Contents
Food dye
Dyes are complex organic chemicals that were originally derived from coal tar, but now from petroleum 1. Certified color additives are categorized as either dyes or lakes. Dyes dissolve in water and are manufactured as powders, granules, liquids or other special purpose forms. They can be used in beverages, dry mixes, baked goods, confections, dairy products, pet foods and a variety of other products 2. Lakes are the water insoluble form of the dye. Lakes are more stable than dyes and are ideal for coloring products containing fats and oils or items lacking sufficient moisture to dissolve dyes. Typical uses include coated tablets, cake and donut mixes, hard candies and chewing gums 2. Unlike other food additives, dyes are not permitted to be used unless the U.S. Food and Drug Administration (FDA) has tested and certified that each batch meets the legal specifications.
The FDA is responsible for regulating all color additives to ensure that foods containing color additives are safe to eat, contain only approved ingredients and are accurately labeled 2. Color additives are used in foods for many reasons: 1) to offset color loss due to exposure to light, air, temperature extremes, moisture and storage conditions; 2) to correct natural variations in color; 3) to enhance colors that occur naturally; and 4) to provide color to colorless and “fun”foods 2. Without color additives, colas wouldn’t be brown, margarine wouldn’t be yellow and mint ice cream wouldn’t be green. Color additives are now recognized as an important part of practically all processed foods we eat 2.
FDA’s permitted colors are classified as subject to certification or exempt from certification,both of which are subject to rigorous safety standards prior to their
approval and listing for use in foods 2.
Certified colors are synthetically produced (or human made) and used widely because they impart an intense,uniform color,are less expensive,and blend more easily to create a variety of hues. There are nine certified color additives approved for use in the United States (see Table 2. Color Additives Subject To Certification for complete list) 3. Certified food colors generally do not add undesirable flavors to foods. One benefit of the certification process is that it provides information about the amounts of dyes sent into commerce each year for use in foods, drugs, and cosmetics. Just three dyes—Red 40, Yellow 5, and Yellow 6—account for 90 percent of all dyes used 1. The FDA’s data show a dramatic five-fold increase in consumption of dyes since 1955 1. That increase is a good indication of how Americans increasingly have come to rely on processed foods, such as soft drinks, breakfast cereals, candies, snack foods, baked goods, frozen desserts, and even pickles and salad dressings, that are colored with dyes.
Colors that are exempt from certification include pigments derived from natural sources such as vegetables, minerals or animals 2. Nature derived color additives are typically more expensive than certified colors and may add unintended flavors to foods 2. Examples of exempt colors include annatto extract (yellow), dehydrated beets (bluish-red to brown), caramel(yellow to tan), beta-carotene (yellow to orange) and grape skin extract (red,green).
Companies like using them because they are cheaper, more stable, and brighter than most natural colorings. However, consumers’ growing preference for natural foods is leading some companies to either not add colorings or to switch to safe natural colorings, such as beta-carotene (a precursor to vitamin A), paprika, beet juice, and turmeric (see back cover). That trend is stronger in Europe than the United States, but some U.S. companies recognize that an “All Natural” label can attract customers and may be moving in that direction. For example, in the United Kingdom Fanta orange soda is colored with pumpkin and carrot extracts while the U.S. version uses Red 40 and Yellow 6. McDonald’s strawberry sundaes are colored only with strawberries in Britain, but Red 40 is used in the United States 4.
To market a new direct food additive or color additive for use in food (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition the FDA for its approval 2. These petitions must provide evidence that the substance is safe for the ways in which it will be used 2.
Because of inherent limitations of science, FDA can never be absolutely certain of the absence of any risk from the use of any substance 2.Therefore, FDA must determine—based on the best science available—if there is a reasonable certainty of no harm to consumers when an additive is used as proposed. If an additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used and how it should be identified on food labels. In 1999, procedures changed so that FDA now consults with USDA during the review process for ingredients that are proposed for use in meat and poultry products. Federal officials then monitor the extent of Americans’ consumption of the new additive and results of any new research on its safety to ensure its use continues to be within safe limits. If new evidence suggests that a product already in use may be unsafe, or if consumption levels have changed enough to require another look, federal authorities may prohibit its use or conduct further studies to determine if the use can still be considered safe. Regulations known as Good Manufacturing Practices (GMP) limit the amount of food ingredients used in foods to the amount necessary to achieve the desired effect 2.
