Ingredient Definitions Committee 2/12/16 Report - AAFCO

Final: 2/25/16 ver 273.046 (old 87.3) Silicon Dioxide73.048 (old 87.13) Sodium Bentonite73.050 (old 87.4) Verxite (incl flake and grits)Binders (73.106-130)73.107 (old 87.2) Lignin SulfonateT73.109 (old T73.300) Sodium salts of Fatty Acids . Stays in tentative section .T73.111 (old T73.301) Potassium Salts of Fatty Acids . Stays in tentative section .Biofuel Production (73.090-104)73.100 Yeast for Production of Distillers ProductsEmulsifiers (73.200-220)73.200 Xanthan gumFloculants (73.221-240)73.221 (old 87.16) Chitosan73.223 (old 87.21) Kraft LigninNutritional Diluents (73.241-249)73.241 (old 87.18) Reed-Sedge PeatPelleting Aids (73.300–340)73.305 (old 87.24) Hide Glue73.307 (old 87.6) Rice By-Products Fractions73.309 (old 87.19) Urea Formaldehyde Condensation Polymer73.105 Sodium Hydroxide Lignin DehydratedSurfactants (73.341-360)73.341 (old 87.10) PoloxaleneThickening agents (73.370-390)73.370 (old 87.23) Cassia Gummoved 73.105,can we double list in 2 or more use categories? –yes if the full definition is with it.Page 8 of 45

Final: 2/25/16 ver 2Delete the current language in 87.1 and replace it with:87.1 Algae Meal – The color additive, algae meal, may be safely used in the manufactureof chicken feed in accordance with the following prescribed conditions:(a) Identity.The color additive dried algae meal is a dried mixture of algae cells (genusSpongiococcum, separated from its culture broth), molasses, cornsteep liquor, and amaximum of 0.3 percent ethoxyquin. The algae cells are produced by suitablefermentation, under controlled conditions, from a pure culture of the genusSpongiococcum.(b) Uses and restrictions.The color additive dried algae meal may be safely used in chicken feed in accordancewith the following prescribed conditions:(1) The color additive is used to enhance the yellow color of chicken skin andeggs.(2) The quantity of the color additive incorporated in the feed is such that thefinished feed:(i) Is supplemented sufficiently with xanthophyll and associatedcarotenoids so as to accomplish the intended effect described in paragraph(b)(1) of this definition; and(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribedin part 573.380 of Title 21 of the Code of Federal Regulations (21 CFR573.380).(c) Labeling.The label of the color additives and any premixes prepared therefrom shall bear inaddition to the information required by 21 CFR 70.25.(1) A statement of the concentrations of xanthophyll and ethoxyquin containedtherein.(2) Adequate directions to provide a final product complying with the limitationsprescribed in paragraph (b) of this definition.(d) Exemption from certification.Certification of this color additive is not necessary for the protection of the public healthand therefore batches thereof are exempt from the certification requirements of section721(c) of the Federal Food, Drug, and Cosmetic Act.21 CFR 73.275Add these new Official Definitions:87.36 Phaffia yeast – The color additive, phaffia yeast, may be safely used in themanufacture of salmonid fish feed in accordance with the following prescribedconditions:(a) Identity.(1) The color additive phaffia yeast consists of the killed, dried cells of anonpathogenic and nontoxicogenic strain of the yeast phaffia rhodozyma.Page 9 of 45

