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China Announces Transition Document for Amended New Chemical Regulation

On October 27, 2020, China's Ministry of Ecology and Environment (MEE) published the Announcement on the Transitional Issues of Environmental Management Registration for New Chemical Substances (hereinafter "the Transition Document").[1] It aims to establish a harmonized transition from the current MEP Order 7 to the coming MEE Order 12, which will become effective on January 1, 2021.[2] More details of MEE Order 12 can be found in our previous CRM newsletter- Breaking News: China Publishes Amended New Chemical Regulation.

Different from the draft version published in early June, the Transition Document specifies that new chemical notifications filed under MEP Order 7 by December 31, 2020, will continue to be reviewed by MEE until June 30, 2021. However, if the registration certificates are not issued by this date, the notifiers must re-submit the dossiers pursuant to MEE Order 12. Therefore, those who are preparing notifications per the requirements under MEP Order 7 should make efforts to submit the dossiers by December 31, 2020.

The Transition Document also elaborates on various issues related to new chemical substances registered under MEP Order 7. For example, the registration certificate holders for Regular Notifications must pass relevant information to downstream customers, keep records, submit a report for the first activity, and report new hazard information to MEE per the provisions of MEE Order 12. Other details suggest some requirements will be loosened. For example, annual reports are only required for hazardous chemicals that are subject to high-priority environmental management. For Simplified Notifications, annual reports are no longer needed, and the registration certificate holders are only required to keep records and report new hazard information to the Chinese authority in accordance with MEE Order 12.

Xusheng Zhang contributed to this article. 

© 2021 Keller and Heckman LLPNational Law Review, Volume X, Number 308



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...

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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.

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...

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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...

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Yin Dai, Keller Heckman, Multi national Food Companies Regulation, Paralegal, Shanghai, China,

Yin Dai joined Keller and Heckman in 2013.  She is a paralegal in the food and drug practice area. She monitors developments impacting the regulations of food, food packaging, drugs and medical devices throughout Asia.  Ms. Dai assists multi-national food and chemical companies in product stewardship and compliance matters, especially in China, Japan, Korea, Thailand, and other ASEAN countries.  She also participates in the clearance for new food related materials in China and other Asian countries.

Prior to joining Keller and Heckman, Ms. Dai...

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