Color Additives Approved for Use in Human Food
Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except for coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time 5.
Table 1. Color Additives Exempt from Batch Certification – Color Additives Approved for Use in Human Food
21 CFR Section | Straight Color | EEC# | Year(2)Approved | Uses and Restrictions | |
---|---|---|---|---|---|
§73.30 | Annatto extract | E160b | 1963 | Foods generally. | |
§73.40 | Dehydrated beets (beet powder) | E162 | 1967 | Foods generally. | |
§73.75 | Canthaxanthin(3) | E161g | 1969 | Foods generally, NTE(7) 30 mg/lb of solid or semisolid food or per pint of liquid food; May also be used in broiler chicken feed. | |
§73.85 | Caramel | E150a-d | 1963 | Foods generally. | |
§73.90 | β-Apo-8′-carotenal | E160e | 1963 | Foods generally, NTE(7): 15 mg/lb solid, 15 mg/pt liquid. | |
§73.95 | β-Carotene | E160a | 1964 | Foods generally. | |
§73.100 | Cochineal extract | E120 | 1969 | Foods generally | |
2009 | Food label must use common or usual name “cochineal extract”; effective January 5, 2011 | ||||
Carmine | E120 | 1967 | Foods generally | ||
2009 | Food label must use common or usual name “carmine”; effective January 5, 2011 | ||||
§73.125 | Sodium copper chlorophyllin(3) | E141 | 2002 | Citrus-based dry beverage mixes NTE(7) 0.2 percent in dry mix; extracted from alfalfa. | |
§73.140 | Toasted partially defatted cooked cottonseed flour | —- | 1964 | Foods generally. | |
§73.160 | Ferrous gluconate | —- | 1967 | Ripe olives. | |
§73.165 | Ferrous lactate | —- | 1996 | Ripe olives. | |
§73.169 | Grape color extract(3) | E163? | 1981 | Nonbeverage food. | |
§73.170 | Grape skin extract (enocianina) | E163? | 1966 | Still & carbonated drinks & ades; beverage bases; alcoholic beverages (restrict. 27 CFR Parts 4 & 5). | |
§73.200 | Synthetic iron oxide(3) | E172 | 1994 | Sausage casings NTE(7) 0.1 percent (by wt). | |
2015 | Hard and soft candy, mints and chewing gum. | ||||
2015 | For allowed human food uses, reduce lead from ≤ 20 ppm to ≤ 5 ppm. | ||||
§73.250 | Fruit juice(3) | —- | 1966 | Foods generally. | |
1995 | Dried color additive. | ||||
§73.260 | Vegetable juice(3) | —- | 1966 | Foods generally. | |
1995 | Dried color additive, water infusion. | ||||
§73.300 | Carrot oil | —- | 1967 | Foods generally. | |
§73.340 | Paprika | E160c | 1966 | Foods generally. | |
§73.345 | Paprika oleoresin | E160c | 1966 | Foods generally. | |
§73.350 | Mica-based pearlescent pigments | —- | 2006 | Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. | |
2013 | Distilled spirits containing not less than 18 % and not more than 23 % alcohol by volume but not including distilled spirits mixtures containing more than 5 % wine on a proof gallon basis. | ||||
2015 | Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, nonalcoholic cocktail mixers and mixes and in egg decorating kits. | ||||
§73.450 | Riboflavin | E101 | 1967 | Foods generally. | |
§73.500 | Saffron | E164 | 1966 | Foods generally. | |
§73.530 | Spirulina extract | —- | 2013 | Candy and chewing gum. | |
2014 | Coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals (excluding extruded cereals). | ||||
§73.575 | Titanium dioxide | E171 | 1966 | Foods generally; NTE(7) 1 percent (by wt). | |
§73.585 | Tomato lycopene extract; tomato lycopene concentrate(3) | E160 | 2006 | Foods generally. | |
§73.600 | Turmeric | E100 | 1966 | Foods generally. | |
§73.615 | Turmeric oleoresin | E100 | 1966 | Foods generally. |
Notes: (2) The year approved is based on the date listed in the “Confirmation of Effective Date” notice for the action as published in the Federal Register. (3) Petitioned for use after the 1960 amendments; not provisionally listed. (7) NTE – not to exceed.
