EFSA lowers ADI on amaranth, completing its re-evaluation of azo dye food colours
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[1] authorised for use in the European Union[2] . 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 The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet. ( ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.)[3] 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 Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. of adults is far below the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs., 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 The maximum amount of a contaminant, naturally occurring toxin or nutrient allowed in foods or animal feeds. might exceed the ADI 6 times[4] . 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[5] .
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[6] ), 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
[1] Azo dyes are synthetic colours that contain an azo group (i.e. two nitrogen atoms linked by a double bond) in their molecular structure.
[2] 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.
[3] 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.
[4] In order to reach the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs., 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.
[5] 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.
[6] 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 Community of humans, animals or plants from the same species., 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 .