Taiwan Expects More Supporting Regulations for Toxic and Concerned Chemicals

Three regulations for management of toxic chemicals and concerned chemicals in Taiwan were revised and issued for public consultation (ending Oct 7th). Approval management of Class 4 toxic chemicals will be incorporated into the existing permit, registration and approval management system of Class 1 to Class 3 toxic chemicals. Monthly reporting of handling quantity will be required even if there is no change to the handling quantity or if the handling quantity is zero. Label elements can be provided either on fold-out labels, tie-on tags and outer packaging in accordance with Taiwan GHS.

The new Toxic and Chemical Substances of Concern Control Act^[1] (TCSCCA), previously known as the Toxic Chemical Substance Control Act (TCSCA) will be fully implemented on Jan 16th, 2020 (CL news^[2]). As planned more than 30 subordinate regulations will be revised or fleshed out to align with the updates in the Act this year. On Aug 8^th, 2019, Taiwan EPA issued the draft amendments of three administrative regulations^[3] for public comments lasting 60 days, including

Permit, Registration and Approval Regulations for Toxic Chemical Substances
Toxic Chemical Substances Handling and Release Quantity Recording Regulations
Toxic Chemical Substances Labeling and Safety Data Sheet Regulations

Since the new TCSCCA will regulate a new category called “substances of concern” (in addition to the current Class 1 to Class 4 toxic chemical substances) to cover substances which are not toxic but do pose environmental and health risks, all the relevant subordinated regulations will be renamed to cover the “substances of concern”. Stringent requirements will be imposed on the handling of substances of concern, e.g. approval in advance for designated handling activities, regular reporting of specific handling records, mandatory labelling and SDS requirements, etc., which are stipulated in the draft amendments of the above mentioned three administrative regulations. In addition, other main amendments are introduced as below.

As proposed the Approval Regulation for Class 4 Toxic Chemical Substances^[4] will be abolished. The current regulation on Class 4 toxic chemicals will remain the same and the requirements will be incorporated into the existing permit, registration and approval management system for Class 1 to Class 3 toxic chemicals. Meanwhile the application and approval procedure will be simplified to a large extent. The authority proposed to change the current “one substance one certificate” to “one company one certificate”.

The current regulations relating to the handling and release quantity recording of toxic chemicals exempt handlers from monthly reporting if there is no change to handling quantity or if the handling quantity is zero. However, this exemption will be deleted since the local authority found it is hard to differentiate between cases where the handler failed to file a report in time from cases where exemptions were applicable. The new requirement will add a significant compliance burden to industry.

In situations where the packaging of a substance or mixture is too small or in such a shape or form it is impossible to display the label elements in line with the requirements of Taiwan GHS, the labeling and SDS regulation proposed to follow EU requirements and allow label elements to be provided either on fold-out labels, tie-on tags and outer packaging. In addition, to ensure chemical hazard information is fully understood by foreign staff in Taiwan, a new provision will be added requiring labels and SDS use Chinese characters as standard, and foreign languages as a supplement if necessary. A one-year grace period will be offered for enterprises to update the labels and SDSs if the amendments are approved.

The new TCSCCA will entail broader control over chemicals. So far, Taiwan's toxic chemical substances list (TCSL) regulates 340 types of toxic chemical substances (click here^[5] to download the list). As estimated more than 5,000 stakeholders are currently involved in the handling of toxic chemicals. The number of enterprises affected could be greatly increased as the publication of more “substances of concern” is expected before Jan 2020.

Taiwan EPA is accelerating the legislative process of relevant regulations. Other recent updates of the supporting regulations of the TCSCCA include:

Revised Enforcement Rules of TCSCCA^[6] proposed in April
Revised Incentive Measures for Toxic and Concerned Chemical Substances Operators^[7] proposed in Feb and approved in Jul
New Regulations of Legal Aids for Whistleblowers Who Report Any Violation of Toxic and Concerned Chemical Substances Control Act^[8] drafted in Mar and approved in Jul