Jun. 23rd, 2025

Industrial Chemical

How to Prepare Hazard and Exposure Assessments for Taiwan's Standard Registration for Existing Chemicals

Introduction

On June 18, 2025, the Taiwan Region's Chemical Substance Management Agency conducted an online briefing. The registration of hazard and exposure assessment information for the first batch of 106 designated existing chemical substances requiring standard registration has officially commenced.

As per the announcement, most enterprises had fulfilled the data requirements outlined in Appendix 3 of the Registration Measures (Items 1 to 7) by the end of 2024. Subsequently, enterprises must either voluntarily or within the deadlines designated by the Central Competent Authority, register the data items specified in Appendix 4 (i.e., Item 8: Hazard Assessment and Item 9: Exposure Assessment).

During the briefing, four substances were designated, requiring the completion of hazard and exposure assessment information registration by the end of 2026. REACH24H reminds relevant enterprises to pay close attention.

What Are the Designated Substances?

The Chemical Substance Management Agency has selected four substances, based on a comprehensive evaluation of their hazard characteristics, exposure scenarios, and data completeness, for which hazard and exposure assessment data must be registered by the designated deadlines.

Substance nameCAS No.
Diantimony trioxide1309-64-4
Sulfuric acid7664-93-9
Toluene108-88-3
Zinc oxide1314-13-2

No deadlines have been specified at this stage for the remaining 102 substances; however, enterprises may opt for voluntary registration.

Hazard and Exposure Assessment Requirements

For hazard assessments, the authorities will provide assessment report templates for the four designated substances. Registrants may submit the official reports directly without additional preparation. If registrants choose not to adopt the official version, they must prepare their own assessment reports.

For exposure assessments, registrants must independently prepare assessment data, as actual exposure scenarios vary among them. At this stage, registrants may first submit basic information on exposure scenarios. If the authorities later determine that a substance or case poses high-risk concerns, they may request supplementary detailed exposure data or conduct on-site inspections. Registrants involved solely in storage, sales, or other activities without unsealing or mixing operations may declare no exposure scenarios and are exempt from submitting exposure assessments.

Operational Requirements and Deadlines

hazard and exposure assessment registration requirements and deadlines.png


Voluntary Registration

In addition to the four designated substances that must submit hazard and exposure assessments by the deadlines, other substances currently have no specified deadlines. However, enterprises may still voluntarily complete the registration.

Note that voluntary registration necessitates the complete submission of hazard and exposure assessment data. For the exposure assessment, in addition to exposure scenario information, it must also include exposure quantity estimation and risk characterization description. In cases involving joint registrants, they must notify their joint registrants to submit the exposure assessment.

Registration CategorySubmitted bySubmission method
Designated Deadline RegistrationThe original case submitter and the person who supplemented the information are the sameOnline Supplementary Information
The original case was submitted by the agent, and the registrant now needs to provide additional information

Official documents

+ E-mail

Voluntary Registration

/

Official documents

+ E-mail

Important Reminder from REACH24H

REACH24H reminds relevant enterprises: the official hazard assessment report templates are anticipated to be published in July. Enterprises should promptly download and review them on the registration platform.

The authorities will send a system notification containing a questionnaire. If enterprises disagree with the templates, they must respond to the questionnaire by December 31, 2025, and submit the hazard assessment data by December 31, 2026. If enterprises agree with the templates, no further action is required.

If you have any questions in this regard, please feel free to contact us at customer@reach24h.com.


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