---
kind: "section"
citation: "21 C.F.R. § 25.32"
title: "21"
number: "25.32"
heading: "Foods, food additives, and color additives."
url: "https://uscodex.org/cfr/21/25.32"
---

# §25.32. Foods, food additives, and color additives.


The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:

- (a) **Issuance, amendment, or repeal of a food standard.**
- (b) Action on a request for exemption for investigational use of a food additive if the food additive to be shipped under the request is intended to be used for clinical studies or research.
- (c) Approval of a color additive petition to change a provisionally listed color additive to permanent listing for use in food, drugs, devices, or cosmetics.
- (d) **Testing and certification of batches of a color additive.**
- (e) **Issuance of an interim food additive regulation.**
- (f) Establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts [182](/cfr/21/part182.md), [184](/cfr/21/part184.md), 186, 582, or 584 of this chapter, and establishment or amendment of a regulation for a prior-sanctioned food ingredient, as defined in §§ [170.3(l)](/cfr/21/170.3.md?p=l) and [181.5(a)](/cfr/21/181.5.md?p=a) of this chapter, if the substance or food ingredient is already marketed in the United States for the proposed use.
- (g) Issuance and enforcement of regulations relating to the control of communicable diseases or to interstate conveyance sanitation under parts [1240](/cfr/21/part1240.md) and [1250](/cfr/21/part1250.md) of this chapter.
- (h) Approval of a request for diversion of adulterated or misbranded food for humans or animals to use as animal feeds.
- (i) Approval of a food additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts [182](/cfr/21/part182.md), [184](/cfr/21/part184.md), 186, 582, or 584 of this chapter, the granting of a request for exemption from regulation as a food additive under [§ 170.39](/cfr/21/170.39.md) of this chapter, or allowing a notification submitted under [21 U.S.C. 348(h)](/usc/21/348.md?p=h) to become effective, when the substance is present in finished food-packaging material at not greater than 5 percent-by-weight and is expected to remain with finished food-packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material.
- (j) Approval of a food additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts [182](/cfr/21/part182.md), [184](/cfr/21/part184.md), 186, 582, or 584 of this chapter, the granting of a request for exemption from regulation as a food additive under [§ 170.39](/cfr/21/170.39.md) of this chapter, or allowing a notification submitted under [21 U.S.C. 348(h)](/usc/21/348.md?p=h) to become effective, when the substance is to be used as a component of a food-contact surface of permanent or semipermanent equipment or of another food-contact article intended for repeated use.
- (k) Approval of a food additive petition or color additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts [182](/cfr/21/part182.md), [184](/cfr/21/part184.md), 186, 582, or 584 of this chapter, or allowing a notification submitted under [21 U.S.C. 348(h)](/usc/21/348.md?p=h) to become effective, for substances added directly to food that are intended to remain in food through ingestion by consumers and that are not intended to replace macronutrients in food.
- (l) Approval of a petition for color additives used in contact lenses, sutures, filaments used as supporting haptics in intraocular lenses, bone cement, and in other FDA-regulated products having similarly low levels of use.
- (m) Action to prohibit or otherwise restrict or reduce the use of a substance in food, food packaging, or cosmetics.
- (n) **Issuance, amendment, or revocation of a regulation pertaining to infant formulas.**
- (o) Approval of a food additive petition for the intended expression product(s) present in food derived from new plant varieties.
- (p) Issuance, amendment, or revocation of a regulation in response to a reference amount petition as described in [§ 101.12(h)](/cfr/21/101.12.md?p=h) of this chapter, a nutrient content claim petition as described in [§ 101.69](/cfr/21/101.69.md) of this chapter, a health claim petition as described in [§ 101.70](/cfr/21/101.70.md) of this chapter, or a petition pertaining to the label declaration of ingredients as described in [§ 10.30](/cfr/21/10.30.md) of this chapter.
- (q) Approval of a food additive petition, the granting of a request for exemption from regulation as a food additive under [§ 170.39](/cfr/21/170.39.md) of this chapter, or allowing a notification submitted under [21 U.S.C. 348(h)](/usc/21/348.md?p=h) to become effective for a substance registered by the Environmental Protection Agency under FIFRA for the same use requested in the petition, request for exemption, or notification.
- (r) Approval of a food additive petition or color additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts [182](/cfr/21/part182.md), [184](/cfr/21/part184.md), 186, 582, or 584 of this chapter, or allowing a notification submitted under [21 U.S.C. 348(h)](/usc/21/348.md?p=h) to become effective for a substance that occurs naturally in the environment, when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.

## Notes

### Amendments

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 76 FR 59248, Sept. 26, 2011; 81 FR 55047, Aug. 17, 2016]

### Authority

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.

### Source

Source: 62 FR 40592, July 29, 1997, unless otherwise noted.

### Amendments

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 76 FR 59248, Sept. 26, 2011; 81 FR 55047, Aug. 17, 2016]