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Safety and Benefits of Food Colors. Sean Taylor, PhD Managing Director Verto Solutions Joseph Borzelleca, PhD Professor, Pharmacology & Toxicology VCU School of Medicine. Overview of Presentation. About IACM History of FD&C colors Safety of FD&C colors

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safety and benefits of food colors

Safety and Benefitsof Food Colors

Sean Taylor, PhD

Managing Director

Verto Solutions

Joseph Borzelleca, PhD

Professor, Pharmacology & Toxicology

VCU School of Medicine

overview of presentation
Overview of Presentation
  • About IACM
  • History of FD&C colors
  • Safety of FD&C colors
  • Colors have not been proven to cause hyperactive behavior
  • Colors: important ingredients
iacm s mission
IACM’s Mission

to actively represent the interests of the color industry by demonstrating the safety of color additives, and to promote the industry's economic growth by actively participating in new color approvals and regulatory and legislative issues that affect the industry worldwide

history of color additives in the us legal framework
History of Color Additives in the US Legal Framework
  • Colors are food additives under 1958 Food, Drug, and Cosmetics Act
  • All color additives require pre-market approval via color petition process
  • Colors listed in US Code of Federal Regulations, Part 21, Section 73 & 74
certified exempt colors
Certified & Exempt Colors
  • Colors can be generally divided into “certified” and “exempt from certification” categories
    • Certified: Testing of each batch by FDA confirms safety
    • “Exempt” colors: no batch testing required

Certified colors: FD&C colors

certified colors 21 cfr 74
Uncertified name

Allura Red AC


Brilliant Blue FCF



Sunset Yellow FCF

Fast Green FCF

Certified color

FD&C Red No. 40

FD&C Red No. 3

FD&C Blue No. 1

FD&C Blue No. 2

FD&C Yellow No. 5

FD&C Yellow No. 6

FD&C Green No. 3

Certified Colors (21 CFR 74)
exempt colors 21 cfr 73
Haematococcus algae meal

Synthetic iron oxide

Fruit juice

Vegetable juice

Dried algae meal

Tagetes (Aztec marigold) meal and extract

Carrot oil

Corn endosperm oil

Paprika/oleoresin (extract)

Phaffia yeast



Titanium dioxide


Annatto extract


Dehydrated beets (beet powder)

Ultramarine blue





Cochineal extract; carmine

Sodium copper chlorophyllin

Toasted partially defatted cooked cottonseed flour

Ferrous gluconate

Ferrous lactate

Grape color extract

Grape skin extract (Enocianina)

Exempt Colors (21 CFR 73)
safety of fd c colors approval process in us
Safety of FD&C ColorsApproval process in US
  • Color additive petition filing
    • Specifications/purity
    • Use/technological justification
    • Toxicological data
      • FDA Redbook requirements
    • Exposure
  • FDA review/public comment process
  • Final rulemaking with allowed use
safety of fd c colors in the us color risk assessment
Safety of FD&C Colors in the USColor Risk Assessment
  • Substantial safety datasets for many colors
    • FDA review led to listing as allowed colors
  • WHO/FAO JECFA Review
    • establish acceptable daily intakes (ADIs)
  • Additional data collected
    • Genotoxicity
    • Allergenicity
    • other studies
no proven causality to hyperactivity historical perspective
No Proven Causality to HyperactivityHistorical perspective

Some research has suggested a link between intake of food colors and hyperactive behavior in children

Feingold diet

Hyperactivity studies (e.g., Isle of Wight)

Meta-analyses (e.g., Schab and Trinh)

Nutrition Foundation: no links

National Research Council: no links

no proven causality to hyperactivity southampton study limitations
No Proven Causality to HyperactivitySouthampton 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


No Proven Causality to HyperactivitySouthampton Study Limitations

  • 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

No Proven Causality to HyperactivitySouthampton Study Limitations

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

No Proven Causality to HyperactivitySouthampton Study Limitations


No Proven Causality to HyperactivitySouthampton Study Limitations

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)

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 HyperactivityReviews of Southampton Work

efsa opinion
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 opinion24
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
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
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
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
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
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.”

colors important ingredients
Colors: Important Ingredients
  • Offset color loss due to light, air, temperature extremes, moisture, and storage conditions
    • Natural color in foods fades
  • Correct natural color variation
  • Enhance naturally occurring color
  • Add variety to wholesome and nutritious foods
colors important ingredients31
Colors: Important Ingredients
  • Provide colorful identity to foods that are otherwise colorless
  • Add aesthetic appeal
  • Protect flavors and vitamins that could be affected by sunlight
  • Play a critical role in how we taste and enjoy food (palatability)
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’

Colors: Important IngredientsA long, safe history of use in food
colors important ingredients technological limitations to natural colors
Colors: Important IngredientsTechnological limitations to natural colors
  • Natural colors are great
  • But, some technological limitations
    • Stability issues for some natural colors
    • Limitations in certain applications
    • Range of colors
    • Limited resources
european labeling
European labeling
  • In Europe, all food additives are given labeling codes commonly referred to as “E-numbers”
  • So, colors were traditionally labeled not by name but by E-number
  • The EU parliament has now required labeling for azo-dyes in Europe:
    • “may have effects on activity and attention in children”
do us labels need a warning label
Do US labels need a warning label?
  • No proven causality to hyperactivity
  • In the US, FD&C colors are already listed by name, not by a vague E-number
  • 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
carmine cochineal
  • US Law: FD&C colors must appear on label
  • Example: Carmine/cochineal is now labeled
    • Consumers have the clear knowledge needed to decide
  • Consumers can make informed choices
colors are important in many applications
Colors are important in many applications
  • Drug dispensing and consumption errors are a significant health problem
  • Pharmacists rate color and shape as the most important attributes for patients to identify medications
  • Colored tablets significantly reduce medication errors
why not use natural colors for drug identification
Why not use natural colors for drug identification?
  • In some cases, this works great
  • But some technological limitations related to the stability of natural colors
    • Shelf-life of the active ingredients >1 year
    • Shelf-life of a natural color may be <1 year
    • Limited palette of stable natural alternatives
  • R&D continues
  • Strong and robust dataset supports the safety of many synthetic colors
  • 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