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International Food Information Council (IFIC) Foundation ingredients & US Food and Administration (FDA)

or centuries, ingredients have served useful functions in a variety Fof . Our ancestors used to preserve meats and fish, added herbs and spices to improve the of foods, preserved fruit with , and pickled cucumbers in a solution. Today, consumers demand and enjoy a food supply that is flavorful, nutritious, safe, convenient, colorful and affordable. Food additives and advances in technology help make that possible. There are thousands of ingredients used to make foods. The Food and Drug Administration (FDA) maintains a list of over 3000 ingredients in its data base “Everything Added to Food in the United Why Are Food and they help control contamination States”, many of which we use at home Ingredients Added to Food? that can cause foodborne illness, every day (e.g., sugar, baking soda, salt, Additives perform a variety of useful including life-threatening botu- vanilla, yeast, spices and colors). functions in foods that consumers lism. One group of Still, some consumers have concerns often take for granted. Some additives — antioxidants — prevents and oils and the foods containing about additives because they may see could be eliminated if we were willing them from becoming rancid or the long, unfamiliar names and think of to grow our own food, harvest and grind it, spend many hours cooking developing an off-flavor. They also them as complex chemical compounds. and canning, or accept increased risks prevent cut fresh fruits such as In fact, every food we eat — whether a just- of food spoilage. But most consumers apples from turning when picked strawberry or a homemade cookie — today rely on the many technological, exposed to air. is made up of chemical compounds that aesthetic and convenient benefits that 2) To Improve or Maintain determine flavor, color, texture and nutrient additives provide. Nutritional Value: value. All food additives are carefully regu- Following are some reasons why and minerals (and fiber) are added lated by federal authorities and various inter- ingredients are added to foods: to many foods to make up for national organizations to ensure that foods 1) To Maintain or Improve those lacking in a person’s diet or are safe to eat and are accurately labeled. Safety and Freshness: lost in processing, or to enhance the nutritional quality of a food. The purpose of this brochure is to Preservatives slow product spoilage Such fortification and enrichment provide helpful background information caused by mold, air, bac- teria, fungi or yeast. In has helped reduce malnutrition in about food and color additives: addition to maintaining the U.S. and worldwide. All prod- what they are, why they are used the quality of ucts containing added nutrients in foods and how they are the food, must be appropriately labeled. regulated for safe use.

1 Types of Food Ingredients The following summary lists the types of common food ingredients, why they are used, and some examples of the names that can be found on product labels. Some additives are used for more than one purpose.

Types of Ingredients What They Do Examples of Uses

Preservatives Prevent food spoilage from bacteria, molds, fungi, or yeast Fruit sauces and jellies, beverages, baked goods, cured (antimicrobials); slow or prevent changes in color, flavor, or texture meats, oils and , cereals, dressings, snack and delay rancidity (antioxidants); maintain freshness foods, fruits and vegetables

Sweeteners Add with or without the extra calories Beverages, baked goods, confections, table-top sugar, substitutes, many processed foods

Color Additives Offset color loss due to exposure to , air, temperature extremes, Many processed foods, (, snack foods, , moisture and storage conditions; correct natural variations in color; cheese, soft drinks, jams/jellies, gelatins, pudding and pie enhance colors that occur naturally; provide color to colorless and fillings) “fun” foods

Flavors and Spices Add specific (natural and synthetic) Pudding and pie fillings, mixes, mixes, salad dressings, candies, soft drinks, ice , BBQ sauce

Flavor Enhancers Enhance flavors already present in foods (without providing their own Many processed foods separate flavor)

Fat Replacers (and components of Provide expected texture and a creamy “mouth-feel” in reduced- Baked goods, dressings, frozen desserts, confections, cake formulations used to replace fats) foods and dessert mixes, dairy products

Nutrients Replace vitamins and minerals lost in processing (enrichment), add Flour, breads, cereals, , macaroni, margarine, salt, nutrients that may be lacking in the diet (fortification) , fruit beverages, energy bars, instant breakfast drinks

