Final Rules: Food Additives and Color Additives
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One of the charges of the Center for Food Safety and Applied Nutrition is to assure that the use of food ingredients and color additives is safe. The authority for this mission is derived from the 1958 food additive and 1960 color additive amendments to the Federal Food, Drug and Cosmetic Act. Towards this end, CFSAN's Office of Food Additive Safety (OFAS) evaluates new petitions to determine if substances are considered safe for addition to the food supply. When a petition for a food additive or color additive is approved, a regulation identifying the conditions of use is published in the Federal Register. For information about additional food ingredient and food contact substance review programs in the Office of Food Additive Safety, consult the Inventory of Effective Food Contact Substance (FCS) Notifications and the Summary of all GRAS Notices; you may also search multiple Food Ingredient and Packaging Inventories.
This dataset documents the final rules issued by the Office of Food Additive Safety since 1994 (and a few others). The Federal Register publication history, with the dates and citations for the final rules, is included along with other identifying information (such as docket numbers), on the individual pages for each petition (click on the petition numbers).
For more information about the petition process, see Questions and Answers About the Petition Process.
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Date of first Final Rule (sorted Z-A) |
Petition No. | Petitioner | Subject Additive and Intended Use | 21 CFR* | Reg removed |
|---|---|---|---|---|---|
| Jul 3, 2024 | Amendment | amending our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food | 180.30 | ||
| Mar 22, 2024 | Amendment | amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective |
170.102 170.105 |
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| Nov 3, 2023 | CAP 0C0317 | Ecoflora SAS | amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). | 73.225 | |
| Aug 9, 2023 | Direct Final Rule | amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS); revoking prior sanctions for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health. |
161.190 164.150 184.1472 184.1555 |
186.1551 | |
| Jan 5, 2023 | FAP 9A4823 | Kellogg Company | amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in breakfast cereals and grain-based bars (e.g., breakfast bars, granola bars, rice cereal bars), and to update the reference for the Vitamin D3 specifications. | 172.380 | |
| Nov 10, 2022 | CAP 0C0316 | GNT USA, Inc. | amending the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated). | 73.530 | |
| Sep 27, 2022 | CAP 0C0318 | Colorcon, Inc. | amending the color additive regulations in 21 CFR Part 73.70 “Calcium Carbonate,” by expanding the permitted uses of calcium carbonate to include use in dietary supplement tablets and capsules, including coatings and printing inks, in amounts consistent with good manufacturing practice. | 73.50 | |
| May 20, 2022 | FAP 8B4820 | Flexible Vinyl Alliance (FVA) | amending the food additive regulations to no longer provide for the use of 25 plasticizers (23 ortho-phthalates and 2 related compounds) in various food contact applications because these uses have been abandoned. |
175.105 175.300 175.320 175.380 175.390 176.170 176.180 176.300 177.1010 177.1200 177.1210 177.1400 177.1460 177.1590 177.2420 177.2600 178.3740 178.3910 |
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| May 20, 2022 | FAP 6B4815 | Breast Cancer Fund (now Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council | denying a food additive petition (FAP 6B4815) submitted by Natural Resources Defense Council, et al., requesting that we amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates. | ||
| May 10, 2022 | CAP 5C0303 | Aker BioMarine Antarctic AS | amending the color additive regulations to provide for the safe use of Antarctic krill meal, composed of the ground and dried tissue of Euphausia superba, with or without the lipid fraction, for use in the feed of salmonid fish, to enhance the color of their flesh. | 73.32 | |
| Oct 6, 2021 | CAP 8C0312 | GW Cosmetics GmbH | amending 21 CFR Part 73 to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes. | 73.2550 | |
| Sep 2, 2021 | CAP 8C0313 | Sensient Colors, LLC | amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice. | 73.69 | |
| Jul 13, 2020 | FAP 8A4821 | Oakshire Naturals LP | amending the food additive regulations to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories. | 172.382 | |
| Aug 1, 2019 | CAP 9C0314 | Impossible Foods, Inc. | amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. | 73.520 | |
| Nov 1, 2018 | CAP 7C0308 | Colorcon, Inc. | amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. | 73.200 | |
| Oct 31, 2018 | CAP 7C0309 | Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke | amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. | 73.2396 | |
| Oct 9, 2018 | FAP 6A4817 | Styrene Information and Research Center | amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned. | 172.515 | |
| Oct 9, 2018 | FAP 5A4810 | Breast Cancer Fund (now the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff | partially granting a petition by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition. |
172.515 177.2600 |
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| Sep 25, 2018 | CAP 7C0311 | Glo Eyes, LLC | amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. | 74.3708 | |
| Sep 20, 2018 | FAP 7A4818 | Juice Products Association | amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. | 172.380 | |
| Jun 7, 2018 | CAP 7C0310 | DSM Biomedical | amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery. | 74.3054 | |
| May 21, 2018 | FAP 5A4811 | Grocery Manufacturers Association (GMA) | denying a petition requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications. | ||
| Nov 7, 2017 | CAP 6C0307 | Wm. Wrigley Jr. Company | amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. | 73.70 | |
| Jul 3, 2017 | CAP 6C0306 | McCormick & Company, Inc. | amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). | 73.530 | |
| May 4, 2017 | FAP 6B4816 | Society of the Plastics Industry, Inc. | amending the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned. | 177.1210 | |
