Regulations on New Chemical Substances Registration Article 5

For a new chemical substance that is not listed in the announced inventory, manufacturers or importers shall not manufacture or import any chemicals containing such new chemical substance prior to submitting a chemical safety assessment report (hereinafter referred to as "assessment report") to the central competent authority and receiving registration approval for the new substance.The manufactures or importers pursuant to the previous paragraph may appoint a domestic company or institute, as a representative to apply for registration approval.But if Toxic and Concerned Chemical Substances Control Act of the central authority in charge of environmental protection has otherwise provision governing chemical substances listed in the announced inventory pursuant to paragraph 1, the provisions of that act shall prevail.
中文原文 新化學物質登記管理辦法第5條
製造者或輸入者對於公告清單以外之新化學物質,未向中央主管機關繳交化學物質安全評估報告(以下簡稱評估報告),並經核准登記前,不得製造或輸入含有該物質之化學品。
前項製造者或輸入者,得委託國內之廠商或機構,代為申請核准登記。
第一項公告清單之化學物質,中央環境保護主管機關依毒性及關注化學物質管理法另有規定者,從其規定。

English translation for reference only; the Chinese text prevails. Not legal advice.