Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
The substance does not show any significant effect on activity and attention in children.
Additional information
EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA, 2008) reported a study on the influence of synthetic colours plus preservative sodium benzoate on children’s behaviour. The study involved 153 3-year old and 144 8- to 9-year old children, selected to represent a broad range of behaviour in the general population including children with normal to high-level behavioural activity. Children who were medicated for Attention-Deficit Hyperactivity Disorder (ADHD) were not included. A Global Hyperactivity Aggregate (GHA) score was the main outcome of the study, this parameter was based on aggregated z-scores of observed behaviours and ratings by teachers, class room observers and parents, plus, for 8- to 9-year old children, a computerised test of attention. Children were exposed to two different mixes of synthetic colours and a placebo control: mix B contained the substance and in addition E110 Sunset Yellow FCF, E122 Carmoisine, E129 Allura Red AC and sodium benzoate. Mix B had no effect on GHA scores in 3-year old children as compared to the placebo control GHA scores. For the 8- to 9-year old children Mix B was reported to have a significant effect on GHA scores. EFSA Panel (EFSA, 2008) concluded that the study provided limited evidence that the two different mixtures of synthetic colours and sodium benzoate tested had a statistically significant effect on activity and attention in children. Since mixtures and not individual additives were tested, it is not possible to ascribe the observed effects to any of the individual compounds. Furthermore, the clinical significance of the observed effects also remains unclear.
EFSA, 2008. Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC). Assessment of the results of the study by McCann et al. (2007) on the effect of some colours and sodium benzoate on children’s behaviour. The EFSA Journal (2008) 660, 1-54.
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