On January 15, 2020, Taiwan Environment Protection Administration (EPA) released the revised Permit Registration and Approval Regulations for Toxic and Concerned Chemical Substances [1], the name of which, before modification, was Permit Registration and Approval Regulations for Toxic Chemical Substances [2]. From the name, it can be seen that the revised regulations have included the management for the permission, registration, and approval of concerned chemical substances. Besides, the management for the approval of Class 4 toxic chemical substances has also been included in the revised Regulations. Therefore, the Approval Regulations for Class 4 Toxic Chemical Substances were repealed on the same day. The revision and repeal entered into effect simultaneously.
First of all, in general, the application procedures and conditions for the four classes of toxic chemicals and concerned chemicals are basically the same. It means that the Class 4 toxic chemical substances and concerned chemical substances will be subject to similar application requirements as Class 1-3 toxic chemical substances.
Next, the requirements for permit, registration, and approval have been updated in the revised Regulations. Provided that the operation sites are located in the same municipality, county or city, the manufacture permit or approval covers import, export, sale, usage, and storage permit, registration, and approval. In a similar way the import permit or approval could cover usage registration or approval, and the sale permit or approval could cover storage permit or approval.
The provisions involving permit modification and extension have been revised as well. According to the new Regulations, enterprises that were ordered to suspend production and business for two or more times or were issued with total fine that exceed the specified limit would have their application to extend the permit rejected. After revision, for the application to modify permit, registration, or approval, it shall be submitted within 20 days rather than 30 days after the related documents are approved. A change of the designated person in charge is still allowed to be submitted within 60 days.
At last, according to Article 16 in the new Regulations, the original "one substance, one document" certification method has been changed to "one document, multiple substances,” Authorities will now individually review the substances based on toxicity and hazards and then issue and merge permits, registrations, and approvals according to the operating place or operator. The change will eliminate the need for enterprises to repeatedly submit the basic information of the operator and the operating place, and the problem of inconsistent validity periods for different permits. These changes will significantly reduce the administrative burden of enterprises applying for permits and reduce unnecessary reviews by local environmental protection agencies.
There are four annexes attached in the Regulations, which stipulate the materials submission for Class 1-3 toxic chemical substances permit, Class 1-3 toxic chemical substances registration, toxic chemical substances, and hazardous concerned chemical substances approval, and low-hazard concerned chemical substances approval.
Recently, EPA also released the revised Toxic and Concerned Chemical Substance Accident Investigation Report Rules, Measures for the Review of the Application for Lifting the Restriction or Prohibition of Toxic Chemical Substances, Toxic and Concerned Chemical Substance Labeling and Safety Data Sheet Management Measures, and Management Measures for Toxic and Concerned Chemical Substance Response Equipment and Detection and Alarm Equipment, they are all supporting documents for the Toxic and Concerned Chemical Substances Control Act (TCCSCA) [3]. For more information, please visit the EPA website to collect the latest news, or you can explore on ChemLinked to learn more about Taiwan TCCSCA.


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