EFSA’s assessment of research into food additives and hyperactivity in children

17.3.2008

<div>The European Food Safety Authority, EFSA, has today published a statement on research published in 2007, which studied the effect of certain food colours and sodium benzoate on hyperactivity in children. Researchers from Southampton University have found a link between these additives and hyperactivity in children. The view of the EFSA is that the findings of the study could not be used as a basis for altering the Acceptable Daily Intake (ADI) values of the additives studied.</div>

The additives included in the study were the preservative sodium benzoate (E211), and the food colours Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow FCF (E110), Ponceau 4R (E124), Allura Red AC (E129), and Azorubine or Carmoisine (E122). With the exception of Quinoline Yellow, the food colours are azo dyes.

In its statement the EFSA concluded that the mixtures of additives tested could slightly increase the activity of some children. However, the effects observed were not statistically significant in all cases. There were also many uncertainties relating to the research findings. The findings were not consistent in all respects, the effects found were relatively weak, and there was an absence of information on the clinical significance of the behavioural changes observed. Because the additives in the study were used as mixtures, there was an inability to pinpoint which individual additives were responsible for the effects observed. The clinical significance of the effects observed remained unclear since it was not known if the small changes in attention and activity would affect schoolwork or other intellectual functioning.

The EFSA did consider it possible, however, that certain individuals might be sensitive to food additives in general or to food colours in particular. However, it is not possible at present to assess how widespread such sensitivity to additives might be in the general population.

Children who consume sweets and soft drinks containing these additives could actually reach intake levels for the additives tested that would be similar to the amounts given in the study.

Southampton University study

The Southampton University study involved one hundred and fifty three 3-year old and one hundred and forty four 8- to 9-year old children. They were given three different drinks, one of which had no additives and two had different mixtures of additives. After the children had consumed the drinks, parents and teachers evaluated the children’s behaviour according to standardized ratings. The older children were also tested using a computerised test of attention. Each drink was used for one week at a time, after which there was a one-week break before moving on to the next drink. With the three-year olds, one additive mixture increased hyperactivity more than the placebo control drink, but the other additive mixture had no effect. With the 8- to 9- year old children both of the drinks containing additives increased the children’s hyperactivity only when the children had consumed at least 85% of the drinks offered. The authors concluded that synthetic colours and a sodium benzoate preservative increase hyperactivity in 3-year old and 8- to 9- year old children.

Taking the matter forward

In the European Union the Commission has the right of initiative in legislative matters. On the basis of the EFSA’s safety assessment the Commission will evaluate whether there are grounds to change the rules concerning the use of additives. The EFSA is currently re-assessing the safety of all permitted food colours, and therefore the colours investigated in this study will also be re-assessed. For some colours, such as Allura Red AC (E129), the new assessments may already be completed during the course of this year.

EFSA opinion:
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178694648892.htm

EFSA press release:
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178694645855.htm

Evaluated study:

McCann D, Barrett A, Cooper A, Crumpler D, Dalen L, Grimshaw K, Kitchin E, Lok K, Porteus L, Prince E, Sonuga-Barke E, Warner JO & Stevenson J (2007). Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial. The Lancet 370: 1560-1567.

ADI, or Acceptable Daily Intake, refers to the maximum acceptable intake of a substance per day, expressed by milligrams (of the substance) per kilograms of body weight per day. The ADI expresses the amount of the additive in question that a person can consume in a day without a health risk.

For more information please contact:
Special researcher Kirsi-Helena Liukkonen, Risk assessment unit, tel. +358 2077 24029
Senior officer Taina Rautio, Product safety unit, tel. +358 2077 24289 (returning 19.3. after 10 a.m.)

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