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Ci 45396

Moderate concern

Restricted color additive: D&C Orange No. 5 is permitted only in externally applied drugs and cosmetics and lip products with maximum 5% concentration; not permitted in food.

Found in

2 products

What it is

Color Index 45396 — D&C Orange No. 5 / Acid Orange 11, a synthetic xanthene dye derived from fluorescein.

Color additive; in the US permitted only for externally applied drugs and cosmetics, including lipsticks, with restrictions. Not a permitted food color in the US.

Why it's flagged

not approved for food use
restricted concentration in cosmetics

What regulators actually say

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Regulatory status

United States — FDA

21 CFR 74.1255 lists D&C Orange No. 5 with restrictions; not permitted in food.

European Union — EFSA

Not authorised as a food additive.

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