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Volume XII, Number 277


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CFDA Announces Draft Regulation to Implement China's New Food Safety Law (Part II)

In the last post, we examined the potential impact of the recently released draft Regulation on the Implementation of the Food Safety Law of the P.R.C. ("draft Regulation").1 Following up on our last post, we now shift our focus to the regulation of domestic food production and related operations under the amended draft Regulation.

Chapter IV of the draft Regulation details the obligations and responsibilities of food producers and operators throughout the commercial chain.2 The draft Regulation clarifies issues surrounding Food Production and Operation License (Chapter I); and details requirements for effective Production and Operation Control (Chapter II). The draft Regulation specifies the responsibilities of Restaurant Service providers (Chapter III). In addition, the Chinese authorities have provided greater details on the regulation of Edible Agricultural Products (Chapter IV).3  Furthermore, to ensure proper traceability of food products, the draft Regulation also requires food producers and operators to properly conduct Recordkeeping (Chapter V) across all phases of their business. We look at each of these issues in turn below.

I.   Food Production and Operation License

The Food Safety Law explicitly mandates a licensing regime for food production and operation activities, respectively (distinctions between these two licenses are explained in the following alert: China's Food Safety Law Takes Effect Today: Are You Ready?) The draft Regulation further clarifies whether certain more novel distribution models are subject to this licensing regime. For example, the draft would require a food operation license prior to engaging in food distribution via phone, conferences or seminars, whereas no such license is needed to distribute food at the place of production, provided the facility has an effective food production license in place.4

The draft Amendment specifically states that online food retailers must operate within the limits of their Chinese business license scope just as is the case for brick and mortar stores.5 For example, if the company's business license only permits marketing of confectionary products, the company would not be permitted to engage in online trading of alcoholic beverages. Notably, the draft Regulation also mandates that online retailers provide its URL and IP address to the local food and drug administrative department (which issues the business license) within 30 working days of obtaining network access.6

II.   Food Production and Operation Control

To ensure effective enforcement, the draft Regulation notes that the legal representative or chief responsible person at the company will bear full responsibility for food safety related issues.7 Such responsibility can be delegated to food safety management personnel only for certain designated aspects of the business (e.g., product entry/exit inspection, food recalls, etc.).8 Failure to establish adequate internal controls that result in a food safety incident may constitute a serious violation under the draft Regulation.9Food producers/operators can authorize a third-party organization to assist with mandatory food safety evaluations for the business.10 For example, food, food additives and food related products must be inspected to confirm compliance with pertinent national Food Safety Standards. However, such inspection and testing can be delegated to an accredited third party. Recalls of unsafe food are classified into the following three levels based upon the potential safety risk involved, with each level subject to a strict deadline to initiate and complete the recall:11

          (1)   Level I Recall: Foods have or may lead to serious health damage
          or death. Recalls are to be conducted within 24 hours.
          (2)   Level II Recall: Foods have led to or may lead to ordinary health
          damage. Recalls are to be conducted within 48 hours.
          (3)   Level III Recall: Foods with non-compliant labels or instructions involving no
           health damage. Recalls are to be conducted within 72 hours.

The draft Regulation also contains various provisions on "recycled food." This term is not defined in the draft Regulation, but should be interpreted (based on other regulations)12 to capture food recalled for safety reasons and potentially other foods. The draft requires that food businesses record and store recycled food products in clearly marked areas, and prohibits the use of recalled food additives to produce/process food additive products.13 Where food or food additives have been recalled, the company must dispose of the material in a timely manner and document the reason for the recall.

The draft Regulation also requires that companies establish a public information disclosure system with information on the company's production/operation license, food enterprise standard, risk classification symbol, inspection results, food recalls, etc.14 We expect the Government to provide more details in the future with regard to the disclosure method and scope of inspection results subject to this requirement.

The draft Regulation makes clear that food producers are responsible for ensuring compliance with the enterprise standard they notify to authorities.15 However, failure to comply with labeled enterprise standard can give rise to a corrective order or civil liability.16

III.   Restaurant Service

The draft Regulation proposes the establishment of a national Food Safety Standard governing the use of food additives in restaurant.17 The name, use level and scope of use for food additives in restaurants would become subject to mandatory public disclosure.18 In the current system, only restaurants which self-produce "hot pot" condiments, beverages or seasonings are required to make such disclosures (on the menu or shown prominently in the restaurant).19 Failure to publish such information can negatively impact the restaurant's record and subject it to more frequent government inspection and lower ranking under China's domestic restaurant management system.20 The restaurant service provider is still the responsible person for food safety risk even if it contracts a service company for cleaning and sterilization services.21

IV.   Edible Agricultural Products

As "Edible agricultural products" is a newly referenced term under the amended Food Safety Law,22and the draft Regulation provides guidance on how such products are regulated. Such products cannot be distributed via centralized trading market until compliance testing is carried out, except where other supporting documentation is readily available (e.g., certificate of place of origin, purchase record and certificate of conformance). For imported agricultural products, the certificate of inspection and quarantine must be provided.23Testing (per the corresponding food risk level) should be conducted regularly by the wholesaler or accredited third party testing entities. Contact information for the local agent along with other product information must be kept on file for at least 6 months.24 Companies selling unpacked agricultural products must prominently display product information (e.g., product name, place of origin, producer/distributor name).25

V.   Recordkeeping and Traceability

In addition to requiring that proper records be kept at all stages of food production and operation, the draft Regulation also specifies requirements particular to companies engaged in food storage and transportation,26 handling food additives,27 online food trading,28 as well as imported agricultural food. 29For example, online food retailers must store information on companies that distribute food, edible agricultural products and food additives on its platform.

