Chemical regulatory updates in Taiwan
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.
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.