Title 21—Food and Drugs--Volume 1
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
§ 172.842   Sorbitan monostearate.
The food additive sorbitan monostearate, which is a mixture of partial stearic and palmitic acid esters of sorbitol anhydrides, may be safely used in or on food in accordance with the following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield essentially a mixture of esters.
(b) The food additive meets the following specifications:
(c) It is used or intended for use, alone or in combination with polysorbate 60 as follows:
(1) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:
(i) Polysorbate 60;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
(3) As an emulsifier, alone or in combination with polysorbate 60 in nonstandardized confectionery coatings and standardized cacao products specified in §§ 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.
(ii) It is used with polysorbate 60 in any combination of up to 1 percent sorbitan monostearate and up to 0.5 percent polysorbate 60 provided that the total combination does not exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.
(4) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
(5) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:
(i) Polysorbate 60.
(ii) Polysorbate 65.
(6) It is used alone as a rehydration aid in the production of active dry yeast in an amount not to exceed 1 percent by weight of the dry yeast.
(7) As an emulsifier, alone or in combination with polysorbate 60, in the minimum quantity required to accomplish the intended effect, in formulations of white mineral oil conforming with § 172.878 and/or petroleum wax conforming with § 172.886 for use as protective coatings on raw fruits and vegetables.
(d) To assure safe use of the additive, in addition to the other information required by the Act:
(1) The label of the additive and any intermediate premixes shall bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.
§ 172.844   Calcium stearoyl-2-lactylate.
The food additive calcium stearoyl-2-lactylate may be safely used in or on food in accordance with the following prescribed conditions:
(a) The additive, which is a mixture of calcium salts of stearoyl lactylic acids and minor proportions of other calcium salts of related acids, is manufactured by the reaction of stearic acid and lactic acid and conversion to the calcium salts.
(b) The additive meets the following specifications:
(c) It is used or intended for use as follows:
(1) As a dough conditioner in yeast-leavened bakery products and prepared mixes for yeast-leavened bakery products in an amount not to exceed 0.5 part for each 100 parts by weight of flour used.
(2) As a whipping agent in:
(i) Liquid and frozen egg white at a level not to exceed 0.05 percent.
(ii) Dried egg white at a level not to exceed 0.5 percent.
(iii) Whipped vegetable oil topping at a level not to exceed 0.3 percent of the weight of the finished whipped vegetable oil topping.
(3) As a conditioning agent in dehydrated potatoes in an amount not to exceed 0.5 percent by weight thereof.
(d) To assure safe use of the additive:
(1) The label and labeling of the food additive and any intermediate premix prepared therefrom shall bear, in addition to the other information required by the act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in any intermediate premixes.
(2) The label or labeling of the food additive shall also bear adequate directions of use to provide a finished food that complies with the limitations prescribed in paragraph (c) of this section.
§ 172.846   Sodium stearoyl lactylate.
The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383-997) may be safely used in food in accordance with the following prescribed conditions:
(a) The additive, which is a mixture of sodium salts of stearoyl lactylic acids and minor proportions of sodium salts of related acids, is manufactured by the reaction of stearic acid and lactic acid and conversion to the sodium salts.
(b) The additive meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 300-301, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined 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.html.
(c) It is used or intended for use as follows when standards of identity established under section 401 of the Act do not preclude such use:
(1) As a dough strengthener, emulsifier, or processing aid in baked products, pancakes, and waffles, in an amount not to exceed 0.5 part for each 100 parts by weight of flour used.
(2) As a surface-active agent, emulsifier, or stabilizer in icings, fillings, puddings, and toppings, at a level not to exceed 0.2 percent by weight of the finished food.
(3) As an emulsifier or stabilizer in liquid and solid edible fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, at a level not to exceed 0.3 percent by weight of the finished edible fat-water emulsion.
(4) As a formulation aid, processing aid, or surface-active agent in dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry weight of the food.
(5) As an emulsifier, stabilizer, or texturizer in snack dips, at a level not to exceed 0.2 percent by weight of the finished product.
(6) As an emulsifier, stabilizer, or texturizer in cheese substitutes and imitations and cheese product substitutes and imitations, at a level not to exceed 0.2 percent by weight of the finished food.
(7) As an emulsifier, stabilizer, or texturizer in sauces or gravies, and the products containing the same, in an amount not to exceed 0.25 percent by weight of the finished food.
(8) In prepared mixes for each of the foods listed in paragraphs (c)(1) through (7) of this section, provided the additive is used only as specified in each of those paragraphs.
(9) As an emulsifier, stabilizer, or texturizer in cream liqueur drinks, at a level not to exceed 0.5 percent by weight of the finished product.
§ 172.848   Lactylic esters of fatty acids.
Lactylic esters of fatty acids may be safely used in food in accordance with the following prescribed conditions:
(a) They are prepared from lactic acid and fatty acids meeting the requirements of § 172.860(b) and/or oleic acid derived from tall oil fatty acids meeting the requirements of § 172.862.
(b) They are used as emulsifiers, plasticizers, or surface-active agents in the following foods, when standards of identity do not preclude their use:
(c) They are used in an amount not greater than required to produce the intended physical or technical effect, and they may be used with shortening and edible fats and oils when such are required in the foods identified in paragraph (b) of this section.
§ 172.850   Lactylated fatty acid esters of glycerol and propylene glycol.
The food additive lactylated fatty acid esters of glycerol and propylene glycol may be safely used in food in accordance with the following prescribed conditions:
(a) The additive is a mixture of esters produced by the lactylation of a product obtained by reacting edible fats or oils with propylene glycol.
(b) The additive meets the following specifications: Water insoluble combined lactic acid, 14-18 percent; and acid number, 12 maximum.
(c) It is used in amounts not in excess of that reasonably required to produce the intended physical effect as an emulsifier, plasticizer, or surface-active agent in food.
§ 172.852   Glyceryl-lacto esters of fatty acids.
Glyceryl-lacto esters of fatty acids (the lactic acid esters of mono- and diglycerides) may be safely used in food in accordance with the following prescribed conditions:
(a) They are manufactured from glycerin, lactic acid, and fatty acids conforming with § 172.860 and/or oleic acid derived from tall oil fatty acids conforming with § 172.862 and/or edible fats and oils.
(b) They are used in amounts not in excess of those reasonably required to accomplish their intended physical or technical effect as emulsifiers and plasticizers in food.
§ 172.854   Polyglycerol esters of fatty acids.
Polyglycerol esters of fatty acids, up to and including the decaglycerol esters, may be safely used in food in accordance with the following prescribed conditions:
(a) They are prepared from corn oil, cottonseed oil, lard, palm oil from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the fatty acids derived from these substances (hydrogenated and nonhydrogenated) meeting the requirements of § 172.860(b) and/or oleic acid derived from tall oil fatty acids meeting the requirements of § 172.862.
(b) They are used as emulsifiers in food, in amounts not greater than that required to produce the intended physical or technical effect.
(c) Polyglycerol esters of a mixture of stearic, oleic, and coconut fatty acids are used as a cloud inhibitor in vegetable and salad oils when use is not precluded by standards of identity. The fatty acids used in the production of the polyglycerol esters meet the requirements of § 172.860(b), and the polyglycerol esters are used at a level not in excess of the amount required to perform its cloud-inhibiting effect. Oleic acid derived from tall oil fatty acids conforming with § 172.862 may be used as a substitute for or together with the oleic acid permitted by this paragraph.
