color additives: recent issues hyperactivity and...

Color Additives: Recent Issues Hyperactivity and Exposure

Sue Ann McAvoy Sensient Colors LLC

IACM Safety and Benefit of Food Colors

Agenda • Hyperactivity and ADHD

• Southampton Study

• Study Limitations

• Study Reviews

• EU actions


Hyperactivity and ADHD


Hyperactivity and ADHD • While widely variable, hyperactivity is

generally defined as overactive and inattentive behavior

• Children may be medically diagnosed with Attention-Deficit Hyperactivity Disorder (ADHD)

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Color Additives and Hyperactivity Concerns: Historical Perspective

• Some past research has suggested a link between intake of food colors and hyperactive behavior in children – Feingold diet

• Pharmacological effect of artificial food colours, flavours and natural salicylates.

– Hyperactivity studies (e.g., Isle of Wight) – Meta-analyses (e.g., Schab and Trinh)

• NIH: No consistent evidence of effect (1983) • Nutrition Foundation: no links • National Research Council: no links



Southampton Study


The Southampton Study


Study Design • Randomised, double-blind, placebo-controlled, crossover trial.

• Two age groups from the general population – 3-year-olds (153 children)

– 8/9-year-olds (144 children)

• Week 1: Baseline (usual diet)

• Over subsequent 6 weeks series of placebo or additive mix drinks given daily in a randomised sequence.

• Hyperactivity measured using parent and teacher ratings, observations of child in preschool setting or classroom and a computerised test of attention for 8/9-year-olds

• Combined to form a new method for assessing hyperactivity: – Global Hyperactivity Aggregate (GHA)

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Two Mixes Used

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FD&C (E-Number) Common Name Mix A Mix B

FD&C Yellow 5 (E102) Tartrazine

E104 Quinoline yellow

FD&C Yellow 6 (E110) Sunset Yellow

E122 Carmoisine

E124 Ponceau 4R

FD&C Red 40 (E129) Allura Red AC

E211 (Preservative) Sodium benzoate

Children given either Mix A or Mix B during the ‘challenge’ periods


Southampton Study: Authors’ Conclusions

• Mixtures of certain artificial colours together with a sodium benzoate preservative in the diet increased hyperactivity in 3 and 8/9 year old children in the general population.

• The average effect varied depending upon the mix and the age group.

• Although the results of the study suggest that some mixtures of certain artificial food colours and benzoate preservative may affect the level of hyperactive behaviour in children, removal of these additives from the diet would not be a panacea for ADHD.

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Study Limitations

No Proven Causality to Hyperactivity Southampton Study Limitations

• Undefined time for drink consumption – Time varied between additive intake and assessment

of behavior

• Body weight not recorded – Dose could not be adjusted

• Behavior assessment data not collected for the respective placebo phases (weeks 1, 3 and 5) – No easy assessment of intra-individual variability


• Observed Effects lack clear statistical significance – Across both age groups – Across both additive groups (Mix A and Mix B)

• Behavior changes only partially significant – Measured in the non-standard global hyperactivity

audit



• The very weakly statistically significant effects were only measured under a constant seven-day treatment period – Would longer exposure exacerbate or eliminate the subtle

effects? – Are the effects transient or persistent?

• If the effects are transient, probably not relevant within a human health discussion.

• No biological mechanism for causal association between the intake of the corresponding additives and the onset of hyperactivity can be derived from the results – Stevenson et al., 2011



• Low mean levels of observed hyperactivity compared to normal inter-individual variation measured in other studies

• Behavioral changes – did not occur in all children in one group – did not occur uniformly across all age groups – not in an even manner for the intake of all additive groups

Slightly amended behavior was observed in all groups given the additives

But this does not necessarily lead to the conclusion that the additive mixes caused an increase in hyperactivity



• It is simply not possible to draw extensive conclusions from this study, which is considered the strongest, most robust thus far

• Extrapolation of the results is not possible when studying mixtures to each individual additive, or to other additives

• Interpretation/mis-interpretation of this study suggests the need for standard guidelines (would be helpful to evaluate conclusions)



Study Reviws

• U.S. Food & Drug Administration (FDA) • European Food Safety Authority (EFSA) • Norwegian Food Safety Authority • German Federal Institute for Risk Assessment (BfR) • Food Safety Australia/New Zealand (FSANZ) • Others (e.g., UK Council on Toxicology)

No Proven Causality to Hyperactivity Reviews of Southampton Work


FDA Food Advisory Committee Meeting

• Reviewed USFDA report discussing available scientific data and whether there is evidence for a link

