What Is A Food Additive?

In its broadest sense, a food additive is any substance added to food. Legally, the term refers to "any substance the intended use of which results or may reasonably be expected to result -- directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food." This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food. The purpose of the legal definition, however, is to impose a premarket approval requirement. Therefore, this definition excludes ingredients whose use is generally recognized as safe (where government approval is not needed), those ingredients approved for use by FDA or the U.S. Department of Agriculture prior to the food additives provisions of law, and color additives and pesticides where other legal premarket approval requirements apply. Direct food additives are those that are added to a food for a specific purpose in that food. For example, xanthan gum -- used in salad dressings, chocolate milk, bakery fillings, puddings and other foods to add texture -- is a direct additive. Most direct additives are identified on the ingredient label of foods. Indirect food additives are those that become part of the food in trace amounts due to its packaging, storage or other handling. For instance, minute amounts of packaging substances may find their way into foods during storage. Food packaging manufacturers must prove to the U.S. Food and Drug Administration (FDA) that all materials coming in contact with food are safe before they are permitted for use in such a manner. (Source: FDA)

Why Are Food and Color Ingredients Added to Food?

A color additive is any dye, pigment or substance which when added or applied to a food, drug or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color. 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. 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. 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. 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. 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 (e.g., FD&C Yellow No. 6. See chart for complete list.). Certified food colors generally do not add undesirable flavors to foods. Colors that are exempt from certification include pigments derived from natural sources such as vegetables, minerals or animals. Nature derived color additives are typically more expensive than certified colors and may add unintended flavors to foods. 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). (Source: FDA)

How Are Additives Approved For Use In Foods?

Today, food and color additives are more strictly studied, regulated and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition. When evaluating the safety of a substance and whether it should be approved, FDA considers: 1) the composition and properties of the substance, 2) the amount that would typically be consumed, 3) immediate and long-term health effects, and 4) various safety factors. The evaluation determines an appropriate level of use that includes a built-in safety margin - a factor that allows for uncertainty about the levels of consumption that are expected to be harmless. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect. Because of inherent limitations of science, FDA can never be absolutely certain of the absence of any risk from the use of any substance. 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' consump

What Are Unregulated Additives?

Under the Food Additives Amendment, two groups of ingredients were exempted from the regulation process. GROUP I - Prior-sanctioned substances - are substances that FDA or USDA had determined safe for use in food prior to the 1958 amendment. Examples are sodium nitrite and potassium nitrite used to preserve luncheon meats. GROUP II - GRAS (generally recognized as safe) ingredients - are those that are generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific evidence. Among the several hundred GRAS substances are salt, sugar, spices, vitamins and monosodium glutamate (MSG). Manufacturers may also request that FDA review the industry's determination of GRAS Status. (Source: FDA)

How are ingredients listed on a product label?

Food manufacturers are required to list all ingredients in the food on the label. On a product label, the ingredients are listed in order of predominance, with the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts. The label must list the names of any FDA-certified color additives (e.g., FD&C Blue No. 1 or the abbreviated name, Blue 1). But some ingredients can be listed collectively as "flavors," "spices," "artificial flavoring," or in the case of color additives exempt from certification, "artificial colors", without naming each one. Declaration of an allergenic ingredient in a collective or single color, flavor, or spice could be accomplished by simply naming the allergenic ingredient in the ingredient list. (Source: FDA)

What are dyes and lakes in color additives?

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. 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. (Source: FDA)

What is the difference between natural and artificial ingredients? Is a naturally produced ingredient safer than an artificially manufactured ingredient?

Natural ingredients are derived from natural sources (e.g., soybeans and corn provide lecithin to maintain product consistency; beets provide beet powder used as food coloring). Other ingredients are not found in nature and therefore must be synthetically produced as artificial ingredients. Also, some ingredients found in nature can be manufactured artificially and produced more economically, with greater purity and more consistent quality, than their natural counterparts. For example, vitamin C or ascorbic acid may be derived from an orange or produced in a laboratory. Food ingredients are subject to the same strict safety standards regardless of whether they are naturally or artificially derived. (Source: FDA)

How do they add vitamins and minerals to fortified cereals?

Adding nutrients to a cereal can cause taste and color changes in the product. This is especially true with added minerals. Since no one wants cereal that tastes like a vitamin supplement, a variety of techniques are employed in the fortification process. In general, those nutrients that are heat stable (such as vitamins A and E and various minerals) are incorporated into the cereal itself (they're baked right in). Nutrients that are not stable to heat (such as B-vitamins) are applied directly to the cereal after all heating steps are completed. Each cereal is unique -- some can handle more nutrients than others can. This is one reason why fortification levels are different across all cereals. (Source: FDA)

What is the role of modern technology in producing food additives?

Many new techniques are being researched that will allow the production of additives in ways not previously possible. One approach is the use of biotechnology, which can use simple organisms to produce food additives. These additives are the same as food components found in nature. In 1990, FDA approved the first bioengineered enzyme, rennin, which traditionally had been extracted from calves' stomachs for use in making cheese. (Source: FDA)