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.

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.