How safe are the color Additives used ?

Color Additives

Color additives are dyes, pigments, or other substances that can impart color when added or applied to a food, drug, cosmetic, or the human body.
FDA classifies color additives as those requiring certification and those not requiring certification (exempt from certification).

((1)). Color additives require certification / Certified Colors / Certfiable Colors :
Synthetic Colors: These do not occur in nature and are produced by chemical synthesis. These colors, especially in the U.S., must be tested for purity and certified, batch by batch, prior to sale to manufacturers. FDA analyses every batch because every batch is a little different from the one before it, the complex organic chemical reaction occurring during manufacturing can throw off a sample’s composition a little different each time. FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. The manufacturer submits a sample from the batch for which it is requesting certification, and FDA tests the sample to determine whether it meets the color additive's requirements for composition and purity. If it does, FDA "certifies" the batch and issues a certification lot number, and uses FDA color name. Only then can that batch be used legally in FDA-regulated products.
Examples :
Non certified...........Certified as
Tartrazine................FD & C Yellow 5..FDA assigned Lot No.…….
Allura Red AC..........FD & C Red 40....FDA assigned Lot No……….
Indigotine................FD & C Blue No.2.FDA assigned Lot No…….

The Federal Food, Drug & Cosmetic (FD&C) Act of 1938 made food color additive certification mandatory and transferred the authority for its testing from USDA to FDA. To avoid confusing color additives used in food with those manufactured for other uses, three categories of certifiable color additives were created :
1 Food, Drug and Cosmetic (FD&C)
- Color additives with application in foods, drugs or cosmetics;
2 Drug and Cosmetic (D&C)
- Color additives with applications in drugs or cosmetics;
3 External Drug and Cosmetic (External D&C)
- Color additives with applications in externally applied drugs (e.g. ointments) and in externally applied cosmetics.

Certified color additives have special names consisting of a prefix, such as FD&C, D&C, or Ext. D&C, a color; and a number. Sometimes a color additive is identified by a shortened form of its name, consisting of just the color and number, such as Yellow 6.
In 1960, the Color Additive Amendments to the FD&C Act placed color additives on a "provisional" list and required further testing using up-to-date procedures. One section of the amendment known as the Delaney Clause, prohibits adding to any food substance that has been shown to cause cancer in animals or man regardless of the dose. Under the amendments, color additives exempt from certification also are required to meet rigorous safety standards prior to being permitted for use in foods.
According to the Nutrition Labeling and Education Act of 1990, a certifiable color additive used in food must be listed in the ingredient statement by its common or usual name. All label printed after July 1, 1991 must comply with this requirement.

((2)). Color additives exempt from certification :
These are obtained largely from plant, animal, or mineral sources. They are not subject to batch certification requirements, but they are still artificial color additives and must comply with regulatory requirements. Both types of color additives are subject to rigorous safety standards.
•-Natural colors,
--the term "natural colors" does not legally exist and is not recognized by FDA.
--It was left up to each manufacturer to define "natural” for itself.
• Nature Identical Colors:
--These colors are also manufactured by chemical synthesis, but do not require FDA certification, and are considered chemically and functionally indistinguishable from the same colorant found in nature, for example : Beta-Carotene synthesized from Acetone.

Colors Exempt from Certification
Annatto extract, B-Apo-8'-carotenal*, Beta-carotene, Beet powder, Canthaxanthin, Caramel color, Carrot oil, Cochineal extract (carmine); Cottonseed flour, toasted partially defatted, cooked; Ferrous gluconate *, Fruit juice, Grape color extract*,
Grape skin extract* (enocianina), Paprika, Paprika oleoresin, Riboflavin, Saffron, Titanium dioxide*, Turmeric, Turmeric oleoresin, Vegetable juice
* These food color additives are restricted to specific uses.

So how safe are they ?
There is no such thing as absolute safety of any substance. Color additives are very safe when used properly. Food Drug Administration (FDA) regulates color additives used in the United States. This includes those used in food (and dietary supplements), drugs, cosmetics, and medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency and must be used only in compliance with the approved uses, specifications, and restrictions. Information on intended uses for a batch of color additive is used to assure that a batch of certified color additive will be used in accordance with the requirements of its listing regulation.

In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Color additives that FDA has found to cause cancer in animals or humans may not be used in FDA-regulated products marketed in the United States.
Approval of a color additive for one intended use does not mean approval for other uses. For example, no color additives have been approved for injection into the skin even though tattoo parlors often claim that the pigments in their inks are "FDA-approved." Likewise, no color additives are approved for permanent makeup (a form of tattooing). And henna is approved for use on the hair, but not the skin. FDA assures that only safe color additives will be used in foods, drugs, cosmetics, and medical devices sold in the United States.

FDA lists color additives that have been shown to be safe for their intended uses in title 21 of the Code of Federal Regulations (CFR). FDA requires batch certification for all color additives listed in 21 CFR part 74 and for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification.