(d) Polyglycerol esters of butter oil fatty acids are used as emulsifiers in combination with other approved emulsifiers in dry, whipped topping base. The fatty acids used in the production of the polyglycerol esters meet the requirements of § 172.860(b), and the polyglycerol esters are used at a level not in excess of the amount required to perform their emulsifying effect.
§ 172.856   Propylene glycol mono- and diesters of fats and fatty acids.
Propylene glycol mono- and diesters of fats and fatty acids may be safely used in food, subject to the following prescribed conditions:
(a) They are produced from edible fats and/or fatty acids in compliance with § 172.860 and/or oleic acid derived from tall oil fatty acids in compliance with § 172.862.
(b) They are used in food in amounts not in excess of that reasonably required to produce their intended effect.
§ 172.858   Propylene glycol alginate.
The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2) may be used as an emulsifier, flavoring adjuvant, formulation aid, stabilizer, surfactant, or thickener in foods in accordance with the following prescribed conditions:
(a) The additive meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 256, which is incorporated by reference (Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection 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.html. ), and the additional specification that it shall have up to 85 percent of the carboxylic acid groups esterified with the remaining groups either free or neutralized.
(b) The additive is used or intended for use in the following foods as defined in § 170.3(n) of this chapter, when standards of identity established under section 401 of the act do not preclude such use:
(1) As a stabilizer in frozen dairy desserts, in fruit and water ices, and in confections and frostings at a level not to exceed 0.5 percent by weight of the finished product.
(2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener in baked goods at a level not to exceed 0.5 percent by weight of the finished product.
(3) As an emulsifier, stabilizer, or thickener in cheeses at a level not to exceed 0.9 percent by weight of the finished product.
(4) As an emulsifier, stabilizer, or thickener in fats and oils at a level not to exceed 1.1 percent by weight of the finished product.
(5) As an emulsifier, stabilizer, or thickener in gelatins and puddings at a level not to exceed 0.6 percent by weight of the finished product.
(6) As a stabilizer or thickener in gravies and in sweet sauces at a level not to exceed 0.5 percent by weight of the finished product.
(7) As a stabilizer in jams and jellies at a level not to exceed 0.4 percent by weight of the finished product.
(8) As an emulsifier, stabilizer, or thickener in condiments and relishes at a level not to exceed 0.6 percent by weight of the finished product.
(9) As a flavoring adjunct or adjuvant in seasonings and flavors at a level not to exceed 1.7 percent by weight of the finished product.
(10) As an emulsifier, flavoring adjuvant, formulation aid, stabilizer or thickener, or surface active agent in other foods, where applicable, at a level not to exceed 0.3 percent by weight of the finished product.
(c) To ensure safe use of the additive, the label of the food additive container shall bear, in addition to the other information required by the act:
(1) The name of the additive, “propylene glycol alginate” or “propylene glycol ester of alginic acid”.
(2) Adequate directions for use.
§ 172.859   Sucrose fatty acid esters.
Sucrose fatty acid esters identified in this section may be safely used in accordance with the following prescribed conditions:
(a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of sucrose with fatty acids and are derived from sucrose and edible tallow or hydrogenated edible tallow or edible vegetable oils. The only solvents which may be used in the preparation of sucrose fatty acid esters are those generally recognized as safe in food or regulated for such use by an appropriate section in this part. Ethyl acetate or methyl ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-propanol) may be used in the preparation of sucrose fatty acid esters.
(b) Sucrose fatty acid esters meet the following specifications:
(1) The total content of mono-, di-, and tri-esters is not less than 80 percent as determined by a method title “Sucrose Fatty Acid Esters, Method of Assay,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
(2) The free sucrose content is not more than 5 percent as determined by Test S.2 in the method titled “Sucrose Fatty Acid Esters, Method of Assay,” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.
(3) The acid value is not more than 6.
(4) The residue on ignition (sulfated ash) is not more than 2 percent.
(5) The total ethyl acetate content is not more than 350 parts per million as determined by a method titled “Determination of Ethyl Acetate,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
(6) Arsenic is not more than 3 parts per million.
(7) Total heavy metal content (as Pb) is not more than 50 parts per million.
(8) Lead is not more than 10 parts per million.
(9) The total content of methyl ethyl ketone or of methanol shall not be more than 10 parts per million as determined by a method titled “Methyl Ethyl Ketone Test; Methyl Alcohol Test,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
(10) The total dimethyl sulfoxide content is not more than 2 parts per million as determined by a method entitled “Determination of Dimethyl Sulfoxide,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
(11) The total isobuytl alcohol (2-methyl-1-propanol) content is not more than 10 parts per million as determined by a method entitled “Determination of Isobutyl Alcohol,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
(c) Sucrose fatty acid esters may be used as follows when standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use:
(1) As emulsifiers as defined in § 170.3(o)(8) of this chapter, or as stabilizers as defined in § 170.3(o)(28) of this chapter, in baked goods and baking mixes as defined in § 170.3(n)(1) of this chapter, in chewing gum as defined in § 170.3(n)(6) of this chapter, in coffee and tea beverages with added dairy ingredients and/or dairy product analogues, in confections and frostings as defined in § 170.3(n)(9) of this chapter, in dairy product analogues as defined in § 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, and in whipped milk products.
(2) As texturizers as defined in § 170.3(o)(32) of this chapter in biscuit mixes, in chewing gum as defined in § 170.3(n)(6) of this chapter, in confections and frostings as defined in § 170.3(n)(9) of this chapter, and in surimi-based fabricated seafood products.
(3) As components of protective coatings applied to fresh apples, avocados, bananas, banana plantains, limes, melons (honeydew and cantaloupe), papaya, peaches, pears, pineapples, and plums to retard ripening and spoiling.
(d) Sucrose fatty acid esters are used in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended effect.
§ 172.860   Fatty acids.
The food additive fatty acids may be safely used in food and in the manufacture of food components in accordance with the following prescribed conditions:
(a) The food additive consists of one or any mixture of the following straight-chain monobasic carboxylic acids and their associated fatty acids manufactured from fats and oils derived from edible sources: Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid, palmitic acid, and stearic acid.
(b) The food additive meets the following specifications:
(1) Unsaponifiable matter does not exceed 2 percent.
(2) It is free of chick-edema factor:
(i) As evidenced during the bioassay method for determining the chick-edema factor as prescribed in paragraph (c)(2) of this section; or
(ii) As evidenced by the absence of chromatographic peaks with a retention time relative to aldrin (RA) between 10 and 25, using the gas chromatographic-electron capture method prescribed in paragraph (c)(3) of this section. If chromatographic peaks are found with RA values between 10 and 25, the food additive shall meet the requirements of the bioassay method prescribed in paragraph (c)(2) of this section for determining chick-edema factor.
(c) For the purposes of this section:
(1) Unsaponifiable matter shall be determined by the method described in the 13th Ed. (1980) of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection 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.html.
(2) Chick-edema factor shall be determined by the bioassay method described in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 28.127-28.130, which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.html.
(3) The gas chromatographic-electron capture method for testing fatty acids for chick-edema shall be the method described in the “Journal of the Association of Official Analytical Chemists,” Volume 50 (No. 1), pages 216-218 (1967), or the modified method using a sulfuric acid clean-up procedure, as described in the “Journal of the Association of the Official Analytical Chemists,” Volume 51 (No. 2), pages 489-490 (1968), which are incorporated by reference. See paragraph (c)(2) of this section for availability of these references.
