PDF Version People have always sought ways to prolong food’s freshness after harvest and slaughter, so that it can be safely eaten at a later time. Archeological evidence shows that the ancient Egyptians ate foods that were not only cooked and baked, but also dried, salted, and fermented. These foods were processed to preserve them. The ancient Chinese discovered that fruit could be ripened by placing it near a kerosene lamp. Neither of these civilizations understood the science behind why these processes worked, but they readily embraced them.
Food additives have been used for centuries, despite their association with modern-day food production. 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.
Today, we have the luxury of living in a time when processes such as canning and freezing are commonplace, when refrigeration and access to a myriad of ingredients and spices make it possible to literally eat any type of food whenever desired. The basic purpose behind processing food is not only to make it safe to eat at a later date, but also look, taste and smell as enticing and as close to freshly prepared as possible. Much of the availability, convenience and variety that Western civilization enjoys in its food supply is directly due to food processing. Food processing often uses specific ingredients added to foods to maintain the sensory properties of the food. These food additives are one of the many things that allow consumers to enjoy crunchy cookies, tender pot roast, moist breads, and crisp salads. Since food that doesn’t taste, look, or smell good won’t be eaten, food additives are an essential ingredient in our food supply.
What Is a Food Additive?
A food additive, in its broadest sense, is any substance added to food. According to regulations 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.
Additives can be used as ingredients to preserve, flavor, blend, enhance the texture, and color food. They play an important role in reducing serious nutritional deficiencies and promoting food safety. Their use ensures the availability of wholesome, appetizing, and affordable foods that meet consumer demands from season to season.
There are thousands of ingredients used to make foods. The Food and Drug Administration (FDA) maintains a list of more than 3000 ingredients in its database “Everything Added to Food in the United States,” many of which we use at home every day (e.g., sugar, baking soda, salt, vanilla, yeast, spices, and colors).
Still, some consumers have concerns about additives because they may see the long, unfamiliar names and think of them as complex chemical compounds. All food additives are carefully regulated by federal authorities and various international organizations to ensure that foods are safe to eat and are accurately labeled. Federal regulations require scientific evidence that each substance is safe at its intended level of use before it may be used in food. All additives are subject to ongoing safety reviews as scientific understanding and methods of testing continue to improve. In addition, regulations known as Good Manufacturing Practices (GMP) limit the amount of food and color additives used to the level necessary to achieve their desired effect.
Why Are Food and Color Ingredients Added to Food?
Additives perform a variety of useful functions in foods that consumers often take for granted. Some additives could be eliminated if we were willing to grow our own food, harvest and grind it, spend many hours cooking and canning, or accept increased risks of food spoilage. But most consumers today rely on the many technological, aesthetic, and convenient benefits that additives provide.
- To Maintain or Improve Safety and Freshness: Preservatives slow product spoilage caused by yeast, mold, bacteria, fungi, or exposure to air. In addition to maintaining the quality of the food, they help control contamination that can cause foodborne illness. One group of preservatives—antioxidants—prevents fats and oils, and the foods containing them, from becoming rancid or developing an off-flavor. They also prevent cut fresh fruits such as apples from turning brown when exposed to air. Examples of preservatives include ascorbic acid, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), and sodium nitrite.
- To Improve or Maintain Nutritional Value: Vitamins and minerals (and fiber) are added to many foods to make up for those lacking in a person’s diet or lost in processing, or to enhance the nutritional quality of a food. Generally, enrichment refers to the restoration of nutrients lost during food processing. In this case, the amount of nutrients added is approximately equal to the natural content in the food before processing. In fortification, the amount of nutrient added may be higher than that present before processing. Fortification also standardizes the contents of nutrients that show variable concentrations. A typical example is the addition of vitamin C to orange juice to standardize vitamin C concentration and compensate for changes due to seasonal and processing variations. Such fortification and enrichment has helped reduce malnutrition in the U.S. and worldwide. Grains, flours, milk, margarine, and other foods are enriched or fortified by adding vitamins A and D, iron, ascorbic acid, calcium, niacin, riboflavin, folic acid, zinc, and thiamin. All products containing added nutrients must be appropriately labeled.