Emulsifiers Allow smooth mixing of ingredients, prevent separation, keep Salad dressings, peanut , , margarine, emulsified products stable, reduce stickiness, control crystallization, frozen desserts keep ingredients dispersed, and to help products dissolve more easily

Stabilizers and Thickeners, Produce uniform texture, improve “mouth-feel” Frozen desserts, dairy products, , pudding and Binders, Texturizers gelatin mixes, dressings, jams and jellies, sauces

Leavening Agents Promote rising of baked goods Breads and other baked goods

Anti-caking agents Keep powdered foods free-flowing, prevent moisture absorption Salt, baking powder, confectioner’s sugar

Humectants Retain moisture Shredded coconut, marshmallows, soft candies, confections

Yeast Nutrients Promote growth of yeast Breads and other baked goods

Dough Strengtheners and Produce more stable dough Breads and other baked goods Conditioners

Firming Agents Maintain crispness and firmness Processed fruits and vegetables

Enzyme Preparations Modify , polysaccharides and fats Cheese, dairy products, meat

Gases Serve as propellant, aerate, or create carbonation Oil cooking spray, whipped cream, carbonated beverages

2 3) Improve Taste, Texture and Appearance: Spices, natural and artificial flavors, and sweeteners are Names Found on Product Labels added to enhance the taste of food. Food colors maintain or improve Ascorbic , , , calcium propionate, sodium erythorbate, sodium nitrite, calcium appearance. Emulsifiers, stabilizers sorbate, potassium sorbate, BHA, BHT, EDTA, tocopherols ( E) and thickeners give foods the texture and consistency consumers expect. Leavening agents allow baked goods to (sugar), , , sorbitol, mannitol, corn syrup, high fructose corn syrup, , , , (acesulfame-K), rise during baking. Some additives help control the acidity and alkalinity FD&C Nos. 1 and 2, FD&C No. 3, FD&C Nos. 3 and 40, FD&C No. 5 () and of foods, while other ingredients help No. 6, B, Citrus Red No. 2, extract, beta-carotene, grape skin extract, extract or maintain the taste and appeal of foods , paprika oleoresin, color, fruit and vegetable juices, (Note: Exempt color additives are with reduced fat content. not required to be declared by name on labels but may be declared simply as colorings or color added) What Is a ? Natural flavoring, artificial flavor, and spices 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 Monosodium glutamate (MSG), hydrolyzed soy , autolyzed yeast extract, disodium guanylate or expected to result — directly or indirectly inosinate — in its becoming a component or other- , cellulose , carrageenan, polydextrose, modified food starch, microparticulated egg protein, wise affecting the characteristics of any guar gum, xanthan gum, whey protein concentrate food.” This definition includes any sub- stance used in the production, processing, Thiamine hydrochloride, (Vitamin B2), niacin, niacinamide, folate or folic acid, beta carotene, treatment, packaging, transportation or potassium iodide, iron or ferrous sulfate, alpha tocopherols, ascorbic acid, , amino storage of food. The purpose of the legal (L-tryptophan, L-lysine, L-leucine, L-methionine) definition, however, is to impose a pre- Soy lecithin, mono- and diglycerides, egg yolks, polysorbates, sorbitan monostearate market approval requirement.