(d) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and as a defoaming agent in accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(e) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the act, the following:
(1) The common or usual name of the acid or acids contained therein.
(2) The words “food grade,” in juxtaposition with and equally as prominent as the name of the acid.
§ 172.861   Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.
The food additive, cocoa butter substitute from coconut oil, palm kernel oil, or both oils, may be safely used in food in accordance with the following conditions:
(a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is manufactured by esterification of glycerol with food-grade fatty acids (complying with § 172.860) derived from edible coconut oil, edible palm kernel oil, or both oils.
(b) The ingredient meets the following specifications:
(c) The ingredient is used or intended for use as follows:
(1) As coating material for sugar, table salt, vitamins, citric acid, succinic acid, and spices; and
(2) In compound coatings, cocoa creams, cocoa-based sweets, toffees, caramel masses, and chewing sweets as defined in § 170.3 (n)(9) and (n)(38) of this chapter, except that the ingredient may not be used in a standardized food unless permitted by the standard of identity.
(d) The ingredient is used in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended effect.
§ 172.862   Oleic acid derived from tall oil fatty acids.
The food additive oleic acid derived from tall oil fatty acids may be safely used in food and as a component in the manufacture of food-grade additives in accordance with the following prescribed conditions:
(a) The additive consists of purified oleic acid separated from refined tall oil fatty acids.
(b) The additive meets the following specifications:
(1) Specifications for oleic acid prescribed in the Food Chemicals Codex, 7th ed. (2010), pp. 743-744, which is incorporated by reference, except that titer (solidification point) shall not exceed 13.5 °C and unsaponifiable matter shall not exceed 0.5 percent. 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 United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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/cfr/ibr-locations.html.
(2) The resin acid content does not exceed 0.01 as determined by ASTM method D1240-82, “Standard Test Method for Rosin Acids in Fatty Acids,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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.html.
(3) The requirements for absence of chick-edema factor as prescribed in § 172.860.
(c) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and defoaming agent in accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(d) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:
(1) The common or usual name of the acid.
(2) The words “food grade” in juxtaposition with and equally as prominent as the name of the acid.
§ 172.863   Salts of fatty acids.
The food additive salts of fatty acids may be safely used in food and in the manufacture of food components in accordance with the following prescribed conditions:
(a) The additive consists of one or any mixture of two or more of the aluminum, calcium, magnesium, potassium, and sodium salts of the fatty acids conforming with § 172.860 and/or oleic acid derived from tall oil fatty acids conforming with § 172.862.
(b) The food additive is used or intended for use as a binder, emulsifier, and anticaking agent in food in accordance with good manufacturing practice.
(c) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:
(1) The common or usual name of the fatty acid salt or salts contained therein.
(2) The words “food grade,” in juxtaposition with and equally as prominent as the name of the salt.
§ 172.864   Synthetic fatty alcohols.
Synthetic fatty alcohols may be safely used in food and in the synthesis of food components in accordance with the following prescribed conditions:
(a) The food additive consists of any one of the following fatty alcohols:
(1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl; manufactured by fractional distillation of alcohols obtained by a sequence of oxidation and hydrolysis of organo-aluminums generated by the controlled reaction of low molecular weight trialkylaluminum with purified ethylene (minimum 99 percent by volume C 2 H 4 ), and utilizing the hydrocarbon solvent as defined in paragraph (b) of this section, such that:
(i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not less than 99 percent of total alcohols and not less than 96 percent of straight chain alcohols. Any nonalcoholic impurities are primarily paraffins.
(ii) Cetyl and stearyl alcohols contain not less than 98 percent of total alcohols and not less than 94 percent of straight chain alcohols. Any nonalcoholic impurities are primarily paraffins.
(iii) The synthetic fatty alcohols contain no more than 0.1 weight percent of total diols as determined by a method available upon request from the Commissioner of Food and Drugs.
(2) Hexyl, octyl, and decyl; manufactured by fractional distillation of alcohols obtained by a sequence of oxidation, hydrolysis, and catalytic hydrogenation (catalyst consists of copper, chromium, and nickel) of organo-aluminums generated by the controlled reaction of low molecular weight trialkylaluminum with purified ethylene (minimum 99 percent by volume C 2 H 4 ), and utilizing an external coolant such that these alcohols meet the specifications prescribed in paragraph (a)(1)(i) and (iii) of this section.
(3) n-Octyl; manufactured by the hydrodimerization of 1,3-butadiene, followed by catalytic hydrogenation of the resulting dienol, and distillation to produce n -octyl alcohol with a minimum purity of 99 percent. The analytical method for n -octyl alcohol entitled “Test Method [Normal-octanol]” dated October 2003, and printed by Kuraray Co., Ltd., 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, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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.html.
(b) The hydrocarbon solvent used in the process described in paragraph (a)(1) of this section is a mixture of liquid hydrocarbons essentially paraffinic in nature, derived from petroleum and refined to meet the specifications described in paragraph (b)(1) of this section when subjected to the procedures described in paragraph (b)(2) and (3) of this section.
(1) The hydrocarbon solvent meets the following specifications:
(i) Boiling-point range: 175 °C-275 °C.
(ii) Ultraviolet absorbance limits as follows:
(2) Use ASTM method D86-82, “Standard Method for Distillation of Petroleum Products,” which is incorporated by reference, to determine boiling point range. Copies of the material incorporated by reference may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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.html.
(3) The analytical method for determining ultraviolet absorbance limits is as follows:
All glassware should be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure, it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of hydrocarbon solvent samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.
Chromatographic tube. 450 millimeters in length (packing section), inside diameter 19 millimeters ±1 millimeter, equipped with a wad of clean Pyrex brand filtering wool (Corning Glass Works Catalog No. 3950 or equivalent). The tube shall contain a 250-milliliter reservoir and a 2-millimeter tetrafluoroethylene polymer stopcock at the opposite end. Overall length of the tube is 670 millimeters.
Stainless steel rod. 2 feet in length, 2 to 4 millimeters in diameter.
Vacuum oven. Similar to Labline No. 3610 but modified as follows: A copper tube one-fourth inch in diameter and 13 inches in length is bent to a right angle at the 4-inch point and plugged at the opposite end; eight copper tubes one-eighth inch in diameter and 5 inches in length are silver soldered in drilled holes (one-eighth inch in diameter) to the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and 12.5-inch points; the one-eighth-inch copper tubes are bent to conform with the inner periphery of the oven.
Beakers. 250-milliliter and 500-milliliter capacity.
Graduated cylinders. 25-milliliter, 50-milliliter, and 150-milliliter capacity.
Tuberculin syringe. 1-milliliter capacity, with 3-inch, 22-gauge needle.
Volumetric flask. 5-milliliter capacity.
Spectrophotometric cells. Fused quartz ground glass stoppered cells, optical path length in the range of 1.000 centimeter ±0.005 centimeter. With distilled water in the cells, determine any absorbance difference.
Spectrophotometer. Spectral range 250 millimicrons—400 millimicrons with spectral slit width of 2 millimicrons or less: under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements:
Absorbance repeatability, ±0.01 at 0.4 absorbance.
Absorbance accuracy, 1 ±0.05 at 0.4 absorbance.
1 As determined by using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. Circular 484 is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
Wavelength repeatability, ±0.2 millimicron.
