BRIEFING

 Erythrosine. FCC 14. Based on comments and information received, the following revisions are proposed to align Erythrosine with the JECFA monograph for Erythrosine prepared at the 86th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA Monograph 22; 2018):

1. Replace footnote 1 with a new footnote 1 with important information for manufacturers regarding FD&C Red No. 3 and add footnote 2 to reference the updated JECFA monograph.

2. Add three synonyms to the list within the chemical information: Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate monohydrate; Disodium; 2′,4′,5′,7′-tetraiodo-3-oxospiro[2-benzofuran-1,9′-xanthene]-3′,6′-diolate; Disodium 2′,4′,5’,7′-tetraiodofluorescein monohydrate.

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. Add the test for Zinc to Inorganic Impurities.

7. Add the test for Inorganic Iodides to Inorganic Impurities.

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

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

10. Add the test for Fluorescein to Organic Impurities.

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

 The proposal is targeted for publication in the First Supplement to FCC 15.

 (FI: G. Clapper)

 Case ID—SUB-2831