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China Is Drafting First E-Cigarette Standard

"Electronic cigarettes may soon become much more widely available in the world's largest tobacco market: The People's Republic of China. With over 300 million smokers, China has the world's largest smoking population - which directly results in approximately 1 million deaths annually." [1] While the global e-cigarette market has experienced rapid growth over the last decade, reduced-harm products have only recently started becoming popular domestically, despite the fact that the modern e-cigarette was invented in China, and the vast majority of e-cigarette devices exported around the world are manufactured in Shenzhen.

But times are changing, as the U.S. clamps down on the e-cigarette industry and requires robust premarket applications, China has taken a major step toward permitting the sale of regulated e-cigarettes by publishing a draft national standard (GB) on "electronic cigarettes." The Standard was notified to the World Trade Organization (WTO) on May 1, 2019.[2]

As its name suggests, the Standard applies to electronic cigarettes, referring to "a system consisting of electronic cigarette device and e-liquid that produce inhalable aerosol." Other novel tobacco products outside this definition are not captured by this Standard.

The comprehensive new Standard consists of the following seven chapters:

1. Scope
2. Reference standards
3. Terms and definitions 
4. Technical requirements
5. Testing methods
6. Packaging, labeling and instruction manual
7. Storage and transportation

The Standard also contains sixteen appendices, including those on the methods for the determination of various substances in the e-liquid, sample labels of e-cigarette device and e-liquid, etc. Particularly, Appendix B provides a positive list of 119 additives that are permitted for use in e-liquid. The use of non-listed additives will be subject to prior safety assessment, with considerations on the edible safety, inhalation safety, stability, addiction, etc. of a substance. We expect that more details about the safety assessment on non-listed substances will be provided in separate regulations. Certain additives also are explicitly prohibited from being used in e-liquid, such as substances purely for coloring purposes, carcinogenic, mutagenic, reproductive toxic and respiratory toxic substances, 2,3-butanedione, etc.

Other notable technical requirements under the draft Standard include:

For e-cigarette device:

§  Mechanic and physical performance, such as sealing, maximum surface temperature, etc.;

§  Electrical performance, such as input/output power, batteries, etc.; and

§  Chemical performance; for example, materials used for components in contact with the mouth or e-liquid must comply with the corresponding food packaging standards of China, such as GB 4806.7 on plastics articles, GB 9685 on food packaging additives, etc.

For e-liquid:

§  Purity and concentration limits for nicotine;

§  Requirements for base liquid, including glycerin, propylene glycol and water;

§  Limits for impurities and contaminants; and

§  Requirements for material in contact with e-liquid; they must comply with the corresponding food packaging standards.

For emissions:

§  Stability of aerosol and nicotine emissions; and

§  Limits for carbonyl compounds and heavy metals.

The new Chinese Standard on e-cigarettes will be published by the State Administration for Market Regulation (SAMR) and the Standardization Administration of China (SAC), but the agency responsible for drafting and maintaining the Standard is the State Tobacco Monopoly Administration. It is unclear when this Standard will be finalized and published; Chinese authorities may release the Standard later this year. Nevertheless, the new Standard will have a significant impact on the regulatory landscape of the manufacturing, sales and import of e-cigarette products in China. Industry should be mindful of its development and make sure that the e-cigarette products manufactured or imported in China entirely comply with the detailed requirements under the new Standard.


[1] See China Smoking Deaths Annually.

[2] See  China Draft National Standard for E-Cigarettes to WTO 

© 2019 Keller and Heckman LLP

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Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney
Partner

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...

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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 was located in Keller and Heckman's Brussels office where he counseled clients on global food packaging matters.

Mr. Ettinger is a member of the Firm's Marketing Committee. In addition, he is on the Executive Board of Mackrell International (a global network of over 75 international law firms), and is Chair of Mackrell International's Regulatory Practice Group.

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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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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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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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