Taiwan chemical regulations of existing and new chemicals has been implemented since 2014. On Jan 16th 2019, the new regulation TCCSCA(Toxic and Concerned Chemical Substances Control Act) was released and has been implemented since Jan 16th 2020. The TCCSCA also replaces the previous Taiwan chemical regulation TCSCA (Toxic Chemical Substance Control Act).
Regulation of New and Existing Chemical Substance
Under TCCSCA, the regulation of Existing Chemical and New Chemicals in Taiwan is named Regulation of New and Existing Chemical Substance, which has been updated in 2019. Specifically, for an existing chemical, if manufacture or import activity in Taiwan is more than 100kg/year, unlike EU REACH, the Phase 1 registration shall be processed within 6 months after the activity occurs. In the Annex 6 of this regulation, a list of 106 Existing Chemical Substance, which is known as the 1st batch of PEC (Priority Existing Chemical) substances is included. Manufacturers or importers in Taiwan shall consider processing full registration from 2020 if their substance is listed in the Annex 6.
Annual Reporting has been introduced into this new regulation and became mandatory in 2020. Companies which have completed new/existing chemical registration/ notification are required to submit the annual report between Apr 1st and Sep 30th. The annual report is used to submit substance activity information in Taiwan from the previous year, which includes basic registrant information, registration number and the manufacture or import volume from the previous year.
Existing Chemical Substances Standard Registration Guidance
On Jun 9th, 2020, the Guidance on Existing Chemical Substances Standard Registration was published from Taiwan Toxic and Chemical Substance Bureau, EPA. The guidance provides detailed registration requirements and advice for collecting required data and preparing dossiers. Under the new guidance, the Taiwan authority encourages alternative test methods, e.g. QSAR, READ-ACROSS, public literature, etc. Data from international databases including ILO, WHO, IRAC, US EPA, etc. shall also be acceptable in Taiwan. For the data owner under EU REACH, their reports may be acceptable in Taiwan chemical registration directly. The guidance also expands the scope of laboratories which the reports will be acceptable from in Taiwan. For example, reports from domestic Taiwan university laboratories will be an option. There is no specific lab qualification requirements of these university laboratories, but the full test report and relevant information to prove report credibility will be required.
Uncertainty Change Under Covid-19
Due to Covid-19, the Taiwan authority is considering extending the original deadline of the first batch of PEC registrations to 2023. Please find the original deadline information below:
>100 ton/year, Dec 31st 2021
1-100 ton/year, Dec 31st 2022
In general, this shall be good news for companies which are preparing for Taiwan chemical registration. It will provide companies with more time to collect the required data, prepare the dossier and especially negotiate with the data owner under EU REACH. However, it may also bring some uncertainties, for example, if the deadline is postponed to 2023, the Taiwan authority needs to firstly process a regulation amendment. This may lead to some new updates; besides, it may also affect the date of releasing the 2nd batch PEC substance list, which was planned to be released in 2024.
During this difficult period, CIRS suggests that companies involved in Taiwan chemical regulatory compliance monitor the latest regulatory updates and gain advice from professional consulting firms who can help them build a registration strategy based on their business situation in Taiwan.
Senior Regulatory Consultant
+353 1477 3708