The final version of the regulation specify 106 priority existing chemical substances (PECs) subject to Taiwan’s standard registration of existing chemical substances should complete the registration within 2 or 3 years and introduced annual report system, requires all chemicals submit the previous one year’s chemical manufacture/import tonnage for local authority strengthen the control of chemicals and risk management.

The main revision of the regulation as follows:

1. Revised regulation requires hazard assessment & exposure assessment report for new and existing chemical substances manufactured or imported at or over 10t/y. This is now in aligns with MoL’s regulation of new chemical substance registration under OHSA.
2. In order to reduce the administrative cost and reduce the burden of the registrant. Authority change the shall be approved by official documents Issue a login or completion code. (amendment articles 11 and 18)
3. For the first time manufacture or importation of an existing chemical substance with an annual quantity of more than 100 kg, the phase I registration is required by authority within 6 months after manufacturing or importation. If the phase I registration number is not obtained after 6 months, no further manufacturing or importation is allowed. If the annual quantity of manufactured or imported existing chemicals is less than 100 kg,  companies may apply for registration on their own initiative
4. Company can apply confidential business information for the existing chemical substance registration, and the new regulation adjust the number of years of information protection for the small quantity registration for PLC

The Regulation also introduced an “Annual report” system, that all registrants should submit annual manufacture/importation activity report including tonnage information to authority between April 1 and September 30. And EPA plans to strengthen post-market inspections.

Reference service link: https://www.accestra.com/services/chemical-regulatory-advisory/