EFSA News Story, 26 July 2010
The European Food Safety Authority’s scientific Panel on additives, the ANS Panel, has assessed the safety of the red food colour Amaranth (E123), completing the re-evaluation of all azo dyes [see Note 1 below] authorised for use in the European Union [see Note 2 below]. EFSA’s scientific advice will help to inform decisions of EU risk managers in relation to food additives.
Amaranth is a red azo dye colour which can be used to colour foods such as aperitif drinks and fish roe. After reviewing all available toxicological data, the Panel concluded that the colour is not genotoxic (does not damage the genetic material of cells) nor carcinogenic. The Panel set an Acceptable Daily Intake (ADI) [see Note3 below] for the substance of 0.15 mg per kg body weight per day, lowering the ADIs previously established in 1984 respectively by the Scientific Committee on Food (0-0.8 mg/kg bw/day) and the Joint FAO/WHO Expert Committee on Food Additives (0-0.5 mg/kg bw/day).
The Panel notes that while the mean exposure of adults is far below the ADI, adults consuming regularly extremely high amounts of Americano (cocktail of vermouth and red aperitif mixer) and aperitif wine drinks containing the colour at the maximum permitted level might exceed the ADI 6 times [see Note 4 below]. Children’s exposure was estimated to be around 30 times lower than the ADI. The Panel calculated exposure to Amaranth on the basis of the maximum levels of use permitted or reported by industry [see Note 5 below].
In line with the European Commission’s request, EFSA started with the assessment of colours as part of its ongoing re-evaluation of the safety of all food additives authorised for use in the EU. In particular, the European Commission asked EFSA to prioritise the assessment of azo dyes colours following publication of a study (McCann et al in 2007 [see Note 6 below]), suggesting a possible link between certain mixtures of colours(including five azo dyes) and the preservative sodium benzoate and hyperactivity in children.
List of opinions on colours adopted so far (10 of which are azo dyes) available at Topics A-Z: Food Colours
 Azo dyes are synthetic colours that contain an azo group (i.e. two nitrogen atoms linked by a double bond) in their molecular structure.
 See COMMISSION REGULATION (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives.
 The Acceptable Daily Intake is the amount of a substance that people can consume on a daily basis during their whole life without any appreciable risk to health.
 In order to reach the ADI, adults would need to consume more than three Americano per day, a cocktail containing 0.3 cl of aperitif mixer coloured with Amaranth, at the maximum permitted level.
 The Panel notes that exposure estimates for amaranth have been carried out using the maximum permitted levels (MPL) of use for Americano, and with the maximum reported levels of use for aperitif wine drinks, which were reported by industry to be at the same level as the MPL. These values may therefore not necessarily reflect typical use levels, and hence may overestimate exposure in high consumers.
 The study conducted by McCann et al (2007), commissioned by the UK Food Standards Agency, involved 153 children aged 3 years old and 144 children aged 8-9 years old from the general population, including children with normal to high level activity, but not children medicated for Attention Deficit Hyperactivity Disorder (ADHD). The study is published in The Lancet and can be found at http://www.thelancet.com/journals/lancet/article/PIIS0140673607613063/abstract.