List of Priority Existing Chemical Substances Subject to Standard Registration (PEC)

Published Date: 2019-03-11
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To gather information on existing chemical substances that are of high hazards, high exposure, or severely lacking in data, the Ministry of Environment in Taiwan shall designate priority existing chemical substances subject to standard registration (PEC substances) in stages, along with the tonnage bands and registration deadlines, in accordance with Article 16 of the Regulations for the Registration of New and Existing Chemical Substances (hereafter referred to as the Regulations). The first batch identified a total of 106 PEC substances, as specified in Appendix 9 of the Regulations. The standard registration for these substances commenced in 2020, with the initial registration period set at 2 to 3 years based on the volume at the time of Phase 1 registration application and the date of obtaining the Phase 1 registration code. However, this deadline has been extended to 5 years due to the COVID-19 pandemic.
Compliance Obligations
For substances listed in the first batch of the 106 PEC substances, those manufactured or imported in quantities of 1 ton or more per year must obtain a standard registration number by December 31, 2024. Substances reaching the 1-ton threshold for the first time after January 1, 2020, must complete standard registration within five years, starting from January 1 of the following year. According to Article 18 of the Regulations, registrants need only submit partial information to obtain a registration number for PEC standard registration. Hazard and exposure assessment information (required for Bands 2–4 standard registration) can be submitted proactively or by the due date determined by the authority.
The authority has prioritized four of the 106 PEC substances, setting a deadline of December 31, 2026, for the submission of their hazard and exposure assessments. The four designated substances are antimony trioxide (CAS No. 1309-64-4), sulfuric acid (CAS No. 7664-93-9), toluene (CAS No. 108-88-3), and zinc oxide (CAS No. 1314-13-2).
The substance is included in the inventory, but if the manufactured/imported volume does not reach 1 ton, no response is required.
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