Compliance Review
Regulations of New and Existing Chemical Substances Registration Was Revised and Published On March 11, 2019, Taiwan Region's EPA released the revised version of New and Existing Chemical Substances Registration Regulation. A total of 106 existing chemical substances were designated to submit the files for standard registration within 2 to 3 years, to effectively improve the grasp of the information on chemical substances which are widely used in domestic, with potentially high hazard and lack of data, and to strengthen the cross-departmental control of chemical substance risks. The Regulation has added Annual reporting requirement that the new registrant should annually file quantity of chemical substances manufactured or entered in the last year during the period of April 1st to September 30th after the approval of registration in order to allow for the competent authority to obtain information on the actual tonnage and flow of chemical substances in the area. Other amendments include the submission of hazard assessment reports and exposure assessment reports for the manufacture or import of more than ten metric tons of a chemical; annual quantities that fall below 100kg may apply for registration voluntarily. The registration confidentiality period for small quantity registration of polymers of low concern increased to 5 years. Also, the registration certificate was replaced by a registration code and a provision was made for registrants to request a recheck of the registration results. Guidance for Standard Registration of Designated Chemical Substances by Stages (draft) Was Promulgated On March 18, 2019 Guidance for Standard Registration of Designated Chemical Substances by Stages (draft) was promulgated. The draft puts forward practical suggestions on how to proceed with existing chemical standard registrations, including the registration obligations, data requirements, normative recommendations on registration data and joint registration procedures which mainly fall under the provisions of Toxic and Concerned Chemical Substances Control ACT (TCCSCA) implemented by Taiwan Region’s EPA as well as the New and Existing Chemical Substances Registration Regulation, so as to assist registrants in complying with their registration obligations.Extension of Supplementation Period
Beginning from July 2, 2019, when the New Chemical Substance Registration or polymers of low concern (PLC) prior verification application requires to be supplemented or corrected if the Supplementation cannot be completed within the time limit due to scientific or technical reasons, then the term to make such correction or to provide the supplementary information may be extended after approval by the competent authority. Currently, these functions can be operated on the platform to allow companies more freedom and flexibility when preparing their applications.