Gelatin, pectin, guar gum, carrageenan, xanthan gum, whey

Baking soda, monocalcium phosphate,

Calcium silicate, iron ammonium citrate, silicon dioxide

Glycerin, sorbitol

Calcium sulfate, ammonium phosphate

Ammonium sulfate, azodicarbonamide, L-

Calcium chloride, calcium lactate

Enzymes, lactase, papain, rennet, chymosin

Carbon dioxide,

3 be brown, margarine wouldn’t be yellow and mint 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 pro- duced (or human made) and used wide- ly because they impart an intense, uni- form color, are less expensive, and blend more easily to create a variety of . 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 Therefore, this definition excludes ingre- the U.S. Food and Drug Administration to foods. dients whose use is (FDA) that all materials coming in con- • Colors that are exempt from certifica- generally recognized tact with food are safe before they tion include derived from as safe (where govern- are permitted for use in such a natural sources such as vegetables, min- ment approval is not manner. erals or animals. Nature derived color needed), those ingredi- additives are typically more expensive ents approved for use by What Is a Color than certified colors and may add unin- FDA or the U.S. Additive? tended flavors to foods. Examples of Department of Agriculture A color additive is any , exempt colors include annatto extract prior to the food additives or substance which (yellow), dehydrated beets (bluish-red provisions of law, and color when added or applied to a to brown), caramel (yellow to tan), additives and pesticides food, drug or cosmetic, or to beta-carotene (yellow to orange) and where other legal premarket the human body, is capable grape skin extract (red, green). approval requirements apply. (alone or through reactions Direct food additives are those with other substances) of imparting How Are Additives Approved that are added to a food for a specific color. FDA is responsible for regulat- for Use in Foods? purpose in that food. For example, xan- ing all color additives to ensure that Today, food and color additives are more than gum — used in salad dressings, foods containing color additives are safe strictly studied, regulated and monitored chocolate milk, bakery fillings, puddings to eat, contain only approved ingredients than at any other time in history. FDA and other foods to add texture — is a and are accurately labeled. has the primary legal responsibility for direct additive. Most direct additives are Color additives are used in foods for determining their safe use. To market a identified on the ingredient label of foods. many reasons: 1) to offset color loss due new direct food additive or color additive Indirect food additives are those that to exposure to light, air, temperature for use in food (or before using an additive become part of the food in trace amounts extremes, moisture and storage already approved for one use in another due to its packaging, storage or other conditions; 2) to correct natural manner not yet approved), a manufacturer handling. For instance, minute amounts variations in color; 3) to enhance colors or other sponsor must first petition FDA of packaging substances may find their that occur naturally; and 4) to provide for its approval. These petitions must way into foods during storage. Food color to colorless and “fun” foods. provide evidence that the substance is packaging manufacturers must prove to Without color additives, wouldn’t safe for the ways in which it will be used.

4 As a result of a 1997 Because of inherent continues to be within safe limits. statutory change, limitations of science, If new evidence suggests that a prod- indirect additives are FDA can never be uct already in use may be unsafe, or if approved via a premarket absolutely certain of the consumption levels have changed enough notification process requiring absence of any risk from the use to require another look, federal authori- the same data as was previously of any substance. Therefore, FDA must ties may prohibit its use or conduct fur- required by petition. determine — based on the best science ther studies to determine if the use can When evaluating the safety of a available — if there is a reasonable cer- still be considered safe. substance and whether it should be tainty of no harm to consumers when an Regulations known as Good approved, FDA considers: 1) the additive is used as proposed. Manufacturing Practices (GMP) limit the composition and properties of the If an additive is approved, FDA issues amount of food ingredients used in foods substance, 2) the amount that would regulations that may include the types of to the amount necessary to achieve the typically be consumed, 3) immediate and foods in which it can be used, the maxi- desired effect. long-term health effects, and 4) various mum amounts to be used, and how it safety factors. The evaluation determines should be identified on food labels. In Summary an appropriate level of use that includes a 1999, procedures changed so that FDA Food ingredients have built-in safety margin — a factor that now consults with USDA during the been used for many years allows for uncertainty about the levels of review process for ingredients that are to preserve, flavor, consumption that are expected to be proposed for use in meat and poultry blend, thicken harmless. In other words, the levels of use products. Federal officials then monitor and color foods, that gain approval are much lower than the extent of Americans’ consumption of and have played what would be expected to have any the new additive and results of any new an important role adverse effect. research on its safety to ensure its use in reducing serious nutritional deficiencies among consumers. These ingredients also help ensure the availability of flavorful, nutri- tious, safe, convenient, colorful and affordable foods that meet consumer expectations year-round. Food and color additives are strictly studied, regulated and monitored. Federal Under the Food Additives Amendment, two groups of ingredients regulations require evidence that each were exempted from the regulation process. substance is safe at its intended level of use before it may be added to foods. GROUP I — Prior-sanctioned substances — are substances that FDA Furthermore, all additives are subject to or USDA had determined safe for use in food prior to the 1958 amendment. ongoing safety review as scientific under- Examples are sodium nitrite and potassium nitrite used to standing and methods of testing continue to improve. Consumers should feel safe preserve luncheon meats. about the foods they eat. GROUP II — GRAS (generally recognized as safe) ingredients — are those that are generally recognized by experts as safe, based on their exten- sive history of use in food before 1958 or based on published scientific evi- dence. 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.

