What are food additives

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” 1). 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 U.S. Food and Drug Administration (FDA) or the U.S. Department of Agriculture (USDA) 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.

Food additives can be used to 2):

Improve the taste or appearance of a processed food

  • Provide color and enhance flavor: Certain colors improve the appearance of foods. Many spices, as well as natural and man-made flavors, bring out the taste of food. For example, beeswax – glazing agent 3) may be used to coat apples to improve their appearance.
  • Give the food a smooth and consistent texture: Emulsifiers prevent liquid products from separating. Stabilizers and thickeners provide an even texture. Anticaking agents allow substances to flow freely.

Improve the keeping quality or stability of a food

  • Control the acid-base balance of foods and provide leavening: Certain additives help change the acid-base balance of foods to get a certain flavor or color. Leavening agents that release acids when they are heated react with baking soda to help biscuits, cakes, and other baked goods rise. For example, sorbitol – humectant 4) may be added to mixed dried fruit to maintain the moisture level and softness of the fruit.

Preserve food when this is the most practical way of extending its storage life.

  • Improve or preserve the nutrient value: Many foods and drinks are fortified and enriched to provide vitamins, minerals, and other nutrients. Examples of commonly fortified foods are flour, cereal, margarine, and milk. This helps make up for vitamins or minerals that may be low or lacking in a person’s diet. All products that contain added nutrients must be labeled.
  • Maintain the wholesomeness of foods: Bacteria and other germs can cause foodborne illnesses. Preservatives reduce the spoilage that these germs can cause. Certain preservatives help preserve the flavor in baked goods by preventing the fats and oils from going bad.
    Preservatives also keep fresh fruits from turning brown when they are exposed to the air. For example, sulphur dioxide – preservative 5) is added to some meat products such as sausage meat to limit microbial growth.

Many substances used as additives also occur naturally, such as vitamin C or ascorbic acid 6) in fruit, or lecithin 7), which is present in egg yolks, soya beans, peanuts and maize. The human body cannot distinguish between a chemical naturally present in a food and that same chemical present as an additive.

Side Effects of Food Additives

Most concerns about food additives have to do with man-made ingredients that are added to foods. Some of these are:

  • Antibiotics given to food-producing animals, such as chickens and cows
  • Antioxidants in oily or fatty foods
  • Artificial sweeteners, such as aspartame, saccharin, sodium cyclamate, and sucralose
  • Benzoic acid in fruit juices
  • Lecithin, gelatins, cornstarch, waxes, gums, and propylene glycol in food stabilizers and emulsifiers
  • Many different dyes and coloring substances
  • Monosodium glutamate (MSG)
  • Nitrates and nitrites in hot dogs and other processed meat products
  • Sulfites in beer, wine, and packaged vegetables

The United States Food and Drug Administration (FDA) has a list of food additives that are thought to be safe. Many have not been tested, but most scientists consider them safe. These substances are put on the “generally recognized as safe (GRAS)” list. This list contains about 700 items.

Congress defines safe as “reasonable certainty that no harm will result from use” of an additive. Examples of items on this list are: guar gum, sugar, salt, and vinegar. The list is reviewed regularly.

Some substances that are found to be harmful to people or animals may still be allowed, but only at the level of 1/100th of the amount that is considered harmful. For their own protection, people with any allergies or food intolerances should always check the ingredient list on the label. Reactions to any additive can be mild or severe. For example, some people with asthma have worsening of their asthma after eating foods or drinks that contain sulfites.

It is important to keep gathering information about the safety of food additives. Report any reactions you have to food or food additives to the FDA Center for Food Safety and Applied Nutrition (CFSAN). Information about reporting a reaction is available at: The Center for Food Safety and Applied Nutrition. (https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/ContactCFSAN/default.htm 8)

What Is a Color Additive ?

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).

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’ 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.

Regulations known as Good Manufacturing Practices (GMP) limit the amount of food ingredients used in foods to the amount necessary to achieve the desired effect.

Why Are Food and Color Ingredients Added to Food ?

Food additives perform a variety of useful functions in foods that consumers often take for granted. Some food 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.

