Food substances affirmed as generally recognized as safe in feed and drinking water of animals (21 CFR 584.200-584.725)

578 21 CFR Ch. I (4–1–11 Edition) § 582.6810 § 582.6810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.6851 Stearyl citrate. (a) Product. Stearyl citrate. (b) Tolerance. This substance is gen erally recognized as safe for use at a level not exceeding 0.15 percent in ac cordance with good manufacturing or feeding practice. Subpart H—Stabilizers § 582.7115 Agar-agar. (a) Product. Agar-agar. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7133 Ammonium alginate. (a) Product. Ammonium alginate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7187 Calcium alginate. (a) Product. Calcium alginate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7255 Chondrus extract. (a) Product. Chondrus extract (carrageenin). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7330 Gum arabic. (a) Product. Acacia (gum arabic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7333 Gum ghatti. (a) Product. Gum ghatti. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7339 Guar gum. (a) Product. Guar gum. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7343 Locust bean gum. (a) Product. Locust (carob) bean gum. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7349 Sterculia gum. (a) Product. Sterculia gum (karaya gum). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7351 Gum tragacanth. (a) Product. Tragacanth (gum tragacanth). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7610 Potassium alginate. (a) Product. Potassium alginate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. § 582.7724 Sodium alginate. (a) Product. Sodium alginate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac turing or feeding practice. PART 584—FOOD SUBSTANCES AF FIRMED AS GENERALLY RECOG NIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS Subpart A [Reserved] VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00588 Fmt 8010 Sfmt 8006 Q:\21\21V6.TXT ofr150 PsN: PC150 579 Food and Drug Administration, HHS § 584.725 Subpart B—Listing of Specific Substances Affirmed as GRAS Sec. 584.200 Ethyl alcohol containing ethyl ace tate. 584.700 Hydrophobic silicas. 584.725 25–Hydroxyvitamin D3. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. Subpart A [Reserved] Subpart B—Listing of Specific Substances Affirmed as GRAS § 584.200 Ethyl alcohol containing ethyl acetate. The feed additive ethyl alcohol con taining ethyl acetate meets the re quirement of 27 CFR 21.62, being not less than 92.5 percent ethyl alcohol, each 100 gallons having had added the equivalent of 4.25 gallons of 100 percent ethyl acetate. It is used in accordance with good feeding practices in rumi nant feed supplements as a source of added energy. [46 FR 52333, Oct. 27, 1981, as amended at 72 FR 41620, July 31, 2007] § 584.700 Hydrophobic silicas. (a) Product. Amorphous fumed hydro phobic silica or precipitated hydro phobic silica (CAS Reg. No. 68611–0944– 099, silane, dichlorodimethyl-, reaction products with silica). (b) Conditions of use. An anticaking/ free-flow agent in vitamin preparations for animal feed. (c) Limitations. Not to exceed 5 per cent in the vitamin preparation. It shall be used in accordance with good manufacturing or feeding practices. It must be of purity suitable for intended use, and it must comply with the fol lowing specifications: (i) Amorphous fumed hydrophobic silica: Not less than 99.0 percent silicon dioxide after ignition. Not more than 3 ppm arsenic. Not more than 0.003 per cent heavy metals (as lead). Not more than 10 ppm lead. Not more than 2.5 percent loss on drying. Not more than 2 percent loss on ignition after drying. Not more than 1 percent insoluble sub stances. Not more than 50 parts per million dichlorodimethylsilane. (ii) Precipated hydrophobic silica: Not less than 94.0 percent silicon diox ide after ignition. Not more than 3 ppm arsenic. Not more than 0.003 percent heavy metals (as lead). Not more than 10 ppm lead. Not more than 7 percent loss on drying. Not more than 8.5 per cent loss on ignition after drying. Not more than 5 percent soluble ionizable salts (as sodium sulfate). Not more than 1 percent insoluble substances. Not more than 50 parts per million dichlorodimethylsilane. [61 FR 43453, Aug. 23, 1996] § 584.725 25–Hydroxyvitamin D3. (a) Product. 