원료수재근거 |
■ U.S. Colorants
The term color additive is defined, in part, by U.S. law as a material which:
(A) is a dye, pigment, or other substance made by a process of synthesis, or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and;
(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substances) of imparting color thereto. Federal Food, Drug, and Cosmetic Act, Section 201(t)(1).
In the United States, a cosmetic containing a colorant (except a coal-tar hair dye) that is not approved by the FDA is regarded as adulterated and subject to regulatory action by FDA. Federal Food, Drug, and Cosmetic Act, Section 601(e).
NOTE: An exception to this requirement exists for coal-tar (synthetic organic) colorants used in hair dyes, provided other regulatory requirements are met (see information in this section under U.S. Hair Colorants and the U.S. Hair Dye Exemption).
Colorants approved for use in the United States are listed in Title 21 of the U.S. Code of Federal Regulations, 21 CFR, Parts 73, 74, and 82.
A listing of the INCI names of U.S. approved colorants may be found in Section 3, Chemical Classes, under the following headings:
. Color Additives - Batch Certified by the U.S. Food and Drug Administration . Color Additive Lakes - Batch Certified by the U.S. Food and Drug Administration . Color Additives - Exempt from Batch Certification by the U.S. Food and Drug Administration
Color Additives Subject to Batch Certification With the exception of coal-tar hair dyes, all synthetic organic color additives are subject to batch certification by the FDA. Each batch of an approved synthetic organic colorant must be tested and certified by the FDA as meeting standards and specifications found in 21 CFR 74.
Color Additives Exempt from Batch Certification Some U.S. approved colorants are exempt from batch certification by the FDA. In order to be legally used in the U.S., however, these colorants must meet specification and use restrictions stipulated in 21 CFR 73.
Abbreviated Labeling Names for U.S. Colorants Official names for colorants subject to batch certification may be found in 21 CFR Parts 73, 74, and 82. These names must be used by the colorant manufacturer to identify the product that has been batch certified by the FDA. Industry proposed an alternative labeling scheme for cosmetic product labeling, and the FDA agreed to accept abbreviated names.
FDA originally proposed the use of abbreviated names for U.S. colorants in the Federal Register on June 6, 1985 (50 FR 23815). At that time, the FDA stated that firms may use the abbreviated names on product labels. In correspondence with CTFA, dated June 7, 1999, the FDA reaffirmed its intention to permit cosmetic firms to use the abbreviated names on product labels while a final rule on the matter is pending.
The abbreviated labeling names apply only to U.S. color additives that are subject to batch certification. Under this scheme, the cosmetic product manufacturer does not have to include FD&C or D&C, EXT, or the type of lake Aluminum, Zirconium, etc., on their product labels. Examples of the abbreviated and the original names associated with U.S. colorants are:
Abbreviated Labeling Name --/-- U.S. FDA Batch Certification Name Blue 1 --/-- FD&C Blue No. 1 Red 6 --/-- D&C Red No. 6 Ext. Violet 2 --/-- Ext. D&C Violet No. 2 Red 40 Lake --/-- FD&C Red No. 40 Aluminum Lake
Other Restrictions for U.S. Colorants There may be specific use restrictions for some U.S. approved colorants, such as: nor external use except eye area. Restrictions for U.S. approved colorants may be found in 21 CFR 73, 74, and 83.
