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Taiwan Update Sep-Oct 2019

1. Taiwan’s EPA published a draft revision of TCCSCA implementation rules

On 9th September, the EPA published a draft revision of the Toxic and Concerned Chemical Substances Control Act (TCCSCA) implementation rules. The revisions are based on Article 41 of the new TCCSCA regarding the management of toxic substances. The consultation will end on 14th October and the regulations will take effect on 16th January 2020. The regulations under consultation are:

  • The permit registration and approval regulations;
  • The regulations on handling and release records;
  • The approval regulations for Class 4 substances; and
  • Labelling and safety data sheets (SDS) regulations.

According to the drafts, the local authorities will be able to issue combined permits or registration documents for each handler or factory. Instead of using a separate document for each substance, the new regulations enable the handlers/factories to use the combined permits to cover all the substances. The draft regulations also include the changes regarding online approvals, record-keeping, labelling and SDS rules.

EPA announcement: https://www.tcsb.gov.tw/cp-21-3650-9f703-1.html


2. EPA launched the Taiwan SIEF Platform

Standard registration of the 106 Priority Existing Chemical substances will start from 2020 and the EPA recently launched a SIEF-like platform for registrants to find co-registrants. Only companies with a Phase 1 registration can join the SIEF. Companies that are data holders but without Phase 1 registration are not allowed to join the platform.

Taiwan SIEF platform: http://tcscachemreg.eri.com.tw/Epareg/content/masterpage/Index.aspx

Application form for joint registration: http://tcscachemreg.eri.com.tw/Epareg/content/login/DownloadList.aspx?enc=25445B75E611AE6BB9D1A322FCCA1889478EF81882DBBAE4


3. EPA published Q&A for TCCSCA
On 28th August, EPA published common Questions and Answers on TCCSCA. The questions have been collected from industry after the publication of the new TCCSCA. The publication includes 420 questions and their official answers on:

  • The regulatory system
  • Registration (system, amendment, expiration etc)
  • Registration code
  • Joint registration platform
  • PEC registration and the implementing rules
  • Annual report
  • Others

TCCSCA Q&A: https://tcscachemreg.epa.gov.tw/Epareg/content/login/DownloadList.aspx?enc=25445B75E611AE6BB9D1A322FCCA1889478EF81882DBBAE4

4. EPA publishes the TCSCCA enforcement rules

On 3rd September, EPA promulgated the Toxic and Concerned Chemical Substances Control Act Enforcement Rules (the Rules). The draft of the Rules was first published in April 2019. Accodring to the Rules:

  • “Online shopping” is defined by the regulation and online shopping will be managed by TCSCCA.
  • The list of concerned chemical substances and their requirements will be published
  • Additional regulations under TCSCCA will be published in the near future

EPA announcement: https://www.tcsb.gov.tw/cp-21-3685-61028-1.html


5. EPA publishes revised draft PEC Registration Guidance

On 30th Sep, EPA published PEC registration Guidance (draft revision). The PEC registration platform and Taiwan SIEF was also published in early September. Compared with the previous draft of PEC guidance this draft provides applications form for the following guidance:

  • Template for third party representative appointment
  • Template for QSAR report
  • Template and guidance for Literature review

Link to the draft PEC guidance: https://tcscachemreg.epa.gov.tw/Epareg/content/login/DownloadList.aspx?enc=5C618A9E7D5F887E916635A81C0AC36400839AF86FB9E098

Authors: Tan Sun and Sophie Guinard