Taiwan to Issue Guidance for Standard Registration of Priority Existing Chemicals

The standard registration for 106 priority existing chemicals (PECs) at or above one tonne a year will begin from Jan 1^st, 2020. The most important supporting guidance was initially drafted in March detailing information companies must file, to what extent diversified data can be accepted and other issues relating to standard registration. It was updated in the end of September after several issues and industry concerns raised during the seminars organized by the authority to familiarize companies with the standard registration of PECs. The final version will soon be finalized by the end of this year.

The updated draft guidance is accessible here^[1].

The Regulation of New and Existing Chemical Substance Registration^[2] creates the PECs registration rules. Companies manufacturing or importing any substance from the PECs list will be required to complete standard registrations before the corresponding registration deadline (see table below).

 For the above mentioned 3 situations, if the phase 1 registration No. is cancelled and then re-applied, the registration deadline for standard registration should still be counted based on the first time when the phase 1 registration No. was obtained. If the registration deadline for standard registration has expired, the standard registration should be completed along with the re-applied phase 1 registration.

Compared to new chemical registration, the existing chemical standard registration allows submission of more diversified data, which includes but is not limited to test reports, systematic literature reviews, QSAR and test plan, etc. The data eligibility criteria is specified for each test endpoint in the guidance. Compared to the first draft, it specifically lists the endpoints (15 physicochemical properties, 2 toxicological data, 3 eco-toxicological data) that can be acquired from the international public database. The recommended databases are provided in the guidance. For example, for short-term toxicity testing on invertebrates (daphnia), data from NITE-Chemical Risk Information Platform(NITE-CHRIP), Japan Chemical Collaborative Knowledge Database(JCHECK), International Programme on Chemical Safety (IPCS), etc. can be accepted.

The Tool for registration of Existing chemical substances (TrEX) is expected to be available soon to enable online standard registration of PECs. TrEX is like “Chemist 4.0” for new chemical registration. Taiwanese local entities (manufacturers, importers and ORs) will be eligible to submit dossiers through the registration tool individually or jointly (joint registration in Taiwan is not mandatory). According to the guidance, for joint registration, the LR’s registration work will be completed at least three months (previously drafted as six months) before the registration deadline. It will leave the joint registrants time to finish their own.

Although the guidance and the registration tool for standard registration of PECs haven’t been finalized, companies likely to jointly register PECs are highly recommended to get a head start to join the “SIEF-like” platform^[3] to find co-registrants. It should be noted that if the online application for joining the platform is rejected 3 times, it is necessary to contact officials and submit the application in writing. In addition, an authorization letter should be submitted if a third-party representative (TPR) is designated to join on behalf of the registrants.