# FD&C RED NO. 40

URL: https://app.greenveil.ai/ingredients/ingredient_cas_25956_17_6
Categories: beauty, cleaning, food, industrial, pharma
Functions: colorant, Dye, Flavouring and nutrient, Fragrance
Identifier: 25956-17-6

> FD&C RED NO. 40 is used as colorant / dye. Greenveil chemical-concern score: 70/100 — High concern based on regulatory listings.. Assessed from 36 sources.

## Safety assessment

- Chemical concern score: 70/100 — High concern based on regulatory listings.
- Confidence: 4
- Rationale: Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (15); CI 16035. (see note 17) is restricted in cosmetic products under Annex III of the EU Cosmetics Regulation (EC) 1223/2009.

## Regulatory status

- EU: restricted — Annex III of EU Cosmetics Regulation (EC) 1223/2009: substances which cosmetic products must not contain except subject to the restrictions laid down. Product types: Hair dye substance in non-oxidative hair dye products Maximum concentration: 0.4%
- EU: allowed_listed — Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products. Conditions of use and warnings: Purity criteria as set out in Commission Directive 95/45/EC (E 129)
- US: commercial use observed — EPA CPDat observed this chemical in 509 composition records across product categories including Laboratory supplies, Personal care, Cleaning products and household care. EPA CPDat classifies this chemical for functional uses including Dye, Fragrance, Flavouring and nutrient.
- US: inactive ingredient database — Route: BUCCAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 48 mg
- US: inactive ingredient database — Route: BUCCAL; Dosage form: TABLET; Potency: 0.01 mg
- US: inactive ingredient database — Route: DENTAL; Dosage form: SOLUTION; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 16 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED, EXTENDED RELEASE; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE PELLETS; Potency: 0.02 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CONCENTRATE; Potency: 0.04 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: DROPS; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: ELIXIR; Potency: 12.5 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SOLUTION; Potency: 0.33 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 38 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Potency: 100 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION/ DROPS; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SYRUP; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 7 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, CHEWABLE; Potency: 40 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Potency: 0.1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Potency: 0.45 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Potency: 2.22 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Potency: 2.5 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SPONGE; Potency: NA
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.
- US: observed in branded food ingredient statements — Observed in 2 USDA branded foods including 1 LITER BOTTLE BLACKCHERRY, 1 LITER BOTTLE DIET BLACK CHERRY.

_Assessed by Greenveil._