Quinoline Yellow

 

Identifiers

INS No. 104
E 104
D&C Yellow #10
EINECS No. 305-897-5
CAS No. 80583-08-0
CI Food Yellow 13
CI No. 47005
C.I. Acid Yellow 3

Physical Description

Quinoline Yellow is a bright greenish-yellow, water soluble dye.  Quinoline Yellow is a mixture of the sodium salts of the mono- and disulfonic acids of 2-[2-quinolinyl]-1H-indene-1,3 [2H]-dione consisting principally of the sodium salt hydro-1,3-dioxo-1H-indene-2-yl]-6-quinolinesulfonic acid and 2-[2,3-dihydro-1,3-dioxo-1H-indene-2yl]-8-quinolinesulfonic acid with lesser amounts of the disodium salts of the disulfonic acids of  2-[2-quinolinyl]-1H-indene-1,3[2H]-dione.

Common Uses

Typical applications for quinoline yellow include beverages, confectionery, meat, bakery, dairy fats and oil, seafood, snacks, dry mixes and seasonings, fruit preparation, convenient food, flavors, cosmetics and pharmaceuticals.

Specifications for Food Use

JECFA (2016)
EU Commission Regulation (EU) No 231/2012

Codex Provisions

The Codex Alimentarius Commission has finalized authorization of Quinoline Yellow use in soups and broths (food category number 12.5) with a maximum permitted level (MPL) of 50 mg/kg and in flavored fluid milk drinks (food category 1.1.4) with a MPL of 10 mg/kg, as noted in the General Standard of Food Additives (GSFA). A large number of other applications of Quinoline Yellow as a color additive in foods and beverages have been proposed and are pending authorization, following completion of the review and comments process. All applications are pending approval at Step 7 of the Step Process. The MPL for these applications range from 50-500 ppm.

Regulatory Approvals

JECFA: ADI of 0-3 mg/kg body weight (73rd Report, 2016)

USA: D&C Yellow #10 is a color additive subject to certification and permanently listed for use in drugs generally (21 CFR 74.1710) and cosmetics (21 CFR 74.2710) at GMP.

EU: ADI of 0.5 mg/kg body weight (EFSA, 2009); EFSA has also established MPLs for use of Quinoline Yellow in foods and beverages in Europe

Safety Assessment

Quinoline Yellow is a synthetic color used in food, beverages, drugs, and cosmetics. While not approved for food use in the US, it is permitted in other countries for use in food, including the EU, Australia and New Zealand. JECFA re-evaluted Quinoline Yellow and D&C Yellow 10 in 2017, concluding that the existing data on Quinoline Yellow and D&C Yellow No. 10 provide a sufficient basis on which to establish an ADI for Quinoline Yellow. The two related long-term studies on D&C Yellow No. 10 in the rat gave the lowest NOAEL of 0.5% in the diet (equivalent to 250 mg/kg bw per day), based on effects on body weight and organ weights at higher dose levels. Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0–3 mg/kg bw (rounded value) for Quinoline Yellow. The Committee noted that the range of estimated dietary exposures to Quinoline Yellow for children based on analytical, reported and/or industry use data, including the conservative estimate by EFSA, was below the upper bound of the ADI (0.3–10%). The Committee concluded that dietary exposure to Quinoline Yellow for children and all other age groups does not present a health concern.

Safety Reviews

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Food Additives and Nutrient Sources added to food; Scientific Opinion on the re-evaluation of Quinoline Yellow. EFSA Journal 2009; 7(11):1329. [40 pp.]. Available online

Safety evaluation of certain food additives: prepared by the Eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Geneva: World Health Organization; 2017 (WHO Food Additives Series, No. 73) Available online