法規工具
FDA 化妝品禁用與限用成分、色素添加劑
美國沒有「已使用原料目錄」這種正面清單 —— 除色素外,化妝品成分上市前不需要批准。所以這裡收的是**禁用/限用清單**與 21 CFR 73/74/82 的色素添加劑清單。另外 MoCRA 之後設施註冊與產品列名是強制的,那是另一條線,見備案索引。
共 74 條
| 編號 | 化學名稱 / 描述 | INCI 名稱 | CAS 號 | 功能 · 附錄 · 限量 |
|---|---|---|---|---|
| US-01 | 硫雙二氯酚 | Bithionol | — | 禁用 · 21 CFR 700.11 · The use of bithionol is prohibited because it may cause photocontact sensitization (21 CFR 700.11). |
| US-02 | 氟氯烴類推進劑(CFC) | Chlorofluorocarbon propellants | — | 禁用 · 21 CFR 700.23 · The use of chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23). |
| US-03 | 氯仿 | Chloroform | — | 禁用 · 21 CFR 700.18 · The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18). |
| US-04 | 滷代水楊酰苯胺類(二溴、三溴、四氯水楊酰苯胺等) | Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) | — | 禁用 · 21 CFR 700.15 · These are prohibited in cosmetic products because they may cause serious skin disorders (21 CFR 700.15). |
| US-05 | 六氯酚 | Hexachlorophene | — | 限用 · Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when no other preservative has been shown to be as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250). |
| US-06 | 汞化合物 | Mercury compounds | — | 限用(僅眼部區域防腐且無替代時,痕量) · 21 CFR 700.13 · Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic problems. The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 per |
| US-07 | 二氯甲烷 | Methylene chloride | — | 禁用 · 21 CFR 700.19 · It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19). |
| US-08 | 禁用牛源物質(瘋牛病風險材料) | Prohibited cattle materials | — | 禁用 · To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials |
| US-09 | 化妝品中的防曬劑(按 OTC 藥品監管) | Sunscreens in cosmetics | — | 限用/按藥品管理 · 21 CFR 700.35 · Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products. |
| US-10 | 氯乙烯(氣霧劑推進劑) | Vinyl chloride | — | 禁用 · 21 CFR 700.14 · The use of vinyl chloride is prohibited as an ingredient of aerosol products, because it causes cancer and other health problems (21 CFR 700.14). |
| US-11 | 含鋯絡合物(氣霧劑) | Zirconium-containing complexes | — | 禁用 · 21 CFR 700.16 · The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin (21 CFR 700.16). |
| US-73.2030 | Annatto | Annatto | — | 21 CFR 73.2030 化妝品準用色素 · 含眼部用途 · 免認證 |
| US-73.2085 | Caramel | Caramel | — | 21 CFR 73.2085 化妝品準用色素 · 免認證 · Caramel is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2087 | Carmine | Carmine | — | 21 CFR 73.2087 化妝品準用色素 · 含眼部用途 · 免認證 |
| US-73.2095 | β-Carotene | β-Carotene | — | 21 CFR 73.2095 化妝品準用色素 · 含眼部用途 · 免認證 · The color additive β-carotene may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices. |
| US-73.2110 | Bismuth citrate | Bismuth citrate | — | 21 CFR 73.2110 化妝品準用色素 · 免認證 · The color additive bismuth citrate may be safely used in cosmetics intended for coloring hair on the scalp, subject to the following restrictions: (1) The amount of bismuth citrate in the cosmetic shall not be in excess of 2.0 percent (w/v). (2) The cosmetic m |
| US-73.2120 | Disodium EDTA-copper | Disodium EDTA-copper | — | 21 CFR 73.2120 化妝品準用色素 · 免認證 · Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics. |
| US-73.2125 | Potassium sodium copper chlorophyllin (chlorophyllin-copper complex) | Potassium sodium copper chlorophyllin (chlorophyllin-copper complex) | — | 21 CFR 73.2125 化妝品準用色素 · 免認證 |
| US-73.2150 | Dihydroxyacetone | Dihydroxyacetone | — | 21 CFR 73.2150 化妝品準用色素 · 僅外用 · 免認證 · Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied cosmetics intended solely or in part to impart a color to the human body. |
| US-73.2162 | Bismuth oxychloride | Bismuth oxychloride | — | 21 CFR 73.2162 化妝品準用色素 · 含眼部用途 · 僅外用 · 免認證 · The color additive bismuth oxychloride may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2180 | Guaiazulene | Guaiazulene | — | 21 CFR 73.2180 化妝品準用色素 · 僅外用 · 免認證 · Guaiazulene may be safely used in externally applied cosmetics in amounts consistent with good manufacturing practice. |
| US-73.2190 | Henna | Henna | — | 21 CFR 73.2190 化妝品準用色素 · 免認證 · The color additive henna may be safely used for coloring hair only. It may not be used for coloring the eyelashes or eyebrows, or generally in the area of the eye. |
