從歐盟實施《化妝品產品資訊檔案》(簡稱PIF)後，接著是東協跟進。目前台灣於2019年5月30日通過了《化粧品產品資訊檔案管理辦法》，待2024年至2026年逐步實施。此外，對岸的中國也對於化妝品的監管有大幅度的修正，也是偏向歐盟的系統，目前法規已經通過並公布，待明年(2021年)元月正式施行。
如此，可以說一方面對於化妝品產品監管的模式做出了改變，另一方面則是更加重視化妝品的安全性這部分。
相應著PIF而來的，就是「安全資料簽署人員」(簡稱SA)，主要是對化妝品的安全性提出完整的安全性評估報告。
這方面歐盟、東協已運作許多年了，但台灣才剛要開始，導致化妝品產業的相關人員對此感到無所適從。
在撰寫化妝品安全性評估報告時，很常參考一個網站 Cosmetic Ingredient Review (CIR)當中的資料。這個於1976年成立並由美國FDA所支持會議，提出了很多關於化妝品原料的安全性報告，並且是透過實驗數據以及專家們的討論後，才做出最終的安全性報導(safety report)。
這次，先將CIR從2012年至今年(2020年)所討論的化妝品成分原料作出整理，希望能讓大家(也包含我自己)在之後找尋資料時可以更方便。
CIR專家會議報告彙整
|
屆數 |
暫定文件 |
最終文件 |
|
155 |
Beta-Alanine Diacetic Acid and Tetrasodium Glutamate Diacetate Cocosnucifera (Coconut)-Derived Ingredients Polysilicone-11
Benzophenones1 Silicates1 Acetyl Hexapeptide-8 and Acetyl Hexapeptide-8 Amide1 Diacetone Alcohol1 Levulinic Acid and Sodium Levulinate1 Red Algae-Derived Ingredients1 Saccharide Humectants1 Ubiquinone Ingredients1 |
59. Methylisothiazolinone 168. Adenosine Ingredients 167. Ascorbyl Glucoside and Sodium Ascorbyl Glucoside 166. Caprylhydroxamic Acid 163. Scutellaria baicalensis-Dervied Ingredients |
|
154 |
169. Adenosine [155] 168. Ascorbyl Glucoside [155] 166. Caprylhydroxamic Acid [155] 165. Glycerin Ethoxylates 164. Methicones 59. Methylisothiazolinone [155] 163. Scutellaria baicalensis [155] 162. Wheat |
161. Honey 154. Palm 153. Pomegranate 160. Soy 159. Vanilla |
|
153 |
161. Honey [154] 154. Palm Tree-derived Ingredients [154] 153. Pomegranate [154] 160. Soy [154] 159. Vanilla [154] |
158. Alkyl Amide MIPA 157. Capryloyl Salicylic Acid 156. Mannitol 155. MCI/MI |
|
152 |
158. Alkyl Amide MIPA [153] 157. Capryloyl Salicylic Acid [153] 156. Mannitol、Sorbitol、Xylitol [153] 155. MCI/MI [153] 154. Palm Tree [154] 153. Pomegranate [154] |
147. Brown Algae 141. Parabens 152. Silica |
|
151 |
141. Parabens [152] 152. Silica [152] |
151. Alkanoyl Lactyl Lactate Salts 150. Alkoxylated Fatty Amides 149. Basic Red 123. Polyaminopropyl Biguanide Squalane、Squalene |
|
150 |
147. Brown Algae [152] |
148. Benzyl Salicylate 146. Fatty Acids & Fatty Acid Salts 145. Salicylic Acid and Salicylates 149. Titanium Complexes |
|
149 |
151. Alkanoyl Lactyl Lactate Salts [151] 150. Alkoxylated Fatty Amides [151] 149. Basic Red 76 [151] 148. Benzyl Salicylate [150] 147. Brown Algae [152] 146. Fatty Acids & Fatty Acid Salts [150] 145. Salicylic Acid [150] |
144. Acrylates Copolymer 143. Hydroxyethyl Urea 142. Methylxanthines 139. Vinylpyrolidone Polymers |
|
148 |
144. Acrylates Copolymers [149] 143. Hydroxyethyl Urea [149] 142. Methylxanthines [149] 141. Parabens [152] 140. Titanium Complexes [150] 139. Vinylpyrrolidone Polymers [149] |
138. Dialkyl Dimer Dilinoleates 132. Ginkgo Biloba 137. Hydrogen Peroxide 136. Polyfluorinated Polymers 135. Polyol Phosphates |
|
147 |
138. Dialkyl Dimer Dilinoleates [148] 132. Ginkgo Biloba [148] 137. Hydrogen Peroxide [148] 136. Polyfluorinated Polymers [148] 135. Polyol phosphates [148] 134. Salicylates |
133. Eucalyptus globulus 131. Triphenyl Phosphate |
|
146 |
133. Eucalypus Globulus [147] 132. Ginkgo Biloba [148] 131. Triphenyl Phosphate [147] |
116. Alkane Diols 129. Malic Acid 125. Peppermint Sultaines 128. Witch Hazel 127. Zinc Salts |
|
145 |
116. Alkane Diols [146] 130. Alkyl Sultaines 129. Malic Acid and Sodium Malate [146] 125. Mentha piperita (Peppermint) [146] 128. Witch hazel [146] 127. Zinc Salts [146] |
