Regulations of New and Existing Chemical Substances Registration Article 9

Upon reviewing information of a new chemical substance submitted by a registrant, the central competent authority shall approve the registration along with an incidental provision to prohibit or restrict handling, and shall require the registrant to regularly report handling conditions, update registration report data, or submit chemical substances hazard information, if the central competent authority determines that there is a concern over the toxicological characteristics of a new chemical substance conforming to the definitions of Class 1, Class 2, or Class 3 toxic chemical substances.Upon reviewing information of a new chemical substance submitted by a registrant, the central competent authority shall approve the registration along with an incidental provision to restrict handling, and shall require the registrant to submit information on exposure assessment and risk assessment, update registration report data, or submit chemical substances hazard information, if the central competent authority determines that there is a concern of environmental pollution or any threat to human health.
中文原文 新化學物質及既有化學物質資料登錄辦法第9條
中央主管機關審查登錄人提交之新化學物質資料,判斷新化學物質之毒性有符合本法第三條所定第一類、第二類或第三類毒性化學物質之分類定義之虞者,應於核准登錄時附以附款,禁止或限制其運作並要求定期申報運作情形、更新登錄相關報告資料或提供化學物質危害資訊。
中央主管機關審查登錄人提交之新化學物質資料,判斷新化學物質有污染環境或危害人體健康之虞者,應於核准登錄時附以附款,限制其運作並要求提報暴露及風險評估資料、更新登錄相關報告資料或提供化學物質危害資訊。

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