Wavelength accuracy, ±1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane, benzene, hexane, and 1,2-dichloroethane designated in the list following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter beaker, add 1 milliliter of purified n- hexadecane and evaporate in the vacuum oven under a stream of nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. (To the residue from benzene add a 5-milliliter portion of purified isooctane, reevaporate, and repeat once to insure complete removal of benzene.)
Dissolve the 1 milliliter of hexadecane residue in isooctane and make to 5 milliliters volume. Determine the absorbance in the 1-centimeter path length cells compared to isooctane as reference. The absorbance of the solution of the solvent residue shall not exceed 0.02 per centimeter path length between 280 and 300 mµ and shall not exceed 0.01 per centimeter path length between 300 and 400 mµ.
Isooctane ( 2,2,4-trimethylpentane ). Use 10 milliliters for the test described in the preceding paragraph. If necessary, isooctane may be purified by passage through a column of activated silica gel (Grade 12, Davison Chemical Co., Baltimore, Md., or equivalent).
Benzene, spectro grade ( Burdick and Jackson Laboratories, Inc., Muskegon, Mich., or equivalent ). Use 80 milliliters for the test. If necessary, benzene may be purified by distillation or otherwise.
Hexane, spectro grade ( Burdick and Jackson Laboratories, Inc., Muskegon, Mich., or equivalent ). Use 650 milliliters for the test. If necessary, hexane may be purified by distillation or otherwise.
1,2-Dichloroethane, spectro grade ( Matheson, Coleman, and Bell, East Rutherford, N.J., or equivalent ). Use 20 milliliters for test. If necessary, 1,2-dichloroethane may be purified by distillation.
Eluting mixtures:
1. 10 percent 1,2-dichloroethane in hexane. Pipet 100 milliliters of 1,2-dichloroethane into a 1-liter glass-stoppered volumetric flask and adjust to volume with hexane, with mixing.
2. 40 percent benzene in hexane. Pipet 400 milliliters of benzene into a 1-liter glass-stoppered volumetric flask and adjust to volume with hexane, with mixing.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n- hexadecane to 5 milliliters with isooctane and determine the absorbance in a 1-centimeter cell compared to isooctane as reference between 280 mµ-400mµ. The absorbance per centimeter path length shall not exceed 0.00 in this range. If necessary, n- hexadecane may be purified by percolation through activated silica gel or by distillation.
Silica gel, 28-200 mesh ( Grade 12, Davison Chemical Co., Baltimore, Md., or equivalent ). Activate as follows: Weigh about 900 grams into a 1-gallon bottle, add 100 milliliters of de-ionized water, seal the bottle and shake and roll at intervals for 1 hour. Allow to equilibrate overnight in the sealed bottle. Activate the gel at 150 °C for 16 hours, in a 2-inch × 7-inch × 12-inch porcelain pan loosely covered with aluminum foil, cool in a dessicator, transfer to a bottle and seal.
Determination of ultraviolet absorbance. Before proceeding with the analysis of a sample determine the absorbance in a 1-centimeter path cell for the reagent blank by carrying out the procedure without a sample. Record the absorbance in the wavelength range of 280 to 400 millimicrons. Typical reagent blank absorbance in this range should not exceed 0.04 in the 280 to 299 millimicron range, 0.02 in the 300 to 359 millimicron range, and 0.01 in the 360 to 400 millimicron range. If the characteristic benzene peaks in the 250 to 260 millimicron region are present, remove the benzene by the procedure described above under “Reagents and Materials,” “Organic Solvents,” and record absorbance again.
Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. Raise and drop the column on a semisoft, clean surface for about 1 minute to settle the gel. Pour 100 milliliters of hexane into the column with the stopcock open and allow to drain to about one-half inch above the gel. Turn off the stopcock and allow the column to cool for 30 minutes. After cooling, vibrate the column to eliminate air and stir the top 1 to 2 inches with a small diameter stainless steel rod. Take care not to get the gel above the liquid and onto the sides of the column.
Weigh out 40 grams ±0.1 gram of the hydrocarbon solvent sample into a 250-milliliter beaker, add 50 milliliters of hexane, and pour the solution into the column. Rinse the beaker with 50 milliliters of hexane and add this to the column. Allow the hexane sample solution to elute into a 500-milliliter beaker until the solution is about one-half inch above the gel. Rinse the column three times with 50-milliliter portions of hexane. Allow each hexane rinse to separately elute to about one-half inch above the gel. Replace the eluate beaker (discard the hexane eluate) with a 250-milliliter beaker. Add two separate 25-milliliter portions of 10 percent 1,2-dichloroethane and allow each to separately elute as before. Finally, add 150 milliliters of 10 percent 1,2-dichloroethane for a total of 200 milliliters. When the final 10 percent 1,2-dichloroethane fraction is about one-half inch above the top of the gel bed, replace the receiving beaker (discard the 1,2-dichloroethane eluate) with a 250-milliliter beaker containing 1 milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters per minute, add two 25-milliliter portions of 40 percent benzene and allow each to separately elute as before to within about one-half inch of the gel bed. Finally, add 150 milliliters of 40 percent benzene for a total of 200 milliliters. Evaporate the benzene in the oven with vacuum and sufficient nitrogen flow to just ripple the top of the benzene solution. When the benzene is removed (as determined by a constant volume of hexadecane) add 5 milliliters of isooctane and evaporate. Repeat once to insure complete removal of benzene. Remove the beaker and cover with aluminum foil (previously rinsed with hexane) until cool.
Quantitatively transfer the hexadecane residue to a 5-milliliter volumetric flask and dilute to volume with isooctane. Determine the absorbance of the solution in 1-centimeter path length cells between 280 and 400 millimicrons using isooctane as a reference. Correct the absorbance values for any absorbance derived from reagents as determined by carrying out the procedure without a sample. If the corrected absorbance does not exceed the limits prescribed in paragraph (b)(1)(ii) of this section, the sample meets the ultraviolet absorbance specifications for hydrocarbon solvent.
(c) Synthetic fatty alcohols may be used as follows:
(1) As substitutes for the corresponding naturally derived fatty alcohols permitted in food by existing regulations in this part or part 173 of this chapter provided that the use is in compliance with any prescribed limitations.
(2) As substitutes for the corresponding naturally derived fatty alcohols used as intermediates in the synthesis of food additives and other substances permitted in food.
§ 172.866   Synthetic glycerin produced by the hydrogenolysis of carbohydrates.
Synthetic glycerin produced by the hydrogenolysis of carbohydrates may be safely used in food, subject to the provisions of this section:
(a) It shall contain not in excess of 0.2 percent by weight of a mixture of butanetriols.
(b) It is used or intended for use in an amount not to exceed that reasonably required to produce its intended effect.
§ 172.867   Olestra.
Olestra, as identified in this section, may be safely used in accordance with the following conditions:
(a) Olestra is a mixture of octa-, hepta-, and hexa-esters of sucrose with fatty acids derived from edible fats and oils or fatty acid sources that are generally recognized as safe or approved for use as food ingredients. The chain lengths of the fatty acids are no less than 12 carbon atoms.
(b) Olestra meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 744-746, 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 United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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/cfr/ibr-locations.html.
(c) Olestra may be used in place of fats and oils in prepackaged ready-to-eat savory (i.e., salty or piquant but not sweet) snacks and prepackaged, unpopped popcorn kernels that are ready-to-heat. In such foods, the additive may be used in place of fats and oils for frying or baking, in dough conditioners, in sprays, in filling ingredients, or in flavors.
