Taiwan Announces Phase 2 Plan for Chemical Registration

By Xunyao Fu, PhD, Regulatory Affairs Lead, Supply Chain Team, UL Solutions

The Taiwan Ministry of Environment (MOENV) has unveiled its roadmap for the second phase of existing chemical substance registration under the Regulations of New and Existing Chemical Substances Registration, identifying twenty-eight substances for initial priority data collection and risk assessment. This initiative builds on the experience gained during Phase 1 and aims to strengthen chemical safety management while aligning with international practices.

For Phase 1, MOENV designated 106 existing chemical substances for standard registration since 2020, requiring data on basic uses, physicochemical properties, and toxicological characteristics. By 2024, over 2000 data files were submitted, enabling authorities to analyze hazards, international regulatory status, and domestic use patterns. These insights will inform future risk management measures, including possible inclusion in toxic or controlled substance lists.

Phase 2 introduces a more proactive and collaborative approach:

Priority List: MOENV has selected 28 substances for initial data collection and evaluation.

Not Final: This list is not the final set of substances requiring additional registration data.

Data Strategy: Authorities will first gather publicly available international hazard information, analyze gaps, and then request registrants to provide missing data—particularly exposure scenarios and use information.

Testing & Collaboration: Non-animal alternative testing methods and joint registration will be encouraged to reduce costs and duplication.

MOENV will amend the registration regulations to incorporate Phase 2 substances and requirements. Stakeholder consultations will be conducted as part of the legal process. Industry participants are invited to download the priority substance list from the Chemical Substance Registration Platform and submit feedback or hazard data via the online form provided.

References

MOENV announcement for launching Phase 2 plan for existing chemical substance registration (in traditional Chinese only)

Regulations of New and Existing Chemical Substances Registration