Chemical regulatory updates in Taiwan

UnderTCCSCA, the regulation of existing chemical and new chemicals in Taiwan isnamed “Regulation of New and Existing Chemical Substance”, which has beenupdated in 2019. Specifically, for an existing chemical, if manufacture orimport activity in Taiwan includes more than 100 kg/year, unlike EU REACH, thePhase 1 registration shall be processed within six months after the activityoccurs. In the Annex 6 of this regulation, a list of 106 existing chemicalsubstances, which is known as the 1st batch of PEC (Priority Existing Chemical)substances is included.Manufacturers orimporters in Taiwan shall consider processing full registration from 2020 iftheir 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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Annualreport

Annualreporting has been introduced into this new regulation and became mandatory in2020. Companies which have completed new/existing chemical registration/notification are required to submit the annual report between 1 April and 30September. The annual report is used to submit substance activity informationin Taiwan from the previous year, which includes basic registrant information,registration number and the manufacture or import volume from the previousyear.

Existingchemical substances standard registration guidance

On 9 June2020, the “Guidance on Existing Chemical Substances Standard Registration” waspublished by the Taiwan Toxic and Chemical Substance Bureau, EPA. The guidanceprovides detailed registration requirements and advice for collecting requireddata and preparing dossiers. Under the new guidance, the Taiwan authorityencourages 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, theirreports may be acceptable in Taiwan chemical registration directly. Theguidance also expands the scope of laboratories, which the reports will beacceptable from in Taiwan. For example, reports from domestic Taiwan universitylaboratories will be an option. There are no specific lab qualificationrequirements of these university laboratories, but the full test report andrelevant information to prove report credibility will be required. 

Uncertaintydue to Covid-19

Due toCovid-19, the Taiwan authority is considering extending the original deadlineof the first batch of PEC registrations to 2023. Please find the originaldeadline information below:

>100ton/year, 31 December 2021

1-100ton/year, 31 December 2022

In general,this shall be good news for companies preparing for Taiwan chemicalregistration. It will provide companies with more time to collect the requireddata, prepare the dossier and especially negotiate with the data owner under EUREACH. However, it may also bring some uncertainties – for example, if thedeadline is postponed to 2023, the Taiwan authority needs to firstly process aregulation amendment. This may lead to some new updates; besides, it may alsoaffect the date of releasing the second batch PEC substance list, which wasplanned to be released in 2024.

During thisdifficult period, CIRS suggests that companies involved in Taiwan chemicalregulatory compliance monitor the latest regulatory updates and gain advicefrom professional consulting firms that can help them build a registrationstrategy based on their business situation in Taiwan.