Table 2. Color Additives Subject To Certification – Color Additives Approved for Use in Human Food
21 CFR Section | Straight Color | EEC# | Year(2)Approved | Uses and Restrictions |
---|---|---|---|---|
§74.101 | FD&C Blue No. 1 | E133 | 1969 | Foods generally. |
1993 | Added Mn spec. | |||
§74.102 | FD&C Blue No. 2 | E132 | 1987 | Foods generally. |
§74.203 | FD&C Green No. 3 | —- | 1982 | Foods generally. |
§74.250 | Orange B(3) | —- | 1966 | Casings or surfaces of frankfurters and sausages; NTE(7) 150 ppm (by wt). |
§74.302 | Citrus Red No. 2 | —- | 1963 | Skins of oranges not intended or used for processing; NTE(7) 2.0 ppm (by wt). |
§74.303 | FD&C Red No. 3 | E127 | 1969 | Foods generally. |
§74.340 | FD&C Red No. 40(3) | E129 | 1971 | Foods generally. |
§74.705 | FD&C Yellow No. 5 | E102 | 1969 | Foods generally. |
§74.706 | FD&C Yellow No. 6 | E110 | 1986 | Foods generally. |
Note: Color additives listed in table 2 must be analyzed and batch certified by FDA before they can be used in any FDA-regulated product marketed in the U.S. This requirement applies to products imported into this country as well as those manufactured domestically. Manufacturers of certified color additives must include on the label the name of the certified color additive, a statement indicating general use limitations, any quantitative limitations in products, and the certification lot number assigned to the batch. Straight colors required to be certified are listed in 21 CFR Part 74. Most lakes are provisionally listed under 21 CFR 81.1 for use as listed in 21 CFR 82.51 (food, drugs, and cosmetics), 21 CFR 82.1051 (drugs and cosmetics), or 21 CFR 82.2051 (externally applied drugs and cosmetics). All FD&C Red No. 40 lakes are permanently listed under 21 CFR 74.340 (food), 74.1340 (drugs), and 74.2340 (cosmetics). FD&C Blue No. 1 and FD&C Yellow No. 5 aluminum lakes for drug and cosmetic use are permanently listed in 21 CFR sections 74.1101, 74.1705, 74.2101, and 74.2705.
Additional notes: (2) The year approved is based on the date listed in the “Confirmation of Effective Date” notice for the action as published in the Federal Register. (3) Petitioned for use after the 1960 amendments; not provisionally listed. (7) NTE – not to exceed.
Table 3. Approved Food Colours in the European Union
E100 | Curcumin |
E101 | (i) Riboflavin |
(ii) Riboflavin-5′-phosphate | |
E102 | Tartrazine |
E104 | Quinoline yellow |
E110 | Sunset Yellow FCF; Orange Yellow S |
E120 | Cochineal; Carminic acid; Carmines |
E122 | Azorubine; Carmoisine |
E123 | Amaranth |
E124 | Ponceau 4R; Cochineal Red A |
E127 | Erythrosine |
E129 | Allura Red AC |
E131 | Patent Blue V |
E132 | lndigotine; Indigo Carmine |
E133 | Brilliant Blue FCF |
E140 | Chlorophylls and chlorophyllins |
E141 | Copper complexes of chlorophyll and chlorophyllins |
E142 | Green S |
E150a | Plain caramel |
E150b | Caustic sulphite caramel |
E150c | Ammonia caramel |
E150d | Sulphite ammonia caramel |
E151 | Brilliant Black BN; Black PN |
E153 | Vegetable carbon |
E155 | Brown HT |
E160a | Carotenes |
E160b | Annatto; Bixin; Norbixin |
E160c | Paprika extract; Capsanthian; Capsorubin |
E160d | Lycopene |
E160e | Beta-apo-8′-carotenal (C30) |
E161b | Lutein |
E161g | Canthaxanthin |
E162 | Beetroot Red; Betanin |
E163 | Anthocyanins |
E170 | Calcium carbonate |
E171 | Titanium dioxide |
E172 | Iron oxides and hydroxides |
E173 | Aluminium |
E174 | Silver |
E175 | Gold |
E180 | Litholrubine BK |
Note: The list was last updated 21 July 2016
Table 4. Banned Additives
Additive | Function | Problem (Year Banned) |
---|---|---|
Artificial Colorings: | ||
Butter yellow | artificial coloring | Toxic, later found to cause liver cancer (1919) |
Green 1 | artificial coloring | Liver cancer (1965) |
Green 2 | artificial coloring | Insufficient economic importance to be tested (1965) |
Orange 1 | artificial coloring | Organ damage (1956) |
Orange 2 | artificial coloring | Organ damage (1960) |
Orange B | artificial coloring | Contained low levels of a cancer-causing contaminant. Orange B was used only in sausage casings to color sausages, but is no longer used in the United States (1978, ban never finalized). |
