Taiwan: Deadline for Standard Registration of 106 PECs proposed to be postponed to 2023

On May 27 Taiwan’s Environmental Protection Administration (EPA) proposed an amendment to the Regulation on New and Existing Chemical Substances. The regulation was first published in 2014 and had previously been amended in March 2019. The legal basis for chemical registration in Taiwan is the Toxic and Concerned Chemical Substance Control Act (TCCSCA), which was enacted on 16 January 2019, amended, and renamed from Toxic Chemical Substance Control Act. The current chemical registration system has been in place since 1st January 2020.

To raise awareness in the chemical sector, Taiwan’s environmental authorities have brought an active conversation with stakeholders, notably by organizing public seminars. These seminars have provided stakeholders with key information on the obligation to register chemicals, as well as practical information on data submission. Taiwan’s environmental authorities expect individual chemical manufacturers or importers to prepare dossiers for standard registration (for chemicals listed in 106 Priority Existing Chemicals (PECs) list). Due to the COVID-19 outbreak, some of the seminars had to be postponed. Last month, EPA updated the fee structure for chemical registration by reducing fee for registrants who use non-animal testing alternatives and for those who need to extend the period of confidentiality.

It had been speculated that the EPA would move the registration deadline following concerns raised by manufacturing and importing associations over their members’ capacity to complete registration in time. Authorities then announced that they would give chemical manufacturers and importers sufficient time for data preparation. According to the recently published amendment, registrants will therefore have 4 years to complete their obligation for standard registration for 106 PECs. Companies that obtained Phase One Registration Code after January 1, 2020 are required to complete the Standard Registration (106 PECs) within four years. For the first batch of 106 PECs, the deadline to extended one more year to December 31, 2023 for quantity above 1 tonne per year. The valid CBI claims for New Chemical Substance is also extended to 5 years irrespective of tonnage.

The amendment also specifies that registration obligation of chemicals that are considered controlled chemicals and concerned chemicals are exempted from registration. The list of Controlled chemicals contains 19 chemicals and is regulated under the Regulations Governing Designation and Handling Permission of Controlled Chemicals. Before handling the Controlled Chemicals, a handler shall apply to the central competent authority for permission. No handling shall be commenced without permission. The list of controlled chemicals will be updated by the central competent authority from time to time.

Considering low exposure risk for onsite Isolated Intermediates, the amendment also changes the requirement for standard registration of new chemical substances under the category of onsite Isolated Intermediates. Standard registration is required only if the annual tonnage is above 10 tonnes. 

The amendment also confirms that registrant will be issued a registration number once they submit information in appendix 3 (one to seven item) and after these have been reviewed by the Authority. Hazard assessment and exposure assessment can be submitted at later stage as communicated by the authority.

Appendix 3: Information items to be submitted for Standard Registration:

1. Information on the registrant and basic identification of the substance
2. Information on manufacture, use and exposure of the substance
3. Hazards classification and labelling
4. Safe use information
5. Physical and chemical properties
6. Toxicological information
7. Ecotoxicological information
8. Hazard assessment
9. Exposure assessment

The proposal for amending the draft of chemical substance registration is open for public consultation until July 26. GPC can forward your suggestions or feedback to the Taiwanese authority before the deadline.