Carmines

carmine safetyIACM Statements
Safety

Synomyns/Identifiers
INS No. 120
Cochineal extract
Carmine
Cochineal
Carminic acid
E 120
CI Natural Red 4
CI No. 75470
Cochineal carmine

EINECS Nos.

  • 215-680-6 (Cochineal)
  • 215-023-3 (Carminic acid)
  • 215-724-4 (Carmines)

CAS Nos.

  • 1343-78-8 (Cochineal)
  • 1260-17-9 (Carminic acid)
  • 1390-65-4 (Carmines)

Physical Description
Cochineal is obtained from the dried bodies of the gravid female insect Coccus cacti; it has been used as a food and textile dye since ancient times. Carmine is a dark red color additive obtained via aqueous extraction of cochineal. Carmine consists of an aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of carminic acid, the coloring principle of cochineal. Cochineal and Carmine both contain the red pigment, Carminic Acid that presents excellent stability against heat and light. Carminic acid is a hydroxyanthraquinone linked to a glucose unit and it comprises approximately 10% of cochineal and 2-4% of its extract. Commercial preparations of carmine contain 20-50% carminic acid. Cochineal is an aqueous extract providing color shades from orange to red and is generally used in low pH applications. It is insoluble in water, glycerine, and propylene glycol. It is stable in light and to oxidation but not at varying pH or microbiological attack. Carminic acid is susceptible to oxidation. Carminic acid is a stable pigment that is soluble in water. Cochineal is soluble in alcohol. Carmine is a water-dispersible powder which is insoluble in alcohol and oil. It is readily attached to proteins thus it has been successfully used to color milk-based products.

Common Uses
Carmine and cochineal can be used for coloring meat products, seafood, confectionery, alcoholic beverages and soft drinks, cider, vinegar, yogurt, baked goods, jams, jellies, dairy products, snack food, convenient food, fruit preparation, seasonings, pharmaceuticals, and cosmetics.

Specifications
US FDA
JECFA

EU Commission Regulation (EU) No 231/2012

Codex Provisions
Carmines are 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) (CODEX STAN 192-1995, 2015).

Regulatory Approvals/Consumption Limits
USA: GMP (21 CFR 73.100)

EU: 0-5 mg/kg (EFSA, 2015)

JECFA: Group ADI of 0-5 mg/kg bw for carmines, as ammonium carmine or the equivalent of Ca, K and Na; no ADI allocated for cochineal extract (55th report, 2000). No ADI allocated for Cochineal Extract (21st report, 1977). The Committee concluded that cochineal extract, carmines, and possibly carminic acid in foods and beverages may provoke allergic reactions in some individuals.

Safety Assessment
A weight of evidence analysis indicates that carminic acid/cochineal extract is not genotoxic. With regard to cochineal, both negative and positive results were reported. In studies where cochineal was said to be mutagenic, few details were available. Cochineal did not cause chromosomal damage in human cells. 13-week studies on rats given oral doses of carmine at levels up to 10 g/kg/day revealed no toxic effects, except widespread staining of tissues in animals treated with the highest concentration. A long-term toxicity study revealed that carmine orally administered at doses of 50, 150, and 500 mg/kg/day for up to 109 weeks produced no adverse effects in rats or their offspring. No adverse effects occurred when rats were fed carmine for three generations at doses of 500 mg/kg/day. Carminic acid/cochineal extract was not carcinogenic when fed to mice over a 2-year period at doses up to 6% of the diet. Carmine was not embryotoxic/teratogenic to the offspring of fertile rats continuously exposed to oral doses of up to 500 mg/kg/day throughout all phases of mating, gestation, lactation, weaning and adult life over three successive generations. Oral doses up to 1000 mg/kg/day throughout pregnancy produced no adverse effects on the embryonic development of rats.

Safety Reviews
JECFA (2001). 55th Report of the JECFA. Evaluation of Certain Food Additives and Contaminants. WHO Tech. Report. Series. No. 901, p. 10. Available online.

U.S. Food and Drug Administration. Carmine; Listing for Food and Drug Use; Exemption from Certification. 32 Fed. Reg. 6131 (19 April 1967).

EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2015. Scientific Opinion on the re-evaluation of cochineal, carminic acid, carmines (E 120) as a food additive. EFSA Journal 2015;13(11):4288, 66 pp. doi:10.2903/j.efsa.2015.4288. Available online.

Full safety monograph, including references, available to IACM members or upon request.