However the change has come about after the agency's independent Committee on Toxicology (COT) evaluated the results of research it had commissioned from the University of Southampton. The findings, while not being taken as hard evidence of a definite connection or as posing a safety threat, add to the growing stack of research on the effects of additives. They could be considered as part of regulatory reassessment processes. The study, which was published in The Lancet yesterday, was conducted in two phases. In stage one, 153 three-year olds and 144 eight- and nine-year olds were given one of two drink mixes containing artificial food colours and additives, or a placebo. The children were drawn from general population and across a range of hyperactivity and ADHD (attention deficit hyperactivity disorder) severities. Mix A contained sunset yellow (E110), tartrazine (E102), carmoisine (E122), ponceau 4R (E124) and sodium benzoate (E110). This same mix was used in an earlier study on a cohort of three-year-olds which was deemed inconclusive because the effects were not confirmed by clinicians. Mix B contained sunset yellow (E110), quinoline yellow (E104), carmoisine (E122), allura red (E129) and sodium benzoate (E110). Phase one lasted six weeks, and every child consuming the mixes and the placebo for one week each, with a one week wash-out period between each. Parents were asked to keep other sources of artificial colours out of the diet, and to keep a diary of violations. Phase two involved some of the children from the older group - responders and non-responders - during two half-day session a week apart, at which they were given either a placebo or an active drink similar to mix A or B, but the whole day's dose was given at once. The conclusions drawn by the researchers were that artificial food colours and additives were seen to exacerbate hyperactive behaviour in children at least up to middle childhood. Dr Andrew Wadge, chief scientist at the FSA, said that while eliminating artificial colourings from the diet of children showing signs of hyperactivity or ADHD could be beneficial, this was just one aspect that could be at play. Other aspects include genetics, premature birth, environment and upbringing. Study author Jim Stevenson said: "Parents should not think that simply taking these additives out of food will prevent hyperactive disorders. We know that many other influences are at work, but this at least is one a child can avoid." This view was echoed by Professor Ieuan Hughes, chair of the COT, who said: "Whilst this research does not prove that the colours used in the study actually cause increased hyperactivity in children, it provides supporting evidence for a link. "It is important to stress that the currently available evidence does not identify whether this association would be restricted to certain food additives or combinations of them." Professor Hughes also noted that there are always constraints to research conducted with children. As for where the FSA will go from here, it has shared the findings of the study with the European Food Safety Authority (EFSA), which is currently assessing the science on safety of all food additives permitted in the EU. Some additives have been allowed for as long as 30 years, without regulatory consideration of science conducted since the original approvals were granted. Industry response to the study and the COT's opinion on it has been measured, with several groups saying they will be taking a close and careful look at the study results. Some initial meeting have already taken place between industry representatives and the FSA. "Companies will clearly take account of these findings as part of their ongoing review of product formulations," said Julian Hunt, director of communications at the Food and Drink Federation (FDF). Given consumer demand for few additives in food and beverage products, many manufacturers are already reducing use of E-numbers, or tweaking their formulas to avoid artificial colours - although there are technical challenges associated with this. In particular, sodium benzoate plays a crucial preservative role in drinks formulations. Hunt stressed that the way in which the additives were tested as a mixture is not how they are used in everyday products. However the particular colours and sodium benzoate were chosen because they were seen to figure most commonly in products aimed at children. "It is important to reassure consumers that the Southampton study does not suggest there is a safety issue with the use of these additives," he said. The Food Additives and Ingredients Association (FAIA) said it welcomed the COT's statement on the research. "It adds new information to the debate on this controversial topic and we will study its findings in detail," it said. The FAIA also pointed out that such was the study design that it is not possible to assess the effect of any of the individual artificial colours on child behaviour. Reference: Journal: The Lancet DOI: 10.1016/S0140-6736(07)61306-3 Title: "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" Authors: J Stevenson
The FSA has issued new advice on certain artificial additives following research into a link with children's behaviour: that eliminating them from the diet could have some benefits for hyperactive kids or those with ADHD.