5 About Food and Questions & Answers Color Additives Q&A

How are ingredients listed Q on a product label? Food manufacturers are required to A 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 tured as powders, granules, liquids or of the National Institutes of Health con- “flavors,”“spices,”“artificial flavoring,” or other special-purpose forms. They can cluded in 1982 that for some children in the case of color addi- be used in beverages, dry mixes, baked with attention deficit hyperactivity dis- tives exempt from goods, confections, dairy products, pet order (ADHD) and confirmed food certification (unless foods and a variety of other products. allergy, dietary modification has pro- otherwise required Lakes are the insoluble form of duced some improvement in behavior. by regulation), the dye. Lakes are more stable than Although the panel said that elimination “artificial colors,” and are ideal for coloring products con- diets should not be used universally to without naming taining fats and oils or items lacking suf- treat childhood hyperactivity, since there each one. Declaration ficient moisture to dissolve dyes. Typical is no scientific evidence to predict which of an allergenic ingredi- uses include coated tablets, cake and donut children may benefit, the panel recog- ent in a collective or single color, flavor, mixes, hard candies and chewing gums. nized that initiation of a trial of dietary or spice could be accomplished by simply treatment or continuation of a diet in naming the allergenic ingredient in the Do additives cause patients whose families and physicians ingredient list. Q childhood hyperactivity? perceive benefits may be warranted. However, a 1997 review published in the What are dyes and lakes in Although this hypothesis was popu- Journal of the American Academy of Child Q color additives? A larized in the 1970's, results from & Adolescent Psychiatry noted there is studies on this issue either have been minimal evidence of efficacy and Certified color additives are cate- inconclusive, inconsistent, or difficult to extreme difficulty inducing children and gorized as either dyes or lakes. A interpret due to inadequacies in study adolescents to comply with restricted Dyes dissolve in water and are manufac- design. A Consensus Development Panel diets. Thus, dietary treatment should not

