The European Food Safety Authority’s scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) has assessed the safety of a group of caramel colours authorised for use in food in the European Union. The Panel has revised the previously established Acceptable Daily Intakes (ADIs) for these colours and set a group ADI covering all caramel colours. The Panel also looked at the safety of some by-products resulting from the production of these colours and recommended to keep their levels in caramel colours as low as technologically possible. This work is part of EFSA’s on-going re-evaluation of all food colours currently authorised in the EU. EFSA’s scientific advice will help to inform decisions of EU policy makers in relation to food colours.
Based on all available data, the Panel concluded that these caramel colours are neither genotoxic, nor carcinogenic and that there is no evidence to show that they have any adverse effects on human reproduction or for the developing child. Given their similar properties, the ANS Panel has established a group Acceptable Daily Intake (ADI) of 300 mg per kg body weight per day (mg/kg bw/day) applicable to all four colours; however, for one of these, caramel E150c, the Panel has set a more restrictive ADI of 100 mg/kg bw/day.
Dr. John Christian Larsen, Chair of the ANS Panel said: “The Panel decided to set a lower ADI for caramel E 150c to take into account uncertainties related to possible effects on the immune system of one of its constituents, 2-acetyl-4-tetrahydroxibutylimidazole (THI). This means that within the group ADI of 300 mg/kg bw/day established for the four caramel colours, only 100 mg/kg bw/day can be made up by E150c”.
The Panel also points out that adults and children who are high consumers of foods containing these colours could exceed the ADIs established for three of these colours (E150a, E150c, E150d) if they are used at the maximum levels reported by industry.
Experts on EFSA’s ANS Panel also noted that by-products are formed during the manufacturing of caramel colours and that the type and levels found in these colours can vary considerably depending on the production process. Scientists looked at the safety of these constituents, some of which are of toxicological concern, such as furan and 5-hydroxymethyl-2-furfural (5-HMF). They recommended that the specifications defined for caramel colours in EU legislation should be updated to include also maximum levels for these constituents.
The scientists on the Panel also looked at other constituents resulting from the production process, namely 2-acetyl-4-tetrahydroxibutylimidazole (THI) present in E150c, and 4-methylimidazole (4-MEI) present in E150c and E150d, for which EU specifications already foresee maximum levels for their presence in the colours.
In order to take into account the uncertainties regarding the possible implications for human health of the effects of THI on the immune system observed in animals, the Panel has set a lower specific ADI for the colour E150c which contains this constituent. Moreover, the Panel would welcome additional studies to further clarify the possible effects of THI on the immune system.
Following a review of the scientific literature on 4-MEI including recent carcinogenicity studies in animals, the Panel considered that the highest exposure level to 4-MEI that could result from the consumption of foods containing E150c and E150d did not give rise to concern. The maximum level established for 4-MEI in the specifications for these two caramel colours was therefore considered to be sufficiently protective.
Nevertheless, the Panel considered that in order to keep consumer exposure to the by-products of caramel colours as low as possible, it would be prudent to keep their levels in caramel colours as low as technologically feasible. In this regard, the Panel recommended further research on the relation between the production of caramel colours and the formation and nature of derived constituents.
Council Directive 89/107/EEC states that all food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. Food colours were among the first additives to be evaluated, therefore, the EU programme for the re-evaluation of food additives foresees that they should be evaluated with priority.
Safety evaluations performed by EFSA’s ANS Panel involve a review of all available, relevant scientific studies as well as data on toxicity in both humans and animals and human exposure to the substance concerned, from which the Panel draws conclusions regarding the safety of the substance.
 Caramel colours are added to food to give a deeper shade of brown and are widely used in a large variety of foods such as non-alcoholic flavoured drinks, confectionary, soups, seasonings, and beer. They are complex mixtures of compounds produced by carefully controlled heat treatment of carbohydrates (sugars). They are classified into four classes depending on the reagent used in their manufacture (ammonia, sulphite or no reagent), and generally known by the E numbers E150a, E150b, E150c, and E150b.
 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.
 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 four classes of caramels had previously been assessed by the EU Scientific Committee for Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) which had established ADIs ranging from 160 to 200 mg/kg per bw/day only for three of the colours (E150b, E150c, and E150d), and not for E150a.
 Commission Directive 2008/128/CE laying down specific purity criteria concerning colours for use in foodstuffs.
 The maximum content of 4-MEI in E150c and E150d is defined in Commission Directive 2008/128/CE laying down specific purity criteria concerning colours for use in foodstuffs.