Final: 2/25/16 ver 2(2) Phaffia yeast may be added to the fish feed only as a component of a stabilizedcolor additive mixture. Color additive mixtures for fish feed use made withphaffia yeast may contain only those diluents that are suitable and are listed inpart 73.1 of Title 21 of the Code of Federal Regulations (21 CFR 73.1) as safe foruse in color additive mixtures for coloring foods.(b) Specifications.Phaffia yeast shall conform to the following specifications and shall be free fromimpurities other than those named to the extent that such impurities may be avoided bygood manufacturing practice:Physical state, solid.Lead (as Pb), not more than 5 parts per million.Arsenic (as As), not more than 2 parts per million.Mercury (as Hg), not more than 1 part per million.Heavy metals, not more than 10 parts per million.Astaxanthin, not less than 0.4 percent.(c) Uses and restrictions.Phaffia yeast may be safely used in the feed of salmonid fish in accordance with thefollowing prescribed conditions:(1) The color additive is used to enhance the pink to orange-red color of the fleshof salmonid fish.(2) The quantity of astaxanthin in finished feed, from phaffia yeast when usedalone or in combination with other astaxanthin color additive sources listed in 21CFR 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) offinished feed.(d) Labeling requirements.(1) The labeling of the color additive and any premixes prepared therefrom shallbear expiration dates for the sealed and open container (established throughgenerally accepted stability testing methods), other information required by 21CFR 70.25, and adequate directions to prepare a final product complying with thelimitations prescribed in paragraph (c) of this definition.(2) The presence of the color additive in finished fish feed prepared according toparagraph (c) of this definition shall be declared in accordance with 21 CFR501.4.(3) The presence of the color additive in salmonid fish that have been fed feedscontaining phaffia yeast shall be declared in accordance with 21 CFR 101.22(b),(c), and (k)(2) and 21 CFR 101.100(a)(2).(e) Exemption from certification.Certification of this color additive is not necessary for the protection of the public health,and therefore batches thereof are exempt from the certification requirements of section721(c) of the Federal Food, Drug, and Cosmetic Act.21 CFR 73.355 (adopted xxxxx)87.100 FD&C Blue No. 1 – The color additive, FD&C Blue No. 1, may be safely used inthe manufacture of animal foods in accordance with the following prescribed conditions:Page 10 of 45

Final: 2/25/16 ver 2(a) Identity.(1) The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl[4-[p-[ethyl (m-sulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene] - 2,5 cyclohexadien - 1 - ylidene] (m-sulfobenzyl) ammonium hydroxide inner salt withsmaller amounts of the isomeric disodium salts of ethyl [4-[p-[ethyl(psulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1ylidene] (p-sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl(o-sulfobenzyl) amino] - α - (o -sulfophenyl) benzylidene]-2,5-cyclohexadien-1ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt.(2) Color additive mixtures for food use made with FD&C Blue No. 1 maycontain only those diluents that are suitable and that are listed in part 73.1 of Title21 of the Code of Federal Regulations (21 CFR 73.1) as safe for use in coloradditive mixtures for coloring foods.(b) Specifications.FD&C Blue No. 1 shall conform to the following specifications and shall be free fromimpurities other than those named to the extent that such other impurities may be avoidedby current good manufacturing practice:Sum of volatile matter (at 135 C) and chlorides and sulfates (calculated assodium salts), not more than 15.0 percent.Water-insoluble matter, not more than 0.2 percent.Leuco base, not more than 5 percent.Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent.Subsidiary colors, not more than 6.0 percent.Chromium (as Cr), not more than 50 parts per million.Manganese (as Mn), not more than 100 parts per million.Arsenic (as As), not more than 3 parts per million.Lead (as Pb), not more than 10 parts per million.Total color, not less than 85.0 percent.(c) Uses and restrictions.FD&C Blue No. 1 may be safely used for coloring foods generally in amounts consistentwith good manufacturing practice except that it may not be used to color foods for whichstandards of identity have been promulgated under section 401 of the Federal Food,Drug, and Cosmetic Act unless added color is authorized by such standards.(d) Labeling.The label of the color additive and any mixtures prepared therefrom intended solely or inpart for coloring purposes shall conform to the requirements of 21 CFR 70.25.(e) Certification.All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in 21CFR 80.21 CFR 74.101Page 11 of 45

