Tartrazine

IACM Statements

Safety

Identifiers

FD&C Yellow #5
INS No. 102
E 102
EINECS No. 217-699-5
CAS No. 1934-21-0
CI Food Yellow 4
CI No. 19140

Physical Description

Tartrazine is a lemon-yellow dye that provides a yellow to orange shade in applications. Tartrazine is principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4-sulfophenyl) 4- [4-sulfophenyl-azo] -1H-pyrazole -3-carboxylic acid. It is soluble in water and sparingly soluble in ethanol. The chemical name is 5-oxo-1-(p-sulfophenyl)-4- [(p-sulfophenyl)azo]-2-pyrazoline-3- carboxylic acid, trisodium salt.

Common Uses

Tartrazine provides a pleasing lemon-yellow color when used in foods, drugs, and cosmetics. For food, it is used to color confections, cereals, snack foods, beverages, condiments, baked goods, powdered mixes, gelatine products, icings, jellies, spices, dressings, sauces, and yogurt.

Specifications for Food Use

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

Codex Provisions

The Codex Alimentarius Commission has finalized authorization of Tartrazine in four food categories, as noted in the General Standard for Food Additives. Approximately 70 other applications of Tartrazine as a color additive in foods and beverages have been proposed and are pending authorization, following completion of the review and comments process. Most applications are at Step 7 of the Step Process with few at Step 4 of the Process. The MPL for most of these applications range from 200-500 ppm, with few exceptions of lower limits in selected types of foods.

Regulatory Approvals

USA: FD&C Yellow #5 is a color additive subject to certification and permanently listed for use in food (21 CFR 74.705), drugs (21 CFR 74.1705), and cosmetics (21 CFR 74.2705), including drugs and cosmetics for eye area at GMP, and its aluminum lake (21 CFR 82.705)

EU: ADI of 0-7.5 mg/kg body weight; EFSA has also established MPLs for use of Tartrazine in foods and beverages in Europe

JECFA: ADI of 0-10 mg/kg body weight (82nd meeting, 2016)

Safety Assessment

Tartrazine is an azo dye used as a synthetic color in the USA, EU, Japan, Canada, India, and other regions. JECFA re-evaluated the safety of tartrazine in 2017 and established an ADI of 0–10 mg/kg bw, on the basis of a NOAEL of 984 mg/kg bw per day in a long-term rat study based on reductions
in body weight at the higher dose level (Borzelleca & Hallagan, 1988b), with application of a 100-fold uncertainty factor. The Committee withdrew the previous ADI of 0–7.5 mg/kg bw per day. The Committee noted that the dietary exposure estimate for European children aged 1–10 years was below the upper bound of the ADI (4–73%) and concluded that dietary exposure to tartrazine for the general population, including children, does not present a health concern.

Safety Reviews

U.S. Food and Drug Administration. Final Rule: Permanent listing of FD&C Yellow No. 5. 50 Fed. Reg. 35774 (4 September 1985).

JECFA (Joint FAO/WHO Expert Committee on Food Additives) (2016) Evaluation of certain food additives (eighty-second report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report series, 100.

EFSA (2009) Scientific Opinion on the re-evaluation of Tartrazine (E 102) on request from the European Commission. EFSA Journal, 7(11), 1331, 52 pp.