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研究生:方韻茹
研究生(外文):FANG, YUN-JU
論文名稱:探討臺灣化粧品法規正面表列中152種色素的安全性
論文名稱(外文):Discussion on the Safety of 152 Pigments on the Positive List of Cosmetic Regulation in Taiwan
指導教授:李文鴻李文鴻引用關係
指導教授(外文):LEE, WEN-HORNG
口試委員:龍明有林麗惠李文鴻
口試委員(外文):LONG, MING-YOULIN, LI-HUEILEE, WEN-HORNG
口試日期:2023-06-14
學位類別:碩士
校院名稱:萬能科技大學
系所名稱:化妝品應用與管理研究所在職專班
學門:民生學門
學類:美容學類
論文種類:學術論文
論文出版年:2023
畢業學年度:111
語文別:中文
論文頁數:300
中文關鍵詞:評估色素安全性毒理化粧品
外文關鍵詞:assesscolorantssafetytoxicitycosmetics
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本份研究旨在探討在臺灣市場中,化粧品法規正面表列中152種色素的安全性。色素可提供化粧品亮麗的顏色和美化外觀的效果,故經常被添加在化粧品當中。不過,某些色素對人體之健康而言,可能具使用上的潛在風險,因此正確評估色素之安全性對於化粧品產業來說非常關鍵。報告中收集了此152種色素之各類資訊,涵蓋色素的物理性質、化學性質、局部試驗資訊、毒理數據、法規資訊、及限制等,並針對這些資料進行詳盡的分析。另亦針對S公司之市售產品A進行安定性/穩定性試驗評估,以了解存於市售產品A的色素,是否具有一定程度的安全性。
據本研究結果所示,152種色素已有被長期使用的記錄,在正常合理的使用狀況下是安全的,且多種色素亦已經過廣泛的毒理學評估和安全性測試。然而,部份色素因具有安全性上的潛在風險,故法規給予相關使用限制。其中,4種色素只能使用在眼部用化粧品以外的產品,17種色素僅能添加在不會接觸到黏膜的產品中,還有36種色素僅能添加在使用後必須立即沖洗之產品當中。而因為色素化學結構與染髮劑之配方交互反應下可能會生成毒性,於152種色素中有36種不能添加在染髮產品中。另外,表列色素中有43種色素僅具有限的毒理數據,僅依歷史上消費者長期使用之記錄而列於正面表列中。故而當這些色素要被使用在產品中時,建議應依照法規屬性使用,保障其在產品中的安全性。本研究中之案例,S公司之市售產品A已上市三年,且無不良反應記錄及品質相關客訴記錄,佐以安定性試驗之結果及毒理數據計算,可證明其所含色素之安全性。
總結而言,化粧品法規之中正面表列的152種色素,大多數在依據法規建議且依照正常且合理的使用方式之下也是安全的。然而,對於可能有潛在安全性風險的色素,建議針對其所缺乏的毒理數據多加考量,才能更有信心地保障消費民眾的安全。
This study aims to investigate the safety of 152 colorants listed in the positive list of cosmetic regulation in Taiwan. Colorants are frequently used ingredients in cosmetics to provide vivid hues of products and enhance visual effects. However, some colorants may pose potential risks to human health, so making accurate safety assessments is crucial for the cosmetics industry. This report compiles information on 152 colorants, including their physical and chemical characteristics, testing data for specific target organs, toxicology information, regulatory details, and restrictions. A comprehensive analysis has been conducted based on this data. Additionally, stability tests were conducted on the commercially available Product A from Company S to assess the safety and stability of the colorants used in the product.
