Sunset Yellow FCF

Identifiers

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

Physical Description

Sunset yellow occurs as a brown-orange powder or granules. It is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2- naphthalenesulfonic acid and subsidiary coloring matters together with sodium chloride and/or sodium sulfate as the principal uncolored components and may be converted to the corresponding aluminum lake.

Common Uses

Sunset yellow can be used to provide an orange color to foods, drugs and cosmetics, including dietary supplements,  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
US FDA
Commission Regulation (EU) No 231/2012

Codex GSFA Provisions

Sunset yellow FCF (INS No. 110) is added to foods and beverages at concentrations up to a maximum permitted level (MPL) as adopted by the Codex Alimentarius Commission. There are more than 60 food categories for which MPLs for sunset yellow have been adopted in the General Standard of Food Additives.

Regulatory Approvals

JECFA: ADI of 0-4 mg/kg bw (74th meeting, 2011)

USA: FD&C Yellow No. 6, along with its aluminum lake (21 CFR 82.706), are subject to certification and may be safely used for coloring foods (including dietary supplements) generally (21 CFR 74.706), drugs generally (21 CFR 74.1706), and cosmetics generally (21 CFR 74.2706) in amounts consistent with GMP.

EU: ADI of 0-4 mg/kg body weight (EFSA, 2014); EFSA has also established MPLs for use of Sunset Yellow in specific foods and beverages in Europe, located in Annex II of Regulation (EC) No 1333/2008

Safety Reviews

Evaluation of Certain Food Additives and Contaminants (Seventy-forth report of the Joint FAO/WHO Expert Committee on food Additives)WHO technical report series No. 966, 2011. Available online

Safety Evaluation of certain food additives and contaminants. (Seventy-fourth meeting of the JECFA) WHO food additives series No. 65, 2012. 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]. Available online

Assessment of FD&C Yellow No. 6 (Sunset Yellow FCF) effects on sperm count, motility and viability in the rat in a 28-day study (Regulatory Toxicology & Pharmacology, 2019). Available online