Erythrosine

 

Identifiers

FD&C Red #3
INS No. 127
E127
EINECS No. 240-474-8
CAS No. 16423-68-0
CI Food Red 14
CI No. 45430

Physical Description

Erythrosine is principally the monohydrate of 9 (o-carboxyphenyl)-6-hydroxy2,4,5,7-tetraiodo-3H-xanthen-3-one, disodium salt, with smaller amounts of lower imidinated fluoresceins. Erythrosine is a bluish pink dye that lends a pink shade to applications.

Common Uses

Erythrosine provides a pleasing watermelon-red color when used in foods and pharmaceuticals. Erythrosine is used to color dietary supplements, confections, beverages, cereals, ice cream cones, frozen dairy desserts, popsicles, frostings and icings, baked goods, dried fruit, frozen breakfast foods, and processed foods (fish, meat and egg products).

Specifications

US FDA
JECFA (2018)
EU Commission Regulation (EU) No 231/2012

Codex Provisions

Erythrosine is added to foods 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).

Regulatory Approvals

USA: FD&C Red #3 is a color additive subject to certification and permanently listed for use in food (21 CFR 74.303) and ingested drugs (21 CFR 74.1303) at GMP

JECFA: ADI of 0-0.1 mg/kg body weight (86th meeting, 2018)

EU: ADI of 0-0.1 mg/kg body weight (EFSA, 2011). Erythrosine is exclusively authorized for use in cocktail and candied cherries, and Bigarreaux cherries (94/36/EC).

Safety Assessment

Erythrosine is a xanthene dye permited as a food color in China, the EU, the USA and other regions. Exposure to erythrosine from its use as a food color additive is generally well below the established ADI of 0.1 mg/kg bw per dayThe most conservative estimated intake of 3.2 mg/person per day (0.053 mg/kg bw per day) for the general population is approximately 50% of the established ADI. Therefore, current use patterns do not present safety concern for consumers.

During its recent (2018) evaluation, JECFA indicated that: The evidence newly available at this meeting indicates that there are no concerns with respect to genotoxicity and reproductive and developmental toxicity of erythrosine. The previously established ADI of 0–0.1 mg/kg bw is based on a NOAEL of 60 mg per person per day (equivalent to 1 mg/kg bw per day for a 60 kg person) identified in a human study, with a default uncertainty factor of 10. Effects in experimental animals were observed at doses at least 60-fold higher than the NOAEL in this human study (Gardner et al, 1987); these effects supported the use of the human data as the basis forthe ADI.

Safety Reviews

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the reevaluation of Erythrosine (E 127) as a food additive. EFSA Journal 2011;9(1):1854. [46 pp.]. doi:10.2903/j.efsa.2011.1854.

Joint FAO/WHO Expert Committee on Food Additives (2018).  Evaluation of certain food additives.  WHO Tech. Rept. Ser. No. 1014.