Final: 2/25/16 ver 287.102 FD&C Blue No. 2 – The color additive, FD&C Blue No. 2, may be safely used inthe manufacture of animal foods in accordance with the following prescribed conditions:(a) Identity.(1) The color additive FD&C Blue No. 2 is principally the disodium salt of 3-dihydro-3-oxo-1H-indole-5sulfonic acid (CAS Reg. No. 860-22-0) with smaller amounts of the disodium saltof ,3-dihydro-3-oxo-1Hindole-5-sulfonic acid (CAS Reg. No. 54947-75-0) and the sodium salt of o-3-oxo-1H-indole-5-sulfonic acid(CAS Reg. No. 605-18-5). Additionally, FD&C Blue No. 2 is obtained byheating indigo (or indigo paste) in the presence of sulfuric acid. The coloradditive is isolated and subjected to purification procedures. The indigo (orindigo paste) used above is manufactured by the fusion of N-phenylglycine(prepared from aniline and formaldehyde) in a molten mixture of sodamide andsodium and potassium hydroxides under ammonia pressure. The indigo isisolated and subjected to purification procedures prior to sulfonation.(2) Color additive mixtures for food use made with FD&C Blue No. 2 maycontain only those diluents that are suitable and that are listed in part 73.1 of Title21 of the Code of Federal Regulations (21 CFR 73.1) as safe for use in coloradditive mixtures for coloring foods.(b) Specifications.The color additive FD&C Blue No. 2 shall conform to the following specifications andshall be free from impurities other than those named to the extent that such otherimpurities may be avoided by current good manufacturing practice:Sum of volatile matter at 135 C (275 F) and chlorides and sulfates (calculated assodium salts), not more than 15 percent.Water insoluble matter, not more than 0.4 percent.Isatin-5-sulfonic acid, not more than 0.4 percent.5-Sulfoanthranilic acid, not more than 0.2 percent.Disodium salt of ,3-dihydro3-oxo-1H-indole-5-sulfonic acid, not more than 18 percent.Sodium salt of ro-3-oxo-1Hindole-5-sulfonic acid, not more than 2 percent.Lead (as Pb), not more than 10 parts per million.Arsenic (as As), not more than 3 parts per million.Mercury (as Hg), not more than 1 part per million.Total color, not less than 85 percent.(c) Uses and restrictions.The color additive FD&C Blue No. 2 may be safely used for coloring foods generally inamounts consistent with current good manufacturing practice except that it may not beused to color foods for which standards of identity have been promulgated under section401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized bysuch standards.(d) Labeling.Page 12 of 45

Final: 2/25/16 ver 2The label of the color additive and any mixtures prepared therefrom intended solely or inpart for coloring purposes shall conform to the requirements of 21 CFR 70.25.(e) Certification.All batches of FD&C Blue No. 2 shall be certified in accordance with regulations in 21CFR 80.21 CFR 74.10287.103 FD&C Green No. 3 – The color additive, FD&C Green No. 3, may be safelyused in the manufacture of animal foods in accordance with the following prescribedconditions:(a) Identity.(1) The color additive FD&C Green No. 3 is principally the inner salt disodiumsalt of clohexadien-1-ylidene]-3sulfobenzenemethanaminium hydroxide (CAS Reg. No. 2353-45-9); with smalleramounts of the isomeric inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3sulfophenyl)methyl] nium hydroxide; of lohexadien-1-ylidene]-4sulfobenzenemethanaminium hydroxide and of lohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide.Additionally, FD&C Green No. 3 is manufactured by the acid catalyzedcondensation of one molecule of 2-formyl-5-hydroxybenzenesulfonic acid withtwo molecules from a mixture consisting principally of 3[(ethylphenylamino)methyl] benzensulfonic acid, and smaller amounts of 4[(ethylphenylamino)methyl] benzenesulfonic acid and 2[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. Theleuco base is then oxidized with lead dioxide and acid or with dichromate andacid to form the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acidis prepared by the potassium permanganate oxidation of 2,2′-(1,2-ethenediyl)bis(5-aminobenzenesulfonic acid) to sodium 5-amino-2-formylbenzenesulfonate.This amine is diazotized and the resulting diazonium salt is hydrolyzed to thedesired 2-formyl-5-hydroxybenzenesulfonic acid.(2) Color additive mixtures for food use made with FD&C Green No. 3 maycontain only those diluents that are suitable and that are listed in part 73.1 of Title21 of the Code of Federal Regulations (21 CFR 73.1) as safe for use in coloradditive mixtures for coloring food.(b) Specifications.The color additive FD&C Green No. 3 shall conform to the following specifications andshall be free from impurities other than those named to the extent that such otherimpurities may be avoided by current good manufacturing practice:Page 13 of 45

