Q.01

What are the FD&C certified color additives permitted in US food, what does FD&C mean, how does FDA batch certification work under 21 CFR Part 74 and 21 CFR Part 80, and how must certified colors be declared on a food label? Include the current status of FD&C Red No. 3 and the FDA plan to phase out petroleum-based dyes.

The FDA currently allows seven FD&C certified colours in US food: Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5 and Yellow No. 6 (21 CFR 74.101, 74.102, 74.203, 74.303, 74.340, 74.705, 74.706). Two non-FD&C certified colours also have narrow food uses: Citrus Red No. 2 (orange skins only, and now proposed for revocation) and Orange B, whose sausage-casing listing was revoked effective September 8, 2026. Red No. 3's food listing ends after January 15, 2027, and that date is now confirmed.

Approach: I searched the current eCFR text of 21 CFR Part 74 and 21 CFR 101.22, and FDA's Regulatory Status of Color Additives list (08/14/2026 edition). The datasets don't hold 21 CFR Part 80 or the phase-out announcements, so those parts come from search snippets of official FDA, HHS, eCFR and Federal Register pages.

1. What "FD&C" means

FD&C refers to the Federal Food, Drug, and Cosmetic Act. FDA says the food colours are called "FD&C" colours because they may also be used in drugs and cosmetics. Certifiable colour names carry one of three prefixes: FD&C, D&C or External D&C. FDA created these names after the 1938 Act (FDA web pages, from search snippets).

2. Certified colours permitted in food (Part 74, Subpart A)

Colour21 CFRFDA statusFood use
FD&C Blue No. 174.101Permanently listed, certification required [1]Foods incl. dietary supplements, GMP [2]
FD&C Blue No. 274.102Permanently listed [3]Same [4]
FD&C Green No. 374.203Permanently listed [5]Same [6]
FD&C Red No. 374.303Food listing ends after Jan 15, 2027 [7]Same, until then [8]
FD&C Red No. 40 (and its lakes)74.340Permanently listed [9]Same [10][11]
FD&C Yellow No. 574.705Permanently listed [12]Same [13]
FD&C Yellow No. 674.706Permanently listed [14]Same [15]
Citrus Red No. 274.302Listed; revocation proposed 23 Jul 2026 (91 FR 46330), comments closed 24 Aug 2026 [16]Skins of mature oranges not intended for processing; max 2.0 ppm on whole fruit [17][18]

Conditions that apply to all of them:

  • None of these colours may be used in a food with a standard of identity (a legal recipe under section 401 of the Act) unless that standard allows added colour (see the cited "uses" paragraphs).
  • Colour mixtures for food may contain only diluents listed in Part 73 [19].
  • Orange B: FDA's final order (91 FR 46276, 23 Jul 2026) revoked its use on frankfurter and sausage casings effective September 8, 2026 [20]. Section 74.250 no longer appears in the current Part 74 text I searched.
  • Lakes: FD&C lakes are provisionally listed under 21 CFR 82.51, and certification is required [21]. Lakes of Red No. 3 lost their listing for all uses in 1990 [7].
  • FD&C Red No. 4 is listed only for externally applied drugs and cosmetics. Its food uses ended in 1976 [22].

3. Batch certification: Part 74 and Part 80

Part 74 (which colours and on what terms). Each listing sets out the colour's identity, specifications, permitted uses, labelling (by reference to § 70.25), and states: "All batches … shall be certified in accordance with regulations in part 80" [23].

  • FDA must analyse and certify every batch before it is used in any FDA-regulated product, whether imported or made in the US [7].
  • The colour manufacturer's label must show the colour's name, its use limits and the certification lot number [7].

Part 80 (how certification works), from search snippets of the eCFR:

  • Request (§ 80.21): the request comes with the fee under § 80.10, unless the firm has an advance deposit account. It also needs a sample taken after the batch is fully mixed: 4 oz for straight colours and lakes, 2 oz for repacks and mixtures. The sample is labelled with the colour name and the manufacturer's batch number.
  • Fees (§ 80.10, per the November 2024 fee rule):
    • Straight colours and lakes: $0.45 per lb, minimum $288.
    • Repacks and mixtures: $45 up to 100 lb, rising on a per-pound scale for larger batches.
  • Certification (§ 80.31): FDA issues a certificate with a lot number if the request has no untrue statements and the batch meets the specifications. Otherwise it refuses certification and tells the requester.
  • When a certificate stops being valid (§ 80.32):
    • It never takes effect if obtained by fraud.
    • It doesn't cover colour that changed in composition before or after the certificate was issued.
    • It expires once the package is opened, unless the colour is being used to colour a product, or is being repacked, mixed or repackaged as allowed.
  • After certification (§§ 80.38 and 80.39): the batch must be identified by its lot number and stored so its composition can't change. The certificate holder must keep separate, complete records of each use and each shipment from the batch.

4. Declaring certified colours on a food label

  • Naming (21 CFR 101.22(k)(1)): use the name in Part 74 or Part 82. The "FD&C" prefix and "No." may be dropped, so "Yellow 5" is acceptable. Lakes must include "Lake" (e.g. "Blue 1 Lake"). An alternative name may follow in parentheses [24].
  • Generic terms: "Artificial Color" or "Color Added" are allowed only for colours exempt from certification [25].
  • Where the statement goes (101.22(c)): where the ordinary consumer is likely to read it. The specific colour must be named when Part 74 requires it [26].
  • Yellow No. 5: it must be declared by name in all foods for human use, including butter, cheese and ice cream [27]. That overrides the usual butter, cheese and ice cream exemption [28].
  • "No artificial colors" claims: from a search snippet, FDA's letter of 5 February 2026 said it will not take enforcement action against such claims on foods that contain no certified colours.

5. FD&C Red No. 3

  • FDA's order of 16 Jan 2025 (90 FR 4628) revokes the listing in food, including dietary supplements, from 15 Jan 2027, and in ingested drugs from 18 Jan 2028 [7].
  • From search snippets: the legal basis is the Delaney Clause. Objections filed for Micro-Tracers, Inc. paused (stayed) the order from 18 Feb 2025.
  • On 5 Aug 2026 (91 FR 50475) FDA rejected the objections, refused a hearing and lifted the stay [7], so both deadlines stand.
  • Section 74.303 still lists food use until the deadline [8]. FDA has asked manufacturers to phase it out before 2027.
  • Red No. 3 lost its cosmetic and externally applied drug uses in 1990 [7].

6. FDA plan to phase out petroleum-based dyes

From search snippets of official HHS and FDA press releases:

  • Announced 22 April 2025. FDA would:
    • set a national standard and timeline for switching to natural colours;
    • start revoking Citrus Red No. 2 and Orange B;
    • work with industry to remove the six other FD&C dyes (Green 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2);
    • speed up approval of natural alternatives;
    • fund research with NIH on how food additives affect children.
  • Progress so far:
    • Orange B is revoked (Section 2 above).
    • Citrus Red No. 2's revocation is still only proposed [16].
    • Natural colours approved since include calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract and beetroot red.
  • The six dyes are still lawful. Removing them depends on voluntary industry action. All six remain permanently listed in Part 74 with no revocation entries.
  • The target date is inconsistent. The April 2025 release says "by the end of next year" (end of 2026). FDA's 2026 communications, as summarised in a search snippet, say end of 2027.

Sources:

Q.02