(d) To compensate for any interference with absorption of fat soluble vitamins, the following vitamins shall be added to foods containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 µg vitamin K 1 per gram olestra.
(e)(1) Vitamins A, D, E, and K present in foods as a result of the requirement in paragraph (d) of this section shall be declared in the listing of ingredients. Such vitamins shall not be considered in determining nutrient content for the nutritional label or for any nutrient claims, express or implied.
(i) An asterisk shall follow vitamins A, D, E, and K in the listing of ingredients;
(ii) The asterisk shall appear as a superscript following each vitamin;
(iii) Immediately following the ingredient list an asterisk and statement, “Dietarily insignificant” shall appear prominently and conspicuously as specified in § 101.2(c) of this chapter;
(2) Olestra shall not be considered as a source of fat or calories for purposes of §§ 101.9 and 101.13 of this chapter.
§ 172.868   Ethyl cellulose.
The food additive ethyl cellulose may be safely used in food in accordance with the following prescribed conditions:
(a) The food additive is a cellulose ether containing ethoxy (OC 2 H 5 ) groups attached by an ether linkage and containing on an anhydrous basis not more than 2.6 ethoxy groups per anhydroglucose unit.
(b) It is used or intended for use as follows:
(1) As a binder and filler in dry vitamin preparations.
(2) As a component of protective coatings for vitamin and mineral tablets.
(3) As a fixative in flavoring compounds.
§ 172.869   Sucrose oligoesters.
Sucrose oligoesters, as identified in this section, may be safely used in accordance with the following conditions:
(a) Sucrose oligoesters consist of mixtures of sucrose fatty acid esters with an average degree of esterification ranging from four to seven. It is produced by interesterification of sucrose with methyl esters of fatty acids derived from edible fats and oils (including hydrogenated fats and oils). The only solvents which may be used in the preparation of sucrose oligoesters are dimethyl sulfoxide, isobutyl alcohol, and those solvents generally recognized as safe in food.
(b) Sucrose oligoesters meet the specifications in the methods listed in the table in this paragraph. The methods for determining compliance with each specification are 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. Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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/cfr/ibr-locations.html. Copies of the methods are available from the sources listed in the table in this paragraph:
(c) The additive is used as an emulsifier (as defined in § 170.3(o)(8) of this chapter) or stabilizer (as defined in § 170.3(o)(28) of this chapter) in chocolate and in butter-substitute spreads, at a level not to exceed 2.0 percent; except that the additive may not be used in a standardized food unless permitted by the standard of identity.
§ 172.870   Hydroxypropyl cellulose.
The food additive hydroxypropyl cellulose may be safely used in food, except standardized foods that do not provide for such use, in accordance with the following prescribed conditions:
(a) The additive consists of one of the following:
(1) A cellulose ether containing propylene glycol groups attached by an ether linkage that contains, on an anhydrous basis, not more than 4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a minimum viscosity of 10 centipoises for a 10 percent by weight aqueous solution at 25 degrees C.
(2) A cellulose ether containing propylene glycol groups attached by an ether linkage having a hydroxypropoxy (OC 3 H 6 OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The common name for this form of the additive is low substituted hydroxypropyl cellulose.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is used or intended for use as an emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener in food, in accordance with good manufacturing practice. The additive also may be used as a binder in dietary supplements, in accordance with good manufacturing practice.
(2) The additive identified in paragraph (a)(2) of this section is used or intended for use as a binder and disintegrator in tablets or wafers containing dietary supplements of vitamins and/or minerals. The additive is used in accordance with good manufacturing practice.
§ 172.872   Methyl ethyl cellulose.
The food additive methyl ethyl cellulose may be safely used in food in accordance with the following prescribed conditions.
(a) The additive is a cellulose ether having the general formula [C 6 H (10 -x-y) O 5 (CH 3 ) x (C 2 H 5 ) y ] n , where x is the number of methyl groups and y is the number of ethyl groups. The average value of x is 0.3 and the average value of y is 0.7.
(b) The additive meets the following specifications:
(1) The methoxy content shall be not less than 3.5 percent and not more than 6.5 percent, calculated as OCH 3 , and the ethoxy content shall be not less than 14.5 percent and not more than 19 percent, calculated as OC 2 H 5 , both measured on the dry sample.
(2) The viscosity of an aqueous solution, 2.5 grams of the material in 100 milliliters of water, at 20 °C, is 20 to 60 centipoises.
(3) The ash content on a dry basis has a maximum of 0.6 percent.
(c) The food additive is used as an aerating, emulsifying, and foaming agent, in an amount not in excess of that reasonably required to produce its intended effect.
§ 172.874   Hydroxypropyl methylcellulose.
The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004-65-3) may be safely used in food, except in standardized foods which do not provide for such use if:
(a) The additive complies with the definition and specifications prescribed in the National Formulary, 12th edition.
(b) It is used or intended for use as an emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener, in accordance with good manufacturing practice.
(c) To insure safe use of the additive, the container of the additive, in addition to being labeled as required by the general provisions of the act, shall be accompanied by labeling which contains adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (b) of this section.
§ 172.876   Castor oil.
The food additive castor oil may be safely used in accordance with the following conditions:
(a) The additive meets the specifications of the United States Pharmacopeia XX (1980).
(b) The additive is used or intended for use as follows:
Hard candy production—As a release agent and antisticking agent, not to exceed 500 parts per million in hard candy.
Vitamin and mineral tablets—As a component of protective coatings.
§ 172.878   White mineral oil.
White mineral oil may be safely used in food in accordance with the following conditions:
(a) White mineral oil is a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic in nature obtained from petroleum. It is refined to meet the following specifications:
(1) It meets the test requirements of the United States Pharmacopeia XX (1980) for readily carbonizable substances (page 532).
(2) It meets the test requirements of U.S.P. XVII for sulfur compounds (page 400).
(3) It meets the specifications prescribed in the “Journal of the Association of Official Analytical Chemists,” Volume 45, page 66 (1962), which is incorporated by reference, after correction of the ultraviolet absorbance for any absorbance due to added antioxidants. Copies of the material incorporated by reference are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
(b) White mineral oil may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the Act, in an amount not greater than that required to produce its intended effect.
(c) White mineral oil is used or intended for use as follows:
§ 172.880   Petrolatum.
Petrolatum may be safely used in food, subject to the provisions of this section.
(a) Petrolatum complies with the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for petrolatum.
(b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b):
Ultraviolet absorbance per centimeter path length:
(c) Petrolatum is used or intended for use as follows:
(d) Petrolatum may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the Act, in an amount not greater than that required to produce its intended effect.
§ 172.882   Synthetic isoparaffinic petroleum hydrocarbons.
Synthetic isoparaffinic petroleum hydrocarbons may be safely used in food, in accordance with the following conditions:
(a) They are produced by synthesis from petroleum gases and consist of a mixture of liquid hydrocarbons meeting the following specifications:
Boiling point 93-260 °C as determined by ASTM method D86-82, “Standard Method for Distillation of Petroleum Products,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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.html.
Ultraviolet absorbance:
260-319 millimicrons—1.5 maximum.
320-329 millimicrons—0.08 maximum.
330-350 millimicrons—0.05 maximum.
Nonvolatile residual: 0.002 gram per 100 milliliters maximum.
Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application of mineral oil, disregarding the last sentence of the procedure, under “Specifications” on page 66 of the “Journal of the Association of Official Analytical Chemists,” Volume 45 (February 1962), which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html. For hydrocarbons boiling below 250 °F, the nonvolatile residue shall be determined by ASTM method D1353-78, “Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;” for those boiling above 121 °C, ASTM method D381-80, “Standard Test Method for Existent Gum in Fuels by Jet Evaporation” shall be used. These methods are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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.html.
(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended technical effect nor to exceed any prescribed limitations.
(c) Synthetic isoparaffinic petroleum hydrocarbons are used or intended for use as follows:
§ 172.884   Odorless light petroleum hydrocarbons.
Odorless light petroleum hydrocarbons may be safely used in food, in accordance with the following prescribed conditions:
(a) The additive is a mixture of liquid hydrocarbons derived from petroleum or synthesized from petroleum gases. The additive is chiefly paraffinic, isoparaffinic, or naphthenic in nature.
(b) The additive meets the following specifications:
(1) Odor is faint and not kerosenic.
(2) Initial boiling point is 300 °F minimum.
(3) Final boiling point is 650 °F maximum.
(4) Ultraviolet absorbance limits determined by method specified in § 178.3620(b)(1)(ii) of this chapter, as follows:
(c) The additive is used as follows:
§ 172.886   Petroleum wax.
Petroleum wax may be safely used in or on food, in accordance with the following conditions:
(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, derived from petroleum, and refined to meet the specifications prescribed by this section.
(b) Petroleum wax meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in this paragraph.
Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of wax samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.
Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.
Reservoir. 500-milliliter capacity, equipped with a 24/40 standard taper male fitting at the bottom and a suitable ball-joint at the top for connecting to the nitrogen supply. The male fitting should be equipped with glass hooks.
Chromatographic tube. 180 millimeters in length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of the column with the female joint is 235 millimeters.) The female fitting should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 3/16 -inch thick with a hole bored in the center to closely fit the stem of the chromatographic tube.
Heating jacket. Conical, for 500-milliliter separatory funnel. (Used with variable transformer heat control.)
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
Evaporation flask ( optional ). 250-milliliter or 500-milliliter capacity all-glass flask equipped with standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated.
Vacuum distillation assembly. All glass (for purification of dimethyl sulfoxide); 2-liter distillation flask with heating mantle; Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters in length and distilling head with separable cold finger condenser. Use of tetrafluoroethylene polymer sleeves on the glass joints will prevent freezing. Do not use grease on stopcocks or joints.
Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5.000 centimeters ±0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1.000 centimeter ±0.005 centimeter. With distilled water in the cells, determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons with spectral slit width of 2 millimicrons or less, under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements:
Absorbance repeatability, ±0.01 at 0.4 absorbance.
Absorbance accuracy, 1 ±0.05 at 0.4 absorbance.
1 As determined by using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. Circular 484 is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.html.
Wavelength repeatability, ±0.2 millimicron.
Wavelength accuracy, ±1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane, benzene, acetone, and methyl alcohol designated in the list following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n- hexadecane and evaporate on the steam bath under a stream of nitrogen (a) loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains. (To the residue from benzene add a 10-milliliter portion of purified isooctane, reevaporate, and repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and n- hexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and make to 25 milliliters volume. Determine the absorbance in the 5-centimeter path length cells compared to isooctane as reference. The absorbance of the solution of the solvent residue (except for methyl alcohol) shall not exceed 0.01 per centimeter path length between 280 and 400 mµ. For methyl alcohol this absorbance value shall be 0.00.
Isooctane ( 2,2,4-trimethylpentane ). Use 180 milliliters for the test described in the preceding paragraph. Purify, if necessary, by passage through a column of activated silica gel (Grade 12, Davison Chemical Company, Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. Purify, if necessary, by distillation or otherwise.
Acetone, A.C.S. reagent grade. Use 200 milliliters for the test. Purify, if necessary, by distillation.
Eluting mixtures:
1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene into a 500-milliliter glass-stoppered volumetric flask and adjust to volume with isooctane, with mixing.
2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene into a 250-milliliter glass-stoppered volumetric flask, and adjust to volume with isooctane, with mixing.
3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380 milliliters of acetone and 200 milliliters of benzene, and mix.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n- hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference point between 280 mµ-400 mµ. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl alcohol. Purify, if necessary, by distillation.
Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18° minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 milliliters of distilled water in a 500-milliliter separatory funnel, mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second 500-milliliter separatory funnel and repeat the extraction with 40 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 40-milliliter extractives three times with 50-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under “Reagents and Materials” for preparation of filter), into a 250-milliliter Erlenmeyer flask, or optionally into the evaporating flask. Wash the first separatory funnel with the second 40-milliliter isooctane extractive, and pass through the sodium sulfate into the flask. Then wash the second and first separatory funnels successively with a 10-milliliter portion of isooctane, and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n- hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane and reevaporate to 1 milliliter of hexadecane. Again, add 10 milliliters of isooctane to the residue and evaporate to 1 milliliter of hexadecane to insure complete removal of all volatile materials. Dissolve the 1 milliliter of hexadecane in isooctane and make to 25-milliliter volume. Determine the reference. The absorbance of the solution should not exceed 0.02 per centimeter path length in the 280 mµ-400 mµ range. ( Note. Difficulty in meeting this absorbance specification may be due to organic impurities in the distilled water. Repetition of the test omitting the dimethyl sulfoxide will disclose their presence. If necessary to meet the specification, purify the water by redistillation, passage through an ion-exchange resin, or otherwise.)
Purify, if necessary, by the following procedure: To 1,500 milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, add 6.0 milliliters of phosphoric acid and 50 grams of Norit A (decolorizing carbon, alkaline) or equivalent. Stopper the flask, and with the use of a magnetic stirrer (tetrafluoroethylene polymer coated bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide through four thicknesses of fluted paper (18.5 centimeters, Schleicher & Schuell, No. 597, or equivalent). If the initial filtrate contains carbon fines, refilter through the same filter until a clear filtrate is obtained. Protect the sulfoxide from air and moisture during this operation by covering the solvent in the funnel and collection flask with a layer of isooctane. Transfer the filtrate to a 2-liter separatory funnel and draw off the dimethyl sulfoxide into the 2-liter distillation flask of the vacuum distillation assembly and distill at approximately 3-millimeter Hg pressure or less. Discard the first 200-milliliter fraction of the distillate and replace the distillate collection flask with a clean one. Continue the distillation until approximately 1 liter of the sulfoxide has been collected.
At completion of the distillation, the reagent should be stored in glass-stoppered bottles since it is very hygroscopic and will react with some metal containers in the presence of air.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium borohydride. 98 percent.
Magnesium oxide ( Sea Sorb 43, Food Machinery Company, Westvaco Division, distributed by chemical supply firms, or equivalent ). Place 100 grams of the magnesium oxide in a large beaker, add 700 milliliters of distilled water to make a thin slurry, and heat on a steam bath for 30 minutes with intermittent stirring. Stir well initially to insure that all the absorbent is completely wetted. Using a Buchner funnel and a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable diameter, filter with suction. Continue suction until water no longer drips from the funnel. Transfer the absorbent to a glass trough lined with aluminum foil (free from rolling oil). Break up the magnesia with a clean spatula and spread out the absorbent on the aluminum foil in a layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 160 °C ±1 °C. Pulverize the magnesia with mortar and pestle. Sieve the pulverized absorbent between 60-180 mesh. Use the magnesia retained on the 180-mesh sieve.