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AEC Microcapsule White Vitamin E (A & E CONNOCK (PERFUMERY & COSMETICS) LTD.) Argile Verte (ARGILETZ S.A.) Bi-Lite 20, 1070 (ENGELHARD CORPORATION) Bi-Lite Ultralite 3186 (ENGELHARD CORPORATION) Bi-Lite Ultrapress 1082 (ENGELHARD CORPORATION) Bi-Lite Ultrawhite 1084 (ENGELHARD CORPORATION) Cardre Mica 8 RFHC (CARDRE, INC.) Cardre Sericite RFHC (CARDRE, INC.) Cashmir K-II (PRESPERSE, INC.) Cellini Blue (ENGELHARD CORPORATION) Cellini Coral (ENGELHARD CORPORATION) Cellini Green (ENGELHARD CORPORATION) Cellini Red (ENGELHARD CORPORATION) Cellini Yellow (ENGELHARD CORPORATION) Chroma-Lite Aqua 4508 (ENGELHARD CORPORATION) Chroma-Lite Black 4498 (ENGELHARD CORPORATION) Chroma-Lite Bronze 4499 (ENGELHARD CORPORATION) Chroma-Lite Brown 4509 (ENGELHARD CORPORATION) Chroma-Lite Dark Blue 4501 (ENGELHARD CORPORATION) Chroma-Lite Gold 4504 (ENGELHARD CORPORATION) Chroma-Lite Green 4503 (ENGELHARD CORPORATION) Chroma-Lite Light Blue 4500 (ENGELHARD CORPORATION) Chroma-Lite Magenta 4505 (ENGELHARD CORPORATION) Chroma-Lite Mauve 4511 (ENGELHARD CORPORATION) Chroma-Lite Purple 4510 (ENGELHARD CORPORATION) Chroma-Lite Red 4506 (ENGELHARD CORPORATION) Chroma-Lite Violet 4507 (ENGELHARD CORPORATION) Chroma-Lite Yellow 4502 (ENGELHARD CORPORATION) Cloisonne Blue (ENGELHARD CORPORATION) Cloisonne Blue Flambe (ENGELHARD CORPORATION) Cloisonne Blue-Green (ENGELHARD CORPORATION) Cloisonne Cerise Flambe (ENGELHARD CORPORATION) Cloisonne Copper (ENGELHARD CORPORATION) Cloisonne Gold (ENGELHARD CORPORATION) Cloisonne Gold CC (ENGELHARD CORPORATION) Cloisonne Golden Bronze (ENGELHARD CORPORATION) Cloisonne Green (ENGELHARD CORPORATION) Cloisonne Imperial Gold (ENGELHARD CORPORATION) Cloisonne Monarch Gold (ENGELHARD CORPORATION) Cloisonne Nu-Antique Blue (ENGELHARD CORPORATION) Cloisonne Nu-Antique Bronze (ENGELHARD CORPORATION) Cloisonne Nu-Antique Copper (ENGELHARD CORPORATION) Cloisonne Nu-Antique Gold (ENGELHARD CORPORATION) Cloisonne Nu-Antique Green (ENGELHARD CORPORATION) Cloisonne Nu-Antique Red (ENGELHARD CORPORATION) Cloisonne Nu-Antique Rouge Flambe (ENGELHARD CORPORATION) Cloisonne Nu-Antique Super Green (ENGELHARD CORPORATION) Cloisonne Orange (ENGELHARD CORPORATION) Cloisonne Red (ENGELHARD CORPORATION) Cloisonne Red CC (ENGELHARD CORPORATION) Cloisonne Regal Gold (ENGELHARD CORPORATION) Cloisonne Rouge Flambe (ENGELHARD CORPORATION) Cloisonne Satin Bronze (ENGELHARD CORPORATION) Cloisonne Satin Copper (ENGELHARD CORPORATION) Cloisonne Satin Gold (ENGELHARD CORPORATION) Cloisonne Satin Rouge (ENGELHARD CORPORATION) Cloisonne sparkle Blue (ENGELHARD CORPORATION) Cloisonne Sparkle Blue Rouge (ENGELHARD CORPORATION) Cloisonne Sparkle Bronze (ENGELHARD CORPORATION) Cloisonne Sparkle Copper (ENGELHARD CORPORATION) Cloisonne Sparkle Gold (ENGELHARD