Allura Red AC - International Association of Color Manufacturers

Identifiers

Allura Red
FD&C Red No. 40
INS No. 129
E129
EINECS No. 247-368-0
CAS No. 25956-17-6
CI Food Red 17
CI No. 16035
Food Red No. 40

Physical Description

Allura red is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid. Allura red is an orange red dye that has a red to brownish shade in applications.

Common Uses

Allura red is used in cereal, beverages, gelatins, puddings, dairy products, frozen treats, powder mixes, icings, jellies, spices, dressings, sauces, baked goods and confections. FD&C Red No. 40 is also used in pharmaceuticals and cosmetics.

Specifications

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

Codex GSFA Provisions

Allura red is added to foods and beverages at concentrations up to a maximum permitted level (MPL) in more than 50 food categories as established by the Codex Alimentarius Commission and published in the General Standard of Food Additives (GSFA).

Regulatory Approvals

USA: FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake are subject to certification and may be safely used for coloring foods (including dietary supplements) (21 CFR 74.340), drugs (21 CFR 74.1340) and cosmetics (21 CFR 74.2340), in amounts consistent with GMP.

EU: ADI of 0-7 mg/kg body weight (EFSA, 2009); EFSA has also established MPLs for use of Allura red AC in specific foods and beverages in Europe.

JECFA: ADI of 0-7 mg/kg body weight (82nd Report, 2016)

Safety Assessment

Allura red is a monoazo dye that is widely used as a synthetic food color in many countries around the world. It was evaluated by the Joint FAO/WHO Expert Committee on Food Additives in 1981 and re-evaluated in 2016. It has also been evaluated by the EU Scientific Committee for Food (SCF) in 1984 and 1989 and by the European Food Safety Authority (EFSA) in 2009, 2012, and 2013. An Acceptable Daily Intake (ADI) of 0-7 mg/kg body weight (bw)/day was established by JECFA in 1981, and during its re-evaluation of the color in 2016, JECFA concluded that new data that became available since its last evaluation do not give reason to revise the ADI and confirmed the ADI of 0–7 mg/kg bw. This ADI has also been maintained by the European review committees.

Safety Reviews

Joint FAO/WHO Expert Committee on Food Additives (JECFA) (2016) JECFA 82nd Report. Evaluation of certain food additives. WHO Technical Report Series, No. 1000. Available online

EFSA ANS Panel (2009) Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal, 7(11), 1327-66. Available online