# FD&C BLUE NO. 1

URL: https://app.greenveil.ai/ingredients/ingredient_inci_acid_blue_9
Categories: beauty, cleaning, food, industrial, pharma
Functions: colorant, Dye, Flavouring and nutrient, Fragrance
Identifier: 2650-18-2

> FD&C BLUE NO. 1 is used as colorant / dye. Greenveil chemical-concern score: 70/100 — High concern based on regulatory listings.. Assessed from 45 sources.

## Safety assessment

- Chemical concern score: 70/100 — High concern based on regulatory listings.
- Confidence: 4
- Rationale: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salts, disodium salt and its ammonium and aluminium salts (15); Acid Blue Acid Blue 9 Ammonium salt; CI 42090. (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: 0.5%
- 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 sset out in Commission Directive 95/45/EC (E 133)
- US: commercial use observed — EPA CPDat observed this chemical in 1968 composition records across product categories including Laboratory supplies, Arts and crafts/office supplies, Personal care. EPA CPDat classifies this chemical for functional uses including Dye, Fragrance, Flavouring and nutrient.
- US: inactive ingredient database — Route: BUCCAL; Dosage form: CONCENTRATE; Potency: NA
- US: inactive ingredient database — Route: BUCCAL; Dosage form: MOUTHWASH; Potency: NA
- US: inactive ingredient database — Route: DENTAL; Dosage form: PASTE; Potency: NA
- US: inactive ingredient database — Route: DENTAL; Dosage form: PASTE, DENTIFRICE; Potency: NA
- US: inactive ingredient database — Route: DENTAL; Dosage form: SOLUTION; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Potency: 26.3 mg
- 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: 0.01 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; Potency: 0.08 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CONCENTRATE; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: ELIXIR; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: FILM, SOLUBLE; Potency: 0.04 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: LIQUID; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SOLUTION; Potency: 0.04 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Potency: 1 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Potency: 1.13 mg/15ml
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SYRUP; Potency: 0.05 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Potency: 27.53 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Potency: 0.52 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Potency: 0.01 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Potency: 0.16 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, SUGAR COATED; Potency: NA
- US: inactive ingredient database — Route: RECTAL; Dosage form: SOLUTION; Potency: 0.01 %w/v
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: FILM; Potency: 0.07 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Potency: 0.03 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Potency: 0.01 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LIQUID; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO; Potency: 0.75 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOAP; Potency: 0.01 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOLUTION; Potency: 0.01 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: DOUCHE; Potency: NA
- US: marketed drug occurrence — FDA NDC lists this ingredient in 3 drug products and 3 package presentations.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as mixture.
- US: observed in branded food ingredient statements — Observed in 1 USDA branded foods including 1 LITER BOTTLE BLACKCHERRY.

_Assessed by Greenveil._