CORPORATION) Cloisonne Sparkle Red (ENGELHARD CORPORATION) Cloisonne Sparkle Rouge (ENGELHARD CORPORATION) Cloisonne Super Blue (ENGELHARD CORPORATION) Cloisonne Super Bronze (ENGELHARD CORPORATION) Cloisonne Super Copper (ENGELHARD CORPORATION) Cloisonne Super Gold (ENGELHARD CORPORATION) Cloisonne Super Green (ENGELHARD CORPORATION) Cloisonne Super Red (ENGELHARD CORPORATION) Cloisonne Super Rouge (ENGELHARD CORPORATION) Cloisonne Violet (ENGELHARD CORPORATION) Colorona Blackstar Blue (RONA) Colorona Blackstar Gold (RONA) Colorona Blackstar Green (RONA) Colorona Blackstar Red (RONA) Colorona Bordeaux (RONA) Colorona Bright Gold (RONA) Colorona Bronze (RONA) Colorona Bronze Fine (RONA) Colorona Bronze Sparkle (RONA) Colorona Carmine Red (RONA) Colorona Chameleon (RONA) Colorona Copper (RONA) Colorona Copper Fine (RONA) Colorona Copper Sparkle (RONA) Colorona Dark Blue (RONA) Colorona Glitter Bordeaux (RONA) Colorona Glitter Bronze (RONA) Colorona Glitter Chameleon (RONA) Colorona Glitter Copper (RONA) Colorona Glitter Sienna (RONA) Colorona Imperial Red (RONA) Colorona Light Blue (RONA) Colorona Magenta (RONA) Colorona Majestic Green (RONA) Colorona Oriental Beige (RONA) Colorona Passion Orange (RONA) Colorona Patina Gold (RONA) Colorona Patina Silver (RONA) Colorona Red Brown (RONA) Colorona Red Gold (RONA) Colorona Russet (RONA) Colorona Sienna (RONA) Colorona Sienna Fine (RONA) Colorona Sienna Sparkle (RONA) Cosmica Blue (ENGELHARD CORPORATION) Cosmica Orange (ENGELHARD CORPORATION) Cosmica Red (ENGELHARD CORPORATION) Covamat (LCW) Covazur GHA (LCW) Covazur LAC2 (LCW) Covazur ZO3 (LCW) Desert Reflections Canyon Sunset (ENGELHARD CORPORATION) Desert Reflections Midnight Sagebrush (ENGELHARD CORPORATION) Desert Reflections Painted Desert Plum (ENGELHARD CORPORATION) Desert Reflections Sunlit Cactus (ENGELHARD CORPORATION) Dichrona BG (RONA) Dichrona BR (RONA) Dichrona BY (RONA) Dichrona RB (RONA) Dichrona RY (RONA) Dichrona YR (RONA) Diophase Gold (NIHON KOKEN KOGYO CO., LTD.) Diophase Silver (NIHON KOKEN KOGYO CO., LTD.) Duocrome BG (ENGELHARD CORPORATION) Duocrome BR (ENGELHARD CORPORATION) Duocrome BV (ENGELHARD CORPORATION) Duocrome BY (ENGELHARD CORPORATION) Duocrome GY (ENGELHARD CORPORATION) Duocrome RB (ENGELHARD CORPORATION) Duocrome RO (ENGELHARD CORPORATION) Duocrome RV (ENGELHARD CORPORATION) Duocrome RY (ENGELHARD CORPORATION) Duocrome Sparkle BR (ENGELHARD CORPORATION) Duocrome Sparkle BY (ENGELHARD CORPORATION) Duocrome Sparkle RB (ENGELHARD CORPORATION) Duocrome Sparkle RY (ENGELHARD CORPORATION) Duocrome YB (ENGELHARD CORPORATION) Duocrome YG (ENGELHARD CORPORATION) Duocrome YR (ENGELHARD CORPORATION) Extender W (RONA) Facemat (LCW) Flamenco Blue (ENGELHARD CORPORATION) Flamenco Gold (ENGELHARD CORPORATION) Flamenco Gold CC (ENGELHARD CORPORATION) Flamenco Green (ENGELHARD