On 8 August 2025, Taiwan’s Ministry of Labor (MOL) finalized amendments to the Regulations on New Chemical Substance Registration, simplifying the registration process for chemical substances.
Background
Taiwan’s Regulations on New Chemical Substance Registration were established under the Toxic and Concerned Chemical Substances Control Act (TCCSCA) to ensure safe management of chemicals manufactured or imported into the country. First promulgated in 2014, the regulations require companies to register new chemical substances before production or import, based on annual tonnage thresholds. Registrations are categorized as standard, simplified, or small quantity, with increasing data requirements depending on volume.
The system was designed to build a comprehensive chemical inventory and support risk assessment and regulatory control. It also includes exemptions for certain low-risk substances, such as naturally occurring materials, low-concern polymers, and chemicals used in research and development.
Latest Developments
Under the updated rules, substances already approved by the Ministry of Environment (MOENV) under the Toxic Chemicals and Concerned Substances Control Act (TCCSCA) no longer require separate registration with MOL. This alignment between MOL and MOENV systems reduces duplication and improves regulatory efficiency.
Key Highlights:
- Transitional provisions (Articles 11 and 12) have been removed, as they expired in 2015.
- Registration categories and tonnage thresholds remain unchanged.
- Clarifications have been added for exemptions covering low-concern polymers and substances used in research and development.
- MOENV now acts as the single point of contact for chemical registrations, providing application codes that enable a coordinated review by both MOENV and MOL.
This update marks a significant step toward streamlined chemical management in Taiwan, easing compliance for industry stakeholders.
Need Support?
H2 Compliance is here to help. Our team of regulatory experts can guide you through the updated requirements within Taiwan and answer any queries that you may have.
Published October 14th, 2025
Article and image were generated with the assistance of Artificial Intelligence.