6 be recommended, except possibly with a Are certain people sensitive to Individuals who have concerns about small number of preschool children who Q FD&C Yellow No. 5 in foods? possible adverse effects from food addi- may be sensitive to tartrazine, known tives or other substances should contact commonly as FD&C Yellow No.5 (See FD&C Yellow No. 5, is used to color their physicians. question below). In 2007, synthetic certi- A beverages, dessert powders, , fied color additives again came under ice cream, custards and other foods. How do they scrutiny following publication of a study FDA’s Committee on Q add vitamins commissioned by the UK Food Standards Hypersensitivity to Food and minerals to Agency to investigate whether certain color Constituents concluded in 1986 fortified cereals? additives cause hyperactivity in children. that FD&C Yellow No. 5 might Adding nutrients Both the FDA and the European Food cause hives in fewer than one out of to a cereal can Safety Authority independently reviewed 10,000 people. It also concluded that A cause taste and color the results from this study and each has there was no evidence the color additive changes in the product. This is concluded that the study does not substan- in food provokes asthma attacks. The law especially true with added minerals. Since tiate a link between the color additives now requires Yellow No.5 to be identified no one wants cereal that tastes like a vita- that were tested and behavioral effects. on the ingredient line. This allows the few who may be sensitive to the color to min supplement, a variety of techniques are employed in the fortification process. What is the difference avoid it. In general, those nutrients that are heat between natural and artificial Q stable (such as vitamins A and E and var- ingredients? Is a naturally produced Do low-calorie sweeteners ious minerals) are incorporated into the ingredient safer than an artificially Q cause adverse reactions? cereal itself (they’re baked right in). manufactured ingredient? No. experts generally Nutrients that are not stable to heat (such Natural ingredients are derived A agree there is no convincing evi- as B-vitamins) are applied directly to the A from natural sources (e.g., soybeans dence of a cause and effect relationship cereal after all heating steps are complet- and corn provide lecithin to maintain between these sweeteners and negative ed. Each cereal is unique — some can product consistency; beets pro- health effects in humans. The handle more nutrients than others can. vide beet powder used as FDA has monitored consumer This is one reason why fortification levels ). Other ingre- complaints of possible are different across all cereals. dients are not found in adverse reactions for more nature and therefore must than 20 years. What is the role of modern be synthetically produced For example, in carefully Q technology in producing as artificial ingredients. Also, controlled clinical studies, food additives? some ingredients found in aspartame has not been shown Many new techniques are being nature can be manufactured arti- to cause adverse or allergic reac- researched that will allow the pro- ficially and produced more economi- tions. However, persons with a rare A duction of additives in ways not previ- cally, with greater purity and more con- hereditary disease known as phenylke- ously possible. One approach is the use sistent quality, than their natural counter- tonuria (PKU) must control their intake of biotechnology, which can use simple parts. For example, vitamin C or ascorbic of from all sources, includ- organisms to produce food additives. acid may be derived from an orange or ing aspartame. Although aspartame con- These additives are the same as food produced in a laboratory. Food ingredi- tains only a small amount of phenylala- components found in nature. In 1990, ents are subject to the same strict safety nine, labels of aspartame-containing FDA approved the first bioengineered standards regardless of whether they are foods and beverages must include a state- , rennin, which traditionally had naturally or artificially derived. ment advising phenylketonurics of the been extracted from calves’ stomachs for presence of phenylalanine. use in making cheese.

7 Additional information is available from the following organizations:

Food and Drug Administration MEAT AND POULTRY HOTLINE: American Dietetic Association www.fda.gov 1-800-535-4555; (ADA) Center for Food Safety and Applied TTY: 1-800-256-7072 www.eatright.org Nutrition (CFSAN) Email: [email protected] 216 W. Jackson Blvd. www.fda.gov/Food Chicago, IL 60606-6995 Food and Nutrition Information Center 5100 Paint Branch Parkway www.nal.usda.gov/fnic/ 312-899-0040 College Park, MD 20740-3835 USDA Ag Research Service The and Anaphylaxis COLORADDITIVESINFORMATION 10301 Baltimore Ave. Network (FAAN) www.fda.gov/ForIndustry/ColorAdditives Beltsville, MD 20705-2351 www.foodallergy.org 301-504-5719 TOLLFREEINFORMATIONLINE: 11781 Lee Jackson Hwy. Email: [email protected] 1-888-SAFEFOOD (723-3366) Suite 160 International Food Information Fairfax, VA 22033 U.S. Department of Agriculture Council (IFIC) Foundation 1-800-929-4040 Food Safety and Inspection Service www.foodinsight.org Email: [email protected] www.fsis.usda.gov Food Safety Education Staff COLORADDITIVEINFORMATIONKEYWORDS: Institute of Food Technologists 1400 Independence Ave., SW food colors, hyperactivity (IFT) Room 2932-S 1100 Connecticut Ave., NW www.ift.org Washington, DC 20250-3700 Suite 430 525 West Van Buren Suite 1000 FOODADDITIVESINFORMATION Washington, DC 20036 Chicago, IL 60607 www.fsis.usda.gov/Fact_Sheets/Additives 202-296-6540 _in_Meat_&_Poultry_Products/index.asp Email: [email protected] 1-800-IFT-FOOD (438-3663) November 2004; revised April 2010 This document was prepared under a partnering agreement between the Food and Drug Administration (FDA) and the International Food Information Council (IFIC) Foundation to provide vital information to consumers on food safety. This partnership agreement does not constitute an endorsement of any products or organizations that support IFIC or the International Food Information Council Foundation.

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