---
kind: "section"
citation: "21 C.F.R. § 584.725"
title: "21"
number: "584.725"
heading: "25-Hydroxyvitamin D 3 ."
url: "https://uscodex.org/cfr/21/584.725"
---

# §584.725. 25-Hydroxyvitamin D 3 .

- (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)](#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.

## Notes

### Amendments

[72 FR 12564, Mar. 16, 2007]

### Authority

Authority: 21 U.S.C. 321, 342, 348, 371.

### Amendments

[72 FR 12564, Mar. 16, 2007]