No.15, Deshengmen West Avenue, Haidian District, Beijing
+86 10-82291199
14北京埃尔维质量认证中心
Ever Win Quality Certification Center (EWC)
北京市西城区车公庄大街甲4号物华大厦A1007室
Room A1007, Wuhua Plaza, Chegongzhuang Avenue, Xicheng District, Beijing
+86 10-68001010
15北京大陆航星质量认证中心股份有限公司
Beijing Daluhangxing Quality Certification Center Co., Ltd. (HXQC)
北京市海淀区玉泉路甲12号七层
7/F, No.jia 12 Yuquan Road, Haidian District, Beijing
+86 10-88266093
16上海挪亚检测认证集团有限公司
NOA Test & Certification (NOA)
中国(上海)自由贸易试验区锦绣东路2777弄26号3层
Building 26 No.2777 East Jinxiu Road, China(Shanghai)Pilot Free Trade Zone, Shanghai
+86 21-50430897
17北京恩格威认证中心有限公司
Beijing NGV Certification Center (NGV)
北京市东城区建国门内大街7号701
Room 701, No.7, Jianguomen Inner Street, Dongcheng District, Beijing
+86 10-64802303-08
18凯新认证(北京)有限公司
Kaixin Certification (Beijing) Co.,Ltd (KCB)
北京东城区新中西街2号新中大厦7层706室
Room 706, Xinzhong Building, Xinzhong West Street, Dongcheng District, Beijing
+86 10-65535910/1/2/3
19福建东南标准认证中心
Southeast Standard Certification Center (SEC)
福州市鼓楼区西门外山头角121号
No.121, Ximenwaishantoujiao, Gulou District, Fuzhou, Fujian Province
+86 591-83762036,83732144
20中环联合(北京)认证中心有限公司
China Environmental United Certification Center Co., Ltd
北京市朝阳区育慧南路1号
No. 1 Yuhuinanlu, Chaoyang District, Beijing
+86 10-59205880
21山东世通质量认证有限公司
Seatone Certification
青岛市竹园路2号
No.2 Zhuyuan Road, Qingdao, Shandong
+86 532-85730069
22北京东方纵横认证中心有限公司
Beijing East Allreach Certification Center Co., Ltd( EACC )
北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街17号121号楼一层
Building 121 Floor 1, Nov. 17, Jingsheng South four Avenue, Jinqiao Technology Industry Base, Tongzhou Park of the Zhongguancun Technology Park, Tongzhou district, Beijing
+86 10-56495881
23北京五洲恒通认证有限公司
Beijing Continental Hengtong Certification Co.,ltd( CHTC )
北京市丰台区角门18号枫竹苑二区1号楼3层303室
Room 303,Mingliuweilai Mansion, No.18 in Jiaomen, Fengtai District, Beijing, China
+86 10-63180681
24上海英格尔认证有限公司
ICAS Certification Center
上海市徐汇区中山西路2368号华鼎大厦801室
Huading Tower, No.2368,West Zhongshan Rd.,Xuhui District, Shanghai
+86 21-51114700,54253540
25北京五岳华夏管理技术中心
Beijing WuYue HuaXia Management & Technique Center (CHC)
北京市宣武区广安门南滨河路23号立恒大厦1号楼502室
Room 502, No. 1 Building, Lihengmingyuan, No.23, South Binhe Road, Guanganmen, Xicheng District, Beijing
+86 10-63310558
26南京国环有机产品认证中心
Organic Food Development and Certification Center of China (OFDC)
南京市玄武区蒋王庙8号
8 Jiang-Wang-Miao Street, Nanjing
+86 25-85287233/85287118
27北京华测食农认证服务有限公司
Beijing CTI Food and Agriculture Certification Service Co., Ltd.
北京市朝阳区东三环北路30号(住宅)楼2-11A
No. 2-11A, No. 30 North Road of East 3rd Ring Road, Chaoyang District, Beijing
+86 10-85967093
28华中国际认证检验集团有限公司
Huazhong International Certification Inspection Group Co., Ltd.
江西省南昌市西湖区站前路96号天集大厦2206室
Room 2206, Tianji Plaza, No. 96, Zhanqian Road, Xihu District, Nanchang, Jiangxi
+86 791-86121595
29山东国鉴认证有限公司
Shandong Guojian Certification Co., Ltd.
山东省济南市市中区舜耕路217号九城尚都办公楼801室
Room 801, Jiuchengshangdu, No.217, Shungeng Road, Shizhong District, Jinan, Shandong Province
+86 531-67618299
30通标标准技术服务有限公司
SGS-CSTC Standards Technical Services Co., Ltd.
北京市海淀区阜城路73号世纪裕惠大厦16层
16F Century YuHui Mansion, No. 73 Fucheng Road, Beijing
+86 10-68456699
31上海天祥质量技术服务有限公司
Intertek Testing Services Ltd., Shanghai
上海市徐汇区宜山路889号齐来工业城2号楼6楼
6/F., Building 2, Comalong Industrial Park, No.889, Yishan Road, Shanghai
+86 21-61194005
32劳氏质量认证(上海)有限公司
Lloyd's Register Quality Assurance -LRQA
上海市黄浦区延安东路550号海洋大厦2017-18、2001-02室
Ocean Masion, No.550 Yanan East Road, Shanghai
+86 21-51585700
33上海挪华威认证有限公司
DNV
上海市虹口区虹桥路1591号9号楼
BLD No.9, No.1591 Hongqiao Road, Hongqiao District, Shanghai
+86 21-32084518

 

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