Sulphite residues and asthma risk
E150b is made using sulphite compounds, and sulphite residues can remain in the finished colourant. Sulphites are a recognised trigger for asthma attacks and sensitivity reactions. In the general population, sulphite sensitivity is estimated at under 2 percent, but in people with asthma the rate rises to between 5 and 13 percent. Reactions range from mild flushing and urticaria to wheezing, chest tightness, and, in rare cases, anaphylaxis.
Sulphite sensitivity affects an estimated 5 to 13 percent of people with asthma, causing symptoms including wheeze, chest tightness, coughing, and urticaria.
2023Regulatory reviewAllergy UK, Sulphites and Airway Symptoms factsheet
UK food law requires 'sulphites' to be declared on pack whenever sulphite content in the finished product exceeds 10mg/kg or 10mg/litre (as total SO2). E150b is named as a sulphite-containing additive that triggers this rule.
2023RegulatoryUK FSA, Food Allergen Labelling and Information Requirements Technical Guidance
Sulphite residues in E150b products can be below 10ppm in many cases, meaning no allergen warning appears on the label even though the manufacturing process involves sulphite compounds.
ObservationalSulfitesABC.com, citing caramel colour specification data
Genotoxicity and carcinogenicity
The EFSA ANS Panel concluded in 2011 that caramel colours, including E150b, are not carcinogenic or genotoxic. Unlike class III (E150c) and class IV (E150d) caramels, E150b is not produced using ammonium compounds, so it does not generate 4-methylimidazole (4-MEI), an impurity that raises carcinogenicity questions for ammonia-process caramels.
EFSA's re-evaluation found caramel colours including E150b are not carcinogenic or genotoxic, and evidence does not indicate adverse effects on human reproduction or child development.
2011Regulatory reviewEFSA ANS Panel, Scientific Opinion on the re-evaluation of caramel colours (E 150 a,b,c,d) as food additives, EFSA Journal 9(3):2004
E150b does not generate 4-MEI because it is produced without ammonium compounds. The 4-MEI carcinogenicity debate applies to E150c and E150d, not to E150b.
2011Regulatory reviewfoodadditives.net, citing EFSA 2011 opinion and manufacturing specifications
Ames test mutagenicity assays across all four caramel colour classes, including class II, found no mutagenic activity with or without metabolic activation.
1992LabAllen et al., referenced in 'Caramel color safety: An update', Food and Chemical Toxicology
Dietary exposure and acceptable daily intake
EFSA established a group acceptable daily intake of 300mg per kilogram of body weight per day for caramel colours. For E150b specifically, exposure estimates for both adults and children were below that level, unlike three of the other caramel classes where some population groups were estimated to exceed the ADI.
EFSA set a group ADI of 300mg/kg body weight per day for E150a, E150b, and E150d. Dietary exposure to E150b was estimated to be below the ADI across all population groups assessed.
2011Regulatory reviewEFSA ANS Panel, Scientific Opinion on the re-evaluation of caramel colours (E 150 a,b,c,d) as food additives, EFSA Journal 9(3):2004