Allura Red AC and other sulphonated mono azo dyesa

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Article
Allura Red AC, Amaranth, Ponceau 4R, Sunset Yellow, Tartrazine, Azorubine/Carmoisine, in vivo genotoxicity
First published in the EFSA Journal
17 June 2013
Adopted
15 May 2013
Type
Statement
Abstract

The ANS Panel has been asked by EFSA to assess the new scientific information that has become available since the adoption of the opinion on the re-evaluation of the food colouring agent Allura Red AC in 2009, in particular the positive findings from an in vivo comet assay in mice. The findings from this study have been interpreted in conjunction with all the available relevant data from genotoxicity testing, metabolism and carcinogenicity, and in consideration of possible species differences between mouse and rat. These new data have been considered in the context of the overall relevant data available not only for Allura Red AC but also for a number of other structurally related sulphonated mono azo dyes authorised as food additives, namely: Amaranth, Ponceau 4R, Sunset Yellow FCF, Tartrazine and Azorubine/Carmoisine. The Panel concluded that the new data by themselves were insufficient at this time to change the conclusions of the 2009 opinion on the safety of Allura Red AC and that there is currently no reason to revise the ADI. The read-across exercise has highlighted a shared pattern of effects for this class of substances that would warrant further investigation The Panel therefore recommended a repetition of the in vivo comet assay in mice, to be performed in compliance with the most recent and internationally validated experimental protocol, using whole cells and examining a wide range of tissues. These recommendations apply to all the sulphonated mono azo dyes included in this review.

Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen and Matthew Wright
Panel on Food Additives and Nutrient Sources Added to Food
Contact
ans [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3234
EFSA Journal 2013;11(6):3234 [25 pp.].
Question Number
On request from
EFSA
Print on demand
Number of Pages
25