126. Ammonia & Ammonium Hydroxide 124. Panthenol 119. Persulfates 117. Polysilsesquioxanes 122. Triglycerides |
|
144 |
116. Alkane Diols [146] 126. Ammonia and Ammonium Hydroxide [145] 125. Mentha piperita (Peppermint) [146] 124. Panthenol [145] 123. Polyaminopropyl Biguanide [151] 122. Triglycerides [145] |
114. Humulus Lupulus (Hops) 115. Bovine Milk Proteins & Protein Derivatives 120. Monoalkylglycol Dialkyl Acid Esters 118. Plant-Derived Proteins and Peptides 113. Polyurethanes 105. Shea 121. Skin and Connective Tissue-Derived Proteins and Peptides |
|
143 |
121. Ectodermal-Derived Proteins and Peptides [144] 120. Monoalkylglycol Dialkyl Acid Esters [144] 119. Persulfates [145] 118. Plant-Derived Proteins and Peptides [144] 117. Polysilsesquioxanes [145] |
111. Ethers and esters of ascorbic acid 110. Hydroxyethyl-3,4-104. Methylenedioxyaniline HCl |
|
142 |
116. Alkane Diols [146] 115. Bovine Milk Proteins [144] 105. Butyrospermum parkii (Shea) [144] 114. Humulus Lupulus (Hops) [144] 113. Polyurethanes [144] |
109. Acryloyldimethyltaurate Polymers 112. Butyl Polyoxyalkylene Ethers 108. Etidronic Acid and Salts of Etidronic Acid 107. Hydroflurocarbon 152a 106. Rosa canina-derived Ingredients |
|
141 |
112. Butyl Polyoxyalkylene Ethers [142] 111. Ethers and Esters of Ascorbic Acid [143] 110. Hydroxyethyl-3,4-Methylenedioxyaniline HCl [143] |
104. Acid Violet 43 103. Alkoxyl Alkyl Silanes 96. Carbonate Salts 102. Citrus Flower and Leaf 100. Citrus Plant and Seed 99. Dialkyl Carbonates 98. PEG Propylene Glycol Derivatives 97. Saccharide Esters |
|
140 |
109. Acryloyldimethyltaurate Polymers [142] 102. Citrus Flower and Leaf [141] 100. Citrus Plant and Seed [141] 108. Etidronic Acid [142] 107. Hydrofluorocarbon-152a [142] 106. Rosa Canina [142] 105. Shea [144] |
101. Citrus Peels 95. Helianthus Annuus (Sunflower) 93. Phosphoric Acid 91. Polyglyceryl Fatty Acid Esters Sarcosines 87. Trimellitic Anhydride Copolymers |
|
139 |
104. Acid Violet 43 [141] 103. Alkoxyl Alkyl Silanes[141] 102. Citrus Flower and Leaf[141] 101. Citrus Peels [140] 100. Citrus Plant and Seed [141] 99. Dialkyl Carbonates [141] 98. PEG Propylene Glycol Esters [141] 97. Saccharide Esters [141] 96. Simple Carbonate Salts [141] |
43. Chamomilla Recutita 90. Hexamethylene Diisocyanate (HDI) Polymers 94. Keratin 92. Sodium Sulfate |
|
138 |
43. Chamomilla Recutita Fatty Acyl Sarcosines [140] 90. HDI Polymers [139] 95. Helianthus Annuus (Sunflower) [140] 94. Keratin [139] 93. Phosphoric Acid & Simple Salts [140] 92. Sodium Sulfate [139] 87. Trimellitic Anhydride Copolymers [140] 91. Polyglyceryl Fatty Acid Esters [140] |
86. Alkonium Clays 84. Apple-Derived 89. 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate (hair dye) 88. Polymerized Tetramethylcyclotetrasiloxanes |
|
137 |
86. Alkonium Clays [138] 84. Apple-Derived Ingredients [138] 90. HDI Polymers [139] 89. 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate (hair dye) [138] 88. Polymerized Tetramethylcyclotetrasiloxanes [138] 87. Trimellitic Anhydride Copolymers [140] |
85. Alkyl Taurate Amides and Taurate Salts 80. Citrus Fruits 83. Inorganic Hydroxides 82. Monoglyceryl Monoesters 79. Nonoxynols 81. Silk Proteins |
|
136 |