Red 1 | artificial coloring | Liver cancer (1961) |
Red 2 | artificial coloring | Possible carcinogen (1976) |
Red 4 | artificial coloring | High levels damaged adrenal cortex of dog; after 1965 it was used only in maraschino cherries and certain pills; it is still allowed in externally applied drugs and cosmetics (1976). |
Red 32 | artificial coloring | Damages internal organs and may be a weak carcinogen; since 1956 it continues to be used under the name Citrus Red 2 only to color oranges (2 ppm) (1956). |
Sudan 1 | artificial coloring | Toxic, later found to be carcinogenic (1919). |
Violet 1 | artificial coloring | Cancer (it had been used to stamp the Department of Agriculture’s inspection mark on beef carcasses) (1973). |
Yellow 1 & 2 | artificial coloring | Intestinal lesions at high dosages (1959). |
Yellow 3 | artificial coloring | Heart damage at high dosages (1959). |
Yellow 4 | artificial coloring | Heart damage at high dosages (1959). |
Other Additives: | ||
agene (nitrogen trichloride) | flour bleaching and aging agent | Dogs that ate bread made from treated flour suffered epileptic-like fits; the toxic agent was methionine sulfoxime (1949). |
cinnamyl anthranilate | artificial flavoring | Liver cancer (1982) |
cobalt salts | stabilize beer foam | Toxic effects on heart (1966) |
coumarin | natural flavoring | Liver poison (1970) |
cyclamate | artificial sweetener | Bladder cancer, damage to testes; now not thought to cause cancer directly, but to increase the potency of other carcinogens (1969). |
diethyl pyrocarbonate (DEPC) | preservative (beverages) | Combines with ammonia to form urethane, a carcinogen (1972) |
dulcin (p-ethoxy-phenylurea) | artificial sweetener | Liver cancer (1950) |
ethylene glycol | solvent | Kidney damage (1998) |
monochloroacetic acid | preservative | Highly toxic (1941) |
nordihydroguaiaretic acid (NDGA) | plant-derived antioxidant | Kidney damage (1968 by FDA, 1971 by USDA) |
oil of calamus | natural flavoring | Intestinal cancer (1968) |
polyoxyethylene-8-stearate (Myrj 45) | emulsifier | High levels caused bladder stones and tumors (1952) |
safrole | natural flavoring (root beer) | Liver cancer (1960) |
thiourea | preservative | Liver cancer (c. 1950) |
Artificial food colors and Attention Deficit Hyperactivity Disorder (ADHD)
Attention-deficit/hyperactivity disorder (ADHD) is a brain disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development 8. Children with attention-deficit/hyperactivity disorder (ADHD) often have elevated risk of school failure, peer rejection, family conflict, substance use disorders, delinquency, underemployment, depression, accidental death, suicide, and physical health problems 9. Attention-deficit/hyperactivity disorder (ADHD) is one of the most commonly diagnosed childhood disorders, affecting approximately 8% of school-age children 10. Studies show that the number of children being diagnosed with ADHD continues to increase, according to the Centers for Disease Control and Prevention 11. About 11% of children ages 4 to 17 (6.4 million kids) have been diagnosed with ADHD as of 2011, up from 7.8% in 2003, according to the CDC 11. Boys (13.2%) were more likely than girls (5.6%) to have ever been diagnosed with ADHD. Boys also are more likely to have the hyperactive-impulsive type, which is easier to spot than the quieter child who is inattentive.
This disorder often begins between ages 3 and 6, according to the National Institute of Mental Health 8. And it’s not just a childhood disease. ADHD may continue through the teenage years and into adulthood.
There are three types of ADHD 8:
- Inattention means a person wanders off task, lacks persistence, has difficulty sustaining focus, and is disorganized; and these problems are not due to defiance or lack of comprehension.
- Hyperactivity means a person seems to move about constantly, including in situations in which it is not appropriate; or excessively fidgets, taps, or talks. In adults, it may be extreme restlessness or wearing others out with constant activity.
