The risk assessor is in the midst of a safety review for all food additives previously approved for use in the EU, as new science has been published since many were originally approved, in some cases as far back as the 1960s.
There are 4 variants of caramel colour in use: plain caramel (150a); caustic sulphite caramel (150b), ammonia caramel (150c) and sulphite ammonia caramel (150d). The group of colours is broadly used in food applications, including beer, brown bread, gravy browning, cola drinks, sauces, dressings and vinegar, whiskey, and confectionery.
EFSA has established a new group acceptable daily intake (ADI) level of 300 mg/kg bw/day for all four colours, based on their similar properties.
However for E150c it has set a more restrictive ADI of 100 mg/kg bw/day. This means that E150c can only contribute 100 mg/kg bw/day out of the 300 mg/kg bw/day total for all colours in the group.
The Joint WHO/FAO Expert Committee on Food Additives (JECFA) had previously established ADIs from 160mg/kg bw/d for E150b, E150c and E150d, but not for E150a.
Dr John Christian Larsen, chair of the ANS panel, explained that the lower ADI for E150c is due to “uncertainties related to possible effects on the immune system observed in animals of one of its constituents, 2-acetyl-4-tetrahydroxibutylimidazole (THI)”, which results from the production process.
The panel said it would welcome further studies on the effects of THI on the immune system.
Another constituent in E150c and E150d, 4-methylimidazole (4-MEI), which has been the subject of animal carcinogenicity studies, as the highest exposure level resulting from the colours was not deemed of concern.
Keep by-products low
EFSA’s panel has also said that the specifications for all four caramel colours hould be updated to give new maximum levels for other by-products that can have ill-effects at high levels, namely furans and 5-hydroxymethl-2-furfural (5-HMF). The levels vary considerably depending on the production process.
In general, however, it said it would be “prudent” to keep by-product levels in caramel colours as low as technically feasible – and further research is recommended into the link between production and formation and nature of their constituents.
US anti-caramel campaign
EFSA’s opinion comes on the heels of a new petition by US-based group Center for Science in the Public Interest (CSPI) for the Food and Drug Administration (FDA) to ban caramel colours.
The petition, filed in February, is based on the presence of 2-methylimidazole (2-MEI) and/or 4-MEI in the variants JECFA defines as class III (E150c) and class IV (E150d).
It cites government research that linked giving laboratory rats extremely high doses of 2-MEI and 4-MEI with increased risk of developing lung, liver, or thyroid cancer or leukemia.
CSPI executive director Michael Jacobson said: “Carcinogenic colorings have no place in the food supply, especially considering that their only function is a cosmetic one. The FDA should act quickly to revoke its approval of caramel colorings made with ammonia.”
Industry associations such as the Grocery Manufacturers Association and the American Beverage Association have defended the use of these colours, noting that trace levels of 2-MEI and 4-MEI are ubiquitous in foods.