因應世界潮流及國內未來化妝品管理走向日漸趨向業者自主管理，未來將走向登錄制度。因此安全評估方面日益重要，開設此課程包括一般安全性試驗方法及替代性試驗方法、相關各國法規介紹及比較，並將介紹產品資訊擋(products information file,PIF)與製作以及安全性評估之計算，亦將進行實例之演練及討論，促進學生於化妝品安全性評估之概念，教導學生有能力製作PIF，並可評估PIF之正確性，並配合業界未來人才之需求。
教學目標Course Objectives
將介紹各國法規, 目前化妝品安全評估面臨之挑戰, 具確效之替代性試驗方法, 產品資訊擋(products information file,PIF)
The regulation in EU, Taiwan and The Association of Southeast Asian Nations (ASEAN).
What are the current challenges in safety assessment of cosmetics alternative methods? What is their actual use and how to perform these tests, What is a Product Information File
先修科目Prerequisites
藥理學
化妝品毒理學/毒理學
化妝品毒理學及風險評估特論
化妝品相關學科
Pharmacy
Cosmetic toxicology/Toxicology
Specific topics on cosmetic toxicology and risk assessment
Cosmstics
教學方式Teaching Methods
評量方式Assessment
參考書目Reference
1. Safety assessment course of cosmetics in EU
2.The regulations of Cosmetics
3.Casarett & Doull's Toxicology: The Basic Science of Poisons (Casarett & Doull Toxicology) by Louis J. Casarett (Nov 20, 2007)
3. Journal paper published in 2013 and 2014.
教學進度Course Schedule
2020/03/06 課程簡介
美白成分之作用原理、化粧品常見不合格案例與其安全性等
Introduction
The mechanism and safety of skin whiten agents.
溫國慶(WEN,KUO-CHING) 2020/03/06 我國現行化粧品衛生管理規範、我國化粧品修法方向及產品資訊
檔案制度規劃
東協化妝品管理法規
國際間化粧品管理規範
歐盟化妝品法規EC 1223/2009
Regulation of cosmetics in Taiwan and Association of Southeast Asian Nations (ASEAN)
Actual legislation of cosmetics in the EU : Regulation EC 1223/2009
溫國慶(WEN,KUO-CHING) 2020/03/06 皮膚生理解剖學病理學、老化與過敏之機轉
Skin physiology and phathalogy
The mechanisms of aging and skin sensitivity
江秀梅(Hsiu-Mei Chiang) 2020/03/13 安全評估之重要因素：危害、風險及風險評估
化粧品系統毒性評估及化粧品安全性評估
Hazard, risk, risk assessment and risk perception : key factors in the safety evaluation of cosmetics.
Exposure to cosmetics: general considerations, calculations
江秀梅(Hsiu-Mei Chiang) 2020/03/20 化粧品安全性評估
化妝品經皮吸收及相關體內體外及替代性測定模式
Dermal absorption of cosmetic ingredients : quantitative in vitro technique, practical and critical scientific considerations.
江秀梅(Hsiu-Mei Chiang) 2020/03/27 化妝品成分及產品之皮膚刺激性、皮膚敏感性、皮膚腐蝕性試驗與替代試驗方法及案例
In vitro evaluation of skin irritation of cosmetic ingredients and products.
Skin sensitization : clinical aspects, mechanism, human volunteer studies, investigated molecules..
江秀梅(Hsiu-Mei Chiang) 2020/04/03 放假
Bordline When is a product o longer a cosmetic
江秀梅(Hsiu-Mei Chiang)李宥萱(Lee, Yu- Hsuan) 2020/04/10 體內體外之眼睛刺激性評估及案例
In vivo and in vitro evaluation of eye irritation, including clinical aspects, and molecules and compounds concerned
溫國慶(WEN,KUO-CHING) 2020/04/17 化妝品安全評估(MOS 計算)
期中考
MOS
Mid-term
江秀梅(Hsiu-Mei Chiang)李宥萱(Lee, Yu- Hsuan) 2020/04/24 體外眼睛刺激性評估：案例
防曬、止汗/制臭等成分之作用原理、化粧品常見不合格案例與其安全性等
In vitro screening techniques of eye irritation
The mechanism and safety of sunscreen, deordants and Antiperspirant.
溫國慶(WEN,KUO-CHING) 2020/05/01 光刺激性及光敏感性及案例
Photoirritation and photoallergy : mechanism and EU in vitro method for photoirritation testing.
江秀梅(Hsiu-Mei Chiang) 2020/05/08 吸入性化妝品安全評估模式
in silico tools
Safety assessment of inhalation cosmetics.
in silico tools
李宥萱(Lee, Yu- Hsuan) 2020/05/15 化妝品中奈米物質之安全性評估及案例
防腐劑等成分之作用原理、化粧品常見不合格案例與其安全性等
Safety assessment of nanomaterials in cosmetic products.
The mechanism and safety of preservatives.
溫國慶(WEN,KUO-CHING)李宥萱(Lee, Yu- Hsuan) 2020/05/22 化妝品基因毒性及致突變性評估及案例
化粧品安全評估方式- 遵循3R理論進行化粧品之皮膚敏感性試驗
Genotoxicity and mutagenicity testing of cosmetics.
江秀梅(Hsiu-Mei Chiang) 2020/05/29 化妝品中天然物之安全性評估及案例
Safety assessment of natural ingredients.
江秀梅(Hsiu-Mei Chiang)李宥萱(Lee, Yu- Hsuan) 2020/06/05 染髮/燙髮等成分之作用原理、化粧品常見不合格案例與其安全性等
化妝品安全性評估報告實例
Some practical examples of safety assessment for cosmetic products.
溫國慶(WEN,KUO-CHING) 2020/06/12 化妝品之產品資訊檔之內容介紹及實作
Product information file of cosmetics
溫國慶(WEN,KUO-CHING)江秀梅(Hsiu-Mei Chiang)李宥萱(Lee, Yu- Hsuan) 2020/06/19 安全評估報告實作
期末考/期末報告
Some practical examples of safety assessment for cosmetic products.
Final-term
溫國慶(WEN,KUO-CHING)江秀梅(Hsiu-Mei Chiang)李宥萱(Lee, Yu- Hsuan) 2020/06/26 彈性教學 2020/07/03 彈性教學