- Impulsivity means a person makes hasty actions that occur in the moment without first thinking about them and that may have high potential for harm; or a desire for immediate rewards or inability to delay gratification. An impulsive person may be socially intrusive and excessively interrupt others or make important decisions without considering the long-term consequences.
Signs and Symptoms of Attention Deficit Hyperactivity Disorder
Inattention and hyperactivity/impulsivity are the key behaviors of ADHD. Some people with ADHD only have problems with one of the behaviors, while others have both inattention and hyperactivity-impulsivity.Most children have the combined type of ADHD.
In preschool, the most common ADHD symptom is hyperactivity.
It is normal to have some inattention, unfocused motor activity and impulsivity, but for people with ADHD, these behaviors:
- are more severe
- occur more often
- interfere with or reduce the quality of how they functions socially, at school, or in a job
Inattention
People with symptoms of inattention may often:
- Overlook or miss details, make careless mistakes in schoolwork, at work, or during other activities
- Have problems sustaining attention in tasks or play, including conversations, lectures, or lengthy reading
- Not seem to listen when spoken to directly
- Not follow through on instructions and fail to finish schoolwork, chores, or duties in the workplace or start tasks but quickly lose focus and get easily sidetracked
- Have problems organizing tasks and activities, such as what to do in sequence, keeping materials and belongings in order, having messy work and poor time management, and failing to meet deadlines
- Avoid or dislike tasks that require sustained mental effort, such as schoolwork or homework, or for teens and older adults, preparing reports, completing forms or reviewing lengthy papers
- Lose things necessary for tasks or activities, such as school supplies, pencils, books, tools, wallets, keys, paperwork, eyeglasses, and cell phones
- Be easily distracted by unrelated thoughts or stimuli
- Be forgetful in daily activities, such as chores, errands, returning calls, and keeping appointments
Hyperactivity-Impulsivity
People with symptoms of hyperactivity-impulsivity may often:
- Fidget and squirm in their seats
- Leave their seats in situations when staying seated is expected, such as in the classroom or in the office
- Run or dash around or climb in situations where it is inappropriate or, in teens and adults, often feel restless
- Be unable to play or engage in hobbies quietly
- Be constantly in motion or “on the go,” or act as if “driven by a motor”
- Talk nonstop
- Blurt out an answer before a question has been completed, finish other people’s sentences, or speak without waiting for a turn in conversation
- Have trouble waiting his or her turn
- Interrupt or intrude on others, for example in conversations, games, or activities
Diagnosis of ADHD requires a comprehensive evaluation by a licensed clinician, such as a pediatrician, psychologist, or psychiatrist with expertise in ADHD. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person’s functioning, and cause the person to fall behind normal development for his or her age. The doctor will also ensure that any ADHD symptoms are not due to another medical or psychiatric condition. Most children with ADHD receive a diagnosis during the elementary school years. For an adolescent or adult to receive a diagnosis of ADHD, the symptoms need to have been present prior to age 12.
ADHD symptoms can appear as early as between the ages of 3 and 6 and can continue through adolescence and adulthood. Symptoms of ADHD can be mistaken for emotional or disciplinary problems or missed entirely in quiet, well-behaved children, leading to a delay in diagnosis. Adults with undiagnosed ADHD may have a history of poor academic performance, problems at work, or difficult or failed relationships.
ADHD symptoms can change over time as a person ages. In young children with ADHD, hyperactivity-impulsivity is the most predominant symptom. As a child reaches elementary school, the symptom of inattention may become more prominent and cause the child to struggle academically. In adolescence, hyperactivity seems to lessen and may show more often as feelings of restlessness or fidgeting, but inattention and impulsivity may remain. Many adolescents with ADHD also struggle with relationships and antisocial behaviors. Inattention, restlessness, and impulsivity tend to persist into adulthood.
Risk Factors for Attention Deficit Hyperactivity Disorder
Scientists are not sure what causes ADHD. Like many other illnesses, a number of factors can contribute to ADHD, such as:
- Genes
- Cigarette smoking, alcohol use, or drug use during pregnancy
- Exposure to environmental toxins during pregnancy
- Exposure to environmental toxins, such as high levels of lead, at a young age
- Low birth weight
- Brain injuries
ADHD is more common in males than females, and females with ADHD are more likely to have problems primarily with inattention. Other conditions, such as learning disabilities, anxiety disorder, conduct disorder, depression, and substance abuse, are common in people with ADHD.
