Food Additive and Color Additive Petitions Under Review or Held in Abeyance
September 30, 2024
The following table is a listing of food additive and color additive petitions filed by FDA's Office of Food Additive Safety (OFAS) that are either under active review or held in abeyance as of the date shown above. This list does not reflect petitions filed after that date, or any change in status for the listed petitions that has occurred after that date.
Abeyance is an administrative category of petitions that are filed but non-active because of deficiencies that were identified during FDA’s review. A petition remains in abeyance until either the petitioner provides OFAS with the required information, requests a final decision based on the data currently in the petition, or requests withdrawal of the petition. When the petitioner provides the information required to address all deficiencies, the petition may be refiled resulting in a new filing date.
More information about Food Additives and Petitions.
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Petition Type/Number
(sorted A-Z) |
Status | Petitioner | Title |
---|---|---|---|
CAP 0C0288 | held in abeyance | Biocompatibles UK Ltd. | Use of C.I. Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS Reg. No. 4499018) reacted with polyvinyl alcohol as a color additive in vascular embolization devices. |
CAP 1C0319 | under review | Gardenia Blue Interest Group | To amend the color additive regulations in 21 CFR 73 to provide for the safe use of Gardenia Blue Powder for use as a color additive in various foods |
CAP 1C0320 | under review | Fermentalg | To amend the color additive regulations in 21 CFR part 73 to provide for the safe use of blue Galdieria (Galdieria sulphuraria) extract as a color additive in various foods. |
CAP 1C0321 | held in abeyance | Australian Laboratory Services, PTY LTD., on behalf of Piotrovska, PTY LTD | To amend 21 CFR 73.200 to expand the permitted uses of synthetic iron oxide as a color additive to include use in edible decorative paint. |
CAP 2C0322 | under review | Motif FoodWorks, Inc. | To amend the color additive regulations in 21 CFR part 73 to provide for the safe use of myoglobin as a color additive in meat and poultry analogue products. |
CAP 3C0323 | under review | Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Chef Ann Foundation, Children's Advocacy Institute, Consumer Federation of America, Consumer Reports, Defend Our Health, Environmental Defense Fund, Environmental Working Group, Feingold Association of the United States, Food & Water Watch, Healthy Babies Bright Futures, Life Time Foundation, Momsrising, Prevention Institute, Public Citizen, Public Health Institute, Public Interest Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S. Birnbaum, and Philip J. Landrigan | Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs |
CAP 3C0324 | under review | Innophos, Inc. | To amend the color additive regulations to provide for the safe use of tricalcium phosphate in poultry (chicken thigh), icing, white chocolate candy melts, doughnut sugar, and sugar for coated candies. |
CAP 3C0325 | under review | Environmental Defense Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, and Environmental Working Group | Request to Revoke Color Additive Listing for Use of Titanium Dioxide in Food |
CAP 4C0326 | under review | Phytolon Ltd. | To amend the color additive regulations in 21 CFR part 73 to provide for the safe use of beetroot red for the coloring of foods generally in amounts consistent with current good manufacturing practice. |
CAP 4C0327 | under review | Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts | To amend the color additive regulations to remove the solvents ethylene dichloride, methylene chloride, and trichloroethylene |
CAP 4C0328 | under review | Sensient Colors, LLC. | To amend the color additive regulations in 21 CFR 73.69 Listing of Color Additives Exempt from Certification: Butterfly pea flower extract to expand the safe use of butterfly pea flower extract to include ready-to-eat cereals, crackers and snack mixes, and chips at levels consistent with good manufacturing practice. |
CAP 4C0330 | held in abeyance | Lonza Greenwood LLC | To amend the color additive regulations in 21 CFR 73.125, Listing of Color Additives Exempt from Certification: Sodium copper chlorophyllin to provide for the safe use of sodium copper chlorophyllin in dietary supplement capsules in an amount ranging from 0.08 to 0.4 percent of the weight of the capsule, and to add fescue grass (Festuca arundinacea) as a permitted source of the color additive. |
CAP 4C0332 | held in abeyance | Phytolon Ltd. | To amend the color additive regulations in 21 CFR part 73, “Listing of Color Additives Exempt From Certification,” to provide for the safe use of prickly pear yellow for the coloring of foods generally in amounts consistent with current good manufacturing practice. |
