EFSA Concludes Safety of Caramel Colors, Lowers ADI for Caramel E150c

Based on all available data, the Panel concluded that these caramel colors 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.

3/9/2011 --- 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 colors authorised for use in food in the European Union. The Panel has revised the previously established Acceptable Daily Intakes (ADIs) for these colors and set a group ADI covering all caramel colors. The Panel also looked at the safety of some by-products resulting from the production of these colors and recommended to keep their levels in caramel colors as low as technologically possible. This work is part of EFSA’s on-going re-evaluation of all food colors currently authorised in the EU. EFSA’s scientific advice will help to inform decisions of EU policy makers in relation to food colors.

Based on all available data, the Panel concluded that these caramel colors 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 colors; 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 colors, only 100 mg/kg bw/day can be made up by E150c[4]”.

The Panel also points out that adults and children who are high consumers of foods containing these colors could exceed the ADIs established for three of these colors (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 colors and that the type and levels found in these colors 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 colors in EU legislation[5] 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 colors.

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 color 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 colors was therefore considered to be sufficiently protective.

Nevertheless, the Panel considered that in order to keep consumer exposure to the by-products of caramel colors as low as possible, it would be prudent to keep their levels in caramel colors as low as technologically feasible. In this regard, the Panel recommended further research on the relation between the production of caramel colors and the formation and nature of derived constituents.