The causes of ADHD and the modifiers of its course are multifactorial. Twin and adoption studies have converged on a heritability of liability for ADHD symptoms of 65% to 75%, but some of the genetic effect is likely due to gene-by-environment interaction 12, 13. It is suggested that, for some susceptible children, an environmental exposure may influence expression of ADHD 14. However, this should not translate to genetic determinism, because genes are expressed by interaction with the environment, including diet. A good example is phenylketonuria (PKU), a well-established 100 % genetic disorder, lack of the gene for the enzyme to metabolize phenylalanine to tyrosine, resulting in a toxic alternative metabolic pathway for phenylalanine. Because the disease develops only in the presence of phenylalanine in the diet, it is 100 % environmental as well as 100 % heritable 15. Thus the fact that ADHD is 80 % heritable means that it is between 20 % and 100 % environmental. Arnold and colleagues can see that heritability could partly be genes for vulnerability to specific environmental factors, such as artificial food colors, insecticides, environmental chemicals, infections, parasites, trauma, poor diet, etc 16.
Numerous environmental factors are suspected to influence ADHD, including prenatal and postnatal toxicant exposures, teratogens, perinatal events, low birth weight, and postnatal environmental conflict and stress 17. Various dietary effects have been of long-standing interest. Among the dietary theories, the hypothesis that allergies or else hypersensitivity to certain foods or ingredients cause learning and behavior problems entered the literature as early as the 1920s 18. A specific hypothesis that food additives, which include synthetic food colorings and flavors, influence ADHD (at that time, hyperkinetic reaction), via either allergenic or pharmacologic mechanisms, was introduced in the 1970s by Feingold 19. He suggested initially that children who are allergic to aspirin are susceptible to synthetic food colors as well as naturally occurring salicylates, but he later focused on food color additives. To treat this reaction, Feingold proposed a diet free of foods with a natural salicylate radical and all synthetic colors and flavors 19.
The topic of synthetic color additives and hyperactivity was heavily studied in the 1970s and 1980s. In 1982, the National Institutes of Health convened a consensus development conference on defined diets and childhood hyperactivity, which recommended further study. A 19839 meta-analysis included 23 studies regarding the efficacy of the Feingold diet; the authors concluded that the composite effect size was too small to be important, setting the tone for two decades of professional skepticism as to the value of dietary intervention in ADHD. In a more recent meta-analysis, Schab and Trinh 20 reviewed 15 double-blind, placebo-controlled studies, plus six others for their supplemental analysis. They concluded that there was a reliable effect linking synthetic colors to ADHD symptoms in parent ratings, but not in teacher or observer ratings, and that the effect was carried by individuals preselected to be diet responsive. The effects seemed to be similar whether or not children were initially selected to be hyperactive. That report helped revive scientific interest in the role of synthetic food colors and has provoked periodic controversy for nearly 40 years between the relationship of food color additives to ADHD.
Overall, from recent meta-analysis of ADHD and synthetic food color additives 21 has provided mixed results. The confidence in or generalizability of the food color findings is limited by the lack of consistency in the findings across information sources, small pooled samples for studies restricted only to FDA-approved colors and for the psychometric test data, outdated studies in the United States, and vulnerability to publication bias of findings from parent studies. Artificial food colors (AFCs) have not been established as the main cause of attention-deficit hyperactivity disorder (ADHD), but accumulated evidence suggests that a subgroup shows significant symptom improvement when consuming an artificial food colors-free diet and reacts with ADHD-type symptoms on challenge with artificial food colors 22.
In conclusion, artificial food colors are not a main cause of ADHD, but they may contribute significantly to some cases, and in some cases may additively push a youngster over the diagnostic threshold 16. The current status of evidence is inconclusive “but too substantial to dismiss” 23. Until safety can be better determined, researchers suggest minimizing children’s exposure to artificial food colors. With the current concerns about childhood obesity, there appears to be no need to make food look more attractive than its natural color. Approximately 33% of children with ADHD may respond to a dietary intervention 21. Although as many as 8% may have symptoms related to food colors, the source of most of this dietary response remains unclear 21. Researchers thus conclude that dietary effects on and treatments of ADHD, including food additives and colors, deserve renewed investigation 21.
According to the British Food Standards Agency 24: “research funded by the FSA has suggested that consumption of mixes of certain artificial food colours and the preservative sodium benzoate could be linked to increased hyperactivity in some children.”
