On August 5, 2025, the Ministry of Environment in China’s Taiwan region announced hazard assessment templates for four Priority Existing Chemical (PEC) substances, including antimony trioxide (CAS No. 1309-64-4), sulfuric acid (CAS No. 7664-93-9), toluene (CAS No. 108-88-3), zinc oxide (CAS No. 1314-13-2)]. These PEC substances are widely used across the region. According to regulations, enterprises that have applied for Standard Registration Levels 2 to 4 for the aforementioned four PEC substances and have obtained Standard Registration Completion Codes shall submit information related to Hazard and Exposure Assessment for PEC substances to the competent authority by December 31, 2026.
Regarding Hazard Assessment Information: To assist enterprises in achieving registration compliance, the competent authority of the Taiwan region has provided hazard assessment report templates for the four PEC substances. Enterprises may access reference documents in the download section of the official website of the Ministry. If registrants accept and adopt the content of the hazard assessment report templates, they need not submit this information again. If registrants disagree with the content of the hazard assessment report templates and decide to independently prepare and submit hazard assessment information, they must first fill out a confirmation survey form by December 31, 2025, and submit self-prepared hazard assessment reports by December 31, 2026.
Regarding Exposure Assessment Information: All enterprises shall update or supplement original registration data related to exposure assessment items (i.e., Section 2: Substance Manufacture, Uses, and Exposure Information) before the deadline. Enterprises engaged in actual or anticipated manufacturing, formulation, or use activities shall simultaneously submit exposure scenario information (i.e., Annex 4 Item 2.1 of the Registration Measures, or Section 9.1 Exposure Scenario Description in registration tools). According to the announcement, other exposure assessment information (exposure quantity estimation, risk characterization) is temporarily not required at this stage.
Subsequently, the competent authority will issue official letters designating relevant registrants to submit hazard and exposure assessment information. It will also notify relevant registrants of submission deadlines through the system and organize explanatory meetings. The competent authority stated this initiative aims to strengthen chemical substance management. Relevant enterprises should note the timeline and operate compliantly to avoid penalties for overdue submissions. Detailed announcements and hazard assessment templates can be accessed at the Chemical Substances Management Agency of the Ministry of Environment.
CIRS Group's Taiwan chemical registration technical team will continue tracking and researching developments in Taiwan's chemical registration regulations. We provide professional regulatory interpretation and compliance advice to enterprises concerned with chemical substance management policies in the Taiwan region. If you wish to understand details further, please contact CIRS Group.
