Environmental Agents Control Act Article 9

Those that intend to manufacture, process, or import environmental agents shall apply to the central competent authority for checking and registration by submitting markings and a sample together with the product’s name, components, performance data, key aspects of the manufacturing process, analytical methods, toxicology report, efficacy (potency) report, and other relevant information or documentation.Manufacture, processing, or import may begin only after the central competent authority has issued a permit.When an environmental agent for which a permit has been issued in the foregoing paragraph is a general use environmental agent, the competent authority shall announce information including the manufacturer or importer, product name, permit number, composition, performance data, and product markings on the Internet in order to facilitate public queries.Customs shall order those persons obligated to pay tax to return within a limited time period any imported environmental agents that have not received the central competent authority’s permission or approval.Passengers or service personnel on transportation vehicles that import small quantities of environmental agents with themselves for personal use are not subject to the restrictions of the foregoing paragraph. Relevant types of environmental agents and permissible amounts shall be determined on the basis of relevant Customs Act regulations.The environmental agents in the foregoing paragraph shall be imported solely for personal use, and may not be sold.
中文原文 環境用藥管理法第9條
製造、加工或輸入環境用藥,應將其名稱、成分、性能、製法之要旨、分析方法、毒理報告、藥效(效力)報告及有關資料或證件,連同標示及樣品,向中央主管機關申請查驗登記,經核發許可證後,始得製造、加工或輸入。
前項取得許可證之環境用藥屬一般環境用藥者,主管機關應於網際網路上公告其製造或輸入廠商、產品名稱、許可證字號、成分、性能及產品標示等資料,方便一般民眾查詢。
輸入未經中央主管機關許可或核准之環境用藥,海關應責令納稅義務人限期辦理退運。
旅客或交通工具服務人員攜帶少量自用環境用藥進口者,不受第一項規定之限制;其種類及限量,依關稅法相關規定辦理。
前項環境用藥,限供自用,不得販售。

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