The results of this study indicate that the 152 colorants have been used for many years and are considered safe under normal and reasonable usage conditions. Many Colorants have undergone extensive toxicological evaluations and safety tests. However, some colorants carry potential safety risks, resulting in regulatory restrictions on their usage. Among these colorants, 4 are restricted to use in products other than eye cosmetics, 17 can only be added to products that do not come into contact with mucous membranes, and 36 can only be added to products that are immediately rinsed off after use. Furthermore, 36 colorants cannot be added to hair dye products due to potential toxicity resulting from the chemical structure of the colorants and their interaction with the hair dye formulations. Additionally, 43 colorants listed in the positive list have limited toxicological data and are included in the positive list solely based on historical records of long-term consumer use. Therefore, when incorporating these colorants into products, it is advisable to adhere to regulatory guidelines to ensure their safety. Furthermore, the commercially available product A from Company S, which has been on the market for three years, has no record of adverse reactions or quality-related complaints. The results of stability tests and calculations of toxicological data provide additional evidence of the safety and stability of the Colorants present in the product.
In conclusion, the majority of the 152 colorants listed in the positive list of cosmetic regulations are considered safe for use when following regulatory recommendations and under normal and reasonable conditions. However, for colorants that may pose safety risks, it is advisable to carefully consider the lack of toxicological data to ensure user safety with greater confidence.
摘要 iii
Abstract v
致謝 vii
目錄 viii
表目錄 xvi
圖目錄 xvi
第一章 緒論 1
1.1 研究背景以及研究動機 1
1.2 化粧品規範演進─產品資訊檔案中色素安全性分析 2
1.2.1 臺灣化粧品產品資訊檔案之內容與演進 2
1.2.2 臺灣法規中152種色素正面表列之制定 4
1.2.3 化粧品產品資訊檔案中的色素安全性的評估 5
1.3 研究目的 6
第二章 文獻探討 7
2.1 美國、歐盟及臺灣化粧品色素規範 7
2.1.1 歐盟化粧品用色素的分類應用及正面表列 8
2.2.2 美國化粧品用色素的分類應用 9
2.2.3 臺灣化粧品中色素的分類應用及限制 9
2.3 色素的化學性質、物理性質、毒理特性以及安全性 16
第三章 研究方法 19
3.1 色素成份之物理性質、化學性質、及毒理特性資料 19
3.1.1 CI 10006 [7][8][9][15] 19
3.1.2 CI 10020 [7][8][14][15] 20
3.1.3 CI 10316 [7][8][16] 22
3.1.4 CI 11680 [7][8][9] 23
3.1.5 CI 11710 [7][8][9] 25
3.1.6 CI 11725 [7][8][15] 26
3.1.7 CI 11920 [7][8][17] 27
3.1.8 CI 12010 [7][8][15] 29
3.1.9 CI 12085 [7][8][9] 30
3.1.10 CI 12120 [7][8][9] 32
3.1.11 CI 12370 [7][8][9] 33
3.1.12 CI 12420 [7][8][9][15] 35
3.1.13 CI 12480 [7][8][15] 36
3.1.14 CI 12490 [7][8][9] 38
