The chemical management system in Taiwan has been subject to significant changes in recent years. Taiwan implemented a registration scheme requiring manufacturers and importers to register new and existing substances prior to entering Taiwan’s market at the end of 2014. Administrative work designed to aid efficient registration was successfully carried out with the issuance and update of supporting documents and registration tools. In addition, Taiwan has completed the phase in of GHS labeling requirements. All chemicals classified under physical hazards, health hazards and/or environment hazards in accordance with the CNS 15030 series standards are subject to GHS compliance.
1. New Chemical
For Taiwan new chemical substance registration, separate regulations under TCSCA and OSHA should be complied with, namely the Regulation on Registration of New and Existing Chemical Substances under TCSCA (EPA’s regulation, effective on 11 Dec 2014) and the Regulation of New Chemical Substances Registration under OSHA (MoL’s regulation, effective on 1 Jan 2015).
Considering the regulatory compliance burdens on potential registrants, Taiwan’s EPA and MoL cooperated and established a single system for the implementation of new chemical registration.
2. Existing Chemical
Taiwan Existing Chemical Substance Inventory (TCSI) is accessible on CSNN website. The existing chemical registration is regulated under Taiwan TCSCA. Taiwan launched its existing chemical substance Phase 1 registration on September 1, 2015. All existing chemical substance manufactured or imported over 0.1 ton per year are subject to Pre-registration before31 Mar 2016. As of April 1st, the late pre-registration of existing chemical substances has been opened.
3. Toxic Chemical under Taiwan TCSCA
Taiwan's toxic chemical substances are classified into Class 1 to Class 4. Handling of toxic chemical substances is contingent on prior notification of the EPA in accordance with the Permit, Registration and Approval Regulations for Toxic Chemical Substances, which is a supporting document for Taiwan TCSCA.
4. Priority Management Chemicals under Taiwan OHSA
Manufacturers, importers, suppliers, or employers are required to report relevant handling information for priority management chemicals to the central competent authority. The Regulation Governing Designation and Handling of Priority Management Chemicals is formulated to specify the designation of priority management chemicals, handling information submission and other application matters.
5. Controlled Chemicals under Taiwan OSHA
Priority management chemicals that are evaluated by the central competent authority and considered as posing excessive exposure risks are further designated as Taiwan’s controlled chemicals. Manufacturers, importers, suppliers, or employers shall not handle the controlled chemicals without operation permission obtained from the authority. The Regulation on Designation and Operation Permission of Controlled Chemicals is formulated to specify the designation of controlled chemicals, conditions of permission, validity, termination or revocation of permission, handling information submission and other application matters.
6. Hazardous Chemicals under Taiwan GHS
The CNS 15030 serial standards were initiated in 2006 based on the 1st revised edition of GHS and revised in 2008 to adopt GHS Rev.2. In 2015, Taiwan finalized updates to 11 of the 28 CNS 15030 serial standards and published the new volume for "hazardous to the ozone layer", which are all aligned with UN GHS Rev.4.
Taiwan has completed three stages of GHS implementation in 2008, 2011 and 2014 covering 3,171 hazardous substances designated by the CLA. Other hazardous chemicals besides the 3,171 substances should also follow the Regulation of Labeling and Hazard Communication of Hazardous Chemicals to comply with Taiwan GHS since 1 Jan 2016. A one year grace period was granted meaning full compliance is actually due by 31 Dec 2016.
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