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On September 19, 2022, Taiwan’s Toxic and Chemical Substances Bureau (TCSB) made public two draft guidance documents1 to help chemical enterprises smoothly comply with registration obligations under the Regulation on New and Existing Chemical Substances Registration (a.k.a. Taiwan REACH).
Guidance for New and Existing Chemical Substances Phase 1 Registration (Draft)2
Compared with the first version issued in 2015, the proposed amendments are mainly changes to the wording, which has no impact on registration application in practice. This draft guidance details the Phase 1 registration process and mainly covers the following content:
- Legal framework and applicable scope.
- Registration types, procedures, and data requirements.
- Registration tools, forms, and platform.
- Provisions related to the review, management and information disclosure after registration application.
Guidance for Dossier Preparation of Hazard and Exposure Assessment of Chemical Substances (Draft)3
To facilitate the preparation of hazard and exposure assessment report for standard registration, the authority drafted this new guidance with reference to the Part B : Hazard Assessment and Part D : Framework for Exposure Assessment of the EU Guidance on Information Requirements and Chemical Safety Assessment4. This draft guidance mainly covers the following content:
- Basic concepts of hazard and exposure assessment.
- Hazard assessment methods for physicochemical properties, human health hazards, environmental hazards, PBT (persistent, bioaccumulative and toxic), etc.
- Exposure assessment methods and tools for occupational and environmental exposures.
Besides, ChemLinked learnt from the authority that technical guidance documents regarding non-testing methods (QSAR, grouping of substances and read-across approach, etc.) are under preparation to keep pace with the global trend in promoting non-testing methods. They are expected to come out soon.
