Toxic and Concerned Chemical Substances Control Act Article 30

Those that manufacture or import certain quantities of existed chemical substances each year shall apply to register chemical substance data from the competent authority before the specified deadline. Those enterprises of manufacturing or importing new chemical substances shall apply to register chemical substance data from the competent authority 90 days prior to the aforementioned activities. Both abovementioned existed and new chemical substances (it is called registered chemical substance thereafter) shall be allowed to manufacture or import after approval of their registration.The manufacturer or importer shall proactively maintain and update the data in Paragraph 1 of approved and registered chemical substances.Chemical substances subject to registration must be regularly declared in compliance with the central competent authority's regulations.The registered content of chemical substance data in Paragraph 1 includes status of manufacture or import, physical, and chemical, toxicological, exposure characteristics, as well as hazardous assessment, and other data items designated to be included in registration by the central competent authority. Based on the annual quantities of manufacture and import along with the substance type, registration may be divided into standard registration, simplified registration, and small quantity registration.The central competent authority shall make registered regulations for the various types of the chemical substances in Paragraphs 1 to 4, including quantity increments, status of manufacture or import, physical, chemical, toxicological, and exposure characteristics, as well as hazardous assessment along with other required documents, for example, registration deadline, the standard registration, simplified registration, small quantity registration, joint registration approaches, review procedures, approval/rejection, revocation or cancellation of registration approval, prohibited or restricted handling approaches, data reporting or addition following registration, document preservation methods, information disclosure, business secret protection methods, and other binding matters.
中文原文 毒性及關注化學物質管理法第30條
製造或輸入每年達一定數量既有化學物質者應依規定期限向中央主管機關申請登錄化學物質資料;製造或輸入新化學物質者應於製造或輸入九十日前向中央主管機關申請登錄化學物質資料。
前開既有化學物質及新化學物質(以下稱應登錄化學物質)經核准登錄後,始得製造或輸入。
前項經核准登錄之化學物質資料,製造或輸入者應主動維護更新。
中央主管機關經評估認有必要者,得通知製造或輸入者限期提出補正資料。
應登錄化學物質應依中央主管機關之規定定期申報。
第一項化學物質資料登錄內容包括製造或輸入情形、物理、化學、毒理、暴露、危害評估或其他經中央主管機關指定應登錄之資料項目,依每年製造或輸入量及物質種類分為標準登錄、簡易登錄及少量登錄。
前四項應登錄化學物質之種類、數量級距、製造或輸入情形、物理、化學、毒理、暴露及危害評估等資料及其他應備文件、登錄期限、標準、簡易、少量及共同登錄方式、審查程序、准駁、撤銷或廢止登錄核准、禁止或限制運作方式、登錄後化學物質資料之申報或增補、文件保存方式、資訊公開、工商機密保護方式及其他應遵行事項之辦法,由中央主管機關定之。

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