During REACH4H’s annual regulatory conference (CRAC 2017 on Nov 1st), Ms. Ya-Hui Ni, the vice president of ERI, examined the current regulatory landscape and introduced the proposed revision of the chemical registration regulation.
Ms. Ni shared in her presentation the statistics of new chemical substances registration approved by the authority by Sep 30th of 2017, including:
- Small quantity registration: 1,956
- Simplified registration: 73
- Standard registration: 25
In addition, 864 applications for prior confirmation of new PLC have been approved by the end of Sep.
Ms. Ni also introduced the draft amendments of the New and Existing Chemical Registration Regulation, including some significant changes to hazard & exposure assessment, review period, confidentiality validity, late pre-registration, annual reporting, etc. The draft proposal has been issued for public comments until 19 Nov 2017. More amendment details have been reported by ChemLinked (CL news).
The newly proposed annual reporting system will place a greater burden on the industry. According to Ms. Ni, the TRP (third party representative) who has been designated for registration work on behalf of the registrant will also be responsible for the submission of annual report.
Another recurring issue raised during CRAC 2017 is the priority existing chemical substances (PECs) designated for the Phase 2 registration (standard registration). The list has been drafted (CL news). It is proposed to be finalized and released before the end of 2017, with chemical name, tonnage band requirements, corresponding registration deadline, etc.