Food Additives & Children: A Parent's Guide
The Southampton study, the EU hyperactivity warning, and what official regulatory agencies actually say about additives in children's food.
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
Why Parents Ask About Food Additives
Food additives in children's products — particularly those in brightly colored candies, breakfast cereals, soft drinks, and snack foods — have attracted substantial parental concern, especially in the context of childhood hyperactivity and attention disorders. This concern intensified following the publication of the 2007 Southampton study, which showed a statistically significant association between consumption of a mixture of artificial food colors and sodium benzoate and increased hyperactivity in some groups of children.
Understanding what scientific research has and has not established, what regulatory agencies have decided, and how to practically interpret food labels is valuable for parents seeking to make informed choices for their children. This guide presents the official positions of the European Food Safety Authority (EFSA), the U.S. Food and Drug Administration (FDA), and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) — not personal dietary advice.
The Southampton Study (2007)
In September 2007, a randomized, double-blind, placebo-controlled study by McCann et al. was published in The Lancet. The study included 153 three-year-old children and 144 eight/nine-year-old children. Participants received one of three drinks daily for six weeks: a drink containing Mix A (six artificial colors + sodium benzoate), Mix B (six different colors + sodium benzoate), or a placebo. Parents, teachers, and independent observers rated hyperactivity using validated rating scales.
The study found statistically significant increases in hyperactivity scores for both age groups consuming the active mixes compared to placebo. The effect size was described as roughly equivalent to one-third to one-quarter of the effect size seen in ADHD. Importantly, the study tested mixtures, not individual colors, so it could not attribute the effect to any single additive.
EFSA evaluated the Southampton study in 2008 and concluded that the evidence did not provide grounds to revise the ADIs for the individual colors, due to study design limitations, unclear mechanistic basis, and the fact that the mixture effect could not be attributed to individual components. However, EFSA recommended further research and the European Commission adopted a precautionary warning label requirement.
The FDA reviewed the same evidence in 2011 and concluded it did not find a causal link that warranted changes to its regulations for these color additives.
The Southampton Six: Individual Profiles
One of the six artificial colors included in both Mix A and Mix B of the Southampton study. EU regulations require the warning label "may have an adverse effect on activity and attention in children" on products containing this color.
One of the six artificial colors included in both Mix A and Mix B of the Southampton study. EU regulations require the warning label "may have an adverse effect on activity and attention in children" on products containing this color.
One of the six artificial colors included in both Mix A and Mix B of the Southampton study. EU regulations require the warning label "may have an adverse effect on activity and attention in children" on products containing this color.
One of the six artificial colors included in both Mix A and Mix B of the Southampton study. EU regulations require the warning label "may have an adverse effect on activity and attention in children" on products containing this color.
One of the six artificial colors included in both Mix A and Mix B of the Southampton study. EU regulations require the warning label "may have an adverse effect on activity and attention in children" on products containing this color.
One of the six artificial colors included in both Mix A and Mix B of the Southampton study. EU regulations require the warning label "may have an adverse effect on activity and attention in children" on products containing this color.
Note: E104 (Quinoline Yellow) was in Mix A of the Southampton study. The exact formulation of each mix differed. All six require the warning label in the EU.
⚠️ The EU Hyperactivity Warning Label
"may have an adverse effect on activity and attention in children"
Under EU Regulation (EC) No 1333/2008, Annex V, food products containing any of the six Southampton colors must carry this statement on the label, following the name or E number of the color. This warning is mandatory for any product sold in the EU that contains tartrazine (E102), quinoline yellow (E104), sunset yellow FCF (E110), carmoisine (E122), ponceau 4R (E124), or allura red AC (E129).
The warning applies to the quantities of these colors typically used in food products. It does not mean the additive is proven to cause ADHD, nor does it constitute medical advice. It is a precautionary consumer information measure. Many manufacturers have reformulated their products to use natural color alternatives to avoid the warning label.
Outside the EU, this warning label is not required. Products sold in the USA, Japan, and Australia/NZ may contain these colors without the statement.
