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Official publication of New and Existing Chemical Registration Regulation

On 11th March, Taiwan Environmental Protection Agency (EPA) published the New and Existing Chemical Registration Regulation. The following are the key points of the regulation:

  • 106 priority existing substances (listed in the Regulation) will be subject to Standard Registration from 1st January 2020 and the registration need to be completed within 2 or 3 years (depending on the conditions).
  • The Unified Window will be used by EPA and Ministry of Labour (MoL) for substance registration.
  • Submission of hazard and exposure assessment are required for new substance registration if the new substance is manufactured or imported at ≥10 tpa (previously this was ≥1000tpa).
  • Annual report will be mandatory from 2020 and should include registration number, registrant information and the manufacture/import volume from the previous year. A single report will be sent to EPA and MoL to reduce the industrial burden.
  • Phase 1 registration of existing chemicals must be submitted within 6 months from the day when the volume of importation or manufacture reach 100kg per year (previously this was 3 months).
  • Confidentiality protection of existing chemical substances and polymer of low concern (PLC) has been extended to 5 years.
  • Registration number will be provided to replace the registration certificate for chemical registration.

The EPA will provide more guidance and will host seminars to facilitate the implementation of the new regulation. The CHEMIST 4.0 was published by the authority to assist the registration process.

Official announcement and regulation can be downloaded (in Traditional Chinese) at

Yordas Group can support you at every stage towards successful notification in Taiwan, from providing up-to-date information and identifying your regulatory obligations, to substance characterisation, commissioning of testing, risk assessment and submission of notifications. We provide in-country representation through our network of local partners. For more information on how these latest regulatory updates may affect your business, call our expert team on +44 (0)1524 510278 or email

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