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2. Dec 2020 | Legislation

Chemical regulatory updates in Taiwan

Bryan Zhou, Senior Regulatory Consultant, CIRS Europe

Taiwan chemical regulations of existing and new chemicals has been implemented in 2014. On 16 January 2019, the new regulation TCCSCA (Toxic and Concerned Chemical Substances Control Act) was released and has been implemented on 16 January 2020. The TCCSCA also replaces the previous Taiwan chemical regulation TCSCA (Toxic Chemical Substance Control Act).
Chemical regulatory updates in Taiwan
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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 includes more than 100 kg/year, unlike EU REACH, the Phase 1 registration shall be processed within six months after the activity occurs. In the Annex 6 of this regulation, a list of 106 existing chemical substances, 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.

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Event tip

Chemical regulations in Asia are also in the focus of the EC WebForum Regulations - Navigating chemical legislation in Asia on April 21, 2021. The virtual event gives an overview over the legislatory situation in China, Japan and Korea.

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Annual report

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 1 April and 30 September. 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 9 June 2020, the “Guidance on Existing Chemical Substances Standard Registration” was published by the 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 are 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 due to 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, 31 December 2021

1-100 ton/year, 31 December 2022

In general, this shall be good news for companies 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 second 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 that can help them build a registration strategy based on their business situation in Taiwan.

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