3.1.15 CI 12700 [7][8][9][15] 39
3.1.16 CI 13015 [7][8][9] 41
3.1.17 CI 14270 [7][8][9] 42
3.1.18 CI 14700 [7][8][9] 44
3.1.19 CI 14720 [7][8][9] 46
3.1.20 CI 14815 [7][8][9][18] 47
3.1.21 CI 15510 [7][8][9][19] 48
3.1.22 CI 15525 [7][8][9] 50
3.1.23 CI 15580 [7][8][9] 51
3.1.24 CI 15620 [7][8][9] 53
3.1.25 CI 15630 [7][8][9] 54
3.1.26 CI 15800 [7][8][9][15] 56
3.1.27 CI 15850 [7][8][20] 57
3.1.28 CI 15865 [7][8][9] 59
3.1.29 CI 15880 [7][8][9] 61
3.1.30 CI 15980 [7][8][9] 62
3.1.31 CI 15985 [7][8][9] 64
3.1.32 CI 16035 [7][8][21] 65
3.1.33 CI 16185 [7][8][9] 67
3.1.34 CI 16230 [7][8][9] 68
3.1.35 CI 16255 [7][8][9][22] 70
3.1.36 CI 16290 [7][8][9] 71
3.1.37 CI 17200 [7][8][9][23] 73
3.1.38 CI 18050 [7][8][9] 74
3.1.39 CI 18130 [7][8][9][15] 76
3.1.40 CI 18690 [7][8][9][15] 77
3.1.41 CI 18736 [7][8][9][15] 79
3.1.42 CI 18820 [7][8][9][15] 80
3.1.43 CI 18965 [7][8][9][15] 82
3.1.44 CI 19140 [7][8][9][24] 83
3.1.45 CI 20040 [7][8][9][15] 85
3.1.46 CI 20470 [7][8][9][25] 86
3.1.47 CI 21100 [7][8][9] 88
3.1.48 CI 21108 [7][8][9] 90
3.1.49 CI 21230 [7][8][9][15] 91
3.1.50 CI 24790 [7][8][9][15] 93
3.1.51 CI 26100 [7][8][9][26] 94
3.1.52 CI 27755 [7][8][9][15] 96
3.1.53 CI 28440 [7][8][9] 98
3.1.54 CI 40215 [7][8][9] 99
3.1.55 CI 40800 [7][8][9][27] 101
3.1.56 CI 40820 [7][8][9] 102
3.1.57 CI 40825 [7][8][9][28] 103
3.1.58 CI 40850 [7][8][9][29] 105
3.1.59 CI 42045 [7][8][9] 107
3.1.60 CI 42051 [7][8][9][30] 108
3.1.61 CI 42053 [7][8][9][15] 110
3.1.62 CI 42080 [7][8][9][15][31] 111
3.1.63 CI 42090 [7][8][9][32] 113
3.1.64 CI 42100 [7][8][9][15] 115
3.1.65 CI 42170 [7][8][9][15] 116
3.1.66 CI 42520 [7][8][9][15][33] 118
3.1.67 CI 42735 [7][8][9] 119
3.1.68 CI 44090 [7][8][9][15] 121
3.1.69 CI 45100 [7][8][9][34] 122
3.1.70 CI 45190 [7][8][9][15] 124
3.1.71 CI 45220 [7][8][9][15] 125
3.1.72 CI 45350 [7][8][9] 127
3.1.73 CI 45370 [7][8][9] 128
3.1.74 CI 45380 [7][8][9] 130
3.1.75 CI 45396 [7][8][9] 132
3.1.76 CI 45405 [7][8][9] 133
3.1.77 CI 45410 [7][8][9] 134
3.1.78 CI 45430 [7][8][9][35] 136
3.1.79 CI 47000 [7][8][9][15] 138
3.1.80 CI 47005 [7][8][9][36][37] 139
3.1.81 CI 50325 [7][8][9][15] 141
3.1.82 CI 50420 [7][8][9][15] 142
3.1.83 CI 51319 [7][8][9][15] 143
3.1.84 CI 58000 [7][8][9] 145
3.1.85 CI 59040 [7][8][9] 146
3.1.86 CI 60724 [7][8][9][15] 148
3.1.87 CI 60725 [7][8][9] 149
3.1.88 CI 60730 [7][8][9] 151
3.1.89 CI 61565 [7][8][9] 152
3.1.90 CI 61570 [7][8][9] 154
3.1.91 CI 61585 [7][8][9] 155
3.1.92 CI 62045 [7][8][9] 157
3.1.93 CI 69800 [7][8][9] 158
3.1.94 CI 69825 [7][8][9] 160
3.1.95 CI 71105 [7][8][9] 161
3.1.96 CI 73000 [7][8][9] 162
3.1.97 CI 73015 [7][8][9][38] 164
3.1.98 CI 73360 [7][8][9] 165
