Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on the food colour Red 2G (E128) based on a request from the Commission related to the re-evaluation of all permitted food additives
Fernando Aguilar, Herman Autrup, Susan Barlow, Laurence Castle, Riccardo Crebelli, Wolfgang Dekant, Karl-Heinz Engel, Natalie Gontard, David Gott, Sandro Grilli, Rainer Gürtler, John Chr. Larsen, Jean-Charles Leblanc, Catherine Leclercq, François Xavier Malcata, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Rietjens, Paul Tobback, Fidel Toldrá.
Acknowledgment
The Panel wishes to thank the members of the Additives working group:
Fernando Aguilar, Dimitrios Boskou, David Gott, Sandro Grilli, Werner Grunow, Karolina Hulshof, John Chr. Larsen, Catherine Leclercq, Jean-Charles Leblanc, Wim Mennes, Alicja Mortensen, Dominique Parent-Massin, Annette Pöting, Iona Pratt, Ivonne Rietjens, Gerrit Speijers, Paul Tobback, Fidel Toldrá.
No abstract available
The European Commission has asked EFSA to re-evaluate all currently permitted food additives. The current opinion is a re-evaluation of the synthetic food colouring substance Red 2G following a pre-evaluation of the available data.
Red 2G has been evaluated previously by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1977 and 1981 and by the EU Scientific Committee for Food (SCF) in 1975. Both bodies allocated an Acceptable Daily Intake (ADI) for Red 2G of 0.1 mg/kg body weight (bw). It was also evaluated by the Nordic Council of Ministers in 2002. The present opinion briefly reports the major studies evaluated by these three bodies and describes the new data available in the literature since 1999 in more detail.
Red 2G is the common name for the mono-azo colour disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulphonate. In the European Union (EU), it is permitted only for use in breakfast sausages with a minimal cereal content of 6 % and burger meat with a minimum vegetable and/or cereal content of 4 %. In both foodstuffs a maximum level of 20 mg/kg is allowed (Directive 94/36/EC).
Considering specifically those foodstuffs in which Red 2G is permitted, and assuming they contain the maximum permitted level of 20 mg/kg, it can be calculated that consumption of 100 g breakfast sausages or 100 g burger meat could result in a dietary exposure of 2 mg Red 2G.
The Panel noted that Red 2G is extensively metabolised to aniline. The Panel noted that the current genotoxicity and carcinogenicity databases on Red 2G and its metabolite, aniline, are limited. However both genotoxic and carcinogenic effects have been observed in rodents treated with aniline.
The Panel based its evaluation on the conclusions of the EU Risk Assessment on aniline. This concluded that aniline should be considered as a carcinogen for which a genotoxic mechanism cannot be excluded, based on the following:
- aniline was genotoxic in vivo in rats and mice,
- there was insufficient mechanistic evidence to discount a genotoxic mechanism for the rodent carcinogenicity,
- based on similar metabolism of aniline in animals and humans a carcinogenic risk for man cannot therefore be excluded.
Red 2G, Acid Red 1, E 128, Ext. D&C Red no 11, CAS 3734-67-6, Food colour, afc panel, opinion, efsa
