- Department:Evaluation Management Division
To improve the data required by domestic authorities for management of chemical substances, the Environmental Protection Administration (EPA) implemented the Regulation of New and Existing Chemical Substances Registration (hereafter, “the Regulations”) effective Dec. 11, 2014. The Regulations have subsequently been amended according to the problems encountered during practical implementation, the opinions of interested parties, changes in international trends for chemical substance registration systems, and the domestic authorities' inter-departmental demands for chemical substance management.
The EPA mentioned that key revisions to the Regulations are as follows:
- In unifying chemical substance registration to comply with relevant laws and regulations, the EPA referred to laws and regulations related to the Regulations on New Chemical Substances Registration, which were formulated by the Ministry of Labor, and supplemented the text explaining the categories to be registered per registration bracket by presenting them in table form. This allows each registration bracket to understand more clearly which categories need to be registered. In addition, the critical quantities for initiating hazard assessment reports and exposure assessment reports were adjusted to be consistent between the EPA and the Ministry of Labor.
- Administrative costs have been reasonably reduced to lower burdens on registrants. Chemical substances that have been approved have been given a registration code; registration documents will no longer be issued.
- Current provisions on chemical substance reviews have been incorporated into detailed lists; and new chemical substance registration linkage and adjustment periods are deleted when they pass the appointed time.
- It is now clearly stipulated that first-time manufacturers or companies importing existing chemical substances for more than 100 kg for the year should file a first-phase existing chemical substance application within six months. Companies who fail to obtain an approved registration before the deadline may not manufacture or import existing chemical substances. Companies manufacturing or importing less than 100 kg of existing chemical substances for the year may voluntarily apply for registration.
- After screening extant chemical substances in the first-phase chemical substance registration data, 106 that are widely circulated in the country, are potentially more hazardous, and lack sufficient information have been listed as existing chemical substances that should be registered.
- Regulations were added asking companies registering existing first-phase chemical substances to also file a confidentiality application with the central competent authority. Considering that registrants whose registration has been approved may need time to submit an application once they learn that they are also required to file a confidentiality application, an appropriate amount of time has been allocated for them to do so.
- To stay on top of the quantitative data for new and existing chemical substances on hand, where the data is used for subsequent management and assessment, registrants whose registration has been approved should declare new and existing chemical substance data that they had manufactured or imported the previous year, beginning Jan. 1, 2019.
- New registrants who have doubts or concerns about the review results may file an application in writing.
For more information on related information, please see the EPA News (https://enews.moenv.gov.tw/enews/fact_index.asp) or the EPA Laws and Regulations Retrieving System (https://oaout.moenv.gov.tw/law/index.aspx), beginning the third day after the information has been announced. Opinions or recommendations about the information are welcome within 60 days of the date of announcement. (Fax number: (02)2325-3823, Email: chjin@epa.gov.tw)
