CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR584.725]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

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

Subpart B - Listing of Specific Substances Affirmed as GRAS

Sec. 584.725 25-Hydroxyvitamin D3.

(a) Product. 25-Hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3[beta], 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]