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On September17, 2020, Taiwan EPA issued a proposed revision to the Standard on Toxic Chemical Substances Handling Application Fee and Chemical Registration Fee. It is now subject to a period of public consultation lasting 60 days.
Taiwan requires administrative fees for new and existing chemical registration. The fees for dossier review, registration extension and modification, certificate issuance, CBI protection, etc. are specified in the standard, which was published on 8 December 2014 and came into force immediately. To align with the revised Regulation of New and Existing Chemical Registration (hereafter referred to as Regulation), the fees for some items are proposed to be adjusted as follows.
Table 1. New and Existing Chemical Substance Registration Fee
Application dossier review (NT$) | Registration extension (NT$) | Certificate (NT$) | Modification of certificate (NT$) | CBI protection (NT$) | Extension of CBI protection (NT$) | |
Phase 1 registration of existing chemical substances | 100 | / | / | / | Current: 0 Proposal: 12,500/item | Current: 0 Proposal: 10,000/item |
Phase 2 standard registration of existing chemical substances | 50,000 | Current: 0 Proposal: 2,000 | Current: 200 Proposal: Delete | Current: 1,500 Proposal: Delete | 12,500/item | Current: 12,500/item Proposal: 10,000/item |
Pre-confirmation of polymers of low concern | 1000 | / | / | / | / | |
Small quantity registration of new chemical substances | 2,000 | 1,000 | Current: 200 Proposal: Delete | Current: 500 Proposal: Delete | 12,500/item | Current: 12,500/item Proposal: 10,000/item |
Simplified registration of new chemical substances | 20,000 | Current: 2,000 Proposal: 1,000 | Current: 200 Proposal: Delete | Current: 1000 Proposal: Delete | 12,500/item | Current: 12,500/item Proposal: 10,000/item |
Standard registration of new chemical substances | 50,000 | / | Current: 200 Proposal: Delete | Current: 1,500 Proposal: Delete | 12,500/item | Current: 12,500/item Proposal: 10,000/item |
According to the revised Regulation, the registration certificate for chemical registration will no longer be issued and only a registration number will be provided. Therefore, the provisions regarding fees for issuance or modification of a certificate will be deleted.
To encourage alternatives to animal testing to generate the data required for registration dossiers, and to accelerate registration and avoid a substantial amount of submissions before the registration deadline, Taiwan EPA has proposed financial incentives. That is, in addition to SMEs and academic institutes, there will be another two circumstances eligible for a 25% reduction in the dossier review fee, including:
l The data of skin corrosion/irritation and eye irritation required in the standard registration are generated by in vitro testing, QSARs or read-across approach;
l The standard registration of priority existing chemical substances is submitted one year before the stipulated registration deadline.
It should be noted thatthe discount will be multiplied if more than one circumstance is met at the same time.
Example: A priority existing substance is manufactured in volumes of 100-1000 tonnes per year, which is subject to standard registration before December 31, 2021. If the registration dossier is submitted before the end of 2020 and the eye irritation data is derived from read-across approach, the fee for dossier review would be 50,000*75%*75%= NT$28,125
