Children's hyperactivity and benzoate
A randomised controlled trial funded by the UK Food Standards Agency gave children aged 3 and 8-9 a drink containing sodium benzoate (the same chemical family as E213) plus one of two mixtures of artificial colours. Both mixtures increased hyperactivity scores compared with placebo, though the effect was not identical across age groups or mixtures. The study could not isolate the benzoate from the colours, so the size of benzoate's own contribution is uncertain. EFSA concluded the evidence was limited but did not rule it out.
Children aged 3 and 8-9 given drinks containing sodium benzoate plus artificial colours showed increased hyperactivity compared with placebo in a double-blind crossover trial.
2007RCTMcCann et al., The Lancet
EFSA's AFC Panel concluded the McCann study provided limited evidence of a small effect on activity and attention in some children, but found results inconsistent across age groups and additive mixtures, and did not change the ADI for sodium benzoate.
2008Regulatory reviewEFSA Scientific Opinion on the assessment of McCann et al. (2007), EFSA Journal 660
Benzene formation with vitamin C
When a benzoate salt and ascorbic acid (vitamin C) are both present in a drink, and the drink is exposed to heat or light, a decarboxylation reaction can produce small amounts of benzene. Benzene is classified by the IARC as a Group 1 carcinogen, meaning it causes cancer in humans, specifically acute myeloid leukaemia. The FDA found levels above 5 parts per billion, the US drinking-water standard, in 10 of 200 soft drinks tested in 2005. Many manufacturers subsequently reformulated to reduce the risk.
Benzene can form in beverages containing benzoate salts and ascorbic acid, particularly under heat and light exposure, through decarboxylation of benzoic acid catalysed by trace metal ions.
2006RegulatoryFDA Q&A on benzene in soft drinks; Cen.acs.org (C&EN reporting)
IARC classifies benzene as Group 1 carcinogenic to humans, with sufficient evidence it causes acute myeloid leukaemia.
2018EstablishedIARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 120
Sensitivity reactions in people with asthma or aspirin intolerance
Benzoates have long been associated with pseudo-allergic reactions, meaning reactions that mimic allergy but do not involve the usual immune pathway. Studies in people with asthma, chronic urticaria or aspirin intolerance have shown that sodium benzoate can trigger histamine and prostaglandin release from gastric tissue in sensitised individuals. Roughly 3-6% of people with aspirin-intolerant asthma report reactions to benzoates. The reaction is not a true allergy and does not show up on standard allergy skin tests.
Sodium benzoate provoked release of histamine and prostacyclin from gastric mucosa in 29 patients with asthma, atopic dermatitis or chronic urticaria; control tissue did not react.
1991ObservationalPacor et al. / Di Gioacchino et al., Allergy and Clinical Immunology International
Among asthmatics with the triad of aspirin intolerance, asthma and nasal polyposis, approximately 3-6% show intolerance to benzoate in oral provocation testing.
2004ObservationalOral provocation testing literature, cited in Balatsinou et al., International Journal of Immunopathology and Pharmacology
Exposure and ADI exceedance in children
EFSA's 2016 re-evaluation of the whole benzoate group (E210-E213) set a group acceptable daily intake of 5mg per kilogram of body weight per day. Its own dietary exposure modelling found that high-consuming toddlers and young children in some European countries could reach up to 10.9mg/kg body weight per day from permitted food uses alone, more than double the ADI. High-consuming older children and adolescents reached up to 7mg/kg/day. EFSA concluded genotoxicity and carcinogenicity were not concerns at these levels, but flagged the exceedance as a reason for ongoing attention.
EFSA set a group ADI of 5mg/kg body weight per day for benzoic acid and its salts (E210-E213). High-consuming toddlers and young children showed estimated exposures of up to 10.9mg/kg/day, exceeding the ADI in some countries.
2016Regulatory reviewEFSA Scientific Opinion on the re-evaluation of benzoic acid (E210), sodium benzoate (E211), potassium benzoate (E212) and calcium benzoate (E213) as food additives, EFSA Journal 4433
EFSA concluded that the available data did not indicate genotoxic or carcinogenic potential for benzoic acid and its salts when used as food additives.
2016Regulatory reviewEFSA Scientific Opinion, EFSA Journal 4433