Ponceau 4R

 

Identifiers

Cochineal Red A
New Coccine
INS No. 124
E 124
EINECS No. 220-036-2
CAS No. 2611-82-7
CI Food Red 7
CI No. 16255

Physical Description

Ponceau 4R is a red dye that provides a dark red shade in applications. The color consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1- naphthylazo)-6,8-naphthalenedisulfonate, and subsidiary coloring matters together with sodium chloride and/or sodium sulfate as the principal uncolored components.  Ponceau 4R is soluble in water and sparingly soluble in ethanol.

Common Uses

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

Specifications

EU Commission Regulation (EU) No 231/2012

JECFA

Codex Provisions

Ponceau 4R is 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). For GSFA MPLs of Ponceau 4R (INS 124), click here.

Regulatory Approvals

JECFA: ADI of 0-4 mg/kg body weight (2011)

EU: ADI of 0.7 mg/kg bw/day (EFSA, 2009). Permitted use levels have been defined in the EU legislation (Directive 94/36/EC).

Safety Assessment

At the twenty-seventh JECFA meeting, the Committee reviewed new data on metabolism, a long-term study in rats that had been exposed in utero and through lactation, a multigeneration feeding study and a teratogenicity study. The Committee noted that the long-term study in rats showed no adverse effects in the kidneys and had a NOEL of 500 mg/kg bw per day based on reduced body weight gain at higher doses. The results of this study in rats and a reconsideration of the severity of the renal effects observed in the long-term study in mice led the Committee to establish an ADI of 0–4 mg/kg bw. The ADI was derived by applying a 100-fold safety factor to the higher NOEL from the mouse dietary study, which was equivalent to 375 mg/kg bw per day. In 2012, the Committee reviewed new data that had become available since its previous review and found no reason to revise the previously established ADI.

Safety Reviews

EFSA Panel on Food Additives and Nutrient Sources added to Food; Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive on request from the European Commission. EFSA Journal 2009; 7(11):1328. [39 pp.]. Available online

JECFA, 2011. 74th Report, Joint FAO/WHO Expert Committee on Food Additives. Evaluation of certain food additives and contaminants. WHO Technical Report Series, No. 966. Available online