- To Improve Taste, Texture, and Appearance: Spices, natural and artificial flavors, and sweeteners are added to enhance the taste of food. Food colors maintain or improve appearance. Emulsifiers, stabilizers and thickeners give foods the texture and consistency consumers expect. Leavening agents allow baked goods to rise during baking. Some additives help control the acidity and alkalinity of foods, while other ingredients help maintain the taste and appeal of foods with reduced fat content.
Other Types and Examples of Food Additives
Low-Calorie Sweeteners
Low-calorie sweeteners add a sweet flavor to foods without adding a significant amount of calories. Most low-calorie sweeteners are generally several hundred to several thousand times sweeter than sucrose (table sugar). While most do not contain any calories, those that do (e.g., aspartame) are used in very small amounts because of their concentrated sweetening power, and thus do not contribute a significant amount of calories. Unlike sucrose, low-calorie sweeteners do not affect insulin levels and can provide a sweet flavor to foods and beverages for people who must limit carbohydrates in their diets, such as people with diabetes. In addition, low-calorie sweeteners do not cause dental cavities (tooth decay).
There are five low-calorie sweeteners currently approved by the Food and Drug Administration (FDA) for use in the United States: acesulfame potassium (Ace-K), aspartame, neotame, saccharin, and sucralose. The table on page 3 summarizes the key traits of each sweetener.
| Low-Calorie Sweeteners Used in the United States |
| Acesulfame potassium | Aspartame | Neotame | Saccharin | Sucralose |
| Approximate Sweetening Power Compared with Sucrose | 200 times sweeter | 200 times sweeter | 7,000 to 13,000 times sweeter | 300 times sweeter | 600 times sweeter |
Metabolism/
Excretion | Not metabolized; excreted by the kidneys unchanged | Upon digestion, breaks down to aspartic acid, phenylalanine, and small amounts of methanol, all of which are metabolized normally | Quickly metabolized and fully eliminated via normal biological processes | Not metabolized; excreted by the kidneys unchanged | Not metabolized; excreted in the feces and urine |
| Date of Initial FDA Approval for Use in Foods | 1988 | 1981 | 2002 | 1900 | 1998 |
| Stability | Highly stable; can be used in cooking and baking | Loses sweetness when exposed to high heat; add to foods at end of cooking cycle | Highly stable; can be used in cooking and baking | Highly stable; can be used in cooking and baking | Highly stable; can be used in cooking and baking |
Food Colors
A color additive is any dye, pigment, or substance which when added or applied to a food 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.
| Certified Color Additives |
| FD&C Blue Nos. 1 and 2 |
| FD&C Green No. 3 |
| FD&C Red Nos. 3 and 40 |
| FD&C Yellow No. 5 (tartrazine) and No. 6 |
| Orange B |
| Citrus Red No. 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. Without color additives, colas wouldn’t be brown, margarine wouldn’t be yellow, and mint ice cream wouldn’t be green.
FDA’s permitted colors are subject to rigorous safety standards prior to their approval and listing for use in foods. Color additives used in foods fall into two groups: those that are subject to certification and those that are exempt from certification.
- Certified colors are synthetically produced (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 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).
Caffeine
Caffeine is a naturally occurring substance found in the leaves, seeds, or fruits of more than 60 plants. Food and beverages derived from cocoa beans, kola nuts, and tea leaves often contain some caffeine. In the United States, coffee is the chief source of dietary caffeine. In addition, caffeine is added to some foods and beverages as a flavoring.
Caffeine from coffee and tea beverages has been part of the world’s diet for thousands of years. Caffeine was classified as “generally recognized as safe” (GRAS) ingredient in 1958, when the FDA first reviewed all food additives for safety. Since that time, numerous studies have been conducted on caffeine and have shown that moderate amounts of caffeine—about 300 milligrams per day—are safe for most adults, including pregnant women.
