The Chemical Substance Management Agency of the Environmental Department in China's Taiwan region recently announced that it will launch the second phase of the existing chemical substance registration plan and provided relevant explanations regarding the priority substances for data collection and evaluation.
Review of the First Phase
To systematically consolidate data on existing chemical substances, in accordance with Article 16 of the New and Existing Chemical Substance Registration Regulations (hereinafter referred to as the Registration Regulations), the competent authority has designated the list of substances, tonnage bands, and deadlines for standard registration in phases. The first phase was launched in 2020, designating 106 existing chemical substances and requiring enterprises to submit relevant information, including basic uses, physicochemical properties, and toxicological data. During this period, the competent authority provided advisory services through a case-based guidance mechanism to assist enterprises in completing their registrations. Through collaborative efforts, the first batch of large-scale registration enterprises completed their data submissions by 2024, submitting over 2,000 documents in total.
The competent authority has integrated and analyzed the registration data. In addition to providing relevant information to respective industry regulatory authorities for management purposes, certain substances have been selected for inclusion in toxic and chemical substances of concern management based on their hazards, international regulatory trends, and usage in the Taiwan region. Alternatively, further submission of hazard and exposure assessment information may be required in accordance with Article 18 of the Registration Regulations.
Framework for the Second Phase
Drawing on the experience from the first phase and feedback from stakeholders, and incorporating local needs and international practices, the competent authority has optimized the implementation framework for the second phase.
Compared to the previous phase, substances in the second and subsequent phases will be screened in batches by the competent authority. Priority will be given to allocating resources to collect publicly available hazard information internationally. After inventory analysis, registrants will be required to supplement data gaps as necessary. The use of non-animal alternative testing methods will be encouraged, and joint registration will be promoted. Additionally, registrants will be specifically required to provide exposure scenarios and usage information to expedite risk assessment and facilitate timely management measures, such as case-specific use restrictions or regulatory listing. A public-private collaboration model will be adopted to jointly safeguard public health and environmental safety.
Implementation Progress and Next Steps
Based on the above framework (as shown in the diagram), the competent authority has preliminarily selected 28 existing chemical substances for priority data collection and evaluation in the second phase (the list is available on the Taiwan Region Chemical Substance Registration Platform). Efforts are currently underway to gradually collect and review detailed publicly available hazard information for these substances. Subsequently, the Registration Regulations will be amended to incorporate the second-phase framework, designated substances, and required data submissions. Stakeholder opinions will be sought in accordance with statutory procedures.
Diagram: Framework for Existing Chemical Substance Registration Screening and Management Planning (Source: Taiwan Region Chemical Substance Registration Platform)
