Scientific experts at EFSA have concluded following a review of new data that there is currently no reason to revise the Acceptable Daily Intake (ADI) for the food colour Allura Red AC. However, EFSA recommends that new tests be carried out to address uncertainties related to the possible genotoxicity (that is, the ability of a substance to damage DNA, the genetic materials of cells) of Allura Red AC. This recommendation applies to the so-called ‘sulphonated mono azo dyes’, a group of six chemically-related food colours including Allura Red AC. Based on the results, EFSA’s experts will, if necessary, reconsider existing ADIs for these substances.
Dr Alicja Mortensen, Chair of EFSA’s Panel on Additives and Nutrient Sources Added to Food (ANS Panel), stated: “In the light of all the data evaluated in this review, the Panel considers that these structurally related dyes could share a pattern of effects that deserve further investigation. However, currently the overall weight of evidence does not warrant a revision of the existing ADIs for these substances. These substances, as all other food additives will be kept under continuous observation and will be re-evaluated in the light of new scientific information arising from the additional testing requested.”
The six colours included in a review performed by ANS Panel are: Allura Red AC (E 129), Amaranth (E 123), Ponceau 4R (E 124), Sunset Yellow FCF (E 110), Tartrazine (E 102) and Azorubine/Carmoisine (E 122). These substances have previously been assessed by the ANS Panel regarding their use in food and are authorised in the EU as food additives.
Besides food use, EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) has evaluated or is in the process of evaluating five of these colours used in animal feed (all of the above except Amaranth). In its 2012 opinion on Allura Red AC, the FEEDAP Panel decided there were insufficient data to demonstrate its safe use in animal feed. Importantly, Allura Red AC was proposed for lifetime use in cats and dogs, leading to a high exposure for these animals.
In order to ensure consistency in their risk assessment approach, EFSA’s experts undertook a self-task to review the available information on genotoxicity from its previous opinions on these substances as food additives, their ongoing evaluation as feed additives, and new relevant published data. The evidence available has been interpreted in the light of guidance on genotoxicity testing adopted by EFSA’s Scientific Committee in 2011.
- The Acceptable Daily Intake (ADI) is the amount of a substance that people can ingest on a daily basis over a lifetime without any appreciable risk to health. The ADI can apply to a specific substance or a group of substances (such as food additives) with similar properties.
- Evaluating genotoxicity is a routine part of the risk assessment process. In October 2011, over one year after the ANS Panel completed its evaluations of azo dye food colours , EFSA’s Scientific Committee completed a review of the current genotoxicity testing and made recommendations on genotoxicity testing strategies. In case of inconclusive, contradictory or equivocal results, the guidance recommends further in vitro or in vivo testing depending on previous results. In addition, it states that assessing different ‘endpoints’ (the expected outcomes of a test or trial, for example liver cancer or developmental effects) in different tissues in the same animal should also be considered.