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Breaking News: China Publishes Long-Awaited Food Safety Law Implementation Regulation

On October 31, 2019, China's State Council published the Regulation on the Implementation of the Food Safety Law  ("Regulation"). [1] The new Regulation contains 10 chapters and 86 articles, outlining detailed rules for food surveillance and assessment, food safety standards, food inspection, food import and export, etc. The Regulation will become effective on December 1, 2019.

Compared with the 2017 draft for comment, see Keller and Heckman's China Regulatory Matters newsletter available here, some of the notable changes are as follows:

  • A food manufacturer or operator may start following a new food safety standard before its date of effectiveness.

  • The food sales and catering services license is now the food operation license, and its period of validation is now five years in order to be consistent with the current food operation licensing regulation. [2]

  • The Regulation contains a definition for "recovered food" which includes food recalled or returned due to a violation of the law, but excludes food continued for sale after the labeling defects are corrected.

  • Prominent labeling is required for the production and operation of genetically modified foods by following the labeling rules promulgated by SAMR and MARA.[3]

  • In addition to the person in charge and some others from the company, the legal representative of a company also will be fined for a company's food safety violations or even fraudulent food advertising, and the fines are increased to up to 10 times the individual's income of the previous year for intentional or very serious illegal acts.

  • The State will reward the informants on food safety violations, especially whistle-blowers inside a company. At the same time, serious violators will be blacklisted and publicized.

The new Regulation qualifies and expands some of the requirements under the Food Safety Law and will serve as a critical food safety regulatory document in the coming years. The industry should be mindful of the requirements under the Regulation to avoid noncompliance that can often lead to disruption of business operations in China.

[1] See http://www.gov.cn/zhengce/content/2019-10/31/content_5447142.htm

[2] See Management Rules for Food Operation Licensing.

[3] SAMR: State Administration for Market Regulation; MARA: Ministry of Agriculture and Rural Affairs.  The GM food labeling rules jointly promulgated by SAMR and MARA are yet to be established; before that, the current Management Rules for the Labeling of Agricultural GMOs by MARA still should be followed.

© 2019 Keller and Heckman LLP

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About this Author

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

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...

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Jenny Li, Keller Heckman, China Food, Drug Regulation, Shanghai, International Trade
Legal Consultant

Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.

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Chen Hu , Keller Heckman, Scientist, Food Chemistry, Regulatory Compliance, Shanghai
Scientist

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...

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Eric Gu, Keller Heckman, China, Shanghai, Food packaging lawyer, Additives regulations Attorney
Associate

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...

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Hua Mary Liu Food & Chemical Scientist Keller Heckman
Scientist

 

Mary Liu is a staff scientist with an expertise in microbiology. She provides technical guidance to the firm’s attorneys on regulatory issues in the area of food, food packaging, cosmetics, pesticides and chemicals across the Asia-Pacific region.  Ms. Liu’s academic background is in microbiology, specifically in food technology and research specialization.  Prior to joining Keller and Heckman, Ms. Liu was a regulatory affairs professional in an American personal-care company. She also had worked for a consulting group where she assisted various clients with regulatory matters...

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