| US-73.2250 | Iron oxides | Iron oxides | — | 21 CFR 73.2250 化妝品準用色素 · 免認證 · Iron oxides are safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2298 | Ferric ammonium ferrocyanide | Ferric ammonium ferrocyanide | — | 21 CFR 73.2298 化妝品準用色素 · 僅外用 · 免認證 · Ferric ammonium ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2299 | Ferric ferrocyanide | Ferric ferrocyanide | — | 21 CFR 73.2299 化妝品準用色素 · 僅外用 · 免認證 · Ferric ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2326 | Chromium hydroxide green | Chromium hydroxide green | — | 21 CFR 73.2326 化妝品準用色素 · 僅外用 · 免認證 · Chromium hydroxide green is safe for use in coloring externally applied cosmetics, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2327 | Chromium oxide greens | Chromium oxide greens | — | 21 CFR 73.2327 化妝品準用色素 · 含眼部用途 · 僅外用 · 免認證 · The color additive chromium oxide greens may be safely used in externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2329 | Guanine | Guanine | — | 21 CFR 73.2329 化妝品準用色素 · 含眼部用途 · 僅外用 · 免認證 |
| US-73.2400 | Pyrophyllite | Pyrophyllite | — | 21 CFR 73.2400 化妝品準用色素 · 僅外用 · 免認證 · Pyrophyllite may be safely used for coloring externally applied cosmetics, in amounts consistent with good manufacturing practice. |
| US-73.2496 | Mica | Mica | — | 21 CFR 73.2496 化妝品準用色素 · 免認證 · Mica is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2500 | Silver | Silver | — | 21 CFR 73.2500 化妝品準用色素 · 免認證 · The color additive silver may be safely used for coloring fingernail polish at a level not to exceed 1 percent of the final product. |
| US-73.2550 | Silver nitrate | Silver nitrate | — | 21 CFR 73.2550 化妝品準用色素 · 僅外用 · 免認證 |
| US-73.2575 | Titanium dioxide | Titanium dioxide | — | 21 CFR 73.2575 化妝品準用色素 · 免認證 · The color additive titanium dioxide may be safely used in cosmetics, including cosmetics intended for use in the ara of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2645 | Aluminum powder | Aluminum powder | — | 21 CFR 73.2645 化妝品準用色素 · 含眼部用途 · 僅外用 · 免認證 · Aluminum powder may be safely used in coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2646 | Bronze powder | Bronze powder | — | 21 CFR 73.2646 化妝品準用色素 · 含眼部用途 · 免認證 · Bronze powder may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2647 | Copper powder | Copper powder | — | 21 CFR 73.2647 化妝品準用色素 · 含眼部用途 · 免認證 · Copper powder may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2725 | Ultramarines | Ultramarines | — | 21 CFR 73.2725 化妝品準用色素 · 含眼部用途 · 僅外用 · 免認證 · The ultramarine pigments may be safely used for coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2775 | Manganese violet | Manganese violet | — | 21 CFR 73.2775 化妝品準用色素 · 免認證 · Manganese violet is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2991 | Zinc oxide | Zinc oxide | — | 21 CFR 73.2991 化妝品準用色素 · 含眼部用途 · 免認證 · Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. |
| US-73.2995 | Luminescent zinc sulfide | Luminescent zinc sulfide | — | 21 CFR 73.2995 化妝品準用色素 · 僅外用 · 免認證 |
| US-74.2052 | D&C Black No. 2 | D&C Black No. 2 | — | 21 CFR 74.2052 化妝品準用色素 · 須批次認證 · D&C Black No. 2 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel. |
| US-74.2053 | D&C Black No. 3 | D&C Black No. 3 | — | 21 CFR 74.2053 化妝品準用色素 · 須批次認證 · Cosmetics containing D&C Black No. 3 must comply with § 700.27 of this chapter with respect to prohibited cattle materials in cosmetic products. D&C Black No. 3 may be safely used for coloring the following cosmetics in amounts consistent with current good man |
| US-74.2101 | FD&C Blue No. 1 | FD&C Blue No. 1 | — | 21 CFR 74.2101 化妝品準用色素 · 含眼部用途 · 須批次認證 · (1) FD&C Blue No. 1 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for color |
| US-74.2104 | D&C Blue No. 4 | D&C Blue No. 4 | — | 21 CFR 74.2104 化妝品準用色素 · 僅外用 · 須批次認證 · D&C Blue No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. |
| US-74.2151 | D&C Brown No. 1 | D&C Brown No. 1 | — | 21 CFR 74.2151 化妝品準用色素 · 僅外用 · 須批次認證 · D&C Brown No. 1 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. |
| US-74.2203 | FD&C Green No. 3 | FD&C Green No. 3 | — | 21 CFR 74.2203 化妝品準用色素 · 須批次認證 · The color additive FD&C Green No. 3 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. |
| US-74.2205 | D&C Green No. 5 | D&C Green No. 5 | — | 21 CFR 74.2205 化妝品準用色素 · 含眼部用途 · 須批次認證 · D&C Green No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. |
| US-74.2206 | D&C Green No. 6 | D&C Green No. 6 | — | 21 CFR 74.2206 化妝品準用色素 · 僅外用 · 須批次認證 · D&C Green No. 6 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. |
| US-74.2208 | D&C Green No. 8 | D&C Green No. 8 | — | 21 CFR 74.2208 化妝品準用色素 · 僅外用 · 須批次認證 · D&C Green No. 8 may be safely used for coloring externally applied cosmetics in amounts not exceeding 0.01 percent by weight of the finished cosmetic product. |
| US-74.2254 | D&C Orange No. 4 | D&C Orange No. 4 | — | 21 CFR 74.2254 化妝品準用色素 · 僅外用 · 須批次認證 · D&C Orange No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. |
來源:美國食品藥品監督管理局。本頁逐條轉錄官方清單,不做增刪改;收錄不等於準用,限值與條件以最新官方文本為準。
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