CORPORATION) Flamenco Orange (ENGELHARD CORPORATION) Flamenco Orange CC (ENGELHARD CORPORATION) Flamenco Pearl (ENGELHARD CORPORATION) Flamenco Pearl CC (ENGELHARD CORPORATION) Flamenco Pearl SEC (ENGELHARD CORPORATION) Flamenco Red (ENGELHARD CORPORATION) Flamenco Satin Blue (ENGELHARD CORPORATION) Flamenco Satin Gold (ENGELHARD CORPORATION) Flamenco Satin Green (ENGELHARD CORPORATION) Flamenco Satin Orange (ENGELHARD CORPORATION) Flamenco Satin Pearl (ENGELHARD CORPORATION) Flamenco Satin Red (ENGELHARD CORPORATION) Flamenco Satin Violet (ENGELHARD CORPORATION) Flamenco Satina (ENGELHARD CORPORATION) Flamenco Sparkle Blue (ENGELHARD CORPORATION) Flamenco Sparkle Gold (ENGELHARD CORPORATION) Flamenco Sparkle Green (ENGELHARD CORPORATION) Flamenco Sparkle Orange (ENGELHARD CORPORATION) Flamenco Sparkle Red (ENGELHARD CORPORATION) Flamenco Sparkle Violet (ENGELHARD CORPORATION) Flamenco Super Blue (ENGELHARD CORPORATION) Flamenco Super Gold (ENGELHARD CORPORATION) Flamenco Super Green (ENGELHARD CORPORATION) Flamenco Super Red (ENGELHARD CORPORATION) Flamenco Super Red CC (ENGELHARD CORPORATION) Flamenco Superpearl (ENGELHARD CORPORATION) Flamenco Superpearl CC (ENGELHARD CORPORATION) Flamenco Twilight Blue (ENGELHARD CORPORATION) Flamenco Twilight Gold (ENGELHARD CORPORATION) Flamenco Twilight Green (ENGELHARD CORPORATION) Flamenco Twilight Red (ENGELHARD CORPORATION) Flamenco Twilight Red CC (ENGELHARD CORPORATION) Flamenco Ultra Fine (ENGELHARD CORPORATION) Flamenco Ultra Silk 2500 (ENGELHARD CORPORATION) Flamenco Ultra Sparkle (ENGELHARD CORPORATION) Flamenco Velvet (ENGELHARD CORPORATION) Flonac ME 10 C (ECKART GMBH & CO. KG) Flonac MF 10 C (ECKART GMBH & CO. KG) Flonac MG 10 C (ECKART GMBH & CO. KG) Flonac MG 30 C (ECKART GMBH & CO. KG) Flonac MI 10 C (ECKART GMBH & CO. KG) Flonac MI 33 C (ECKART GMBH & CO. KG) Flonac ML 10 C (ECKART GMBH & CO. KG) Flonac MM 10 C (ECKART GMBH & CO. KG) Flonac MS 10 C (ECKART GMBH & CO. KG) Flonac MS 20 C (ECKART GMBH & CO. KG) Flonac MS 30 C (ECKART GMBH & CO. KG) Flonac MS 33 C (ECKART GMBH & CO. KG) Flonac MS 40 C (ECKART GMBH & CO. KG) Flonac MS 50 C (ECKART GMBH & CO. KG) Flonac MS 60 C (ECKART GMBH & CO. KG) Flonac MS 70 C (ECKART GMBH & CO. KG) Flonac MU 10 C (ECKART GMBH & CO. KG) Flonac MX 10 C (ECKART GMBH & CO. KG) Flonac MX 30 C (ECKART GMBH & CO. KG) Gemtone Amber (ENGELHARD CORPORATION) Gemtone Amethyst (ENGELHARD CORPORATION) Gemtone Emerald (ENGELHARD CORPORATION) Gemtone Garnet (ENGELHARD CORPORATION) Gemtone Goldstone (ENGELHARD CORPORATION) Gemtone Jade (ENGELHARD CORPORATION) Gemtone Mauve Quartz (ENGELHARD CORPORATION) Gemtone Moonstone (ENGELHARD CORPORATION) Gemtone Ruby (ENGELHARD CORPORATION) Gemtone Sapphire (ENGELHARD CORPORATION) Gemtone Sunstone (ENGELHARD CORPORATION) Gemtone Sunstone CC (ENGELHARD CORPORATION) Gemtone