86. Alkonium Clays [138] 85. Alkyl Taurate Amides and Taurate Salts [137] 84. Apple-derived Ingredients [138] 83. Inorganic Hydroxides [137] 82. Monoglyceryl Monoesters [137] 79. Nonoxynols [137] 81. Silk [137] |
78. Polysaccharide Gums 77. Soy Proteins and Peptides 76. Trialkyl Trimellitates |
|
135 |
80. Citrus Fruit [137] 79. Nonoxynols [137] 78. Polysaccharide Gums [136] 77. Soy Proteins and Soy Peptides [136] 76. Trialkyl Trimellitates [136] |
75. Centella Asiatica 69. PEGs Cocamine 74. Polyenes 73. Polysorbates |
|
134 |
75. Centella Asiatica-Derived Ingredients [135] 69. PEGs Cocamines [135] 74. Polyenes [135] 73. Polysorbates [135] |
72. Ceramides 71. Lecithin 70. PEG Diesters 68. Sodium Benzotriazolyl Butylphenol Sulfonate |
|
133 |
72. Ceramides [134] 71. Lecithin & other Phosphoglycerides [134] 70. PEG Diesters [134] 69. PEGs Cocamine [135] 68. Sodium Benzotriazolyl Butylphenol Sulfonate [134] |
67. Avena Sativa 66. Glycerin 54. Hydroquinone 65. PCA 64. Pegylated Alkyl Glycerides 51. p-Hydroxyanisole 63. Polysiloxanes 62. Propylene Glycol Esters 61. Sorbitan Esters |
|
132 |
67. Avena sativa [133] 66. Glycerin [133] 54. Hydroquinone [133] 51. p-Hydroxyanisole [133] 65. PCA (2-Pyrrolidone-5-Carboxylic Acid) [133] 64. PEGylated Alkyl Glycerides [133] 63. Polysiloxanes [133] 62. Propylene Glycol Esters [133] 61. Sorbitan Esters [133] |
60. Alkyl Phosphates 2-Amino-3-Hydroxypyridine (hair dye) 56. Camellia Sinensis Citrus-Derived Peel Oils 59. Methylisothiazolinone 58. Styrene Copolymers |
|
131 |
60. Alkyl Phosphates 2-amino-3-hydroxypyridine (hair dye) [132] 56. Camellia Sinensis [132] Citrus-Derived Peel Oils 54. Hydroquinone [133] 51. p-Hydroxyanisole [133] 59. Methylisothiazolinone [132] 58. Styrenes [132] |
57. Barium Sulfate 55. Fatty Acid Amidopropyl Dimethylamines 41. Hydrolyzed Wheat Protein and Hydrolyzed Wheat Gluten 53. Magnesium Sulfate 52. PEG-150 Pentaerythrityl Tetrastearate 47. Rosmarinus 50. Tripeptide-1, Hexapeptide-12, their Metal Salts and Fatty Acyl Derivatives, and Palmitoyl Tetrapeptide-7 |
|
130 |
57. Barium Sulfate [131] 56. Camellia Sinensis [132] 55. Fatty Acid Amidopropyl Dimethylamines [131] 41. Hydrolyzed Wheat Protein & Hydrolyzed Wheat Gluten [131] 54. Hydroquinone [133] 53. Magnesium Sulfate [131] 52. PEG-150 Pentaerythrityl Tetrastearate [131] 51. p-Hydroxyanisole [133] 47. Rosmarinus Officinalis (Rosemary) [131] 50. Tripeptide-1, Hexapeptide-12, their Metal Salts and Fatty Acyl Derivatives, and Palmitoyl Tetrapeptide-7 [131] |
49. Alkyl Betaines Monosaccharides, Disaccharides & Related Ingredients 48. Pentaerythrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate 46. Tocopherols & Tocotrienols |
|
129 |
49. Alkyl Betaines Monosaccharides, Disaccharides and Related Ingredients [130] 48. Pentaerythrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate [130] 47. Rosmarinus Officinalis (Rosemary) [131] 46. Tocopherols and Tocotrienols [130] |
39. Achillea Millefolium-Derived Ingredients 37. Alumina & Aluminum Hydroxide 45. Amino Acid Alkyl Amides 44. Anthemis Nobilis-Derived Ingredients 43. Chamomilla Recutita-Derived Ingredients 42. Formic Acid and Sodium Formate 40. Phytosterols |
|
128 |
39. Achillea Millefolium-Derived Ingredients [129] 45. Amino Acid Alkyl Amides [129] 44. Anthemis Nobilis-Derived Ingredients [129] 43. Chamomilla Recutita-Derived Ingredients [129] 42. Formic Acid and Sodium Formate [129] 41. Hydrolyzed Wheat Protein & Hydrolyzed Wheat Gluten [131] 40. Phytosterols [129] |