Celite 545. Johns-Manville Company, diatomaceous earth, or equivalent.
Magnesium oxide-Celite 545 mixture ( 2 + 1 ) by weight. Place the magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions, respectively, by weight in a glass-stoppered flask large enough for adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture to a glass trough lined with aluminum foil (free from rolling oil) and spread it out on a layer about 1 centimeter to 2 centimeters thick. Reheat the mixture at 160 °C ±1 °C for 2 hours, and store in a tightly closed flask.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-millimeter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter path length between 280 mµ and 400 mµ when tested as prescribed under “Organic solvents.” Usually three portions of wash solvent are sufficient.
Before proceeding with analysis of a sample, determine the absorbance in a 5-centimeter path cell between 250 mµ and 400 mµ for the reagent blank by carrying out the procedure, without a wax sample, at room temperature, recording the spectra after the extraction stage and after the complete procedure as prescribed. The absorbance per centimeter path length following the extraction stage should not exceed 0.040 in the wavelength range from 280 mµ to 400 mµ; the absorbance per centimeter path length following the complete procedure should not exceed 0.070 in the wavelength range from 280 mµ to 299 mµ, inclusive, nor 0.045 in the wavelength range from 300 mµ to 400 mµ. If in either spectrum the characteristic benzene peaks in the 250 mµ-260 mµ region are present, remove the benzene by the procedure under “Organic solvents” and record absorbance again.
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to preequilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks.
Place a representative 1-kilogram sample of wax, or if this amount is not available, the entire sample, in a beaker of a capacity about three times the volume of the sample and heat with occasional stirring on a steam bath until the wax is completely melted and homogeneous. Weigh four 25-gram ±0.2 gram portions of the melted wax in separate 100-milliliter beakers. Reserve three of the portions for later replicate analyses as necessary. Pour one weighed portion immediately after remelting (on the steam bath) into a 500-milliliter separatory funnel containing 100 milliliters of the preequilibrated sulfoxide-phosphoric acid mixture that has been heated in the heating jacket at a temperature just high enough to keep the wax melted. ( Note: In preheating the sulfoxide-acid mixture, remove the stopper of the separatory funnel at intervals to release the pressure.)
Promptly complete the transfer of the sample to the funnel in the jacket with portions of the preequilibrated isooctane, warming the beaker, if necessary, and using a total volume of just 50 milliliters of the solvent. If the wax comes out of solution during these operations, let the stoppered funnel remain in the jacket until the wax redissolves. (Remove stopper from the funnel at intervals to release pressure.) When the wax is in solution, remove the funnel from the jacket and shake it vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of preequilibrated isooctane. After separation of the liquid phases, allow to cool until the main portion of the wax-isooctane solution begins to show a precipitate. Gently swirl the funnel when precipitation first occurs on the inside surface of the funnel to accelerate this process. Carefully draw off the lower layer, filter it slowly through a thin layer of glass wool fitted loosely in a filter funnel into the first 250-milliliter separatory funnel, and wash in tandem with the 30-milliliter portions of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture, replacing the funnel in the jacket after each extraction to keep the wax in solution and washing each extractive in tandem through the same three portions of isooctane.
Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter), containing 480 milliliters of distilled water, mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 80-milliliter extractives three times with 100-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium Sulfate under “Reagents and Materials” for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n- hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once.
Quantitatively transfer the residue with isooctane to a 25-milliliter volumetric flask, make to volume, and mix. Determine the absorbance of the solution in the 5-centimeter path length cells compared to isooctane as reference between 280 mµ-400 mµ (take care to lose none of the solution in filling the sample cell). Correct the absorbance values for any absorbance derived from reagents as determined by carrying out the procedure without a wax sample. If the corrected absorbance does not exceed the limits prescribed in this paragraph (b), the wax meets the ultraviolet absorbance specifications. If the corrected absorbance per centimeter path length exceeds the limits prescribed in this paragraph (b), proceed as follows:
Quantitatively transfer the isooctane solution to a 125-milliliter flask equipped with 24/40 joint and evaporate the isooctane on the steam bath under a stream of nitrogen to a volume of 1 milliliter of hexadecane. Add 10 milliliters of methyl alcohol and approximately 0.3 gram of sodium borohydride. (Minimize exposure of the borohydride to the atmosphere. A measuring dipper may be used.) Immediately fit a water-cooled condenser equipped with a 24/40 joint and with a drying tube into the flask, mix until the borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with intermittent swirling. At the end of this period, disconnect the flask and evaporate the methyl alcohol on the steam bath under nitrogen until the sodium borohydride begins to come out of the solution. Then add 10 milliliters of isooctane and evaporate to a volume of about 2-3 milliliters. Again, add 10 milliliters of isooctane and concentrate to a volume of approximately 5 milliliters. Swirl the flask repeatedly to assure adequate washing of the sodium borohydride residues.
Fit the tetrafluoroethylene polymer disc on the upper part of the stem of the chromatographic tube, then place the tube with the disc on the suction flask and apply the vacuum (approximately 135 millimeters Hg pressure). Weight out 14 grams of the 2:1 magnesium oxide-Celite 545 mixture and pour the adsorbent mixture into the chromatographic tube in approximately 3-centimeter layers. After the addition of each layer, level off the top of the adsorbent with a flat glass rod or metal plunger by pressing down firmly until the adsorbent is well packed. Loosen the topmost few millimeters of each adsorbent layer with the end of a metal rod before the addition of the next layer. Continue packing in this manner until all the 14 grams of the adsorbent is added to the tube. Level off the top of the adsorbent by pressing down firmly with a flat glass rod or metal plunger to make the depth of the adsorbent bed approximately 12.5 centimeters in depth. Turn off the vacuum and remove the suction flask. Fit the 500-milliliter reservoir onto the top of the chromatographic column and prewet the column by passing 100 milliliters of isooctane through the column. Adjust the nitrogen pressure so that the rate of descent of the isooctane coming off of the column is between 2-3 milliliters per minute. Discontinue pressure just before the last of the isooctane reaches the level of the adsorbent. ( Caution: Do not allow the liquid level to recede below the adsorbent level at any time.) Remove the reservoir and decant the 5-milliliter isooctane concentrate solution onto the column and with slight pressure again allow the liquid level to recede to barely above the adsorbent level. Rapidly complete the transfer similarly with two 5-milliliter portions of isooctane, swirling the flask repeatedly each time to assure adequate washing of the residue. Just before the final 5-milliliter wash reaches the top of the adsorbent, add 100 milliliters of isooctane to the reservoir and continue the percolation at the 2-3 milliliter per minute rate. Just before the last of the isooctane reaches the adsorbent level, add 100 milliliters of 10 percent benzene in isooctane to the reservoir and continue the percolation at the aforementioned rate. Just before the solvent mixture reaches adsorbent level, add 25 milliliters of 20 percent benzene in isooctane to the reservoir and continue the percolation at 2-3 milliliters per minute until all this solvent mixture has been removed from the column. Discard all the elution solvents collected up to this point. Add 300 milliliters of the acetone-benzene-water mixture to the reservoir and percolate through the column to elute the polynuclear compounds. Collect the eluate in a clean 1-liter separatory funnel. Allow the column to drain until most of the solvent mixture is removed. Wash the eluate three times with 300-milliliter portions of distilled water, shaking well for each wash. (The addition of small amounts of sodium chloride facilitates separation.) Discard the aqueous layer after each wash. After the final separation, filter the residual benzene through anhydrous sodium sulfate prewashed with benzene (see Sodium sulfate under “Reagents and Materials” for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the separatory funnel with two additional 20-milliliter portions of benzene which are also filtered through the sodium sulfate. Add 1 milliliter of n- hexadecane and completely remove the benzene by evaporation under nitrogen, using the special procedure to eliminate benzene as previously described under “Organic Solvents.” Quantitatively transfer the residue with isooctane to a 25-milliliter volumetric flask and adjust to volume. Determine the absorbance of the solution in the 5-centimeter path length cells compared to isooctane as reference between 250 mµ-400 mµ. Correct for any absorbance derived from the reagents as determined by carrying out the procedure without a wax sample. If either spectrum shows the characteristic benzene peaks in the 250 mµ-260 mµ region, evaporate the solution to remove benzene by the procedure under “Organic Solvents.” Dissolve the residue, transfer quantitatively, and adjust to volume in isooctane in a 25-milliliter volumetric flask. Record the absorbance again. If the corrected absorbance does not exceed the limits prescribed in this paragraph (b), the wax meets the ultraviolet absorbance specifications.
