Taiwan EPA issued on 14 Sep 2017 a proposed revision to the Regulation of New and Existing Chemical Substances Registration. The draft proposal (click here to download) will be open to a 60-day public consultation.
Most of the changes are the same as introduced by Taiwan EPA at a seminar held in Taipei on 18 Jul 2017, including the following aspects:
Hazard & exposure assessment,
Deletion of expired articles,
Registration certificate,
Dossier supplementation or correction,
Review period,
Confidentiality validity,
Late pre-registration,
Annual reporting, etc.
The details have been reported by ChemLinked (CL news).
In addition, some more new updates introduced in the draft proposal are summarized below:
(1) CBI protection
Taiwan authority hasn’t provided a method to apply for CBI non-disclosure for the phase 1 registration of existing chemical substances. At present the registrant name and the corresponding registration No. of existing chemical substances are not accessible on the online platform. However, in the draft proposal, CBI application will be available for phase 1 registration of existing chemical substances and confidentiality will be valid for five years.
(2) Annual report
In the seminar held in Jul, an annual reporting mechanism was introduced. More specifically, in the published draft proposal, from 1 Jan 2019, the annual reporting system will be implemented. The submission of annual report will start on 1 Mar and will end on 30 Jun each year rather than the previously stated “before 31 Jan each year”. The required information for submission includes registrant information, registration No., and the volume of manufacture or importation in the last year.
(3) Review period
Review period for the standard registration of existing chemical substances is specified as 90 working days.
* Recently ChemLinked held a webinar focused on chemical management in Taiwan. Ms. Yea-Jen Jeng and Dr. Ken-Yen Liu from Taiwan Chemical Substances Registration Center were invited to examine the current regulatory landscape and introduce the latest updates. The webinar proceedings are now accessible on ChemLinked.
According to Dr. Ken-Yen Liu from Taiwan Chemical Substances Registration Center, the revision on the Regulation of New and Existing Chemical Substances Registration will be finalized by the end of this year. In addition, the list of priority existing chemical substances (currently 122 PECs drafted) needing Phase 2 registration (standard registration) will be officially published for public comments in early October. Please stay tuned with our site.