Aspartame and Phenylketonuria (PKU)
Aspartame (E951) contains phenylalanine as part of its molecular structure. Phenylalanine is an essential amino acid that is harmless for most people, but individuals with phenylketonuria (PKU) — an inherited metabolic disorder — cannot properly metabolize phenylalanine. In children with untreated PKU, phenylalanine accumulates and can cause serious neurological damage.
EU law requires all products containing aspartame to carry the statement "Contains a source of phenylalanine" on the label. This warning is specifically important for parents of children with PKU, who must carefully manage phenylalanine intake from all dietary sources. PKU is typically detected through newborn screening programs and is managed under close medical supervision.
For children without PKU, the phenylalanine in aspartame is no different from phenylalanine in other foods and poses no additional concern at typical intake levels.
Nitrites in Processed Meats
Sodium nitrite (E250) and related compounds are used to preserve processed meats such as hot dogs, bacon, ham, and luncheon meats — foods that often feature prominently in children's diets. Regulatory agencies worldwide including EFSA, FDA, and JECFA have set maximum permitted levels for nitrites in food based on a risk-benefit assessment weighing the risk from nitrosamines against the critical food safety benefit of preventing botulism.
The World Cancer Research Fund (WCRF) and EFSA have both noted that processed meat consumption is associated with increased colorectal cancer risk, partly attributed to nitrosamine formation. Both organizations recommend limiting processed meat intake. This does not apply specifically to children, but dietary guidance recommending balanced and varied diets generally leads to moderation of highly processed foods in children's diets.
Reading Labels: What to Look For
Products in EU must carry hyperactivity warning
Avoid for children with phenylketonuria
Check for this when Southampton Six colors are also present
Labeling required when >10 mg/kg in EU; important for children with asthma
Common in processed meats; EFSA recommends monitoring intake
This is a reference list based on official regulatory requirements, not a list of additives to avoid. Consult your healthcare provider for personalized dietary guidance.
ADI Values and Children
Acceptable Daily Intake (ADI) values are expressed per kilogram of body weight, which means they scale with body size. A child weighing 30 kg has an ADI of 1,200 mg/day for aspartame (at 40 mg/kg bw/day), compared to 2,800 mg/day for a 70 kg adult. Because children eat more relative to their body weight than adults, ADI calculations built on body weight already account for higher relative food consumption in children.
ADI values also incorporate large safety margins — typically 100-fold safety factors applied to the highest no-observed-adverse-effect level (NOAEL) found in animal studies. In practice, average dietary exposure to most individual food additives from typical consumption patterns is well below the ADI. However, for children who consume large amounts of a small number of highly processed foods that contain the same additive, exposure from that additive may be higher.
EFSA regularly evaluates dietary exposure to food additives across different European population groups, including children, to ensure that ADI values remain appropriate. These evaluations are available in EFSA's scientific opinions.
Frequently Asked Questions
Do the Southampton Six colors cause ADHD?
Is aspartame safe for children?
What does "E number" mean on a food label?
Should I avoid giving my child products with the EU hyperactivity warning?
Are organic or "natural" foods free of food additives?
Sources
- McCann D et al. (2007): Food additives and hyperactive behaviour in children — The Lancet 370(9598):1560–1567
- EFSA (2008): Assessment of Southampton study — EFSA Journal 2008;6(11):839
- EU Regulation (EC) No 1333/2008, Annex V (Warning labels)
- EFSA (2009): Scientific opinion on the re-evaluation of tartrazine as a food additive — EFSA Journal 2009;7(11):1331
- FDA (2011): Food Advisory Committee meeting — Color additives and hyperactivity in children
- EFSA (2017): Re-evaluation of monosodium glutamate (E621) — EFSA Journal 2017;15(7):4910
- JECFA Evaluations Database — apps.who.int/food-additives-contaminants-jecfa-database/
- EU Regulation (EC) No 1333/2008, Annex II (Permitted food additives)