21 CFR 73.1 - Diluents in color additive mixtures for food use exempt from certification.
| Substances | Definitions and specifications | Restrictions |
|---|---|---|
| Calcium disodium EDTA (calcium disodium ethyl- enediamine- tetraacetate) | Contains calcium disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6766-87-6) as set forth in the Food Chemicals Codex, 3d ed., p. 50, 1981 | May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous calcium disodium ethyl-enediamine-tetraacetate). |
| Castor oil | As set forth in U.S.P. XVI | Not more than 500 p.p.m. in the finished food. Labeling of color additive mixtures containing castor oil shall bear adequate directions for use that will result in a food meeting this restriction. |
| Dioctylsodium sulfosuccinate | As set forth in sec. 172.810 of this chapter | Not more than 9 p.p.m. in the finished food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. |
| Disodium EDTA (disodium ethyl- enediamine- tetraacetate) | Contains disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6381-92-6) as set forth in the Food Chemicals Codex, 3d ed., p. 104, 1981 | May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous disodium ethyl- enediamine- tetraacetate). |
| Substances | Definitions and specifications | Restrictions |
|---|---|---|
| Alcohol, SDA-3A | As set forth in 26 CFR pt. 212 | No residue. |
| n-Butyl alcohol | Do. | |
| Cetyl alcohol | As set forth in N.F. XI | Do. |
| Cyclohexane | Do. | |
| Ethyl cellulose | As set forth in sec. 172.868 of this chapter | |
| Ethylene glycol monoethyl ether | Do. | |
| Isobutyl alcohol | Do. | |
| Isopropyl alcohol | Do. | |
| Polyoxyethylene sorbitan monooleate (polysorbate 80) | As set forth in sec. 172.840 of this chapter | |
| Polyvinyl acetate | Molecular weight, minimum 2,000 | |
| Polyvinylpyrrolidone | As set forth in sec. 173.55 of this chapter | |
| Rosin and rosin derivatives | As set forth in sec. 172.615 of this chapter | |
| Shellac, purified | Food grade |
| Substances | Definitions and specifications | Restrictions |
|---|---|---|
| Acetone | As set forth in N.F. XI | No residue. |
| Alcohol, SDA-3A | As set forth in 26 CFR pt. 212 | Do. |
| Benzoin | As set forth in U.S.P. XVI | |
| Copal, Manila | ||
| Ethyl acetate | As set forth in N.F. XI | Do. |
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| Ethyl cellulose | As set forth in sec. 172.868 of this chapter | |
| Methylene chloride | Do. | |
| Polyvinylpyrrolidone | As set forth in sec. 173.55 of this chapter | |
| Rosin and rosin derivatives | As set forth in sec. 172.615 of this chapter | |
| Silicon dioxide | As set forth in sec. 172.480 of this chapter | Not more than 2 pct of the ink solids. |
| Terpene resins, natural | As set forth in sec. 172.615 of this chapter | |
| Terpene resins, synthetic | Polymers of α- and β-pinene | |
| Substances | Definitions and specifications | Restrictions |
|---|---|---|
| Polyvinylpyrrolidone | As set forth in sec. 173.55 of this chapter | In or as food-tablet coatings; limit, not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidone shall bear adequate directions for use that will result in a food meeting this restriction. |
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-04701 RIN Docket No. FDA-2012-N-0010 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective March 7, 2013. 21 CFR Parts 73, 172, 173, 176, 177, 178, 184, and 189 The Food and Drug Administration (FDA) is amending certain regulations regarding food and color additives to correct minor errors (such as misspelled chemical names) and to update office names and addresses. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 341 - Definitions and standards for food
§ 342 - Adulterated food
§ 343 - Misbranded food
§ 348 - Food additives
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 355 - New drugs
§ 361 - Adulterated cosmetics
§ 362 - Misbranded cosmetics
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-07294 RIN Docket No. s. FDA-2011-C-0344 and FDA-2011-C-0463 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 2, 2013. See section VII for related information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 1, 2013. 21 CFR Part 73 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-04701 RIN Docket No. FDA-2012-N-0010 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective March 7, 2013. 21 CFR Parts 73, 172, 173, 176, 177, 178, 184, and 189 The Food and Drug Administration (FDA) is amending certain regulations regarding food and color additives to correct minor errors (such as misspelled chemical names) and to update office names and addresses. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-26242 RIN Docket No. 2004C‐0078) DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of withdrawal. 21 CFR Part 73 The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 4C0276) proposing that the color additive regulations be amended to provide for the safe use of synthetic iron oxide as a color additive in or on cooked meat products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21917 RIN Docket No. FDA-2012-C-0900 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. 21 CFR Part 73 The Food and Drug Administration (FDA) is announcing that GNT USA, Inc. (GNT) has filed a petition proposing that the color additive regulations be amended to provide for the safe use of spirulina concentrate, made from the edible blue-green cyanobacterium Arthrospira platensis (also known as Spirulina platensis ) as a color additive in food.