21 C.F.R. Subpart H—Other Specific Usage Additives
Title 21 - Food and Drugs
The following surfactants and related adjuvants may be safely added to pesticide use dilutions by a grower or applicant prior to application to the growing crop:
n-Alkyl (C8-C18) amine acetate, where the alkyl groups (C8-C18) are derived from coconut oil, as a surfactant in emulsifier blends at levels not in excess of 5 percent by weight of the emulsifier blends that are added to herbicides for application to corn and sorghum. Di-n-alkyl (C8-C18) dimethyl ammonium chloride, where the alkyl groups (C8-C18) are derived from coconut oil, as surfactants in emulsifier blends at levels not in excess of 5 percent by weight of emulsifier blends that are added to herbicides for application to corn or sorghum. Diethanolamide condensate based on a mixture of saturated and unsaturated soybean oil fatty acids (C16-C18) as a surfactant in emulsifier blends that are added to the herbicide atrazine for application to corn. Diethanolamide condensate based on stripped coconut fatty acids (C10 C18) as a surfactant in emulsifier blends that are added to the herbicide atrazine for application to corn. α-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a proplyene tetramer isomer) with an average of 4–14 or 30–70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4–14 or 30–70. Ethylene dichloride. Polyglyceryl phthalate ester of coconut oil fatty acids. α-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4–14 or 30–70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4–14 or 30–70. α-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with 1 mole of ethylene oxide. Sodium acrylate and acrylamide copolymer with a minimum average molecular weight of 10,000,000 in which 30 percent of the polymer is comprised of acrylate units and 70 percent acrylamide units, for use as a drift control agent in herbicide formulations applied to crops at a level not to exceed 0.5 ounces of the additive per acre. The food additive 1,3-butylene glycol (CAS Reg. No. 107–88–0) may be safely used in food in accordance with the following prescribed conditions: (a) It is prepared by the aldol condensation of acetaldehyde followed by catalytic hydrogenation. (b) The food additive shall conform to the identity and specifications listed in the monograph entitled “1,3-Butylene Glycol” in the Food Chemicals Codex, 4th ed. (1996), p. 52, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (c) It is used in the manufacture of sausage casings as a formulation aid as defined in §170.3(o)(14) of this chapter and as a processing aid as defined in §170.3(o)(24) of this chapter. [62 FR 26228, May 13, 1997] Calcium lignosulfonate may be safely used in or on food, subject to the provisions of this section. (a) Calcium lignosulfonate consists of sulfonated lignin, primarily as calcium and sodium salts. (b) It is used in an amount not to exceed that reasonably required to accomplish the intended physical or technical effect when added as a dispersing agent and stabilizer in pesticides for preharvest or postharvest application to bananas. The food additive calcium lactobionate may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is the calcium salt of lactobionic acid (4-(β,D-galactosido)-D-gluconic acid) produced by the oxidation of lactose. (b) It is used or intended for use as a firming agent in dry pudding mixes at a level not greater than that required to accomplish the intended effect. Epoxidized soybean oil may be safely used in accordance with the following prescribed conditions: (a) The additive is prepared by reacting soybean oil in toluene with hydrogen peroxide and formic acid. (b) It meets the following specifications: (1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 8.0 percent, as determined by the American Oil Chemists' Society (A.O.C.S.) method Cd 9–57, “Oxirane Oxygen,” reapproved 1989, which is incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR part 51. Copies are available from the American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826–3489, or may be examined at the Division of Petition Control (HFS–215), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., suite 1200, Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (2) The maximum iodine value is 3.0, as determined by A.O.C.S. method Cd 1–25, “Iodine Value of Fats and Oils Wijs Method,” revised 1993, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section. (3) The heavy metals (as Pb) content cannot be more than 10 parts per million, as determined by the “Heavy Metals Test,” of the “Food Chemicals Codex,” 4th ed. (1996), pp. 760–761, Method II (with a 2-gram sample and 20 microgram of lead ion in the control), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (c) The additive is used as a halogen stabilizer in brominated soybean oil at a level not to exceed 1 percent. [60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999] The food additives