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For Taiwan new chemical substance registration, separate regulations under TCSCA and OSHA should be complied with. To facilitate the implementation of new chemical registration in Taiwan and reduce regulatory compliance burdens on potential registrants, both the Environmental Protection Administration (EPA) and Ministry of Labor (MoL) have agreed to establish a single system for registration under the EPA.
Major changes have been made to the registration of new and existing chemical substances under TCSCA (EPA’s regulation) which was published on the 5th of Dec (ChemLinked news on 10 Dec 2014). Compared with the regulation of new chemical substance registration under OHSA (MoL’s regulation), which was published at the end of Dec, almost all aspects have been aligned except for hazard & exposure assessment requirements for general new chemical substances (non-CMR). MoL’s regulation requires hazard & exposure assessment for new chemical substances manufactured or imported at or over 10t/y, while EPA’s regulation only requires for those at or over 1000t/y.
In the near future, registrants will be able to submit one dossier using a single submission system for new chemical substance registration under both EPA and MoL. The two ministries will work together to review the dossier. Under the new system general new chemical substances manufactured or imported at or over 10t/y should provide hazard & exposure information and CMRs should provide such information at or over 1 t/y.
At the end of last month, a meeting was held to develop the single submission registration system. The two ministries are currently considering issues like review fee and registration No. The ministries are also in negotiations about the prospect of using a single certificate for new chemical substance registration. In this way a single registration No. will facilitate any post-registration management and information communication between upper and downstream users.
The EPA and MoL will continue to address industry concerns on future chemical registration regulations. They have accepted there will be some teething issues and according to Shao-ying Yuan, director general of the EPA's Department of Environmental Sanitation and Toxic Substance Management, they are willing to review and revise provisions that prove unpractical and unreasonable two years after implementation.
