Backgrounder On Food Additives Despite their association with modern-day food production, food additives have been used for centuries. Our ancestors used salt to preserve meats and fish; added herbs and spices to improve the flavor of foods; preserved fruit with sugar; and pickled or canned vegetables such as cucumbers with vinegar. Additives have been used for many years to preserve, flavor, blend, thicken and color foods, and have played an important role in reducing serious nutritional deficiencies among Americans. Additives help assure the availability of wholesome, appetizing and affordable foods that meet consumer demands from season to season. Today, food and color additives are more strictly regulated than at any time in history. Federal regulations require evidence that each substance is safe at its intended level of use before it may be added to foods. All additives are subject to ongoing safety review as scientific understanding and methods of testing continue to improve. What Is A Food Additive? What is considered 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. Usage in Food Additives perform a variety of useful functions in foods that we often take for granted. Since we are no longer an agrarian society, additives help to keep food wholesome and appealing while en route to markets. During this journey, food is subjected to a number of factors such as temperature changes, oxidation, exposure to microbes, etc., which can change their original composition. Additives play a key role in maintaining food qualities and characteristics consumers demand. There are five main uses for food additives: To maintain product consistency. What makes salt flow freely? How can salad dressings and peanut butter stay smooth and not separate? Certain ingredients such as emulsifiers, stabilizers, thickeners and anti-caking agents help ensure consistent food texture and characteristics. To improve or maintain nutritional value. Nutrients in food can either be lacking or lost during processing. Cereals, milk, margarine and other foods can be enriched or fortified by additives such as vitamins A and D, iron, ascorbic acid, calcium carbonate, niacin, riboflavin, folic acid, zinc oxide and thiamin. To maintain palatability and wholesomeness. Foods naturally lose flavor and freshness due to aging and exposure to natural elements such as mold, air, bacteria, fungi or yeast. Preservatives such as ascorbic acid, butylated hydroxyanisole (BHA), buylated hydroxytoluene (BHT) and sodium nitrite help to slow product spoilage and rancidity while maintaining taste. To provide leavening or control acidity/alkalinity. Leavening agents help cakes, biscuits and other goods to rise during baking. Other additives help modify the acidity and alkalinity of foods for proper flavor, taste and color. To enhance flavor or impart desired color. Many spices and natural and synthetic flavors enhance the taste of foods. Colors, likewise, enhance the appearance of certain foods to meet consumer expectations. Regulation of Additives The Federal Food, Drug and Cosmetic (FD&C) Act of 1938 gave the Food and Drug Administration (FDA) authority over food and food ingredients. Passed in 1958, the Food Additives Amendment to the FD&C Act requires FDA approval for the use of an additive prior to its inclusion in food. It also requires the manufacturer to prove an additive's safety for the ways it will be used. Two groups of substances were exempt from the Food Additives Amendment. Substances sanctioned by FDA or USDA prior to 1958 and substances considered generally recognized as safe (GRAS). These include substances such as salt, sugar, spices, vitamins and monosodium glutamate among several hundred others. Since 1958, FDA and USDA have continued to monitor all prior sanctioned and GRAS substances in response to new scientific information and evidence on the safety of these substances. Similar legislation governing color additives was passed in 1960 called the Color Additive Amendments to the FD&C Act. Both the Food Additives Amendment and the Color Additive Amendments include a provision which prohibits the approval of an additive if it is found to cause cancer in humans or animals. This clause is often referred to as the Delaney Clause, named for its congressional sponsor, Rep. James Delaney (D-N.Y.). Regulations known as Good Manufacturing Practices (GMP) limit the amount of food and color additives used in foods to achieve the desired effect. Color Additives All color additives permitted for use in foods are classified as "certifiable" or "exempt from certification." Certifiable color additives are man-made, with each batch being tested by the manufacturer and FDA. This approval process, known as color additive certification, assures the safety, quality, consistency and strength of the color additive prior to its use in foods. There are nine certified colors approved for use in the United States. Color additives that are exempt from certification include pigments derived from natural sources such as vegetables, minerals or animals, and man-made counterparts of natural derivatives. Whether a color additive is manufactured from natural sources (such as beets which provide beet coloring) or are man-made (such as FD&C Red No. 3) has no bearing on its safety. Artificial color additives can be produced more economically, with greater purity and more consistent quality than some of their natural counterparts. FDA Approval Approximately 100 new food and color additive petitions are submitted to FDA annually. Most of these petitions are for indirect additives such as packaging materials. A food or color additive petition must provide convincing evidence that the proposed additive performs as it is intended. Upon approval, FDA issues regulations including the types of foods in which an additive can be used, the maximum amounts to be used, and how it must be identified on food labels. Additives proposed for use in meat and poultry products also must receive specific authorization by USDA. FDA operates an Adverse Reaction Monitoring System (ARMS) to help serve as an ongoing safety check of all additives. The system monitors and investigates all complaints by individuals or their physicians that are believed to be related to specific foods; food and color additives; or vitamin and mineral supplements. The ARMS computerized database helps officials decide whether reported adverse reactions represent a real public health hazard associated with food, so that appropriate action can be taken. Additives and Hyperactivity In the 1970s, it was suggested by some scientists that food additives may be linked to childhood hyperactivity. Well-controlled studies conducted since that time, however, have produced no evidence that food additives cause hyperactivity or learning disabilities in children. A Consensus Development Panel of the National Institutes of Health (NIH) concluded in 1982 that there was no scientific evidence to support the claim that additives or colorings cause hyperactivity. Scientific studies conducted since the early 1980s continue to support the NIH panel's conclusion. Reprinted from the International Food Information Council Foundation, 1995

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