gibberellic acid and its potassium salt may be used in the malting of barley in accordance with the following prescribed conditions: (a) The additives meet the following specifications: (1) The gibberellic acid is produced by deep-culture fermentation of a suitable nutrient medium by a strain of Fusarium moniliforme or a selection of this culture. (2) The gibberellic acid produced is of 80 percent purity or better. (3) The empirical formula of gibberellic acid is represented by C19H22O6. (4) Potassium gibberellate is the potassium salt of the specified gibberellic acid. (5) The potassium gibberellate is of 80 percent purity or better. (6) The gibberellic acid or potassium gibberellate may be diluted with substances generally recognized as safe in foods or with salts of fatty acids conforming to §172.863. (b) They are used or intended for use in the malting of barley under conditions whereby the amount of either or both additives present in the malt is not in excess of 2 parts per million expressed as gibberellic acid, and the treated malt is to be used in the production of fermented malt beverages or distilled spirits only, whereby the finished distilled spirits contain none and the finished malt beverage contains not more than 0.5 part per million of gibberellic acid. (c) To insure the safe use of the food additives the label of the package shall bear, in addition to the other information required by the Act: (1) The name of the additive, “gibberellic acid” or “potassium gibberellate”, whichever is appropriate. (2) An accurate statement of the concentration of the additive contained in the package. (3) Adequate use directions to provide not more than 2 parts per million of gibberellic acid in the finished malt. (4) Adequate labeling directions to provide that the final malt is properly labeled as described in paragraph (d) of this section. (d) To insure the safe use of the additive the label of the treated malt shall bear, in addition to the other information required by the Act, the statements: (1) “Contains not more than 2 parts per million ___”, the blank being filled in with the words “gibberellic acid” or “potassium gibberellate”, whichever is appropriate; and (2) “Brewer's malt—To be used in the production of fermented malt beverages only” or “Distiller's malt—To be used in the production of distilled spirits only”, whichever is appropriate. The food additive potassium bromate may be safely used in the malting of barley under the following prescribed conditions: (a)(1) It is used or intended for use in the malting of barley under conditions whereby the amount of the additive present in the malt from the treatment does not exceed 75 parts per million of bromate (calculated as Br), and the treated malt is used only in the production of fermented malt beverages or distilled spirits. (2) The total residue of inorganic bromides in fermented malt beverages, resulting from the use of the treated malt plus additional residues of inorganic bromides that may be present from uses in accordance with other regulations in this chapter promulgated under sections 408 and/or 409 of the act, does not exceed 25 parts per million of bromide (calculated as Br). No tolerance is established for bromide in distilled spirits because there is evidence that inorganic bromides do not pass over in the distillation process. (b) To assure safe use of the additive, the label or labeling of the food additive shall bear, in addition to the other information required by the Act, the following: (1) The name of the additive. (2) Adequate directions for use. (c) To assure safe use of the additive, the label or labeling of the treated malt shall bear, in addition to other information required by the Act, the statement, “Brewer's Malt—To be used in the production of fermented malt beverages only”, or “Distiller's Malt—To be used in the production of distilled spirits only”, whichever is the case. Glycerol ester of wood or gum rosin may be safely used in food in accordance with the following prescribed conditions: (a) It has an acid number of 3 to 9, a drop-softening point of 88 °C–96 °C; and a color of N or paler as determined in accordance with Official Naval Stores Standards of the United States. It is purified by countercurrent steam distillation. (b) It is used to adjust the density of citrus oils used in the preparation of beverages whereby the amount of the additive does not exceed 100 parts per million of the finished beverage. [42 FR 14491, Mar. 15, 1977, as amended at 70 FR 15758, Mar. 29, 2005] The food additive glycerides and polyglycides of hydrogenated vegetable oils may be safely used in food in accordance with the following prescribed conditions: (a) The additive is manufactured by heating a mixture of hydrogenated oils of vegetable origin and polyethylene glycol in the presence of an alkaline catalyst followed by neutralization with any acid that is approved or is generally recognized