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FD&C red no. 40

CAS 64553-31-7 · 70/100 · High conf.

Also registered as 3 other CAS numbers

66813-73-8 · 84069-24-9 · 25956-17-6

Concern score

70/100High concern based on regulatory listings.
High confidence

FD&C red no. 40 in plain language

What it is

On cosmetic ingredient lists it appears as “CI 16035”.

Also known as CI 16035 · Curry red · Allura red ac · Allura red ac dye · Allura red · D&C red no. 40

Show all 26 names

F d & c red #40 lake · F d & c red #40 · Allura Red C.I.16035 · CI food red 17 · Red 40 · Ci-food red 17 · E129 · F d & c red no. 40 · Fancy red · FD&C red 40 · Fdc red 40 dye · Fdc red no. 40 · Japan food red no. 40 · Japan red 40 · C.I. Food Red 17 · C.I. Red 40 · CI-(1975)NO.16035 · E-129 · Ins NO.129 · INS-129

What it does

Used in cosmetics as a colourant and a hair dye. CI 16035 is classed chemically as a monoazo colour.

  • Colorant
  • Hair dyeing
  • Colour
  • Colourant
  • Fragrance
  • Flavouring
Is it a concern?
High concern: no hazard classifications on record. It is restricted in EU cosmetics.

Why it's flagged

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.

RestrictedEU EC — restricted

The score describes this ingredient's chemical identity — its hazard profile from published classifications and regulatory status — not the safety of any product it appears in.

Regulation

Restrictions first, then routine listings from published regulatory sources.

  • EU Annex III — restricted
  • EU Annex IV — permitted colorant
  • EU permitted colorant
  • EU restricted in cosmetics
  • Inactive ingredient in US drugs

Recorded in these product areas

  • Found in consumer products
  • Beauty
  • Cleaning
  • Pharma
  • Food
  • Industrial

  • EUEC

    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%

    restricted
    View source →
  • USFDAinactive ingredient database29 entries — 5 administration routes
    • Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 2 mgSource →
    • Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE PELLETS; Potency: 0.02 mgSource →
    • Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 1 mgSource →
    • Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 1 mgSource →
    • Route: ORAL; Dosage form: CONCENTRATE; Potency: 0.04 mg/1mlSource →
    • Route: ORAL; Dosage form: DROPS; Potency: NASource →
    • Route: ORAL; Dosage form: ELIXIR; Potency: 12.5 mg/5mlSource →
    • Route: ORAL; Dosage form: POWDER, FOR SOLUTION; Potency: 0.33 mg/5mlSource →
    • Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 3 mgSource →
    • Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 38 mgSource →
    • Route: ORAL; Dosage form: SUSPENSION; Potency: 100 mg/5mlSource →
    • Route: ORAL; Dosage form: SUSPENSION/ DROPS; Maximum daily exposure: 1 mgSource →
    • Route: ORAL; Dosage form: SYRUP; Maximum daily exposure: 3 mgSource →
    • Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 7 mgSource →
    • Route: ORAL; Dosage form: TABLET, CHEWABLE; Potency: 40 mgSource →
    • Route: ORAL; Dosage form: TABLET, COATED; Potency: 0.1 mgSource →
    • Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Potency: 0.45 mgSource →
    • Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Potency: 2.22 mgSource →
    • Route: ORAL; Dosage form: TABLET, FILM COATED; Potency: 2.5 mgSource →
    • Route: SUBLINGUAL; Dosage form: TABLET; Potency: NASource →
    • Route: TOPICAL; Dosage form: SHAMPOO; Maximum daily exposure: 2 mgSource →
    • Route: TOPICAL; Dosage form: SPONGE; Potency: NASource →
    • Route: ORAL; Dosage form: CAPSULE, COATED; Potency: NASource →
    • Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 16 mgSource →
    • Route: DENTAL; Dosage form: SOLUTION; Potency: NASource →
    • Route: BUCCAL; Dosage form: TABLET; Potency: 0.01 mgSource →
    • Route: BUCCAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 48 mgSource →
    • Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: NASource →
    • Route: ORAL; Dosage form: CAPSULE, COATED, EXTENDED RELEASE; Potency: NASource →
  • EUEFSAEFSA opinion5 entries
    • Safety of Allura Red AC in feed for cats and dogs (EFSA FEEDAP)Source →
    • Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive (EFSA ANS)Source →
    • Scientific Opinion on the safety and efficacy of Allura Red AC (E 129) in feed for cats and dogs (EFSA FEEDAP)Source →
    • Statement on Allura Red AC and other sulphonated mono azo dyes authorised as food and feed additives (EFSA ANS)Source →
    • Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga) (EFSA FEEDAP)Source →
  • EUCosIngActive4 entries
    • CI 16035 is classed chemically as a monoazo colour. It conforms to the formula: Restriction: IV/32 (CI 16035) III/191 (Curry Red)Source →
    • Curry Red is classed chemically as a monoazo colour. It conforms to the formula: Restriction: III/191 (Curry Red) IV/32 (CI 16035)Source →
    • Cosmetics Regulation annex IV / ref 32.Source →
    • Cosmetics Regulation annex III / ref 191.Source →
  • EUECallowed_listedAnnex 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)
    • 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)Source →
  • GLOBALJECFAEvaluatedJECFA evaluation record.
  • GLOBALJECFA0-7 mg/kg bwJECFA evaluation lists ADI 0-7 mg/kg bw. Functional class: colour.
    • JECFA evaluation lists ADI 0-7 mg/kg bw. Functional class: colour.Source →
  • USEPAcommercial use observedEPA 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.
    • 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.Source →
  • USFDAlisted in openFDA substanceopenFDA substance registry classifies this ingredient as chemical.
    • openFDA substance registry classifies this ingredient as chemical.Source →
  • USUSDA FoodData Centralobserved in branded food ingredient statementsObserved in 2 USDA branded foods including 1 LITER BOTTLE BLACKCHERRY, 1 LITER BOTTLE DIET BLACK CHERRY.
    • Observed in 2 USDA branded foods including 1 LITER BOTTLE BLACKCHERRY, 1 LITER BOTTLE DIET BLACK CHERRY.Source →

