Color dye additives for only Foods 6P T462

Color dye additives for only Foods 6P   NOT DRUGS and COSMETICS,

 

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먹 COLOR FOO List 4P.docx

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먹 COLOR FOOD Chart 6P.docx

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Color Additive Status List,

https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list

Color Additive Status List

 

Summary of Color Additives for Use in the United States in

Foods, Drugs, Cosmetics, Medical Devices,

https://www.fda.gov/industry/color-additive-inventories/summary-color-additives-use-united-states-foods-drugs-cosmetics-and-medical-devices

Summary of Color Additives for Use in the United States

 

Notice: This document is not intended to be used as a substitute for the regulations that list color additives for use in the United States and the conditions imposed on their use in food, drugs, cosmetics, and medical devices, respectively.

These regulations are located in Title 21 of the Code of Federal Regulations Parts 73, 74, 81, 82. For approved conditions of use, the reader should refer to the regulation for the specific color additive of interest. Please note that color additives listed for use in drugs or cosmetics are not permitted for use in eye area products, injected products, or surgical sutures, unless the regulation for the color additive so states in the uses and restrictions paragraph. In this document, all color additives listed for suture use can be found in the table of color additives approved for use in medical devices. Additional information on color additives can be obtained from the Color Additive Status list. Important clarifications are detailed in the End Notes section.

 

Table of Contents

Color Additives Approved for Use in Human Food

- Part 73, Subpart A: Color additives exempt from batch certification,

- Part 74, Subpart A: Color additives subject to batch certification,

 

Color Additives Approved for Use in Drugs

- Part 73, Subpart B: Color additives exempt from batch certification,

- Part 74, Subpart B: Color additives subject to batch certification,

 

Color Additives Approved for Use in Cosmetics

- Part 73, Subpart C: Color additives exempt from batch certification,

- Part 74, Subpart C: Color additives subject to batch certification,

 

Color Additives Approved for Use in Medical Devices

- Part 73, Subpart D: Color additives exempt from batch certification,

- Part 74, Subpart D: Color additives subject to batch certification,

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Color Additives Approved for Use in Human Food,
Part 73, Subpart A: Color additives exempt from batch certification(1),

 

21 CFR Section	Straight Color	EEC#	Year(2)Approved	Uses and Restrictions
§73.30	Annatto extract	E160b	1963	Foods generally.
§73.40	Dehydrated beets (beet powder)	E162	1967	Foods generally.
§73.69	Butterfly pea flower extract	----	2021	Alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, and soft candy.
§73.70	Calcium carbonate	E170	2017	Hard and soft candies and mints, inks used on the surface of chewing gum.
§73.75	Canthaxanthin(3)	E161g	1969	Foods generally, NTE(7) 30 mg/lb of solid or semisolid food or per pint of liquid food; May also be used in broiler chicken feed.
§73.85	Caramel	E150a-d	1963	Foods generally.
§73.90	β-Apo-8'-carotenal	E160e	1963	Foods generally, NTE(7): 15 mg/lb solid, 15 mg/pt liquid.
§73.95	β-Carotene	E160a	1964	Foods generally.
§73.100	Cochineal extract	E120	1967	Foods generally
§73.100	Carmine	E120	2009	Food label must use common or usual name "carmine"; effective January 5, 2011
§73.125	Sodium copper chlorophyllin(3)	E141	2002	Citrus-based dry beverage mixes NTE(7) 0.2 percent in dry mix; extracted from alfalfa.
§73.140	Toasted partially defatted cooked cottonseed flour	----	1964	Foods generally.
§73.160	Ferrous gluconate	----	1967	Ripe olives.
§73.165	Ferrous lactate	----	1996	Ripe olives.
§73.169	Grape color extract(3)	E163?	1981	Nonbeverage food.
§73.170	Grape skin extract (enocianina)	E163?	1966	Still & carbonated drinks & ades; beverage bases; alcoholic beverages (restrict. 27 CFR Parts 4 & 5).
§73.200	Synthetic iron oxide(3)	E172	1994	Sausage casings NTE(7) 0.1 percent (by wt).
§73.200	Synthetic iron oxide(3)	E172	2015	Hard and soft candy, mints and chewing gum.
§73.200	Synthetic iron oxide(3)	E172	2015	For allowed human food uses, reduce lead from ≤ 20 ppm to ≤ 5 ppm.
§73.200	Synthetic iron oxide		2018	Dietary supplement tablets and capsules, including coatings and printing inks.
§73.250	Fruit juice(3)	----	1966	Foods generally.
§73.250	Fruit juice(3)	----	1995	Dried color additive.
§73.260	Vegetable juice(3)	----	1966	Foods generally.
§73.260	Vegetable juice(3)	----	1995	Dried color additive, water infusion.
§73.300	Carrot oil	----	1967	Foods generally.
§73.340	Paprika	E160c	1966	Foods generally.
§73.345	Paprika oleoresin	E160c	1966	Foods generally.
§73.350	Mica-based pearlescent pigments	----	2006	Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum.
§73.350	Mica-based pearlescent pigments	----	2013	Distilled spirits containing not less than 18 % and not more than 23 % alcohol by volume but not including distilled spirits mixtures containing more than 5 % wine on a proof gallon basis.
§73.350	Mica-based pearlescent pigments	----	2015	Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, nonalcoholic cocktail mixers and mixes and in egg decorating kits.
§73.450	Riboflavin	E101	1967	Foods generally.
§73.500	Saffron	E164	1966	Foods generally.
§73.520	Soy leghemoglobin	----	2019	Ground beef analogue products, NTE 0.8% by weight of uncooked ground beef analogue product.
§73.530	Spirulina extract	----	2013	Candy and chewing gum.
§73.530	Spirulina extract	----	2014	Coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals (excluding extruded cereals).
§73.530	Spirulina extract	----	2017	Seasonally color the shells of hard-boiled eggs.
§73.575	Titanium dioxide	E171	1966	Foods generally; NTE(7) 1 percent (by wt).
§73.585	Tomato lycopene extract; tomato lycopene concentrate(3)	E160	2006	Foods generally.
§73.600	Turmeric	E100	1966	Foods generally.
§73.615	Turmeric oleoresin	E100	1966	Foods generally.

