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Electronic Code of Federal Regulations

e-CFR data is current as of October 10, 2019

Title 21Chapter ISubchapter E → Part 584


Title 21: Food and Drugs


PART 584—FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS


Contents

Subpart A [Reserved]

Subpart B—Listing of Specific Substances Affirmed as GRAS

§584.200   Ethyl alcohol containing ethyl acetate.
§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 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. Amorphous fumed hydrophobic silica or precipitated hydrophobic 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 percent 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 following 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 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 D3.

(a) Product. 25-Hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3β, 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 limitations 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 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 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 premixes) is uniformly blended throughout the feed or drinking water.

(iii) An expiration date on all premix labeling.

(iv) A statement on all premix labeling (feed and drinking water forms) that 25-hydroxyvitamin D3 should not be used simultaneously in both feed and water.

[72 FR 12564, Mar. 16, 2007]

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