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Statement on Allura Red AC and other sulphonated mono azo dyes authorised as food and feed additives


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


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.