---
kind: "section"
citation: "21 C.F.R. § 14.140"
title: "21"
number: "14.140"
heading: "Establishment of a color additive advisory committee."
url: "https://uscodex.org/cfr/21/14.140"
---

# §14.140. Establishment of a color additive advisory committee.


The Commissioner will establish a color additive advisory committee under the following circumstances:

- (a) The Commissioner concludes, as a matter of discretion, that it would be in the public interest for a color additive advisory committee to review and make recommendations about the safety of a color additive on which important issues are pending before FDA and for interested persons to present information and views at an oral public hearing before a color additive advisory committee.
- (b) There is an issue arising under [section 721(b)(5)(B)](/cfr/21/721.md?p=b-5-B) of the FD&C Act concerning the safety of a color additive, including its potential or actual carcinogenicity, that requires the exercise of scientific judgment and a person who would be adversely affected by the issuance, amendment, or repeal of a regulation listing a color additive requests that the matter, or the Commissioner as a matter of discretion determines that the matter should, be referred to a color additive advisory committee.
  - (1) [Paragraph (b)](#b) does not apply to any issue arising under the transitional provisions in [section 203](/cfr/21/203.md) of the Color Additive Amendments of 1960 relating to provisional listing of commercially established colors. A color additive advisory committee to consider any such matter will be established under [paragraph (a)](#a) of this section.
  - (2) A request for establishment of a color additive advisory committee is to be made in accordance with [§ 10.30](/cfr/21/10.30.md). The Commissioner may deny any petition if inadequate grounds are stated for establishing a color additive advisory committee. A request for establishment of a color additive advisory committee may not rest on mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires scientific judgment and justifies a hearing before a color additive advisory committee. When it conclusively appears from the request for a color additive advisory committee that the matter is premature or that it does not involve an issue arising under [section 721(b)(5)(B)](/cfr/21/721.md?p=b-5-B) of the FD&C Act or that there is no genuine and substantial issue of fact requiring scientific judgment, or for any other reason a color additive advisory committee is not justified, the Commissioner may deny the establishment of a color additive advisory committee.
  - (3) Establishment of a color additive advisory committee on the request of an interested person is conditioned upon receipt of the application fee specified in [§ 14.155](/cfr/21/14.155.md).
  - (4) Any person adversely affected may request referral of the matter to a color additive advisory committee at any time before, or within 30 days after, publication of an order of the Commissioner acting upon a color additive petition or proposal.

## Notes

### Authority

Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264, 284m, 284m-1; Pub. L. 107-109, 115 Stat. 1419.

### Source

Source: 44 FR 22351, Apr. 13, 1979, unless otherwise noted.