Following are some reasons why food additives are added to foods 9):

  • To Maintain or Improve Safety and Freshness: Preservatives slow product spoilage caused by mold, air, bacteria, fungi or yeast. In addition to maintaining the quality of the food, they help control contamination that can cause foodborne illness, including life-threatening botulism. 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.
  • 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. Such fortification and enrichment has helped reduce malnutrition in the U.S. and worldwide. All products containing added nutrients must be appropriately labeled.
  • 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.

Common food additives

Acidity regulator

A food additive, which controls the acidity or alkalinity of a food. Added to beverages, frozen desserts, chocolate, low acid canned foods, baking powder.

Names Found on Product Labels: Lactic acid, citric acid, ammonium hydroxide, sodium carbonate.

  • acid
  • acidifier
  • acidity regulator
  • alkali
  • base
  • buffer
  • buffering agent
  • pH adjusting agent

Anticaking agent

Reduces the tendency of particles of food to adhere to one another. Keep powdered foods free-flowing, prevent moisture absorption. Added to Salt, baking powder, confectioner’s sugar.

Names Found on Product Labels: Calcium silicate, iron ammonium citrate, silicon dioxide.

  • anticaking agent
  • anti-stick agent
  • drying agent
  • dusting agent

Antifoaming agent

A food additive, which prevents or reduces foaming.

  • antifoaming agent
  • defoaming agent

Antioxidant

A food additive, which prolongs the shelf-life of foods by protecting against deterioration caused by oxidation.

  • antibrowning agent
  • antioxidant
  • antioxidant synergist

Bleaching agent

A food additive (non-flour use) used to decolourize food. Bleaching agents do not include pigments.

  • bleaching agent

Bulking agent

A food additive, which contributes to the bulk of a food without contributing significantly to its available energy value.

  • bulking agent
  • filler

Carbonating agent

A food additive used to provide carbonation in a food.

  • carbonating agent

Carrier

A food additive used to dissolve, dilute, disperse or otherwise physically modify a food additive or nutrient without altering its function (and without exerting any technological effect itself) in order to facilitate its handling, application or use of the food additive or nutrient.

  • carrier
  • carrier solvent
  • diluent for other food additives
  • encapsulating agent
  • nutrient carrier

Color

A food additive, which adds or restores colour in a food.

Names Found on Product Labels: FD&C Blue Nos. 1 and 2, FD&C Green No. 3, FD&C Red Nos. 3 and 40, FD&C Yellow Nos. 5 and 6, Orange B, Citrus Red No. 2, annatto extract, beta-carotene, grape skin extract, cochineal extract or carmine, paprika oleoresin, caramel color, fruit and vegetable juices, saffron (Note: Exempt color additives are not required to be declared by name on labels but may be declared simply as colorings or color added).

  • colour
  • decorative pigment
  • surface colorant

Color retention agent

A food additive, which stabilizes, retains or intensifies the colour of a food.

  • color adjunct
  • color fixative
  • color retention agent
  • color stabilizer.

Dough Strengtheners and Conditioners

Produce more stable dough. Added to breads and other baked goods.

Names Found on Product Labels: Ammonium sulfate, azodicarbonamide, L-cysteine

Emulsifier

A food additive, which forms or maintains a uniform emulsion of two or more phases in a food. Keep emulsified products stable, reduce stickiness, control crystallization, keep ingredients dispersed, and to help products dissolve more easily. Used in salad dressings, peanut butter, chocolate, margarine, frozen desserts

Names Found on Product Labels: Soy lecithin, mono- and diglycerides, egg yolks, polysorbates, sorbitan monostearate.

  • clouding agent
  • crystallization inhibitor
  • density adjustment agent (flavouring oils in beverages)
  • dispersing agent
  • emulsifier
  • plasticizer
  • surface active agent
  • suspension agent.