The artificial colours are 24:
- sunset yellow FCF (E110)
- quinoline yellow (E104)
- carmoisine (E122)
- allura red (E129)
- tartrazine (E102)
- ponceau 4R (E124)
A European Union-wide mandatory warning must be put on any food and drink (except drinks with more than 1.2% alcohol) that contains any of the six colours. The label must carry the warning “may have an adverse effect on activity and attention in children” 24.
The Food Standards Agency is publicising the product ranges to encourage the food industry to participate in the voluntary ban 25. The Food Standards Agency is encouraging manufacturers to work towards finding alternatives to these colours. Some manufacturers and retailers have already taken action to remove them.
Toxicology of food dyes
This review 26 finds that all of the nine currently US-approved food dyes (table 2 above) raise health concerns of varying degrees. Red 3 causes cancer in animals, and there is evidence that several other dyes also are carcinogenic 26. Three dyes (Red 40, Yellow 5, and Yellow 6) have been found to be contaminated with benzidine or other carcinogens 26. At least four dyes (Blue 1, Red 40, Yellow 5, and Yellow 6) cause hypersensitivity reactions 26. Numerous microbiological and rodent studies of Yellow 5 were positive for genotoxicity. Toxicity tests on two dyes (Citrus Red 2 and Orange B) also suggest safety concerns, but Citrus Red 2 is used at low levels and only on some Florida oranges and Orange B has not been used for several years. The inadequacy of much of the testing and the evidence for carcinogenicity, genotoxicity, and hypersensitivity, coupled with the fact that dyes do not improve the safety or nutritional quality of foods, indicates that all of the currently used dyes should be removed from the food supply and replaced, if at all, by safer colorings 26. It is recommended that regulatory authorities require better and independent toxicity testing, exercise greater caution regarding continued approval of these dyes, and in the future approve only well-tested, safe dyes 26.
FD&C Yellow No.5, is used to color beverages, dessert powders, candy, ice cream, custards and other foods. FDA’s Committee on Hypersensitivity to Food
Constituents concluded in 1986 that FD&C Yellow No.5 might cause hives in fewer than one out of 10,000 people. It also concluded that there was no evidence the color additive in food provokes asthma attacks. The law now requires Yellow No.5 to be identified on the ingredient line. This allows the few who may be sensitive to the color to avoid it 2.
Summary
Food dyes, synthesized originally from coal tar and now petroleum, have long been controversial. Many dyes have been banned because of their adverse effects on laboratory animals 1. This report 1 finds that many of the nine currently approved dyes raise health concerns. However due to the lack of evidence of harm on human as per FDA approved artificial food colors and the limited evidence of association of artificial food colors on ADHD syndrome, it’s best for consumers to avoid any artificial food colors if at all possible. The only strong evidence that consumption of mixes of certain artificial food colors and the preservative sodium benzoate could be linked to increased hyperactivity in some children and ADHD was with these 24:
- sunset yellow FCF (E110)
- quinoline yellow (E104)
- carmoisine (E122)
- allura red (E129)
- tartrazine (E102)
- ponceau 4R (E124)
In Europe, as of July 2010 most foods that contain any of the six artificial food colors must carry labels warning they “may cause hyperactivity in children” 24. As such the UK Food Standards Agency is encouraging the food industry to participate in the voluntary ban 25. The UK Food Standards Agency is encouraging manufacturers to work towards finding alternatives to these colours. Some manufacturers and retailers have already taken action to remove them.
