Regulations for Cosmetic Product Information File Management Article 4
A person who has taken cosmetic safety evaluation training courses which are provided domestic or foreign university which complies with Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education (hereinafter referred to as " domestic or foreign university"), or by central competent authority, and complied with the following conditions, the person may serve as a signatory for the safety report of product information file mentioned in Subparagraph 16 of Paragraph 1 of the preceding article:1. who graduated from department of medicine, department of pharmacy, or toxicology, cosmetic and other related departments or graduate schools at the domestic university or the foreign university.2. Who graduated from the department of chemistry or chemical engineering at the domestic or foreign university before 2019.6.30, and had at least five years of relevant work experience in cosmetic safety evaluation.The content and hours of cosmetic safety evaluation training courses mentioned in the preceding paragraph shall be:1. Cosmetic management regulations: including cosmetic hygiene management regulations of R.O.C (Taiwan), international cosmetic hygiene regulations, and the system of cosmetic product information file in R.O.C. (Taiwan); at least 4 hours.2. Applications and risks of cosmetic ingredients: including the action principles and safety of whitening, sunscreen, antiperspirant, deodorant, hair-dyeing, permanent waving and other ingredients, and common cosmetic adverse effects and violations; at least 8 hours.3. Methods of cosmetic safety evaluation: including skin anatomy and physiology, cosmetic percutaneous absorption capacity, skin irritation, the mechanism and symptom of photoaging and photoallergy, the safety evaluation of nanomaterials, the safety evaluation of natural substance cosmetic, the cosmetic risk assessment, toxicological evaluation methods(skin irritation, skin sensitization, skin corrosivity, eye irritation and genetic toxicity and mutagenicity test), systemic toxicity and margin of safety, and alternative methods of animal testing; at least 36 hours.4. Concluding the product safety evaluation: at least 6 hours.
中文原文 化粧品產品資訊檔案管理辦法第4條
曾修習由國內大學或符合大學辦理國外學歷採認辦法之國外大學（以下併稱國內、外大學）或中央主管機關所開設化粧品安全性評估訓練課程，並符合下列情形之一者，得任前條第一項第十六款之安全資料簽署人員：
一、國內、外大學醫學系、藥學系、或化粧品學、毒理學及其相關系、所畢業。
二、於中華民國一百零八年六月三十日前，自國內、外大學化學或化工系、所畢業，具五年以上化粧品安全評估相關工作經驗。
前項安全性評估訓練課程之內容及時數，規定如下：
一、化粧品管理法規：包括我國化粧品衛生管理規範、國際間化粧品管理規範及我國化粧品產品資訊檔案制度；至少四小時。
二、化粧品成分之應用及風險：包括美白、防曬、止汗、制臭、染髮、燙髮與其他成分之作用原理與安全性，及化粧品常見不良反應或違規案例；至少八小時。
三、化粧品安全評估方式：包括皮膚生理解剖學、化粧品經皮吸收能力、化粧品皮膚刺激、光老化與光過敏之機轉與臨床症狀、奈米安全性評估、天然物化粧品安全性評估、化粧品風險評估、毒理評估方法（皮膚刺激性、皮膚敏感性、皮膚腐蝕性、眼睛刺激性及基因毒性與致突變性測試）、系統性毒性與安全臨界值及動物試驗替代性方法；至少三十六小時。
四、產品安全性評估結論製作：至少六小時。
一、國內、外大學醫學系、藥學系、或化粧品學、毒理學及其相關系、所畢業。
二、於中華民國一百零八年六月三十日前，自國內、外大學化學或化工系、所畢業，具五年以上化粧品安全評估相關工作經驗。
前項安全性評估訓練課程之內容及時數，規定如下：
一、化粧品管理法規：包括我國化粧品衛生管理規範、國際間化粧品管理規範及我國化粧品產品資訊檔案制度；至少四小時。
二、化粧品成分之應用及風險：包括美白、防曬、止汗、制臭、染髮、燙髮與其他成分之作用原理與安全性，及化粧品常見不良反應或違規案例；至少八小時。
三、化粧品安全評估方式：包括皮膚生理解剖學、化粧品經皮吸收能力、化粧品皮膚刺激、光老化與光過敏之機轉與臨床症狀、奈米安全性評估、天然物化粧品安全性評估、化粧品風險評估、毒理評估方法（皮膚刺激性、皮膚敏感性、皮膚腐蝕性、眼睛刺激性及基因毒性與致突變性測試）、系統性毒性與安全臨界值及動物試驗替代性方法；至少三十六小時。
四、產品安全性評估結論製作：至少六小時。