38. Alkyl PEG/PPG Ethers 36. Dialkyl Sulfosuccinate Salts 35. Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine) HCl (hair dye) 34. Isethionate Salts 24. Methyl Glucose Polyethers and Esters 33. Polyquaternium 22 & 39 32. Tromethamine |
|
127 |
39. Achillea Millefolium-Derived Ingredients 38. Alkyl PEG/PPG Ethers [129] 37. Alumina and Aluminum Hydroxide [129] 36. Dialkyl Sulfosuccinate Salts [128] 35. Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine) HCl (hair dye) [128] 34. Isethionate Salts [128] 25. Methyl Glucose Polyethers & Esters [128] 33. Polyquaternium-22 and Polyquaternium-39 [128] 32. Tromethamine [128] |
31. Animal- and Plant-Derived Amino Acids 30. Boron Nitride 25. Hypericum Perforatum 29. Nitrocellulose and Collodion |
|
126 |
31. Animal- and Plant- Derived Amino Acids [127] 30. Boron Nitride [127] 24. Methyl Glucose Polyethers and Esters [128] 29. Nitrocellulose [127] |
28. Alkyl Esters 27. Alkyl Ethylhexanoates 26. 6-Hydroxyindole 23. Modified Terephthalate Polymers 22. Nylon 21. Talc |
|
125 |
28. Alkyl Esters [126] 27. Alkyl Ethylhexanoates [126] 26. 6-Hydroxyindole [126] 25. Hypericum Perforatum-Derived Ingredients [127] 24. Methyl Glucose Polyethers and Esters [128] 23. Modified Terephthalate Polymers [126] 22. Nylon [126] 21. Talc [126] |
20. PEGylated Oils 19. Tin(IV) Oxide |
|
124 |
20. PEGylated Oils [125] 19. Tin(IV) Oxide [125] |
9. α-Amino Acids 14. Dimethicone Crosspolymers 11. Bis-Diglyceryl Polyacyladipate-2 and Bis-Diglyceryl Polyacyladipate-1 18. Borosilicate Glasses 10. Chlorphenesin 15. Diakyl Malates 12. Microbial Polysaccharides 17. Panax (spp) Root-Derived Ingredients 16. Polyether Lanolins 13. Vitis Vinifera (Grape)-Derived Ingredients |
|
123 |
18. Borosilicate Glasses [124] 17. Panax spp. Root-Derived Ingredients [124] 16. Polyether Lanolins [124] 15. Dialkyl Malates [124] 14. Dimethicone Crosspolymers [124] 13. Vitis Vinifera (Grape) Derived Ingredients [124] 12. Microbial Polysaccharide Gums [124] 11. Bis-Diglyceryl Polyacyladipates [124] 10. Chlorphenesin [124] 9. α Amino Acids [124] |
8. Cucumis Sativus 7. Synthetic Fluorphlogopite |
|
122 |
8. Cucumis sativus (cucumber) derived ingredients [123] 7. Synthetic Fluorphlogopite [123] |
6. Alkyl PEG sulfosuccinates 5. Ammonium hectorites 4. Citric acid group 2. Ethanolamine and ethanolamine salts 3. Ethanolamides 1. Galactomannans |
|
121 |
6. Alkyl PEG Sulfosuccinates [122] 5. Ammonium Hectorite Ingredients [122] 4. Citric Acid, Inorganic Citrate Salts and Alkyl Citrate Esters [122] 3. Ethanolamides [122] 2. Ethanolamine and Ethanolamine Salts [122] 1. Galactomannans [122] |
Alkyl Glyceryl Ethers
2-Amino-4-Hydroxyethylaminoanisole
Decyl Glucosides
Lauriminodipropionic Acid
Pentarylthityl Tetraesters |
|
120 |
|
Crosslinked Alkyl Acrylates |
註1：第155屆會議有多提出草稿文件，但此先編入暫時文件中
註2：原料前的編號主要依據暫訂文件中的順序作編號，以利對照何時成為最終文件
註3：暫訂文件中的原料後方編號為成為最終文件的會議屆數
參考資料來源：CIR Past Panel Meeting
如果仔細看的話，可以發現有些原料可能經過多次的修改與討論才成了最終文件，甚至有一、兩個原料是有發佈最終文件後，又再重新討論並重新發佈。而這些原料也表示安全評估人員在評估安全性時，特別需要注意的。
同時這也表示，安全性資料是與時俱進的，所以也要實時的更新作為評估依據的資料，才不會做出了錯誤的報告。
以上資料為彙整CIR網站中的資料，如有錯誤歡迎指出以利改正。
以上論述為個人觀點，不具任何代表性。
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