Scientific Opinion on the re-evaluation Tartrazine (E 102)

Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Tartrazine (E 102). Tartrazine has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1966 and the EU Scientific Committee for Food (SCF) in 1975 and. Both committees established an Acceptable Daily Intake (ADI) of 0-7.5 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. New studies included a study by Sasaki et al. from 2002 reporting effects on nuclear DNA migration in the mouse in vivo Comet assay, a study by McCann et al. from 2007 that concluded that exposure to a mixture including Tartrazine resulted in increased hyperactivity in 3-year old and 8-to 9-year old children and studies on neurodevelopment by Tanaka. The Panel notes that Tartrazine was negative in long-term carcinogenicity studies and that the effects on nuclear DNA migration observed in the mouse in vivo Comet assay are not expected to result in carcinogenicity. The Panel also concurrs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI, and additionally considered that the Tanaka study can also not be used as a basis for altering the ADI. The Panel concludes that the present database does not give reason to revise the ADI of 7.5 mg/kg bw/day. The Panel also concludes that at the maximum reported levels of use, refined intake estimates are below the ADI. The Panel concludes that Tartrazine appears to be able to elicit intolerance reactions in a small fraction of the exposed population.The Panel also notes that sensitive individuals may react to Tartrazine at dose levels within the ADI. Tartrazine, FD&C Yellow No. 5, E 102, CAS 1934-21-0, 3-carboxy-5-hydroxy-1-(4'-sulphophenyl Tartrazine consists essentially of 3-carboxy-5-hydroxy-1-(4'-sulphophenyl)-4-(4'-sulphophenylazo) pyrazole trisodium salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salts are also permitted (Directive 2008/128/EC). KEY WORDSThe purity is specified as not less than 85 % total colouring matters, calculated as the sodium salt. The remaining 15 % may be accounted for by sodium chloride or sodium sulphate (but this is never mentioned explicitly), water insoluble matter not more than 0.2 %, subsidiary colouring matters not more than 1.0 % and organic compounds other than colouring matters with a total not more than 0.5 % (4-hydrazinobenzene sulphonic acid, 4-aminobenzene-1-sulphonic acid, 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid, 4,4′-diazoaminodi(benzene sulphonic acid), tetrahydroxysuccinic acid).The absorption, distribution, metabolism and excretion of Tar...

Toxicological and safety assessment of tartrazine as a synthetic food additive on health biomarkers: A review

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Protective effect of blackthorn fruits (Prunus spinosa) against tartrazine toxicity development in albino Wistar rats

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