Examples :
Color additive,FDA approved
FD&C Blue No.1
(.)Human Foods:Foods generally./1969,Added Mn spec./1993,
(.)Drugs:Ingested drugs generally./1969, Externally applied drugs/1982,Eye area use (include lake)/1994
(.)Cosmetics: Cosmetics generally./1982, Allows MnO2 in manufacture/1993

DC Green No.5
(.)Drugs:Drug generally/1982,Eye area use (includes lake)/1994
(.)Cosmetics:Cosmetic generally/1982, Eye area use/1994.

If the color 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. Color additives proposed for use in meat and poultry products also must receive specific authorization by USDA.

Reactions to color additives are rare. It is possible, but rare, to have an allergic-type reaction to a color additive. For example, FD&C Yellow No. 5 may cause itching and hives in some people. This color additive is widely found in beverages, desserts, processed vegetables, drugs, makeup, and other products. FDA requires all products containing FD&C Yellow No. 5 to identify it on their labels so that consumers who are sensitive to the dye can avoid it. On medicine labels, this certified color additive is also identified by its uncertified name, "tartrazine". FDA certified more than 2 million pounds of Tartrazine (FD & C Yellow No.5) yearly.

FDA can take action against companies if there are violations. In the absence of a voluntary action such as a product recall, FDA can issue warning letters, detentions, and import alerts for products that are found to be unsafe or to contain color additives that are prohibited, misused, or not properly identified as ingredients. FDA can also seize such products. Color additive violations are a common reason for detaining imported cosmetic products that are offered for entry into the United States. Color additives in foods and cosmetics marketed abroad are not subject to the same safeguards as those marketed in the United States.

Only 9 certified colors approved for use in food in the USA, they are :
(1) FD & C Blue No.1.……….(Brilliant Blue FCF)…………use for : Beverages, dairy products powders, jellies, confections, condiments, icings, syrups, extracts
(2) FD & C Blue No.2.……….(Indigo Carmine / Indigotine)..use for : Baked goods, cereals, snack foods, ice cream, confections, cherries
(3) FD & C Green No.3.……....(Fast Green FCF)…………..use for : Beverages, puddings, ice cream, sherbert, cherries, confections, baked goods, dairy products
(4) FD & C Red No.3.………..(Erythrosine)………………..use for : Cherries in fruit cocktail and in canned fruits for salads, confections, baked goods, dairy products, snack foods
(5) FD & C Red No.40.………(Allura Red AC)…………….use for : Gelatins, puddings, dairy products, confections, beverages, condiments
(6) FD & C Yellow No.5……..(Tartrazine)………………….use for : Custards, beverages, ice cream, confections, preserves, cereals
(7) FD & C Yellow No.6……..(Sunset Yellow FCF)………..use for : Cereals, baked goods, snack foods, ice cream, beverages, dessert powders, confections
(8) Orange B………………………………………………….use for : These food color additives are restricted to specific uses.
(9) Citrus Red No.2…………………………………………..use for : These food color additives are restricted to specific uses.

Issue on FD & C Red No.3
In 1990, FDA discontinued the provisional listing of all lake forms of FD&C Red No.3 and its dye form used in external drugs and cosmetics. The uses were
terminated because one study of the color additive in male rats showed an association with thyroid tumors. In announcing the decision, FDA that any human risk
posed by FD&C Red No.3 was extremely small and was based less on safety concerns than the legal mandate of the Delaney Clause. FD&C Red No.3 remains
permanently listed for use in food and ingested drugs, although FDA has announced its intent to propose rescinding those listings.
Decision about the safety of food color additives sometimes changed :
Since absolute safety of any substance can never be proven, decisions about the safety of color additives or other food ingredients are made on the best scientific
evidence available. Because scientific knowledge is constantly evolving, federal officials often review earlier decisions to assure that the safety assessment of a food
substance remains up-to-date. Any change made in previous clearances should be recognized as an assurance that the latest and best scientific knowledge is being
applied to enhance the safety of the food supply.

Do food color additives cause hyperactivity ?
Although this theory was popularized in the 1970's, well-controlled studies conducted since then have produced no evidence that food color additives cause
hyperactivity or learning disabilities in children. A Consensus Development Panel of the National Institutes of Health concluded in 1982 that there was no scientific evidence to support the claim that colorings or other food additives cause hyperactivity. The panel said that elimination diets should not be used universally to treat childhood hyperactivity, since there is no scientific evidence to predict which children may benefit.

Dyes and Lakes
Certifiable color additives are available for use in food 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.
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.

Delaney clause
In 1960, amendments to the Food, Drug, and Cosmetic Act of 1938 added the so-called Delaney anti-cancer clause to FDA's legal mandate. Among other things,
the clause prohibits marketing any color additive the agency has found to cause cancer in animals or humans, regardless of amount.
FDA applied the Delaney clause in 1990 when it outlawed several uses of the strawberry-toned FD&C Red No. 3. The banned uses include cosmetics and
externally applied drugs, as well as uses of the color's non-water-soluble "lake." FDA previously had allowed these "provisional" uses while studies were in progress
to evaluate the color's safety. Research later showed large amounts of the color causes thyroid tumors in male rats.

References : U.S. Food and Drug Administration,
Center for Food Safety and Applied Nutrition.