as safe for this use to yield the finished product. (b) The additive consists of a mixture of mono-, di- and tri-glycerides and polyethylene glycol mono- and di-esters of fatty acids (polyglycides) of hydrogenated vegetable oils and meets the following specifications: (1) Total ester content, greater than 90 percent as determined by a method entitled “Determination of Esterified Glycerides and Polyoxyethylene Glycols,” approved November 16, 2001, printed by Gattefosse S.A.S., and incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety, 5100 Paint Branch Pkwy., College Park, MD 20740 or you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (2) Acid value, not greater than 2, and hydroxyl value, not greater than 56 as determined by the methods entitled “Acid Value,” p. 934 and “Hydroxyl Value,” p. 936, respectively, in the Food Chemicals Codex, 5th ed., effective January 1, 2004, and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academies Press, 500 Fifth St. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (3) Lead, not greater than 0.1 mg/kg as determined by the American Oil Chemists' Society (A.O.C.S.) method Ca 18c–91, “Determination of Lead by Direct Graphite Furnace Atomic Absorption Spectrophotometry,” updated 1995, and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826–3489, or may be examined in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (4) 1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/kg), and ethylene oxide, not greater than 1 mg/kg, as determined by a gas chromatographic method entitled “Determination of Ethylene Oxide and 1,4-Dioxane by Headspace Gas Chromatography,” approved November 5, 1998, printed by Gattefosse S.A.S., and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51; see paragraph (b)(1) of this section for availability of the incorporation by reference. (c) The additive is used or intended for use as an excipient in dietary supplement tablets, capsules, and liquid formulations that are intended for ingestion in daily quantities measured in drops or similar small units of measure. [71 FR 12620, Mar. 13, 2006] The food additive stearyl monoglyceridyl citrate may be safely used in food in accordance with the following provisions: (a) The additive is prepared by controlled chemical reaction of the following: (b) The additive stearyl monoglyceridyl citrate, produced as described under paragraph (a) of this section, meets the following specifications:
Acid number 40 to 52. Total citric acid 15 to 18 percent. Saponification number 215–255. (c) The additive is used or intended for use as an emulsion stabilizer in or with shortenings containing emulsifiers. The food additive succistearin (stearoyl propylene glycol hydrogen succinate) may be safely used in food in accordance with the following prescribed conditions: (a) The additive is the reaction product of succinic anhydride, fully hydrogenated vegetable oil (predominantly C16 or C18 fatty acid chain length), and propylene glycol. (b) The additive meets the following specifications:
Acid number 50–150. Hydroxyl number 15–50. Succinated ester content 45–75 percent. (c) The additive is used or intended for use as an emulsifier in or with shortenings and edible oils intended for use in cakes, cake mixes, fillings, icings, pastries, and toppings, in accordance with good manufacturing practice. The polymer of ethylene oxide may be safely used as a foam stabilizer in fermented malt beverages in accordance with the following conditions. (a) It is the polymer of ethylene oxide having a minimum viscosity of 1,500 centipoises in a 1 percent aqueous solution at 25 °C. (b) It is used at a level not to exceed 300 parts per million by weight of the fermented malt beverage. (c) The label of the additive bears directions for use to insure compliance with paragraph (b) of this section. Methacrylic acid-divinylbenzene copolymer may be safely used in food in accordance with the following prescribed conditions: (a) The additive is produced by the polymerization of methacrylic acid and divinylbenzene. The divinylbenzene functions as a cross-linking agent and constitutes a minimum of 4 percent of the polymer. (b) Aqueous extractives from the additive do not exceed 2 percent (dry basis) after 24 hours at 25 °C. (c) The additive is used as a carrier of vitamin B12 in foods for special dietary use. The food additive may be safely used in food in accordance with the following prescribed conditions: (a) Acacia (gum arabic) is the dried gummy exudate from stems and branches of trees of various species of the genus Acacia, family Leguminosae. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 5th Ed. (2004), pp. 210 and 211, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the National Academies Press, 500 Fifth St. NW., Washington, DC 20001 (Internet address: http://www.nap.edu). Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federa_regulations/ibr_locations.php. (c) The ingredient is used as a thickener, emulsifier, or stabilizer in alcoholic beverages at a use level not to exceed 20 percent in the final beverage. [70 FR 8034, Feb. 17, 2005] The additive may be safely used as an antimicrobial agent specific for Listeria monocytogenes (L. monocytogenes) in accordance with the following conditions: (a) Identity. (1) The additive consists of a mixture of equal proportions of six different individually purified lytic-type (lacking lysogenic activity) bacteriophages (phages) specific against L. monocytogenes. (2) Each phage is deposited at, and assigned an identifying code by, a scientifically-recognized culture collection center, and is made available to FDA upon request. (3) The additive is produced from one or more cell cultures of L. monocytogenes in a safe and suitable nutrient medium. (b) Specifications. (1) The additive achieves a positive lytic result (OD600 ≤ 0.06) when tested against any of the following L. monocytogenes isolates available from American Type Culture Collection (ATCC): ATCC 35152 (serogroup 1/2a), ATCC 19118 (serogroup 4b), and ATCC 15313 (serogroup 1/2b). The analytical method for determining the potency of the additive entitled “Determination of Potency of LMP–102TM ,” dated October 9, 2003, and printed by Intralytix, Inc., is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (2) The mean phage titer of each monophage in the additive is 1 x 109 plaque forming units (PFU)/ml. The analytical method for determining phage titer entitled “Method to Determine Lytic Activity/Phage Titer,” dated November 6, 2001, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section. (3) The phages present in the preparation must not contain a functional portion of any of the toxin-encoding sequences described in 40 CFR 725.421(d). No sequences derived from genes encoding bacterial 16S ribosomal RNA are present in the complete genomic sequence of the phages. (4) L. monocytogenes toxin, listeriolysin O (LLO), is not greater than 5 hemolytic units (HU)/ml. The analytical method for determining LLO entitled “Quantitation of Listeriolysin O Levels in LMP–102TM ,” dated September 27, 2004, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section. (5) The additive is negative for L. monocytogenes. The modified version of the U.S. Department of Agriculture's method for determining L. monocytogenes entitled “LMP–102TM Listeria monocytogenes Sterility Testing,” dated May 24, 2004, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section. (6) The additive is negative for gram-positive and gram-negative bacteria capable of growing in commonly used microbiological media (e.g., Luria-Bertani (LB) medium), including Escherichia coli, Salmonella species and coagulase-positive Staphylococci, as determined by the “Method to Determine Microbial Contamination,” dated July 11, 2003, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section. (7) Total organic carbon (TOC) is less than or equal to 36 mg/kg. The analytical method for determining TOC entitled “Determination of Total Organic Carbon by Automated Analyzer,” dated March 30, 2001, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section. (c) Conditions of use. The additive is used in accordance with current good manufacturing practice to control L. monocytogenes by direct application to meat and poultry products that comply with the ready-to-eat definition in 9 CFR 430.1. Current good manufacturing practice is consistent with direct spray application of the additive at a rate of approximately 1 mL of the additive per 500 cm2 product surface area. [71 FR 47731, Aug. 18, 2006]
Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart H—Other Specific Usage Additives
§ 172.710 Adjuvants for pesticide use dilutions.
§ 172.712 1,3-Butylene glycol.
§ 172.715 Calcium lignosulfonate.
§ 172.720 Calcium lactobionate.
§ 172.723 Epoxidized soybean oil.
§ 172.725 Gibberellic acid and its potassium salt.
§ 172.730 Potassium bromate.
§ 172.735 Glycerol ester of wood or gum rosin.
§ 172.736 Glycerides and polyglycides of hydrogenated vegetable oils.
§ 172.755 Stearyl monoglyceridyl citrate.
------------------------------------------------------------------------ Reactant Limitations------------------------------------------------------------------------Citric acid.............................. .............................Monoglycerides of fatty acids............ Prepared by the glycerolysis of edible fats and oils or derived from fatty acids conforming with § 172.860.Stearyl alcohol.......................... Derived from fatty acids conforming with § 172.860, or derived synthetically in conformity with § 172.864.------------------------------------------------------------------------
§ 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
§ 172.770 Ethylene oxide polymer.
§ 172.775 Methacrylic acid-divinylbenzene copolymer.
§ 172.780 Acacia (gum arabic).
§ 172.785 Listeria-specific bacteriophage preparation.
