PART 584—FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS 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 containing ethyl acetate meets the requirement 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 ruminant 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. (b) Conditions of use. (c) Limitations. (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 percent 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 substances. Not more than 50 parts per million dichlorodimethylsilane. (ii) Precipated hydrophobic silica: Not less than 94.0 percent silicon dioxide 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 percent 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 D 3 (a) Product. 3 (b) Conditions of use. 3 (c) Limitations. (2) The product must comply with the following specifications: (i) Not less than 94.0 percent 25-hydroxyvitamin D 3 (ii) Not more than 1 percent of any individual sterol. (iii) Not more than 5 percent water. (iv) Not more than 20 parts per million (ppm) lead. (v) Not more than 20 ppm aluminum. (vi) Not more than 1.0 percent solvents 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 D 3 (ii) Adequate use directions to ensure that 25-hydroxyvitamin D 3 (iii) An expiration date on all premix labeling. (iv) A statement on all premix labeling (feed and drinking water forms) that 25-hydroxyvitamin D 3 [72 FR 12564, Mar. 16, 2007]