- Center for Science in the Public Interest. Food Dyes: A Rainbow of Risks. https://cspinet.org/resource/food-dyes-rainbow-risks[↩][↩][↩][↩][↩]
- U.S. Food and Drug Administration. Food ingredients and colors. https://www.fda.gov/downloads/Food/FoodIngredientsPackaging/ucm094249.pdf[↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩]
- U.S. Food and Drug Administration. Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices. https://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm[↩][↩][↩]
- Environmental Health Perspectives. The Artificial Food Dye Blues. https://ehp.niehs.nih.gov/118-a428[↩]
- U.S. Food and Drug Administration. Color Additives. https://www.fda.gov/ForIndustry/ColorAdditives/default.htm[↩]
- Food Standards Agency. Current EU approved additives and their E Numbers. https://www.food.gov.uk/science/additives/enumberlist[↩]
- Center for Science in the Public Interest. Chemical Cuisine. https://cspinet.org/eating-healthy/chemical-cuisine[↩]
- The National Institute of Mental Health. Attention Deficit Hyperactivity Disorder. https://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml[↩][↩][↩]
- Chronis-Tuscano A, Molina BS, Pelham WE, et al. Very early predictors of adolescent depression and suicide attempts in children with attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 2010;67:1044–1051. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3382065/[↩]
- Centers for Disease Control and Prevention. Mental health in the United States: Prevalence of diagnosis and medication treatment for attention-deficit/hyperactivity disorder—United States, 2003. Morbidity and Mortality Weekly Report. 2005;54:842–847. https://www.ncbi.nlm.nih.gov/pubmed/16138075[↩]
- Centers for Disease Control and Prevention. Attention-Deficit / Hyperactivity Disorder (ADHD). https://www.cdc.gov/ncbddd/adhd/[↩][↩]
- Purcell S. Variance components models for gene-environment interaction in twin analysis. Twin Res. 2002;5:554–571. https://www.ncbi.nlm.nih.gov/pubmed/12573187[↩]
- Nigg J, Nikolas M, Burt SA. Measured gene-by-environment interaction in relation to attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2010;49:863–873. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928573/[↩]
- Stevenson J, Sonuga-Barke E, McCann D, et al. The role of histamine degradation gene polymorphisms in moderating the effects of food additives on children’s ADHD symptoms. Am J Psychiatry. 2010;167:1108–1115. https://www.ncbi.nlm.nih.gov/pubmed/20551163[↩]
- Pearce N. Epidemiology in a changing world: variation, causation, and ubiquitous risk factors. I J Epidemiol. 2011;40:503–512. https://www.ncbi.nlm.nih.gov/pubmed/21247886[↩]
- Arnold LE, Lofthouse N, Hurt E. Artificial Food Colors and Attention-Deficit/Hyperactivity Symptoms: Conclusions to Dye for. Neurotherapeutics. 2012;9(3):599-609. doi:10.1007/s13311-012-0133-x. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3441937/[↩][↩]
- Nigg JT. Temperament and developmental psychopathology. J Child Psychol Psychiatry. 2006;47:395–422. https://www.ncbi.nlm.nih.gov/pubmed/16492265[↩]
- Shannon WR. Neuropathic manifestations in infants and children as a result of anaphylatic reactions to foods contained in their diet. Am J Dis Child. 1922;24:89–94.[↩]
- Feingold BF. Hyperkinesis and learning disabilities linked to artificial food flavors and colors. Am J Nurs. 1975;75:797–803. https://www.ncbi.nlm.nih.gov/pubmed/1039267[↩][↩]
- Schab DW, Trinh NH. Do artificial food colors promote hyperactivity in children with hyperactive syndromes? A meta-analysis of double-blind placebo-controlled trials. J Dev Behav Pediatr. 2004;25:423–434. https://www.ncbi.nlm.nih.gov/pubmed/15613992 [↩]
- Nigg JT, Lewis K, Edinger T, Falk M. Meta-Analysis of Attention-Deficit/Hyperactivity Disorder or Attention-Deficit/Hyperactivity Disorder Symptoms, Restriction Diet, and Synthetic Food Color Additives. Journal of the American Academy of Child and Adolescent Psychiatry. 2012;51(1):86-97.e8. doi:10.1016/j.jaac.2011.10.015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4321798/[↩][↩][↩][↩]
- Dietary Sensitivities and ADHD Symptoms: Thirty-five Years of Research. Clinical Pediatrics Vol 50, Issue 4, pp. 279 – 293. First published date: December-02-2010. 10.1177/0009922810384728[↩]
- Nigg JT, Lewis K, Edinger T, Falk M. Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. J Am Acad Child Adolesc Psychiatry. 2012;51:86–97. doi: 10.1016/j.jaac.2011.10.015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4321798/[↩]
- Food Standards Agency. Food colours and hyperactivity. https://www.food.gov.uk/science/additives/foodcolours[↩][↩][↩][↩][↩]
- Food Standards Agency. Products free from the colours associated with hyperactivity. https://www.food.gov.uk/science/additives/foodcolours/colourfree[↩][↩]
- International Journal of Occupational and Environmental Health Volume 18, 2012 – Issue 3. Toxicology of food dyes. http://dx.doi.org/10.1179/1077352512Z.00000000034[↩][↩][↩][↩][↩][↩]