Final: 2/25/16 ver 2Sum of volatile matter at 135 C (275 F) and chlorides and sulfates (calculated assodium salts), not more than 15 percent.Water-insoluble matter, not more than 0.2 percent.Leuco base, not more than 5 percent.Sum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than 0.5percent.Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic acid,disodium salts, not more than 0.3 percent.2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 percent.Subsidiary colors, not more than 6 percent.Chromium (as Cr), not more than 50 parts per million.Arsenic (as As), not more than 3 parts per million.Lead (as Pb), not more than 10 parts per million.Mercury (as Hg), not more than 1 part per million.Total color, not less than 85 percent.(c) Uses and restrictions.The color additive FD&C Green No. 3 may be safely used for coloring foods generally inamounts consistent with current good manufacturing practice except that it may not beused to color foods for which standards of identity have been promulgated under section401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized bysuch standards.(d) Labeling.The label of the color additive and any mixtures prepared therefrom intended solely or inpart for coloring purposes shall conform to the requirements of 21 CFR 70.25.(e) Certification.All batches of FD&C Green No. 3 shall be certified in accordance with regulations in21CFR 80.21 CFR 74.20387.104 FD&C Red No. 3 – The color additive, FD&C Red No. 3, may be safely used inthe manufacture of animal foods in accordance with the following prescribed conditions:(a) Identity.(1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 (ocarboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo-3H-xanthen-3-one, disodium salt,with smaller amounts of lower imdinated fluoresceins.(2) Color additive mixtures for food use made with FD&C Red No. 3 may containonly those diluents that are suitable and that are listed in part 73.1 of Title 21 ofthe Code of Federal Regulations (21 CFR 73.1) as safe for use in color additivemixtures for coloring foods.(b) Specifications.FD&C Red No. 3 shall conform to the following specifications and shall be free fromimpurities other than those named to the extent that such other impurities may be avoidedby good manufacturing practice:Page 14 of 45

Final: 2/25/16 ver 2Volatile matter (at 135 C.) and chlorides and sulfates (calculated as the sodiumsalts), total not more than 13 percent.Water-insoluble matter, not more than 0.2 percent.Unhalogenated intermediates, total not more than 0.1 percent.Sodium iodide, not more than 0.4 percent.Triiodoresorcinol, not more than 0.2 percent.2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic acid, not more than 0.2 percent.Monoiodofluoresceins not more than 1.0 percent.Other lower iodinated fluoresceins, not more than 9.0 percent.Lead (as Pb), not more than 10 parts per million.Arsenic (as As), not more than 3 parts per million.Total color, not less than 87.0 percent.(c) Uses and restrictions.FD&C Red No. 3 may be safely used for coloring foods generally in amounts consistentwith good manufacturing practice except that it may not be used to color foods for whichstandards of identity have been promulgated under section 401 of the Federal Food,Drug, and Cosmetic Act unless added color is authorized by such standards.(d) Labeling.The label of the color additive and any mixtures prepared therefrom intended solely or inpart for coloring purposes shall conform to the requirements of 21 CFR 70.25.(e) Certification.All batches of FD&C Red No. 3 shall be certified in accordance with regulations in 21CFR 80.21 CFR 74.30387.105 FD&C Red No. 40 – The color additive, FD&C Red No. 40, may be safely usedin the manufacture of animal foods in accordance with the following prescribedconditions:(a) Identity.(1) The color additive FD&C Red No. 40 is principally the disodium salt of -2-naphthalenesulfonic acid.(2) Color additive mixtures for food use (including dietary supplements) madewith FD&C Red No. 40 may contain only those diluents that are suitable and thatare listed in part 73.1 of Title 21 of the Code of Federal Regulations (21 CFR73.1) as safe for use in color additive mixtures for coloring foods.(3) The listing of this color additive includes lakes prepared as described in 21CFR 82.51, except that the color additive used is FD&C Red No. 40 and theresultant lakes meet the specification and labeling requirements prescribed by 21CFR 82.51.(b) Specifications.FD&C Red No. 40 shall conform to the following specifications and shall be free fromimpurities other than those named to the extent that such other impurities may be avoidedby good manufacturing practice:Page 15 of 45

Final: 2/25/16 ver 2Sum of volatile matter (at 135 C.) and chlorides and sulfates (ca

consider not printing it to review. 1. Publish the tentative definition in the OP for T33.21 Yellow Grease, Feed Grade. 2. Replace the current definition of 87.1 Algae Meal with the official definition (from the color additive definition 21 CFR 73.275) in the OP of 87.1 Dried Algae Meal. 3.