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Color Additives Approved for Use in Human Food,
Part 74, Subpart A: Color additives subject to batch certification(4)

21 CFR Section	Straight Color	EEC#	Year(2)Approved	Uses and Restrictions
§74.101	FD&C Blue No. 1	E133	1969	Foods generally.
§74.101	FD&C Blue No. 1	E133	1993	Added Mn spec.
§74.102	FD&C Blue No. 2	E132	1987	Foods generally.
§74.203	FD&C Green No. 3	----	1982	Foods generally.
§74.250	Orange B(3)	----	1966	Casings or surfaces of frankfurters and sausages; NTE(7) 150 ppm (by wt).
§74.302	Citrus Red No. 2	----	1963	Skins of oranges not intended or used for processing; NTE(7) 2.0 ppm (by wt).
§74.303	FD&C Red No. 3	E127	1969	Foods generally.
§74.340	FD&C Red No. 40(3)	E129	1971	Foods generally.
§74.705	FD&C Yellow No. 5	E102	1969	Foods generally.
§74.706	FD&C Yellow No. 6	E110	1986	Foods generally.

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End Notes;;

1. The color additives Astaxanthin, Astaxanthin dimethyldisuccinate, Ultramarine blue, Canthaxanthin, Haematococcus algae meal, Synthetic iron oxide, Dried algae meal, Tagetes (Aztec marigold) meal and extract, Corn endosperm oil, Paracoccus pigment, and Phaffia yeast are approved for specific uses in animal food (see 21 CFR 73.35, 73.37, 73.50, 73.75, 73.185, 73.200, 73.275, 73.295, 73.315, 73.352, and 73.355, respectively). 

 

2. The year approved is based on the date listed in the "Confirmation of Effective Date" notice for the action as published in the Federal Register. 

 

3. Petitioned for use after the 1960 amendments; not provisionally listed.

4. Color additives listed in 21 CFR Parts 74 and 82 must be analyzed and batch certified by FDA before they can be used in any FDA-regulated product marketed in the U.S. This requirement applies to products imported into this country as well as those manufactured domestically. Manufacturers of certified color additives must include on the label the name of the certified color additive, a statement indicating general use limitations, any quantitative limitations in products, and the certification lot number assigned to the batch. Straight colors required to be certified are listed in 21 CFR Part 74. Most lakes are provisionally listed under 21 CFR 81.1 for use as listed in 21 CFR 82.51 (food, drugs, and cosmetics), 21 CFR 82.1051 (drugs and cosmetics), or 21 CFR 82.2051 (externally applied drugs and cosmetics). All FD&C Red No. 40 lakes are permanently listed under 21 CFR 74.340 (food), 74.1340 (drugs), and 74.2340 (cosmetics). FD&C Blue No. 1 and FD&C Yellow No. 5 aluminum lakes for drug and cosmetic use are permanently listed in 21 CFR sections 74.1101, 74.1705, 74.2101, and 74.2705.

 

5. Color additives that are permitted for general use may not be used in the area of the eye, in injections, or in surgical sutures unless such use is specified in the color additive listing regulation. Currently no color additives are listed for use in injected products (such as tattoos or permanent makeup). 

 

6. Color additives that are permitted for external application may not be used in the area of the eye, in injections, or in surgical sutures unless such use is specified in the color additive listing regulation. Currently no color additives are listed for use in injected products (such as tattoos or permanent makeup). Some color additives that are permitted for external application also may be permitted in mouthwashes, dentifrices, or lipsticks in limited amounts specified in the color additive listing regulations. 

    NTE - not to exceed.

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To access regulations from the Government Printing Office Website, click on the hyperlinks below. This opens the Electronic Code of Federal Regulations . Select the desired section below.

 

Part	Sections	Titles
73	73.1-73-3128	Listing of Color Additives Exempt from Certification
74	74.101-74.3710	Listing of Color Additives Subject to Certification
81	81.1-81.32	General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
82	82.3-82.2707a	Listing of Certified Provisionally Listed Colors and Specifications