Tan Opal (ENGELHARD CORPORATION) Gemtone Tan Opal CC (ENGELHARD CORPORATION) Gemtone Topaz (ENGELHARD CORPORATION) Genapol PDC (CLARIANT GMBH_) Hot Dots - Blue (CHARM GIRL, INC.) Hot Dots - Green (CHARM GIRL, INC.) Hot Dots - Red (CHARM GIRL, INC.) HydroSpers-B-335198 (U.S. COSMETICS CORPORATION) Lipmat (LCW) Lipomic 601 (LIPO CHEMICALS, INC.) Lipomic 601 BN (LIPO CHEMICALS, INC.) LI-S-100 (U.S. COSMETICS CORPORATION) Low Lustre Pigment (RONA) Lumiral (LCW) MCP-45 (PRESPERSE, INC.) Mearlcite SRA (ENGELHARD CORPORATION) Mearlmica MMCF (ENGELHARD CORPORATION) Mearlmica MMSV (ENGELHARD CORPORATION) Mearlmica SVA (ENGELHARD CORPORATION) Mibiron N-50 (RONA) Mica Black (RONA) Mica DD 8302 (ENGELHARD CORPORATION) Mica FHC (CARDRE, INC.) Mica M (RONA) Mica MRP (RONA) Mica PP (CARDRE, INC.) Mica S/MM3 (KOBO PRODUCTS, INC.) Mica SI 2 (CARDRE, INC.) Mica, Cosmetic, Bacteria Controlled 280 (WHITTAKER, CLARK & DANIELS, INC.) Micapoly MSL Red (CREATIONS COULEURS) Micapoly MSL White (CREATIONS COULEURS) Micapoly MSL Yellow (CREATIONS COULEURS) Micapoly Ocean Blue WR (CREATIONS COULEURS) Micapoly UV Cristal (CREATIONS COULEURS) Micapoly UV Crystal (C.I.T. SARL) Micapoly UV Shadow (C.I.T. SARL) Micapoly UV Zinc (C.I.T. SARL) Micapoly WOE Black (CREATIONS COULEURS) Micapoly WOE Blue (CREATIONS COULEURS) Micapoly WOE Brown (CREATIONS COULEURS) Micapoly WOE Geranium (CREATIONS COULEURS) Micapoly WOE Green 70 (CREATIONS COULEURS) Micapoly WOE Manganese Violet (CREATIONS COULEURS) Micapoly WOE Melon (CREATIONS COULEURS) Micapoly WOE Pink (CREATIONS COULEURS) Micapoly WOE Red (CREATIONS COULEURS) Micapoly WOE Violet (CREATIONS COULEURS) Micapoly WOE White (CREATIONS COULEURS) Micapoly WOE Yellow (CREATIONS COULEURS) Micasoft MSL Black (CREATIONS COULEURS) Micasomes AE (COLLABORATIVE LABORATORIES, INC.) Micasomes DM (COLLABORATIVE LABORATORIES, INC.) Micasomes HOH (COLLABORATIVE LABORATORIES, INC.) Micro Mica (CHARLES B. CHRYSTAL COMPANY, INC.) Microna Matte Black (RONA) MIcrona Matte Blue (RONA) Microna Matte Orange (RONA) Microna Matte Red (RONA) Microna Matte White (RONA) Microna Matte Yellow (RONA) Micronasphere M (RONA) MI-S-100 (U.S. COSMETICS CORPORATION) NAI-S (U.S. COSMETICS CORPORATION) Naturaleaf Powder (RONA) SA-Excel Mica JP-2 (U.S. COSMETICS CORPORATION) Satin Mica (RONA) Serica 5 (LCW) Sericite 300 S (LCW) Sericite DNN (IKEDA CORPORATION) Sericite FHC (CARDRE, INC.) Sericite FSE (PRESPERSE, INC.) Sericite GMS-4C (PRESPERSE, INC.) Sericite GMS-4C-020 (PRESPERSE, INC.) Sericite PP (CARDRE, INC.) Sericite SI 2 (CARDRE, INC.) Sericite SL (PRESPERSE, INC.) Sericite SL-012 (PRESPERSE, INC.) Sericite SLZ-012P (PRESPERSE, INC.) Sericite WL (IKEDA CORPORATION) Shinju White 100T (ENGELHARD CORPORATION) Silk Mica (RONA) SilPower (LG COSMETIC R & D CENTER) SilPower Plus (LG COSMETIC R & D CENTER) SM-1000 (PRESPERSE, INC.) SM-2000 (PRESPERSE, INC.) Soloron Silver (RONA) Soloron Silver Fine (RONA) SP-29 UVS (PRESPERSE, INC.) Submica E (LCW) Submica N (LCW) Timica Brilliant Gold (ENGELHARD CORPORATION) Timica Copper (ENGELHARD CORPORATION) Timica Extra Bright 1500 (ENGELHARD CORPORATION) Timica Extra Large Sparkle (ENGELHARD CORPORATION) Timica Gold Sparkle (ENGELHARD CORPORATION) Timica Golden Bronze (ENGELHARD CORPORATION) Timica Nu-Antique Bronze (ENGELHARD CORPORATION) Timica Nu-Antique Copper (ENGELHARD CORPORATION) Timica Nu-Antique Gold (ENGELHARD CORPORATION) Timica Nu-Antique Silver (ENGELHARD CORPORATION) Timica Pearlwhite (ENGELHARD CORPORATION) Timica Radiant Gold (ENGELHARD CORPORATION) Timica Silkwhite (ENGELHARD CORPORATION) Timica Silver Sparkle (ENGELHARD CORPORATION) Timica Sparkle (ENGELHARD CORPORATION) Timiron MP-10 Pearl Flake (RONA) Timiron MP-1001 Supersheen (RONA) Timiron MP-1005 Supersilk (RONA) Timiron MP-111 Ultraluster (RONA) Timiron MP-1117 Satin (RONA) Timiron MP-115 Starluster (RONA) Timiron MP-127 Soft Gold (RONA) Timiron MP-149 Diamond Cluster (RONA) Timiron MP-155 Blue (RONA) Timiron MP-175 Red (RONA) Timiron MP-176 Blue Red (RONA) Timiron MP-18 Transwhite (RONA) Timiron MP-20 Fine Gold (RONA) Timiron MP-24 Karat Gold (RONA) Timiron MP-25 Gold Plus (RONA) Timiron MP-26 Gold Glow (RONA) Timiron MP-28 Transgold (RONA) Timiron MP-29 Sun Gold Sparkle (RONA) Timiron MP-30 Pearl Sheen (RONA) Timiron MP-45 Gleamer Flake (RONA) Timiron MP-47 Sparkle (RONA) Timiron MP-99 Snowflake (RONA) Timiron Silk Blue (RONA) Timiron Silk Gold (RONA) Timiron Silk Green (RONA) Timiron Silk Red (RONA) Timiron Splendid Blue (RONA) Timiron Splendid Copper (RONA) Timiron Splendid Gold (RONA) Timiron Splendid Green (RONA) Timiron Splendid Red (RONA) Timiron Splendid Violet (RONA) Timiron Starlight Blue (RONA) Timiron Starlight Gold (RONA) Timiron Starlight Green (RONA) Timiron Starlight Red (RONA) Timiron Super Blue (RONA) Timiron Super Copper (RONA) Timiron Super Gold (RONA) Timiron Super Green (RONA) Timiron Super Red (RONA) Timiron Super Silver (RONA) Timiron Super Silver Fine (RONA) Timiron Super Violet (RONA) Toshiki Mica GS-61D (NIKKO CHEMICALS CO., LTD.) Toshiki Mica HP-18K (NIKKO CHEMICALS CO., LTD.) Toshiki Sericite JA-A3 (NIKKO CHEMICALS CO., LTD.) Toshiki Sericite JF-25-3 (NIKKO CHEMICALS CO., LTD.) Toshiki Sericite JSF-25-3 (NIKKO CHEMICALS CO., LTD.) Toshiki Sericite JW-A5 (NIKKO CHEMICALS CO., LTD.) Toshiki Sericite OS-61D (NIKKO CHEMICALS CO., LTD.) Toshiki Super Mica A (NIKKO CHEMICALS CO., LTD.) Toshiki Super Mica D (NIKKO CHEMICALS CO., LTD.) Ultrapearl Silver White Luster (ULTRA CHEMICAL, INC.) Velvet Veil 310 (PRESPERSE, INC.) Velvetveil A (IKEDA CORPORATION) Velvetveil X (IKEDA CORPORATION) Velvetveil Y (IKEDA CORPORATION) Velvetveil Z (IKEDA CORPORATION) |