CAP 4C0334 | under review | GNT USA, LLC | To amend the color additive regulations in part 73 (21 CFR part 73), Listing of Color Additives Exempt From Certification, to provide for the safe use of spirulina extract in foods generally in amounts consistent with good manufacturing practice. |
CAP 6C0281 | held in abeyance | FMC Health and Nutrition | To amend the color additive regulations in 21 CFR 73.125 to provide for the safe use of sodium copper chlorophyllin to include foods generally (with the exception of meat, poultry, fish, and standardized foods) |
FAP 0A4216 | under review | Glenn Scott | Petition to prohibit the use of BHA. |
FAP 0A4824 | held in abeyance | Unilever | To amend food additive regulations to provide for the safe use of potassium iodate in salt added to select food categories as a source of dietary iodine |
FAP 1A2671 | held in abeyance | U S Department of Commerce | Sodium nitrite in white fish |
FAP 1A4827 | under review | General Mills, Inc. | To amend the food additive regulations in § 172.380 (21 CFR 172.380) Vitamin D3 to provide for the safe use of vitamin D3 as a nutrient supplement in yogurt at a level higher than what is currently permitted. |
FAP 1A4828 | held in abeyance | Monaghan Mushrooms Ireland Unlimited Company | To amend the food additive regulations in 21 CFR 172.382 to provide for the safe use of vitamin D2 mushroom powder produced by exposing dried and powdered edible cultivars of Agaricus bisporus to ultraviolet light. |
FAP 1A4829 | held in abeyance | Lallemand Inc. | To amend the food additive regulations to provide for the safe use of vitamin D2 heat-killed ("inactive") baker's yeast as a source of vitamin D2 in specific food categories |
FAP 2A3672 | held in abeyance | Calorie Control Council (CCC) | Cyclamate (cyclamic acid, calcium cyclamate, and sodium cyclamate) |
FAP 2A4832 | under review | PHM Brands | To amend the food additive regulations in § 173.300 (21 CFR 173.300; Chlorine dioxide) to provide for production of the additive via an electrolytic method from a brine solution containing chloride salts. |
FAP 2A4833 | under review | Cargill, Inc. | to amend the food additive regulations (21 CFR 173.356) Hydrogen peroxide, to provide for the safe use of hydrogen peroxide (CAS Reg. No. 7722-84-1) as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. |
FAP 2A4834 | under review | Kerry Ingredients and Flavours Ltd. | To provide for the safe use of vitamin D3 as a nutrient supplement in powdered drink mixes added to water or carbonated water at levels not to exceed 180 international units per 360 milliliters (mL) as consumed, excluding drinks or drink mixes that are specially formulated or processed for infants (Refs. 1 and 2). If calcium is added, calcium is present at levels greater than or equal to 150 milligrams of calcium per 360 mL as consumed. |
FAP 2B4312 | held in abeyance | American Meat Institute | Single-use rubber threads used in the processing and packaging of food, including meat and poultry |
FAP 2B4831 | under review | Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Maricel Maffini, and Linda Birnbaum | To amend the food additive regulations to remove or restrict authorizations for the use of bisphenol A (BPA). |
FAP 2M4741 | held in abeyance | Steris Corp | Approved sources of gamma rays from sealed units of the radionuclides cobalt-60 or cesium-137 to reduce microorganisms on dietary supplements and nutritional function foods |
FAP 3A4836 | under review | Kerry Inc. | To amend the food additive regulations in 21 CFR part 172 to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products at a level not to exceed 3 percent. |
FAP 3B4837 | under review | Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini | To amend the food additive regulations to remove authorization of fluorinated polyethylene |
FAP 4A4839 | under review | Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts | To amend the food additive regulations to remove the solvents benzene, ethylene dichloride, methylene chloride, and trichloroethylene |
FAP 4M4807 | held in abeyance | Casa de Mesquite, LLC | Use of ionizing radiation to treat mesquite bean flour |
FAP 8A4772 | held in abeyance | Lubrizol Advanced Materials, Inc. | Use of cassia gum as a stabilizer in frozen dairy desserts and to improve texture and water retention in cheeses, meat and poultry products |
FAP 8M4822 | held in abeyance | Gateway America LLC | To amend our food additive regulations to provide for the safe use of sources of ionizing radiation to control food-borne pathogens in finfish and flatfish. |
FAP 9M4697 | held in abeyance | Grocery Manufacturers Association (formerly National Food Processors Assn.) | Use of ionizing radiation on certain refrigerated, frozen or dried meat, poultry, fruit or vegetable products |
Petition Type/Number
(sorted A-Z) |
Status | Petitioner | Title |
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