25–Hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3b, 25-diol). (b) Conditions of use. This substance is generally recognized as safe as a source of vitamin D3 activity in feed or drinking water of broiler chickens when used in accordance with the limi tations in paragraph (c) of this section. (c) Limitations. (1) Not to exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water. It shall be used in accordance with good manufacturing and feeding practices. (2) The product must comply with the following specifications: (i) Not less than 94.0 percent 25 hydroxyvitamin D3. (ii) Not more than 1 percent of any individual sterol. (iii) Not more than 5 percent water. (iv) Not more than 20 parts per mil lion (ppm) lead. (v) Not more than 20 ppm aluminum. (vi) Not more than 1.0 percent sol vents and non-detectable levels of 2’, 4’, 5’, 7’-tetraiodofluorescin. (3) Product labeling shall bear the following: (i) A statement to indicate that the maximum use level of 25 hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb in drinking water. (ii) Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all pre mixes) is uniformly blended through out the feed or drinking water. (iii) An expiration date on all premix labeling. (iv) A statement on all premix label ing (feed and drinking water forms) that 25-hydroxyvitamin D3 should not VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00589 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 580 21 CFR Ch. I (4–1–11 Edition) Pt. 589 be used simultaneously in both feed and water. [72 FR 12564, Mar. 16, 2007] PART 589—SUBSTANCES PROHIB ITED FROM USE IN ANIMAL FOOD OR FEED Subpart A—General Provisions Sec. 589.1 Substances prohibited from use in ani mal food or feed. Subpart B—Listing of Specific Substances Prohibited From Use in Animal Food or Feed 589.1000 Gentian violet. 589.1001 Propylene glycol in or on cat food. 589.2000 Animal proteins prohibited in rumi nant feed. 589.2001 Cattle materials prohibited in ani mal food or feed to prevent the trans mission of bovine spongiform encephalopathy. AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. Subpart A—General Provisions § 589.1 Substances prohibited from use in animal food or feed. (a) The substances listed in this part have been prohibited from use in ani mal food or feed by the Food and Drug Administration because of a deter mination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in such food or feed. Use of any of these substances in viola tion of this part causes the animal food or feed involved to be adulterated and in violation of the Act. (b) This part includes only a partial list of substances prohibited from use in animal food or feed; it is for easy reference purposes and is not a com plete list of substances that may not lawfully be used in such animal food or feed. No substance may be used in ani mal food or feed unless it meets all ap plicable requirements of the Act. (c) The Food and Drug Administra tion either on its own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish, amend, or repeal a regulation under this part on the basis of new scientific evaluation or in formation. Any such petition shall in clude an adequate scientific basis to support the petition, shall be the form set forth in § 571.1 of this chapter, and will be published in the FEDERAL REG ISTER for comment if it contains rea sonable ground. [45 FR 28319, Apr. 29, 1980] Subpart B—Listing of Specific Sub stances Prohibited From Use in Animal Food or Feed § 589.1000 Gentian violet. The Food and Drug Administration has determined that gentian violet has not been shown by adequate scientific data to be safe for use in animal feed. Use of gentian violet in animal feed causes the feed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act (the act), in the ab sence of a regulation providing for its safe use as a food additive under sec tion 409 of the act, unless it is subject to an effective notice of claimed inves tigational exemption for a food addi tive under § 570.17 of this chapter, or unless the substance is intended for use as a new animal drug and is subject to an approved application under section 512 of the act, or an index listing under section 572 of the act, or an effective notice of claimed investigational ex emption for a new animal drug under part 511 of this chapter or § 516.125 of this chapter. [72 FR 69131, Dec. 6, 2007] § 589.1001 Propylene glycol in or on cat food. The Food and Drug Administration has determined that propylene glycol in or on cat food has not been shown by adequate scientific data to be safe for use. Use of propylene glycol in or on cat food causes the feed to be adulter ated and in violation of the Federal Food, Drug, and Cosmetic Act (the act), in the absence of a regulation pro viding for its safe use as a food additive under section 409 of the act, unless it is subject to an effective notice of claimed investigational exemption for a food additive under § 570.17 of this chapter, or unless the substance is in tended for use as a new animal drug VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00590 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150