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Editor's Note: This article was originally published in March 2025 to analyze the draft amendments to the Regulations on New Chemical Substances Registration, and was updated on August 11, 2025 to introduce the finalized version.
On August 8, 2025, Taiwan’s Ministry of Labor (MOL) published the revised Regulations on New Chemical Substances Registration, with only some editorial changes compared to its proposed draft. It came into effect immediately.
Proposed draft in March 2025 For new chemical substance registration in Taiwan, compliance with both the Regulations of New and Existing Chemical Substances Registration （MoE’s regulation）and the Regulations on New Chemical Substances Registration (MoL’s regulation) is required. In response to the overlap between these regulations, MoL is set to revise its regulation. The draft revision is currently open for public consultation until May 5, 2025. At present, registration dossiers are submitted through a unified window, allowing both ministries jointly review the submissions. However, only the MoE issues registration codes, thus eliminating the need for separate approvals from both ministries. In light of this, Article 6 of the Regulations on New Chemical Substances Registration will be revised for clarification. In addition, since the original Toxic Chemical Substance Control Act (TCSCA), the overarching law for chemical registration administered by the MoE, has been renamed the Toxic and Concerned Chemical Substance Control Act (TCCSCA) in 2019, the proposed revision will reflect this change in the relevant articles. Furthermore, considering that the buffer period outlined in the regulation has expired and is no longer necessary, Articles 11 and 12 will be deleted. |