3.1.99 CI 73385 [7][8][9] 167
3.1.100 CI 73900 [7][8][9] 168
3.1.101 CI 73915 [7][8][9] 170
3.1.102 CI 74100 [7][8][9] 171
3.1.103 CI 74160 [7][8][9] 172
3.1.104 CI 74180 [7][8][9][15] 174
3.1.105 CI 74260 [7][8][9] 175
3.1.106 CI 75100 [7][8][39] 177
3.1.107 CI 75120 [7][8][9][40] 179
3.1.108 CI 75125 [7][8][9][41] 180
3.1.109 CI 75130 [7][8][9] 182
3.1.110 CI 75135 [7][8] 183
3.1.111 CI 75170 [7][8][9] 185
3.1.112 CI 75300 [7][8][9][42] 186
3.1.113 CI 75470 [7][8][9][43] 188
3.1.114 CI 75810 [7][8][9][44] 189
3.1.115 CI 77000 [7][8][9][45] 191
3.1.116 CI 77002 [7][8][9][46] 192
3.1.117 CI 77004 [7][8][9][47] 193
3.1.118 CI 77007 [7][8][9][48] 195
3.1.119 CI 77015 [7][8][9] 196
3.1.120 CI 77019 [7][8][9][49][50] 198
3.1.121 CI 77120 [7][8][9][51][52] 199
3.1.122 CI 77163 [7][8][9][15] 201
3.1.123 CI 77220 [7][8][9][53] 202
3.1.124 CI 77231 [7][8][9] 203
3.1.125 CI 77266 [7][8][9][54] 205
3.1.126 CI 77267 [7][8][9][54] 206
3.1.127 CI 77268:1 [7][8][9][54] 207
3.1.128 CI 77288 [7][8][9] 209
3.1.129 CI 77289 [7][8][9][55] 210
3.1.130 CI 77346 [7][8][9] 211
3.1.131 CI 77400 [7][8][9][55] 213
3.1.132 CI 77480 [7][8][9][56] 214
3.1.133 CI 77489 [7][8][9] 215
3.1.134 CI 77491 [7][8][9][57] 216
3.1.135 CI 77492 [7][8][9][57] 218
3.1.136 CI 77499 [7][8][9][57] 219
3.1.137 CI 77510 [7][8][9] 221
3.1.138 CI 77713 [7][8][9][58] 222
3.1.139 CI 77742 [7][8][9] 223
3.1.140 CI 77745 [7][8][9] 225
3.1.141 CI 77820 [7][8][9][59] 226
3.1.142 CI 77891 [7][8][9][60][61] 227
3.1.143 CI 77947 [7][8][9][62] 229
3.1.144 Lactoflavin [7][8][9][63] 230
3.1.145 Caramel [7][8][9][64] 232
3.1.146 Capsanthin, capsorubin [7][8][9][65] 233
3.1.147 Beetroot Red [7][8][9][66] 235
3.1.148 Anthocyanins [7][8][9][67] 236
3.1.149-1 Aluminum Stearate [7][8][9][68] 238
3.1.149-2 Zinc Stearate [7][8][9][68] 239
3.1.149-3 Magnesium Stearate [7][8][9][68] 241
3.1.149-4 Calcium Stearate [7][8][9][68] 242
3.1.150 Bromothymol Blue [7][8][9][15] 243
3.1.151 Bromocresol Green [7][8][9][15] 245
3.1.152 Acid Red 195 [7][8][9][15] 246
3.2 化粧品產品安定性測試 248
第四章 結果與討論 252
4.1 152種色素成份分析整理結果 252
4.2 產品A中色素的安全性 271
4.2.1 產品中各色素之安全限值 271
第五章 結論 273
參考文獻 274
附錄 281
附錄一、歐盟化粧品色素正面表列(共153種)[1] 281
附錄二、美國可用色素表列(共65種) 298

表目錄
表1- 1:化粧品色素分類說明[5] 5
表2- 1 歐盟化粧品可用色素之分類 8
表2- 2 美國化粧品可用之色素的分類 9
表2- 3 化粧品色素成份使用限制表修正規定[5] 10
表2- 4 19項不適用於化粧品色素成份使用限制表附註三之色素表列 15
表2- 5 化學性質以及物理性質 17
表2- 6 毒理特性 18
表3- 1 S公司市售產品A中含有之色素成份含量範圍 249
表3- 2 S公司市售產品A產品規格範圍 250
表3- 3 三個月安定性測試 250
表3- 4 兩個月高溫安定性測試 251
表3- 5 -18℃至25℃溫度循環測試四次 251
表3- 6 UV光照測試 251

圖目錄
圖1- 1 化粧品登錄、各類型化粧品的產品資訊檔案及GMP實行日期[3] 3
圖1- 2 製作指引中所列出之PIF所需內容[4] 4
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