News Details
Taiwan Amends New Chemical Substance Registration Regulations to Streamline Process and Avoid Duplicate Applications
On August 8, Taiwan’s Ministry of Labor officially amended several provisions of the Regulations on the Registration of New Chemical Substances, aiming to cut down on redundant procedures and make compliance easier for businesses.
Under the revised rules, if a new chemical substance has already been approved and registered with the Ministry of Environment under the Toxic and Concerned Chemical Substances Control Act (TCCSCA), manufacturers or importers no longer need to apply for a separate registration with the Ministry of Labor. This exemption applies because the data requirements for both systems are largely the same.
The legal text has also been updated to replace the outdated reference to the Toxic Chemical Substances Control Act with the current TCCSCA. Transitional provisions whose grace periods have already expired have been removed entirely.
Key changes and provisions:
Registration categories remain divided into standard, simplified, and small-quantity types, with classification based on annual manufacturing or import volume.
Standard registration requirements are tiered from Level 1 to Level 4, with corresponding data obligations, including substance identification, manufacturing/use/exposure information, hazard classification and labeling, safety measures, physicochemical properties, toxicological data, hazard assessment, and exposure assessment.
Simplified registration and small-quantity registration have reduced data requirements but still require key safety and hazard details.
Annual quantity thresholds are clearly set (e.g., under 100 kg = small quantity; 100 kg to 1 ton = simplified; over 1 ton = standard). Special provisions apply for scientific research, process R&D, site-limited intermediates, and polymers of low concern.
Low-concern polymers that have already been approved by the Ministry of Environment under the TCCSCA do not require additional documentation when applying for registration.
The Ministry of Labor emphasizes that this amendment aligns with the “one government” principle and establishes a joint review and single-window acceptance system with the Ministry of Environment. Under this arrangement, the Ministry of Environment accepts all applications, coordinates joint reviews, consolidates feedback, and issues registration codes.
Impact on Industry:
The changes reduce administrative burden by duplicate dossiers for both agencies, saving significant time and resources. Companies are encouraged to ensure their submissions to the Ministry of Environment meet the full data requirements, as these will now be accepted by the Ministry of Labor without further review.
We acknowledge that the above information has been compiled from National Association of Small and Medium Enterprises R.O.C. .
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