EFSA Lowers ADI on Amaranth, Completing its Re-evaluation of Azo Dye Food Colours
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.

Jul 27 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 authorised for use in the European Union. 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) 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. 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.
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 ), suggesting a possible link between certain mixtures of colours(including five azo dyes) and the preservative sodium benzoate and hyperactivity in children.
From last Tuesday (July 20), article 24 of the regulation (EC) No. 1333/2008, requires that products containing the disputed “Southampton colors” need to bear a warning label “may have an adverse effect on activity and attention in children”. German ingredients specialist WILD has expanded its portfolio of colors from natural sources and coloring foodstuffs and offers forward-looking solutions for a variety of applications to avoid this warning label and allow for clean labeling.
Especially the confectionery industry has to master the challenges linked to the growing consumer demand for more naturally formulated products and the requirements of the regulation (EC) No. 1333/2008 of 16 December 2008 on food additives. The 2007 “Southampton Study”, which looked at six artificial colors – Tartrazine (E 102), Quinoline Yellow (E 104), Sunset Yellow (E 110), Carmoisine (E 122), Ponceau 4R (E 124) and Allura Red (E 129) – in connection with hyperactivity in children, is the reason for the discussion of artificial colors that finally turned out into the new regulation. It requires that products containing the disputed “Southampton colors” bear the warning label “may have an adverse effect on activity and attention in children”. Manufacturers are therefore increasingly rethinking the use of artificial colors in their products, and gradually replacing them with colors from nature.
WILD has added seven coloring foodstuffs to its Colors From Nature range in order to meet the growing demand for colors from natural sources. These are natural extracts and concentrates from plants, fruits or vegetables. Each of the ingredients corresponds to the type of fruit for which it is named. New to the WILD color portfolio are banana, mango, mandarin, redcurrant, elderberry and lime and allow for clean labeling without E-numbers. The new coloring foodstuffs are especially suited for use in confectionery such as hard candies, dragees, jelly gums and ice cream. New sources were tapped for their development and the raw materials carefully selected for their coloring properties.