The chart below provides information on the caffeine content of various foods and beverages.
| | Milligrams of Caffeine |
| Item | Typical | Range* |
| Coffee (8 fl. oz. cup) | | |
Brewed, drip method | 85 | 65–120 |
Brewed, percolator | 75 | 60–85 |
Decaffeinated, brewed | 3 | 2–4 |
Espresso (1 fl. oz. serving)
| 40 | 30–50 |
| Teas (8 fl. oz. cup) | | |
Brewed | 40 | 20–90 |
Instant | 28 | 24–31 |
Iced (8 fl. oz. glass) | 25 | 9–50 |
| Some soft drinks (8 fl. oz.) | 24 | 20–40 |
| Energy drinks (8 fl. oz.) | 75 | 72–75 |
| Cocoa beverage (8 fl. oz.) | 6 | 3–32 |
| Chocolate milk beverage (8 fl. oz.) | 5 | 2–7 |
| Milk chocolate (1 oz.) | 6 | 1–15 |
| Dark chocolate, semi-sweet (1 oz.) | 20 | 5–35 |
| Baker’s chocolate (1 oz.) 26 26 | | |
| Chocolate-flavored syrup (1 fl. oz.) | 4 | 4 |
*For the coffee and tea products, the range varies due to brewing method, plant
variety, brand of product, etc. |
| Source: Compiled by the International Food Information Council. |
Food Ingredient Labeling
Ingredient labeling is an important source of information for consumers about the composition of packaged foods. Federal food, meat, and poultry laws require a statement of ingredients on most food labels. Both FDA and United States Department of Agriculture (USDA) regulations require that ingredients be listed in order of their predominance in a food by their common, specific names.
Regulation of Food Additives and Ingredients
The Federal Food, Drug and Cosmetic Act (FDCA) of 1938 provides the FDA legal authority over food, food ingredients, and additives. The Food Additives Amendment to the FDCA, passed in 1958, 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. In 1960, the Color Additive Amendments to the FDCA requires that conditions for safe use of a color additive be established by regulation. Burden for proving safety is placed on the manufacturer.
Two groups of substances are exempt from the Food Additives Amendment. Substances sanctioned by the FDA or USDA prior to 1958 and substances generally recognized as safe (GRAS). These include substances such as salt, sugar, spices, caffeine, vitamins, monosodium glutamate (MSG), and several hundred other food ingredients. Since 1958, the FDA and USDA continue to monitor prior sanctioned and GRAS substances in response to new scientific information and evidence on the safety of these substances.
FDA Approval of Food Additives
Approximately 100 new food and color additive petitions are submitted to the FDA annually. A food or color additive petition must provide convincing evidence that the proposed additive performs as it is intended and is safe for human consumption under the intended conditions of use. Upon approval, the FDA issues regulations including the types of foods in which an additive can be used, the maximum amounts to be used, and how they must be identified on food labels. Additives proposed for use in meat and poultry products must also receive specific authorization by USDA.
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’ 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.
Food Additives and Health
The FDA operates the 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 a specific food, 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 risk associated with food so that appropriate action can be taken.
Both the Food Additives Amendment and the Color Additive Amendment include a provision that prohibits the approval of an additive if it is found to cause cancer in humans or animals. This clause, referred to as the Delaney Clause, says that no additive known to be carcinogenic can be approved for use in food in any amount. The enforcement of the Delaney clause presents a challenge for regulators. According to the FDA, regulators have faced a dilemma in light of technological advances that enable scientists to identify smaller and smaller concentrations of a substance and conduct more sensitive toxicological tests. Are such tiny amounts a health threat? Scientists have yet to answer this question. Congress has held hearings to examine the pros and cons of liberalizing the Delaney clause. Debates on the issue continue.
In the 1970s, some scientists suggested that food additives or colors may be linked to childhood hyperactivity. Since that time, well-controlled studies have been conducted and have produced no evidence that food additives or colors cause hyperactivity or learning disabilities in children. In 1982, the Consensus Development Panel of the National Institutes of Health (NIH) concluded that there was no scientific evidence to support the claim that additives or colorings cause hyperactivity. However, the panel noted that for some children with attention deficit hyperactivity disorder (ADHD) and confirmed food allergy, dietary modification has produced some improvement in behavior. 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. Subsequent scientific studies continue to support the NIH panel’s conclusion.1
1 Taylor and Dormedy, Allergy 1998;53: (Suppl.46) 80-82. Adverse reactions to tartrazine have been reported anecdotally but a cause and effect relationship has not been established in controlled challenge studies. There is even less firm evidence for allergic reactions to other synthetic (FDC approved) coloring materials. In these cases, there has been considerable controversy about the proper method to carry out blinded challenges.
Originally printed in the 2007-2009 IFIC Foundation Media Guide on Food Safety and Nutrition
