Sunset Yellow FCF

IACM Statements

Safety

Identifiers

FD&C Yellow #6
INS No. 110
E 110
EINECS No. 220-491-7
CAS No. 2783-94-0
CI Food Yellow 3
CI No. 15985
Orange Yellow S

Physical Description

Sunset Yellow FCF is a synthetic yellow dye that provides a reddish-orange shade in applications. Sunset Yellow is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2- naphthalenesulfonic acid. The trisodium salt of 3-hydroxy-4[(4-sulfophenyl)azo]-2,7- naphthalenesulfonic acid may be added in smaller amounts.

Common Uses

Sunset Yellow provides a pleasing orange color when used in foods, drugs and cosmetics. Sunset Yellow is used to color many different types of foods including cereals, snack foods, baked goods, gelatins, beverages, dessert powders, crackers, and sauces.

Specifications

JECFA (2011)
US FDA
Commission Regulation (EU) No 231/2012

Codex Provisions

Sunset Yellow FCF is added to foods and beverages at concentrations up to a maximum permitted level (MPL) as established by the Codex Alimentarius Commission and published in the General Standard of Food Additives (GSFA). For GSFA MPLs of Sunset Yellow (110), click here.

Regulatory Approvals

USA: FD&C Yellow #6 is a color additive subject to certification and permanently listed for use in food (21 CFR 74.706), drugs (21 CFR 74.1706), and cosmetics (21 CFR 74.2706) at GMP.

EU: ADI of 0-4 mg/kg body weight; EFSA has also established MPLs for use of Sunset Yellow in foods and beverages in Europe, located in Annex II of Regulation (EC) No 1333/2008

JECFA: ADI of 0-4 mg/kg body weight (74th Report, 2011)

Safety Assessment

JECFA most recently evaluated Sunset Yellow FCF in 2012, noting at that time that there were five additional long-term repeateddose feeding studies that tested Sunset Yellow FCF at dietary concentrations equivalent to doses of 7500 mg/kg bw per day in mice and up to 2500 mg/kg bw
per day in rats. One of these long-term studies in rats, which included in utero exposure, had a NOAEL of 375 mg/kg bw per day for reduced body weight among pups. On the basis of this NOAEL and the usual 100-fold uncertainty factor, the Committee established an ADI of 0–4 mg/kg bw (with rounding). The previous ADI of 0–2.5 mg/kg bw was withdrawn. The Committee noted that EFSA’s conservative 97.5th percentile dietary exposure for children was above the ADI, whereas the 90th percentile dietary exposure for children, estimated by the more realistic FSANZ
approach, was 3% of the upper limit of the ADI. In consequence, the Committee concluded that the dietary exposure of children to Sunset Yellow FCF does not present a health concern.

Safety Reviews

U.S. Food and Drug Administration. Final Rule: Permanent listing of FD&C Yellow No. 6. 51 Fed. Reg. 41765 (19 November 1986).

JECFA (Joint FAO/WHO Expert Committee on Food Additives), 2011. Seventy-forth report of the Joint FAO/WHO Expert Committee on food Additives. Toxicological evaluation of certain food additives. WHO technical report series; no. 966. Available online

EFSA ANS Panel (2014) Reconsideration of the Temporary ADI and Refined Exposure Assessment for Sunset Yellow FCF (E 110). EFSA Journal, 12(7), 3765 [39 pp].