---
kind: "section"
citation: "21 C.F.R. § 73.1095"
title: "21"
number: "73.1095"
heading: "β-Carotene."
url: "https://uscodex.org/cfr/21/73.1095"
---

# §73.1095. β-Carotene.

- (a) **Identity and specifications.**
  - (1) The color additive β-carotene shall conform in identity and specifications to the requirements of § [73.95(a)(1)](/cfr/21/73.95.md?p=a-1) and [(b)](/cfr/21/73.95.md?p=a-b).
  - (2) The diluents in color additive mixtures for drug use containing β-carotene are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring ingested drugs.
- (b) **Uses and restrictions.** The color additive β-carotene may be safely used in coloring drugs generally, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
- (c) **Labeling requirements.** The labeling of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of [§ 70.25](/cfr/21/70.25.md) of this chapter.
- (d) **Exemption from certification.** Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of [section 721(c)](/cfr/21/721.md?p=c) of the act.

## Notes

### Amendments

[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

### Source

Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.

### Amendments

[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]