Taiwan requires hazard and exposure data for carbon black, MDI and silicon carbide

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Companies adopting official sample reports are exempt from preparing assessments

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Taiwan's Ministry of Environment (MOENV) has asked registrants of three widely used priority existing chemicals (PECs) to file hazard and exposure assessment information by 31 December 2027.

The three PECs, carbon black, 4,4'-methylene diphenyl diisocyanate (MDI) and silicon carbide, are among the 106 PECs designated for standard registration under Taiwan's existing chemicals registration rules.

The requirement applies to companies whose registered tonnage bands fall within tiers 2 to 4 of standard registration and which have already obtained standard registration completion codes, the ministry's Chemicals Administration (CHA) said in an announcement on 18 August.

Under Article 18(2) of Taiwan's Regulations of New and Existing Chemical Substances Registration, registrants that have completed standard registration of existing substances must submit hazard and exposure assessment information – the data items listed in Appendix 4 of the regulations – either proactively or by a deadline set by the central competent authority.

Hazard assessment

CHA has published sample (model) hazard assessment reports for the three substances in the download section of its chemical substances registration platform. Registrants that adopt the model content in full will not need to submit their own hazard assessment information.

Companies intending to prepare their own reports must confirm this by completing an official survey form by 31 December this year, before submitting their self-prepared hazard assessment by 31 December 2027.

Exposure assessment

All relevant companies must update or supplement the exposure-related items in their original standard registration dossiers before the deadline – section two of Appendix 3, covering manufacturing and import information, lifecycle description, and exposure information.

Those with actual or anticipated manufacturing, formulation or use activities must additionally submit exposure-scenario information, namely item 2.1 under Appendix 4 of the regulations or section 9.1 of the registration tool.

Other exposure assessment elements, namely exposure estimation and risk characterisation, are not required at this stage.

CHA said it will issue letters to the affected registrants, and these companies have already been notified of submission deadlines and briefing sessions via email.

Reminder on earlier batch

Separately, the agency reminded registrants of four substances designated on 28 October 2025 – antimony trioxide, sulfuric acid, toluene, and zinc oxide – that their hazard and exposure assessment submissions are due by 31 December this year, urging them to complete the process promptly.

CHA has also revised the sample hazard assessment reports for the four substances, adopting more cautious and precise wording. Statements that a substance "does not have" a given hazard, such as acute toxicity or sensitisation, now read "currently no evidence showing" that hazard, so as not to imply the hazard's absence has been conclusively demonstrated. The updated sample reports are also available on the registration platform's download section.

Taiwan’s PEC programme

Taiwan regulates PECs under its new and existing chemicals registration system, also known as Taiwan REACH, which is governed by the Toxic and Concerned Chemical Substances Control Act (TCCSCA). The PECs programme is advancing along two tracks: follow-up assessment of already-registered substances and expansion of the PEC list itself.

Phase 1 registration

MOENV designated 106 existing substances as PECs, requiring standard registration by companies manufacturing or importing more than one tonne per year. More than 2,000 dossiers were submitted by the 31 December 2024 deadline. The ministry is consolidating the data and reviewing candidates for further action.

Follow-up hazard and exposure assessments of Phase 1 substances

Under Article 18 of the registration regulations, MOENV can go back to companies that have already completed standard registration and demand hazard and exposure assessment information. This is happening in batches:

  • batch one (October 2025) – antimony trioxide, sulfuric acid, toluene and zinc oxide – submissions due by 31 December this year; and
  • batch two (August 2026) – carbon black, MDI and silicon carbide – submissions due by 31 December 2027.

The ministry has previously said more PECs may be designated for additional hazard and exposure data filings on a rolling prioritisation basis, and that not all 106 substances will be subject to the requirement.

Phase 2 registration – in preparation

Separately, MOENV is expanding the PECs list, which would trigger fresh standard registration obligations:

The ministry plans to amend the registration regulations to formally incorporate the Phase 2 framework and substance list.