In a laboratory study involving mice 10) dietary emulsifiers promoted colon cancer in a mouse model by altering gut microbes and increasing gut inflammation. Our digestive tract is home to 100 trillion bacteria. Collectively known as the gut microbiota, these bacteria help with metabolism and maintaining a healthy immune system. Changes in this microbial community can cause chronic diseases. Dietary emulsifiers are added to many processed foods to improve texture and extend shelf life. Chemically similar to detergents, they have been shown to alter the mucus barrier and the microbes associated with it. To determine whether these might play a role in chronic diseases, the researchers fed mice low levels of 2 commonly used emulsifiers, carboxymethylcellulose or polysorbate-80, in drinking water or in food 11).

Mice fed the emulsifiers for 12 weeks developed low-grade intestinal inflammation and metabolic syndrome — a group of conditions that increase the risk for type 2 diabetes, heart disease, and stroke. Mice that were genetically engineered to be more prone to inflammation and gut microbe changes developed colitis when fed the emulsifiers.

Mice that consumed the emulsifiers had an altered bacterial composition and thinner intestinal mucus, so that bacteria were closer to the cells lining the colon. The mice also had weight gain, increased food consumption, increased fat mass, and impaired glucose handling, a sign of metabolic syndrome.

When the researchers fed emulsifiers to germ-free mice, which don’t have gut microbiota, the mice showed no signs of gut inflammation, mucus thinning, or metabolic syndrome. This suggests that the effects of the emulsifiers were most likely caused by altering gut bacteria.

When gut microbes from normal, emulsifier-fed mice were transplanted into germ-free mice that hadn’t been fed emulsifiers, the mice developed low grade inflammation, increased fat mass, and glucose intolerance. These results showed that changes in the gut microbiota caused by dietary emulsifiers can drive inflammation and metabolic changes.

Here, the researchers demonstrate in a preclinical model of colitis-induced colorectal cancer that regular consumption of dietary emulsifiers, carboxymethylcellulose or polysorbate-80, exacerbated tumor development. Enhanced tumor development was associated with an altered microbiota metagenome characterized by elevated levels of lipopolysaccharide and flagellin. We found that emulsifier-induced alterations in the microbiome were necessary and sufficient to drive alterations in major proliferation and apoptosis signaling pathways thought to govern tumor development. Overall, our findings support the concept that perturbations in host–microbiota interactions that cause low-grade gut inflammation can promote colon carcinogenesis.

The researchers are now testing additional emulsifiers. They are also designing experiments to examine the effects of food additives in humans.

Emulsifying salt

A food additive, which, in the manufacture of processed food, rearranges proteins in order to prevent fat separation.

  • emulsifying salt
  • emulsifying salt synergist
  • melding salt.

Enzyme Preparations

Modify proteins, polysaccharides and fats. Added to cheese, dairy products, meat.

Names Found on Product Labels: Enzymes, lactase, papain, rennet, chymosin

Fat Replacers (and components of formulations used to replace fats)

Provide expected texture and a creamy “mouth-feel” in reduced-fat foods. Used in baked goods, dressings, frozen desserts, confections, cake and dessert mixes, dairy products.

Names Found on Product Labels: Olestra, cellulose gel, carrageenan, polydextrose, modified food starch, microparticulated egg white protein, guar gum, xanthan gum, whey protein concentrate.

Firming agent

A food additive, which makes or keeps tissues of fruit or vegetables firm and crisp, or interacts with gelling agents to produce or strengthen a gel. Maintain crispness and firmness. Added to processed fruits and vegetables.

Names Found on Product Labels: Calcium chloride, calcium lactate, aluminium ammonium sulfate, aluminium sulfate

  • firming agent

Flavor and spices

Add specific flavors (natural and synthetic) to pudding and pie fillings, gelatin dessert mixes, cake mixes, salad dressings, candies, soft drinks, ice cream, BBQ sauce

Names Found on Product Labels: Natural flavoring, artificial flavor, and spices.

Flavor enhancer

A food additive, which enhances the existing taste and/or odour of a food.

Names Found on Product Labels: Monosodium glutamate (MSG), hydrolyzed soy protein, autolyzed yeast extract, disodium guanylate or inosinate.

  • flavour enhancer
  • flavour synergist

Flour treatment agent

A food additive, which is added to flour or dough to improve its baking quality or colour.