• 2-Day meeting, March 30/31, 2011 • Food Advisory Committee, 14 members

– Academic experts (pediatrics, psychiatry, neurotoxicity, behavioral, development)

– 2 consumer representatives – 2 industry representatives (no voting privileges)

• Invited participants, consumer groups • Public comments


Food Advisory Committee Findings

• Were FDA evaluation criteria robust? – Yes, 13-1 – Should criteria/review be modified? Yes 8-6

• Is there a causal relationship? – No, 11-3

• Should recommendation regarding additive free diet for children which show effects still be given? – Yes 13-1


Food Advisory Committee Findings

• Should a warning labeling be required? – No, 8-6

• Are further studies needed? – Yes, 13-1


EFSA Opinion • EFSA’s AFC Panel were assisted by experts in behavior, child psychiatry,

allergy and statistics • Conclusions:

– study provided limited evidence that the mixtures of additives tested had a small effect on the activity and attention of some children.

– Effects observed were not consistent for the two age groups and for the two mixtures used in the study.

– findings of the McCann et al study could not be used as a basis for altering the acceptable daily intakes

• Noted limitations: – inability to pinpoint which additives may have been responsible for the effects

observed in the children given that mixtures and not individual additives were tested


EFSA Opinion • Findings could be relevant for specific individuals showing sensitivity to

food additives in general or to food colours in particular

• Not possible to assess how widespread such sensitivity, if present, would be in the general population (Stevenson et al., 2011)

• The significance of the effects on the behaviour of the children was unclear since it was not known if the small changes in attention and activity observed would interfere with schoolwork or other intellectual functioning

• The Panel noted that the majority of the previous studies used children described as hyperactive and these were therefore not representative of the general population


Norwegian Food Safety Authority

• The increase in hyperactivity reported in the Southampton study after children were challenged with artificial food colours and sodium benzoate in two different mixtures (A and B) were considered small

• Findings were not consistent between the two age groups and the two mixtures

• Study provides limited support to an increase in hyperactive behavior from mixtures of artificial food colors and sodium benzoate


BfR Expert Opinion • Findings suggest indications of a possible association between the intake

of specific food additives and increased hyperactivity in children • Observed effects are low compared with normal inter-individual variation • Behavioral changes do not occur in all children in a group; nor do they

occur in a statistically significant manner in all age and additive groups. • Trial does not supply any clear evidence of a possible causal association

between additive intake and the observed effects; No biological mechanism be identified from the findings for a causal association of this kind.

• Additives must be listed on the label of packaged foods. This means that consumers wishing to avoid any intake of the additives concerned for precautionary reasons can refrain from consuming these foods.


FSANZ opinion

• Concluded that there are no public health and safety concerns due to the results of the study

• No public health and safety risk from the consumption of foods containing added colors as part of a balanced diet


What have other experts said? Attention Deficit Disorder Association

• No research proving that other treatments, such as neurobiofeedback, nutritional supplements, hypnosis, visual therapy, or changes in the diet are effective in relieving AD/HD symptoms.


What have other experts said? CHADD/Natl. Resource Ctr. on ADHD

“Dietary treatments eliminate -- or take out -- one or more foods in someone's diet (for example, sugar, candy and food with red dye). The idea is that being sensitive to certain foods can cause symptoms of AD/HD. Careful research, however, has not supported this treatment.” http://www.help4adhd.org/en/treatment/complementary/WWK6S


EU Actions


European labeling

• In Europe, all food additives are given labeling codes commonly referred to as “E-numbers”

• Colors are traditionally labeled not by name but by E-number

• The EU parliament now requires labeling for the Southampton colors in Europe: – “may have effects on activity and attention in

children”


Do ingredient labels need a warning for colors?

• No proven causality to hyperactivity

• As with all food ingredients, if consumers choose to not eat a specific ingredient, they can see it on the label and make an informed product choice

Colors: Important Ingredients A long, safe history of use in food

• Society has come to accept coloring not as fraudulent, but as a permissible and useful signal of food taste

• Simply, colors make food more enjoyable.

• Consumer studies shown consumers will not buy foods with color variations from the ‘norm’



Summary • Southampton Study is intriguing • No proven causality for hyperactive behavior • Colors are useful additives that provide

important and beneficial technical effects • Colors are already clearly labeled and this

allows consumers to make informed choices


Thank You

color additives: recent issues hyperactivity and...

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