On June 18, 2025, the Chemical Substances Administration (TCSA) under Taiwan’s Ministry of Environment held an online briefing on the Preparation and Submission Methods for Hazard and Exposure Assessment Data for Standard Registration of Existing Chemical Substances. The briefing provided relevant explanations regarding the completion deadlines for Items 8 and 9 hazard and exposure assessment data (i.e., risk assessment reports) for designated priority chemical substances (PEC substances) under standard registration, the confirmation method for hazard assessment report examples, the data items and methods to be submitted for each registration category, etc. This officially initiated the submission of hazard and exposure assessment information for 106 existing chemical substances within designated deadlines.
According to the relevant provisions of the Regulations on the Registration of New and Existing Chemical Substances Data (hereinafter referred to as the Registration Regulations), enterprises carrying out standard registration for the first batch of 106 PEC substances within the designated period only need to complete the data requirements for Items 1-7. Upon approval by the competent authority, they will be issued an Existing Chemical Substance Standard Registration Completion Code. Subsequently, registrants shall complete the Item 8 and Item 9 risk assessment report data within the period specified by the competent authority.
After evaluating factors such as the substance's hazard characteristics, annual manufacturing and import volume, exposure scenarios, and data completeness, the competent authority of Taiwan Region has selected 4 PEC substances, requiring registrants to complete the submission of Item 8 and Item 9 data. These 4 substances include: 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).The competent authority of Taiwan Region will provide hazard assessment report examples for the relevant substances (expected to be published in July this year). If registrants agree with the example, they do not need to complete Item 8 registration; they only need to review and update the content of Items 1 and 2 based on the actual situation and prepare the exposure scenario information for Item 9. If they disagree, they can refer to the example and complete Item 8 hazard assessment themselves and prepare Item 9 exposure assessment data for registration. Relevant registrants (expected to be notified via official document and system in July) need to confirm the hazard assessment report examples for the aforementioned substances by the end of 2025 and complete the registration of hazard and exposure assessment data by the end of 2026 (specific methods and planning see Figures 1 and 2).
Figure 1 Designated Deadline Registration Method (Source: Taiwan Region Competent Authority Briefing)
Figure 2 Designated Deadline Registration Schedule Plan (Source: Taiwan Region Competent Authority Briefing
The briefing also explained the registration subjects and submission methods. For individual registration and the lead registrant/members of joint registration, the items and requirements that should be completed when submitting Items 8 and 9 data are shown in Figure 3. For individual and joint registration scenarios, upon submission, one can choose to supplement data online or complete the registration via official document + email attachment using these two forms (Figure 4).
#1. Notification and submission of a hazard assessment report are required only if there is disagreement on using the sample to complete the hazard assessment registration.
#2. In the registration tool (v3.0), it is possible to check the declaration stating: All substances imported by our company are only stored, transported, and sold, with no opening or mixing activities during the process.
Figure 3 Designated Deadline Registration Types and Items to be Completed (Source: Taiwan Region Competent Authority Briefing)
Figure 4 Common Scenarios for Individual and Joint Registration (Source: Taiwan Region Competent Authority Briefing)
For other designated substances not mentioned in this meeting (besides the above 4 substances), the competent authority has not yet specified a deadline; registrants can still proactively complete the registration and must fully submit all hazard and exposure assessment data items (including exposure estimation and risk characterization).
The competent authority will subsequently hold another briefing to supplement information on issues such as the preparation methods and key content for hazard assessment report examples, suggestions for preparing exposure scenario data, and data submission methods. Meanwhile, the competent authority of Taiwan Region indicated that the second batch PEC substance list is also under planning.
The Chemical Registration Technical Team of CIRS Group in Taiwan Region will continue to track and study the progress of Taiwan Region's chemical registration regulations and provide professional regulatory interpretation and compliance advice to enterprises concerned about Taiwan Region's chemical substance management policies. Please pay attention to the news and meeting notices released by CIRS Group.
If you wish to further understand the details, please contact CIRS Group.
