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Taiwan Publishes New Chemical Control Law

Taiwan's Toxic Chemical Substances Control Act ("TCSCA") was first promulgated in 1986. It regulates toxic chemical substances and establishes a system for the registration of chemical substances. On December 21, 2018, Taiwan's legislature passed the latest amendment to TCSCA and renamed it the Toxic and Chemical Substances of Concern Control Act. The new Act was formally published on January 16, 2019.[1]

The new Act expanded the original five chapters and 44 articles to eight chapters and 75 articles. As its name suggests, the biggest change in the new Act is the addition of "chemical substances of concern,"

i.e., chemical substances other than toxic chemical substances determined by the authority as posing the risk of polluting the environment or endangering human health based on their characteristics or public concern. As a result, a new Chapter Three has been created to address the evaluation, prevention, and administration of chemical substances of concern.

The requirements for chemical substances registration are also revised accordingly. Like toxic chemical substances, if the authority determines that the characteristics of a new chemical substance may meet the definition for "chemical substances of concern," it must - at the time of granting registration - attach conditions requiring the manufacturer or importer to supply information on the hazards of the chemical substance, update the registration materials or regularly report the operations, and, if necessary, the authority may prohibit or restrict the operations.

Other significant changes include:

  • The manufacturer or importer must proactively maintain and update registered chemical substances information, and the government may demand additional information
  • A new chapter on "Accident Prevention and Emergency Response" has been created, requiring operators to submit hazard prevention and contingency plans to the government
  • The government will set up a fund, collecting chemical substances operating fees from the operators of certain chemical substances
  • Online purchase of toxic and chemical substances of concern is prohibited

Other than a few articles on the national chemical management meeting, report of violations, etc. that took effect on January 16, the majority of the new Act will become effective one year after its publication. Accordingly, the Environmental Protection Administration (EPA) of Taiwan will proceed with revising about 33 sub-regulations. 

The new Toxic and Chemical Substances of Concern Control Act significantly changes TCSCA and the regulation of chemicals in Taiwan. Interested parties should be mindful of this development and make sure that the chemical substances manufactured or imported in Taiwan fully comply with the more demanding requirements under the new Act.

© 2021 Keller and Heckman LLPNational Law Review, Volume IX, Number 23



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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Wilfred Feng, Keller Heckman, registration programs, herbicide development scientist, Consultant, Shanghai, China

Wilfred Feng joined Keller and Heckman in 2005.

Mr. Feng provides technical assistance to clients on regulatory issues focusing on food and drug regulation and chemical control laws in Asia, including food additives, food labeling, food packaging, dietary supplements, drugs, medical devices, cosmetics, pesticides, bioengineered products, and industry and specialty chemicals.

Mr. Feng has an extensive background in regulatory affairs, government affairs, marketing, and project management and has worked in several...

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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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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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