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On March 24, 2023, the Toxic and Chemical Substances Bureau (TCSB) under Taiwan EPA released the Guidance on Chemical Substances Hazard and Exposure Assessment (Ver. 1) (hereinafter referred to as the Guidance) and a tool for chemical hazard assessment.
Compared with the draft issued in September 2022, the final version elaborates in more detail the hazard assessment information (item 8) and exposure assessment information (item 9) required in the standard registration of new and existing chemical substances (Level 2~4), and the principles and methods in preparing the hazard and exposure assessment report.
The Guidance consists of eight chapters and appendices:
Registration regulation (Chapter 1)
Basic concepts of hazard and exposure assessment and Terms and definitions (Chapter 2)
Hazard assessment methods for physicochemical properties, human health hazards, environmental hazards, PBT (persistent, bioaccumulative and toxic), etc. (Chapter 3~6)
Exposure assessment methods and tools for occupational and environmental exposures (Chapter 7~8)
Process categories (PROC) and environmental release categories (ERC), templates for hazard and exposure assessment (Appendices)
The Guidance is formulated referring to the EU Guidance on Information Requirements and Chemical Safety Assessment. The TCSB has reorganized the data requirements and exemption principles to clarify logic.
If the hazard and exposure assessment report has already been prepared with reference to other assessment methods or parameters before the introduction of this Guidance, the reference source and applicability must be stated. If it is reasonable after official review, it will not be required to update the report in accordance with this newly issued Guidance, but it will still be required to update the exposure assessment information based on actual or expected exposure scenarios in Taiwan.
As for the tool, it is not mandatory to use, but developed by the authority to assist in simple hazard confirmation and assessment of dose effects on human health and the environment based on the GHS classification standards - CNS 15030 series standards. With the built-in calculation formula and preset parameters, the registrant can complete the dose-response assessment by only inputting toxicological and eco-toxicological information and a small amount of exposure information. The final assessment document can be uploaded as an attachment for the application of chemical registration. A manual was released at the same time to assist registrants in using the tool.
In addition, the Guidance for New and Existing Chemical Substances Phase 1 Registration was updated and released. The amendments are mainly to the wording, which has no impact on registration application in practice.
