---
kind: "section"
citation: "21 C.F.R. § 573.550"
title: "21"
number: "573.550"
heading: "25-hydroxyvitamin D 3 ."
url: "https://uscodex.org/cfr/21/573.550"
---

# §573.550. 25-hydroxyvitamin D 3 .


The food additive, 25-hydroxyvitamin D3, may be safely used in accordance with the following prescribed conditions:

- (a) The additive is used or intended for use as a source of vitamin D3 activity in animal feed or drinking water in accordance with good manufacturing and feeding practices as follows:
  - (1) In feed or drinking water of layer and breeder chickens not to exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water.
  - (2) **In feed or drinking water of turkeys not to exceed—**
    - (i) 92 ppb in feed; or
    - (ii) In drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age.
- (b) The additive consists of not less than 94 percent 25-hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3β, 25-diol).
- (c) **The additive meets the following specifications—**
  - (1) **Not more than 1 percent of any individual sterol.**
  - (2) **Not more than 5 percent water.**
  - (3) **Not more than 20 parts per million (ppm) lead.**
  - (4) **Not more than 20 ppm aluminum.**
  - (5) Not more than 1.0 percent solvents and non-detectable levels of 2′, 4′, 5′, 7′ tetraiodofluorescin.
  - (6) **Not more than 1 ppb 1, 25-dihydroxycholecalciferol.**
- (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain:
  - (1) **The name of the additive.**
  - (2) A statement to indicate the maximum use level of 25-hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb in drinking water for layer and breeder chickens.
  - (3) A statement to indicate for turkeys the maximum use level of 25-hydroxyvitamin D3 must not exceed 92 ppb in feed; or in drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age.
  - (4) Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all premixes) is uniformly blended throughout the feed or drinking water.
  - (5) **An expiration date on all premix labeling.**
  - (6) A statement on all premix labeling (feed and drinking water forms) that 25-hydroxyvitamin D3 cannot be used simultaneously in both feed and water.

## Notes

### Amendments

[83 FR 49486, Oct. 2, 2018]

### Authority

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

### Source

Source: 41 FR 38652, Sept. 10, 1976, unless otherwise noted.

### Amendments

[83 FR 49486, Oct. 2, 2018]