Citrus Red No. 2 is a synthetic azo dye historically used to enhance the appearance of orange peels. In the United States, its use is restricted by FDA (21 CFR §74.302) to coloring the rinds of fresh oranges not intended for processing at ≤2 ppm, subject to certification and labeling requirements
CR2 is not permitted in Europe, Codex, or most global markets due to its classification as a Group 2B carcinogen by IARC and the withdrawal of specifications by JECFA, which set its ADI as “not to be used.”
With increasing consumer demand for natural, clean-label colors, and regulatory alignment toward carotenoid-based alternatives, the use of CR2 is rapidly becoming obsolete.
Why Replace Citrus Red No. 2
Health & Regulatory Concerns
1. Carcinogenicity: IARC classifies CR2 as Group 2B, possibly carcinogenic.
2. JECFA: Withdraw specifications; set “ADI not to be used.”
3. Regulatory bans: EU and Codex do not authorize CR2; only the U.S. maintains a narrow peel-use exception.
4. Consumer perception: Negative associations with azo dyes drive reformulation toward natural systems.
Functional Rationale
1. Target hue: Orange to orange-red peel coloration.
2. Performance needs: Stability under light, heat, and handling; resistance to migration into pulp.
3. Alternative systems: Carotenoids (β-carotene, annatto, paprika) provide equivalent or superior hue with regulatory approval and consumer acceptance.
Regulatory Landscape for Citrus Red No. 2
| Region / Authority | Current Status | Key Restrictions | Implications for R&D |
| United States (FDA) | Permitted under 21 CFR §74.302 | Peel-use only; ≤2 ppm; batch certification required; labeling if present. | Strict limitation to fresh peel coatings; no expansion into processed foods. |
| European Union (EFSA/EC) | Banned | Not listed in EU colorant list (Reg. 1333/2008). No E-number assignment. | Must use authorized carotenoids (E160a, E160b, E160c). |
| Codex Alimentarius (GSFA) | Not authorized | Absent from GSFA permitted colors. | CR2 excluded from Codex-aligned markets. |
| JECFA (WHO/FAO) | No ADI; not to be used | Specifications withdrawn. | International trade excludes CR2. |
| IARC | Group 2B carcinogen | “Possibly carcinogenic to humans.” | Supports phase-out and natural replacement adoption. |
Manufacturers of Natural Alternatives
1. Oterra A/S (Denmark; Global)
Oterra supplies β-carotene emulsions and orange carrot concentrates (FruitMax, CapColors). Offered as oil suspensions and water-soluble systems (0.1–20% active carotenoid), they provide bright yellow-orange hues stable at pH 3–7.
Approved under FDA exempt-from-certification list and EFSA E160a. Available in clean-label, non-GMO formats with pilot application support.
2. Sensient Colors (USA; Global)
Sensient offers paprika oleoresins and β-carotene dispersions (Pure-S Orange) with high stability against heat and pH variation. Paprika extracts (capsanthin/capsorubin) are standardized for consistent orange-red hues.
Permitted as E160c in the EU and GRAS in the U.S. Formulations include microencapsulated variants for oxidation resistance.
3. GNT Group – EXBERRY (Netherlands; Global)
GNT provides Coloring Foods derived from paprika and carrot for “Brilliant Orange” solutions. Products are labeled as foods/concentrates rather than additives, meeting clean-label demands.
Formats include powders and dispersions, stable across typical food pH and applicable for coatings.
4. Lycored (Israel/USA; Global)
Lycored produces Blakeslea trispora β-carotene and tomato-derived carotenoids in emulsions and powders. Demonstrated stability under light, heat, and acidic matrices, suitable for both beverages and surface applications.
FDA and EFSA-approved (E160a). Lycored publishes stability datasets to guide R&D.
5. Givaudan (Naturex, France; Global)
Naturex supplies Carrot’Brite and Carotene emulsions, compliant with E160a. Offered in RSPO MB oil-dispersible and water-soluble forms, suitable for peel coatings.
Supported by Knowde-accessible technical data sheets.
6. DDW (Givaudan Sense Colour, USA/Global)
DDW manufactures annatto extracts in bixin (oil-soluble) and norbixin (water-soluble) formats, delivering stable orange to orange-red hues.
Widely used in cheese and coatings; regulated as E160b. Technical support includes formulation stability guidance and application trials.
Formulation Considerations
1. Hue coverage: β-carotene = yellow-orange; paprika = orange-red; annatto = orange to deep orange-red. Blends allow peel-matching flexibility.
2. Dosage: Typically 0.02–0.15% active carotenoid, adjusted for surface coating concentration.
3. pH compatibility: Carotenoids remain stable across pH 3–7 (common in coatings), unlike anthocyanins.
4. Stability: Carotenoids are prone to oxidation and photodegradation; encapsulation and antioxidants (tocopherols, ascorbate) improve shelf life.
5. Application method: Oil-dispersed or encapsulated emulsions ensure even peel coverage; systems must prevent migration into pulp.
6. Packaging: Use amber, oxygen-barrier packaging with nitrogen flushing for bulk stability.
Conclusion
Citrus Red No. 2 is effectively obsolete outside of the narrow FDA peel-use exception, with JECFA, EFSA, Codex, and IARC all reinforcing restrictions.
Natural carotenoids (β-carotene, annatto, paprika, carrot extracts) provide regulatory-approved, clean-label, and stable alternatives for peel and coating applications.
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