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Safety and Benefits of Food Colors

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

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  1. Safety and Benefitsof Food Colors Sean Taylor, PhD Managing Director Verto Solutions Joseph Borzelleca, PhD Professor, Pharmacology & Toxicology VCU School of Medicine

  2. 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

  3. 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

  4. Current Members

  5. 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

  6. 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

  7. Uncertified name Allura Red AC Erythrosine Brilliant Blue FCF Indigotine Tartrazine 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)

  8. 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 Riboflavin Saffron Titanium dioxide Turmeric/oleoresin Annatto extract Astaxanthin Dehydrated beets (beet powder) Ultramarine blue Canthaxanthin Caramel beta-Apo-8'-carotenal beta-Carotene 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)

  9. 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

  10. Food additive petition:FDA recommended toxicity testing

  11. 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

  12. Safety of FD&C Colors in the USFD&C Blue No. 1 and Green No. 3

  13. Safety of FD&C Colors in the USFD&C Blue No. 2

  14. Safety of FD&C Colors in the USFD&C Red No. 3

  15. Safety of FD&C Colors in the USThe Azo dyes: Red 40, Yellow 5, Yellow 6

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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)

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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.

  27. 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

  28. 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.

  29. 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

  30. 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

  31. 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)

  32. 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

  33. 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

  34. 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”

  35. 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

  36. 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

  37. 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

  38. 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

  39. Summary • 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

  40. Colors are Safe and Beneficial

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