| May 4, 2017 | FAP 4B4808 | Environmental Defense Fund, Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment | denying a petition to revoke the Threshold of Regulation (TOR) exemption No. 2005-006 to no longer exempt from our food additive regulations the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods; issue a new FDA regulation to prohibit the use of perchlorates in antistatic agents for use in food-contact articles; and amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers. | ||
| Nov 22, 2016 | FAP 6B4814 | 3M Corporation | amending the food additive regulations to no longer provide for the use of two specific perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods because these uses have been abandoned. | 176.170 | |
| Nov 1, 2016 | CAP 6C0305 | Milton W. Chu, M.D. | amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs). |
73.3126 74.3045 |
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| Jul 18, 2016 | FAP 3A4801 | Dean Foods Company and WhiteWave Foods Company | amending the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted. |
172.379 172.380 |
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| Apr 15, 2016 | FAP 2A4796 | Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, and National Council of La Raza | amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. | 172.345 | |
| Jan 4, 2016 | FAP 4B4809 | Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Children's Environmental Health Network, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment | amending the food additive regulations to no longer provide for the use of three specific perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods because new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs. | 176.170 | |
| Sep 30, 2015 | CAP 5C0302 | E. & J. Gallo Winery | amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits. | 73.350 | |
| Aug 21, 2015 | CAP 4C0300 | Colorcon, Inc. | amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. | 73.1530 | |
| Jun 16, 2015 | FAP 4A4803 | Eastman Chemical Company | amending the food additive regulations by removing the upper bound of the melting point range in the regulation for the antioxidant tertiary butylhydroquinone (TBHQ) and adding a purity acceptance criterion. | 172.185 | |
| Jun 8, 2015 | CAP 5C0301 | Signature Brands, LLC | amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica in egg decorating kits for coloring boiled shell eggs, in amounts consistent with good manufacturing practice (GMP). | 73.350 | |
| Jun 8, 2015 | CAP 4C0299 | EMD Millipore Corp. | amending the color additive regulations to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes. | 73.350 | |
| Mar 20, 2015 | CAP 3C0298 | Wm. Wrigley Jr. Company | amending the color additive regulations to provide for the expanded safe use of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum. | 73.200 | |
| Aug 12, 2014 | FAP 2A4788 | Abbott Laboratories | amending the food additive regulations in 21 CFR 172.380 to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement beverages and meal replacement bars that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feeding. | 172.380 | |
| May 21, 2014 | FAP 9A4778 | Ajinomoto Co., Inc. | amending the food additive regulations in part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172), to provide for the safe use of advantame as a non-nutritive sweetener in tabletop applications and powdered beverage mixes. | 172.803 | |
| Apr 14, 2014 | FAP 1M4727 | National Fisheries Institute | amending the food additive regulations to provide for the safe use of ionizing radiation for control of food-borne pathogens in crustaceans at a maximum absorbed dose of 6.0 kiloGray (kGy). | 179.26 | |
| Apr 11, 2014 | CAP 2C0297 | GNT USA, Inc. | amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. | 73.530 | |
| Dec 6, 2013 | FAP 1A4784 | Nexira | amending the food additive regulations to provide for the expanded safe use of acacia (gum arabic) in foods. | 172.780 | |
| Nov 29, 2013 | FAP 0A4782 | United States Pharmacopeial Convention | amending select food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition (FCC 7). |
172.345 172.379 172.380 172.665 172.712 172.736 172.780 172.800 172.804 172.810 172.812 172.831 172.841 172.862 172.867 172.869 173.160 173.165 173.228 173.280 173.310 |
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| Aug 13, 2013 | CAP 2C0293 | Mars, Inc. | amending the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum. | 73.530 | |
| Jul 12, 2013 | FAP 2B4791 | U.S. Representative Edward J. Markey | amending the food additive regulations to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. | 175.300 | |
| Jun 12, 2013 | CAP 2C0294 | E. & J. Gallo Winery | amending the color additive regulations to provide for the expanded safe use of mica-based pearlescent pigments as color additives in certain distilled spirits. | 73.350 | |
| Apr 1, 2013 | CAP 1C0291 | CooperVision, Inc. | 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) ... as color additives in contact lenses. | 73.3106 | |
| Apr 1, 2013 | CAP 1C0292 | CooperVision, Inc. | amending the color additive regulations to provide for the safe use of additional ... 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. | 73.3100 | |
| Dec 4, 2012 | FAP 2A4785 | Ecolab, Inc. | amending the food additive regulations to provide for the safe use of sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) as an antimicrobial agent for use in wash water for fruits and vegetables without the requirement of a potable water rinse. | 173.405 | |
| Nov 30, 2012 | FAP 9M4695 | U.S. Department of Agriculture, Food Safety and Inspection Service | amending the food additive regulations to provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life. | 179.26 |
*Definitions
- 21 CFR: Title 21 of the Code of Federal Regulations.
- Substance: The name of the substance listed in the CFR.
- CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
- Petitions (see also Questions and Answers About the Petition Process)
- FAP: Food Additive Petition
- CAP: Color Additive Petition
- GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 2016)
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Date of first Final Rule (sorted Z-A) |
Petition No. | Petitioner | Subject Additive and Intended Use | 21 CFR* | Reg removed |
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