At the CRAC-HCF 2020 Virtual Forum held by REACH24H on November 24, 2020, Ms. Yahui Ni from the Environmental Resource & Information Co., Ltd. (ERI), introduced the regulatory framework of Taiwan’s new and existing chemical registration system (Taiwan REACH) and the ongoing efforts made by regulatory authorities.
Ms. Ni’s speech was mainly centered on the registration of 106 PECs, which represented industry’s first exposure to joint registration mechanism during which data ownership and reliability issues were encountered.
Data Sourcing Standards & Prohibitions
Taiwan’s EPA (Environmental Protection Administration) encourages registrants to firstly cite international public databases (16 recommended in the Guidance for PECs Registration) for data and secondly, to use systematic literature reviews, QSAR, read-across, and testing proposal to fulfil requirements for all testing endpoints. It is however, not allowed to directly refer to the ECHA database. Additionally, the registrants shall not cite the literatures owned by private enterprises, such as BASF, DUPONT, etc. For data in reports such as OECD SIDS, EURAR where all references have been attached, purchase of the authorization is recommended.
Testing Proposals & Cost-Sharing Mechanism
Testing proposals can be accepted for 4 toxicological and 11 eco-toxicological endpoints and the content cover a piece of A4 paper is enough. If there is lack of data on evaluation of the endpoint, while a testing report is indispensable to prove the hazards, the authority will entrust a lab to conduct the test with costs shared by all the registrants of the substance.
Phased Registration & Technical Support
According to the Guidance for PECs Registration issued in June this year, Taiwan allows registrants to submit partial information (only items 1~7) to obtain a registration code. The items 8 and 9 for hazard and exposure assessment (required for PECs manufactured or imported above 10 tonne per year) can be submitted later. Industry representatives expressed their concerns whether there is enough support to aid the preparation of hazard and exposure information and if there is a clear timeline for submission. According to Ms. Ni, the authority understands it is quite professional to prepare such information and they will offer sufficient help and training to the stakeholders. The EPA will potentially release a guidance for hazard and exposure assessment next year.
Post-market Surveillance & Inspection
Finally, Ms. Ni indicated that the authority will strengthen the post-market inspection or surveillance on approved registrations, including simplified registration for R&D and standards registration.
