Brilliant Blue FCF

 

IACM Statements

Safety

Identifiers

FD&C Blue #1
INS No. 133
E133
EINECS No. 223-339-8
CAS N0. 3844-45-9
CI Food Blue 2
CI No. 42090
Food Blue No. 1

Physical Description

Brilliant Blue is a greenish blue dye that adds a blue shade in applications. The colorant is principally the disodium salt of ethyl [4-p- [ethyl (m-sulfobenzyl) amino] -α−(o-sulfophenyl) benzylidene] -2,5-cyclohexadien-1-ylidene] (m-sulfobenzyl)ammonium hydroxide inner salt with smaller amounts of isomeric disodium salts of ethyl [4-p- [ethyl (p-sulfobenzyl) amino] -α – (o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-sulfobenzyl)ammonium hydroxide inner salt and ethyl [ 4-p-[ethyl (o-sulfobenzyl) amino] α-(o-sulfophenyl) benzylidene] -2,5-cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt. Brilliant Blue FCF is soluble in water and slightly soluble in ethanol.

Common Uses

Brilliant Blue FCF adds a distinctive, bright blue hue to confections, beverages, cereals, frozen dairy desserts, popsicles, cakes and cupcakes, chewing gum, frostings and icings.

Specifications

US FDA
JECFA (2017)
Commission Regulation (EU) No 231/2012

Codex Provisions

Brilliant Blue is added to foods and beverages at concentrations up to a maximum permitted level (MPL) as established by the Codex Alimentarius Commission. There are  more than 50 food categories for which Brilliant Blue is approved, which are published in the General Standard of Food Additives (GSFA).

Regulatory Approvals

USA: FD&C Blue #1 is a color additive subject to certification and permanently listed for use in food (21 CFR 74.101), drugs (21 CFR 74.1101) and cosmetics (21 CFR 74.2101), including drugs and cosmetics for eye area, at GMP

EU: ADI of 0-6 mg/kg body weight (EFSA, 2010); EFSA has also established MPLs for use of Brilliant Blue in foods and beverages in Europe

JECFA: ADI of 0-6 mg/kg body weight (84th Report; 2017)

Safety Assessment

Brilliant Blue FCF is a dye with a triphenylmethane base structure permitted in the EU, Japan, USA and other regions. JECFA re-evaluated Brilliant Blue FCF in 2017 and concluded that the available data support the revision of the ADI for Brilliant Blue FCF and that the study on long-term toxicity in
rats should be considered as the pivotal study (IRDC, 1981b; Borzelleca, Depukat & Hallagan, 1990). In this study, a NOAEL of 631 mg/kg bw per day was identified, and the Committee established an ADI of 0–6 mg/kg bw based on this NOAEL by applying an uncertainty factor of 100 for interspecies and intraspecies differences. The Committee noted that the conservative dietary exposure estimate of 5 mg/kg bw per day (95th percentile for children) is less than the upper limit of the ADI of 0–6 mg/kg bw established for Brilliant Blue FCF and concluded that dietary exposure to Brilliant Blue FCF for children
and all other age groups does not present a health concern.

Safety Reviews

U.S. Food and Drug Administration. Final Rule: Permanent listing of FD&C Blue No. 1. 47 Fed. Reg. 42563 (28 September 1982).

Evaluation of certain food additives: eighty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives (WHO technical report series; no. 1007) 2017. Available online

EFSA ANS Panel (2010) Scientific Opinion on the re-evaluation of Brilliant Blue (E 133) as a food additive. EFSA Journal, 8(11), 1853 [36 pp]. Available online