USPUSP-NF
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Allura Red
Allura Red AC
CI Food Red 17
Disodium 6-hydroxy-5-(2-methoxy-5-methyl-4-sulfonatophenylazo)-2-naphthalenesulfonate
CI 16035
Class: Monoazo C18H14N2O8S2Na2 Formula wt 496.43
129 [25956-17-6] WZB9127XOA fd&c red no. 40

BRIEFING

Allura Red. FCC 15. Based on comments and information received, the following revisions are proposed to align Allura Red with the JECFA monograph for Allura Red AC prepared at the 82nd meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA Monograph 19; 2016):

  1. Add footnote 2: "Portions of this monograph are reproduced with permission from the Food and Agriculture Organization of the United Nations JECFA Monograph 19 (2016)."

  2. Add two synonyms to the list within the Chemical Information section.

  3. Revise the Description.

  4. In the Assay, remove the requirement for Method III from the test for Total Color.

  5. Update the test method and Acceptance criteria in the test for Lead.

  6. Replace the Uncombined Intermediates and Products of Side Reactions test with the Organic Compounds Other Than Coloring Matters test in Organic Impurities.

  7. Replace the existing test for Subsidiary Colors in Specific Tests with a new Subsidiary Coloring Matters test in Organic Impurities.

  8. Add the test for Unsulfonated Primary Aromatic Amines to Organic Impurities.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 This proposal is targeted for publication in the Second Supplement to FCC 15.

 (FI: G. Clapper)

 Case ID—SUB-3116

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