(c) Petroleum wax may contain one or more of the following adjuvants in amounts not greater than that required to produce their intended effect:
(1) Antioxidants permitted in food by regulations issued in accordance with section 409 of the act.
(2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long chain (C 16 -C 22 ) alcohols and acrylic acid, or poly(alkylmethacrylate) (CAS Reg. No. 179529-36-3), made from long chain (C 18 -C 22 ) methacrylate esters, having:
(i) A number average molecular weight between 40,000 and 100,000;
(ii) A weight average molecular weight (MW w ) to number average molecular weight (MW n ) ratio (MW w /MW n ) of not less than 3; and
(iii) Unreacted alkylacrylate or alkylmethacrylate monomer content not in excess of 14 percent, as determined by a method entitled “Method for Determining Weight-Average and Number-Average Molecular Weight and for Determining Alkylacrylate Monomer Content of Poly(alkylacrylate) used as Processing Aid in Manufacture of Petroleum Wax,” 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 Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday 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.html. Petroleum wax shall contain not more than 1,050 parts per million of poly(alkylacrylate) or poly(alkylmethacrylate) residues as determined by a method entitled “Method for Determining Residual Level of Poly(alkylacrylate) in Petroleum Wax,” which is incorporated by reference. Copies are available from the addresses cited in this paragraph.
(d) Petroleum wax is used or intended for use as follows:
§ 172.888   Synthetic petroleum wax.
Synthetic petroleum wax may be safely used in or on foods in accordance with the following conditions:
(a) Synthetic petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, prepared by either catalytic polymerization of ethylene or copolymerization of ethylene with linear (C 3 to C 12 ) alpha-olefins, and refined to meet the specifications prescribed in this section.
(b) Synthetic petroleum wax meets the ultraviolet absorbance limits of § 172.886(b) when subjected to the analytical procedure described therein.
(c) Synthetic petroleum wax has a number average molecular weight of not less than 500 nor greater than 1,200 as determined by vapor pressure osmometry.
(d) Synthetic petroleum wax may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the act, in an amount not greater than that required to produce its intended effect.
(e) Synthetic petroleum wax is used or intended for use as follows:
§ 172.890   Rice bran wax.
Rice bran wax may be safely used in food in accordance with the following conditions:
(a) It is the refined wax obtained from rice bran and meets the following specifications:
(b) It is used or intended for use as follows:
§ 172.892   Food starch-modified.
Food starch-modified as described in this section may be safely used in food. The quantity of any substance employed to effect such modification shall not exceed the amount reasonably required to accomplish the intended physical or technical effect, nor exceed any limitation prescribed. To insure safe use of the food starch-modified, the label of the food additive container shall bear the name of the additive “food starch-modified” in addition to other information required by the Act. Food starch may be modified by treatment prescribed as follows:
(a) Food starch may be acid-modified by treatment with hydrochloric acid or sulfuric acid or both.
(b) Food starch may be bleached by treatment with one or more of the following:
(c) Food starch may be oxidized by treatment with chlorine, as sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of dry starch.
(d) Food starch may be esterified by treatment with one of the following:
(e) Food starch may be etherified by treatment with one of the following:
(f) Food starch may be esterified and etherified by treatment with one of the following:
(g) Food starch may be modified by treatment with one of the following:
(h) Food starch may be modified by a combination of the treatments prescribed by paragraphs (a), (b), and/or (i) of this section and any one of the treatments prescribed by paragraph (c), (d), (e), (f), or (g) of this section, subject to any limitations prescribed by the paragraphs named.
(i) Food starch may be modified by treatment with the following enzymes:
§ 172.894   Modified cottonseed products intended for human consumption.
The food additive modified cottonseed products may be used for human consumption in accordance with the following prescribed conditions:
(a) The additive is derived from:
(1) Decorticated, partially defatted, cooked, ground cottonseed kernels; or
(2) Decorticated, ground cottonseed kernels, in a process that utilizes n- hexane as an extracting solvent in such a way that no more than 60 parts per million of n- hexane residues and less than 1 percent fat by weight remain in the finished product; or
(3) Glandless cottonseed kernels roasted to attain a temperature of not less than 250 °F in the kernel for not less than 5 minutes for use as a snack food, or in baked goods, or in soft candy; or
(4) Raw glandless cottonseed kernels may be used in hard candy where the kernel temperature during cooking will exceed 250 °F for not less than 5 minutes.
(b) The additive is prepared to meet the following specifications:
(1) Free gossypol content not to exceed 450 parts per million.
(2) It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As.
(c) To assure safe use of the additive, the label of the food additive container shall bear, in addition to other information required by the act, the name of the additive as follows:
(1) The additive identified in paragraph (a)(1) of this section as “partially defatted, cooked cottonseed flour”.
(2) The additive identified in paragraph (a)(2) of this section as “defatted cottonseed flour”.
(3) The additive identified in paragraph (a)(3) of this section as “roasted glandless cottonseed kernels”.
(4) The additive identified in paragraph (a)(4) of this section as “raw glandless cottonseed kernels for use in cooked hard candy”.
(d) The Food and Drug Administration and the Environmental Protection Agency have determined that glandless cottonseed kernels permitted for use by this section are a distinct commodity from glanded cottonseed.
§ 172.896   Dried yeasts.
Dried yeast ( Saccharomyces cerevisiae and Saccharomyces fragilis ) and dried torula yeast ( Candida utilis ) may be safely used in food provided the total folic acid content of the yeast does not exceed 0.04 milligram per gram of yeast (approximately 0.008 milligram of pteroyglutamic acid per gram of yeast).
§ 172.898   Bakers yeast glycan.
Bakers yeast glycan may be safely used in food in accordance with the following conditions:
(a) Bakers yeast glycan is the comminuted, washed, pasteurized, and dried cell walls of the yeast, Saccharomyces cerevisiae. It is composed principally of long chain carbohydrates, not less than 85 percent on a dry solids basis. The carbohydrate is composed of glycan and mannan units in approximately a 2:1 ratio.
(b) The additive meets the following specifications on a dry weight basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium botulinum, or any other recognized microbial pathogen or any harmful microbial toxin.
(d) The additive is used or intended for use in the following foods when standards of identity established under section 401 of the Act do not preclude such use:
(e) The label and labeling of the ingredient shall bear adequate directions to assure that use of the ingredient complies with this regulation.