Speaking at the 15th Chemical Regulatory Annual Conference (CRAC) in Shanghai on November 16, 2023, Ms. Ni Ya-hui from the Environmental Resource & Information Co., Ltd. (ERI) shared the registration status and urges companies to prepare their registration dossier promptly to avoid delays.
Taiwan’s standard registration of 106 priority existing chemical substances (PECs) will end on December 31, 2024. According to Ms. Ni, approximately one-third of registrants have been successfully submitted their registrations dossiers, and around 40% are actively preparing for submission. However, about 20% of registrants are still hoping for another extension, despite the authority's repeated statements that no further extensions will be granted.
The standard registration of 106 PECs (≥ 1 t/y) in Taiwan commenced in 2020 and the deadline was extended due to the COVID-19 pandemic through the revision to the New and Existing Chemical Registration Regulation (CL news). Although the deadline has been postponed significantly, it should be noted that the final deadline is approaching by the end of next year.
Many registrants mistakenly believe that submitting dossiers before the deadline is sufficient, but in reality, obtaining the registration code by the deadline is necessary. This differs significantly from the EU REACH, as Taiwan requires each application to be reviewed and assigned a registration code upon approval.
Ms. Ni emphasized that while one year may seem sufficient for registration, the practical deadline is challenging. It is estimated that approximately 4,000 applications from around 1,500 companies will be submitted. To avoid delays and penalties, it is recommended to submit the dossier no later than the first half of 2024 and allocate at least six months for the official review and correction process.
The authority has made significant efforts to assist companies in fulfilling their registration obligations. As per the revised Regulation, registrants now only need to submit partial information (items 1-7) to obtain a registration code. The hazard and exposure assessment information (required for Band 2-4) can be submitted later within the allocated time. Diversified data, including test reports, literature reviews, QSAR, test plans, and international public database data, can be used for standard registration. The authority has prepared four guidance documents on the use of predictive toxicology data, including the QSAR ToolBox User Manual, Overview of Validation Methods of QSAR Model，Principles on Grouping of Chemicals, and Read-Across Assessment Framework. Additional instructional videos on QSAR and Read-Across are expected to be released by the end of this year.
Ms. Ni also provides information on the recent upgrade of Taiwan’s Environmental Protection Administration (EPA) to a full-scale Ministry of Environment. As part of this upgrade, the Toxic and Chemical Substances Bureau (TCSB) under the EPA transformed to the Chemical Substance Management Agency. This upgrade entails significant enhancements in terms of manpower and budget, enabling the authority to strengthen the implementation of various departmental tasks for chemical management.