Expert safety opinions

Independent scientific assessments cited by the records we hold, with the year and link where the record gives one.

  • SCCS

    EU Scientific Committee on Consumer Safety

    No SCCS opinion on file.

  • CIR

    Cosmetic Ingredient Review (US expert panel)

    No CIR safety assessment on file.

  • EFSA

    European Food Safety Authority

    • Safety of Allura Red AC in feed for cats and dogs (EFSA FEEDAP)

      2015 · EU EFSA listing · Read the source →

    • Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive (EFSA ANS)

      2009 · EU EFSA listing · Read the source →

    • Scientific Opinion on the safety and efficacy of Allura Red AC (E 129) in feed for cats and dogs (EFSA FEEDAP)

      2012 · EU EFSA listing · Read the source →

    • Statement on Allura Red AC and other sulphonated mono azo dyes authorised as food and feed additives (EFSA ANS)

      2013 · EU EFSA listing · Read the source →

    • Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga) (EFSA FEEDAP)

      2021 · EU EFSA listing · Read the source →

  • JECFA

    Joint FAO/WHO Expert Committee on Food Additives

    • JECFA evaluation record.

      Year not recorded · GLOBAL JECFA listing · Read the source →

    • JECFA evaluation lists ADI 0-7 mg/kg bw. Functional class: colour.

      Year not recorded · GLOBAL JECFA listing · Read the source →

Evidence & sources

No graded research studies for FD&C red no. 40 yet. This record is compiled from the published data sources below — registries and regulatory listings, not study findings.

10 data sources

Where this comes from

  • CosIng

    regulatory · updated 2026-09-23

    Open →

  • EU CosIng Cosmetics Regulation Annexes

    regulatory · updated 2020-08-14

    Open →

  • EFSA OpenFoodTox

    regulatory · updated 2026-10-04

    Open →

  • EPA Chemical and Products Database

    exposure · updated september 11, 2014

    Open →

  • EPA DSSTox Identifiers

    chemistry · updated 2025-12-29

    Open →

  • FDA Inactive Ingredient Database

    regulatory · updated 2026-01-09

    Open →

  • FDA GSRS UNII

    registry · updated 2026-02-26

    Open →

  • WHO JECFA Database

    regulatory · updated 2026-10-04

    Open →

  • openFDA Substance

    registry · updated 2026-05-24

    Open →

  • USDA Branded Foods

    product_occurrence · updated 2026-02-19

    Open →
Reference links (1)
Openfda substance

codexalimentarius.net

Read →

Suitability

Context-specific fit derived from published classifications and the current ingredient evidence profile.

Food use

Food-use source coverage is present in the current record.

Good fit

The ingredient appears in food-oriented source coverage or allowed-use references, which makes food use easier to support than a context with no domain signal at all.

Fragrance avoidance

Not a strong fit for fragrance avoidance because it carries Fragrance.

Avoid

The ingredient itself is a fragrance-linked signal, so it is better treated as an avoid case when fragrance exposure is the main concern.

Where it has been recorded

How often EPA CPDat has listed FD&C red no. 40 in a product composition. These are source records, not Greenveil catalog products.

Source records

509

Named organisations

6

Laboratory suppliesPersonal careCleaning products and household careFood and drugCleaning and safetyPesticides

Typical roles

ColorantHair dyeingColourColourantFragranceFlavouring
See products using FD&C red no. 40 →

Catalog

Found in these products

Their ingredient lists include FD&C red no. 40; each product's own rating depends on its whole formula, so it is shown on the product page, not here.

See all 302 →Find products without it →

Co-occurrence

Often appears with

Ingredients that frequently appear alongside FD&C red no. 40 in the catalog.