"Food operation", per Article 2 of the Law, includes both food distribution and restaurant service.
Article 195, "edible agricultural food" is defined as "plants, animals, microorganism and their related products which are obtained during the agricultural activities of plantation, farming, picking-up, fishing, protected agricultural, biological engineering and so on, and formed after the preliminary processing procedures, like sorting, shelling, peeling, smashing, cleaning cutting, freezing, waxing, classification, packaging and so on, but their basic natural properties and chemistry nature is not changed." This would include fresh fruit sold by weight.
4       Article 33
5       Article 61
6       Article 62
7       Article 39
8       Article 40
9       Article 175 (2)
10      Article 42
11      Article 65
12    "Recycled food" is defined in Notice 619 of 2006 by the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). See Notice on Strict Prohibition on Using Recycled Food as Raw Materials for Production in Food Production and Processing (《关于严禁在食品生产加工中使用回收食品作为生产原料等有关问题的通知》(国质检食监〔2006〕619号)), available at http://www.sda.gov.cn/WS01/CL1601/91953.html. The AQSIQ notice describes four scenarios that would be classified as "recycled food", including not only recalled foods, recollected food, food returned by downstream distributors, as well as food detained/confiscated by the authorities.
13    Article 32
14    Article 44
15   Article 30; some local governments have issued guidelines for the notification of enterprise standards. For example, Notice on the Publication of Provisions on the Notification of Food Safety Enterprise Standards of Shanghai (Provisional), http://www.wsjsw.gov.cn/wsj/n429/n432/n2354/n2362/u1ai134129.html
16    Article 179
17    Article 27, see also国家食药总局召开餐饮服务环节使用食品添加剂座谈会, available at http://www.ccas.com.cn/Article/HTML/107422.html
18    Article 53
19    Article 42, Operating Procedure for Food Safety in Restaurant Service (《餐饮服务食品安全操作规范》), China Food and Drug Administration (CFDA), http://www.sda.gov.cn/WS01/CL0851/65144.html
20    Article 10 and 11, Notice on Printing the Administrative Provisions for the Credit Information of Food Safety Supervision of Restaurant Service Unit (《餐饮服务单位食品安全监管信用信息管理办法》), http://www.sda.gov.cn/WS01/CL0851/67813.html
21    Article 58
22    According to Article 2 of the Law, the safety and quality management of edible agricultural products shall still follow the Agricultural Product Quality Safety Law of the People's Republic of China.
23    Article 71
24    Article 73
25    Article 72
26    Article 52
27    Article 59
28    Article 64
29    Article 73

© 2022 Keller and Heckman LLPNational Law Review, Volume VI, Number 27

About this Author

David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

86 21-6335-1000
Chen Hu , Keller Heckman, Scientist, Food Chemistry, Regulatory Compliance, Shanghai

Chen Hu joined Keller and Heckman in April 2009. He provides technical assistance in the area of food, food packaging, and chemical control, in matters related to regulatory compliance in Asian-Pacific regions.

Mr. Hu works closely with government authorities and trade associations in various phases of regulatory development. Mr. Hu has prepared and submitted hundreds of Chinese applications for registration of food packaging materials, food additives, new food ingredients, and new chemical substances. He is experienced in auditing plant...

86 21 6335 1000
Eric Gu, Keller Heckman, China, Shanghai, Food packaging lawyer, Additives regulations Attorney

Eric Gu advises domestic and foreign clients on the requirements and regulations for a variety of consumer products, including foods, food additives, food packaging materials, drugs, cosmetics, medical devices, and associated labeling, with a focus on China, Japan, Korea, Thailand, and other Asian countries.

Prior to joining Keller and Heckman, Mr. Gu worked as an attorney in law firms in Shanghai and New York and acquired deep understanding of both China and U.S. laws and practice. While attending the University of Wisconsin Law School, Mr. Gu...

86 21 6335 1000
Mark Thompson Business & Trade Attorney Keller Heckman

Mark Thompson advises a wide array of businesses and trade associations on global compliance requirements applicable to finished foods, food additives, food packaging materials, cosmetics, industrial chemicals, and associated labeling in Asia, the U.S., and the European Union. Mr. Thompson also has significant experience relating to the regulation of drugs and genetically modified organisms (GMO) in Asia. From 2009 through 2016, Mr. Thompson was based in Keller and Heckman’s Shanghai Representative office. During that time, he assisted foreign and domestic companies in evaluating and...