  • dough conditioner
  • dough strengthening agent
  • flour bleaching agent
  • flour improver
  • flour treatment agent

Foaming agent

A food additive, which makes it possible to form or maintain a uniform dispersion of a gaseous phase in a liquid or solid food.

  • aerating agent
  • foaming agent
  • whipping agent.

Gases

Serve as propellant, aerate, or create carbonation. Used with oil cooking spray, whipped cream, carbonated beverages.

Names Found on Product Labels: Carbon dioxide, nitrous oxide

Gelling agent

A food additive, which gives a food texture through formation of a gel.

  • gelling agent

Glazing agent

A food additive, which when applied to the external surface of a food, imparts a shiny appearance or provides a protective coating.

  • coating agent
  • film forming agent
  • glazing agent
  • polishing agent
  • sealing agent
  • surface-finishing agent

Humectant

A food additive, which prevents food from drying out by counteracting the effect of a dry atmosphere. Retain moisture. Added to shredded coconut, marshmallows, soft candies, confections.

Names Found on Product Labels: Glycerin, sorbitol.

Leavening Agents

Promote rising of baked goods. Used in breads and other baked goods.

Names Found on Product Labels: Baking soda, monocalcium phosphate, calcium carbonate.

Nutrients

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

Names Found on Product Labels: Thiamine hydrochloride, riboflavin (Vitamin B2), niacin, niacinamide, folate or folic acid, beta carotene, potassium iodide, iron or ferrous sulfate, alpha tocopherols, ascorbic acid, Vitamin D, amino acids (L-tryptophan, L-lysine, L-leucine, L-methionine).

Packaging gas

A food additive gas, which is introduced into a container before, during or after filling with food with the intention to protect the food, for example, from oxidation or spoilage.

  • packaging gas

Preservative

A food additive, which prolongs the shelf-life of a food by protecting against deterioration caused by microorganisms.

Names Found on Product Labels: Ascorbic acid, citric acid, sodium benzoate, calcium propionate, sodium erythorbate, sodium nitrite, calcium sorbate, potassium sorbate, BHA, BHT, EDTA, tocopherols (Vitamin E).

  • antimicrobial preservative
  • antimicrobial synergist
  • antimould and antirope agent
  • antimycotic agent
  • bacteriophage control agent
  • fungistatic agent
  • preservative

Propellant

A food additive gas, which expels a food from a container.

  • propellant

Raising agent

A food additive or a combination of food additives, which liberate(s) gas and thereby increase(s) the volume of a dough or batter.

  • raising agent

Sequestrant

A food additive, which controls the availability of a cation.

  • sequestrant

Stabilizer

A food additive, which makes it possible to maintain a uniform dispersion of two or more components.

  • binder
  • colloidal stabilizer
  • emulsion stabilizer
  • foam stabilizer
  • stabilizer
  • stabilizer synergist

Sweetener

A food additive (other than a mono- or disaccharide sugar), which imparts a sweet taste to a food.

Names Found on Product Labels: Sucrose (sugar), glucose, fructose, sorbitol, mannitol, corn syrup, high fructose corn syrup, saccharin, aspartame, sucralose, acesulfame potassium (acesulfame-K), neotame.

  • bulk sweetener
  • intense sweetener
  • sweetener

Thickener

A food additive, which increases the viscosity of a food. Produce uniform texture, improve “mouth-feel.” Used in frozen desserts, dairy products, cakes, pudding and gelatin mixes, dressings, jams and jellies, sauces.

Names Found on Product Labels: Gelatin, pectin, guar gum, carrageenan, xanthan gum, whey.

  • binder
  • bodying agent
  • texturizing agent
  • thickener
  • thickener synergist

Yeast Nutrients

Promote growth of yeast. Used in breads and other baked goods.

Names Found on Product Labels: Calcium sulfate, ammonium phosphate.

Food additives to avoid

Table 1. Banned Additives 

AdditiveFunctionProblem (Year Banned)
Artificial Colorings:
Butter yellowartificial coloringToxic, later found to cause liver cancer (1919)
Green 1artificial coloringLiver cancer (1965)
Green 2artificial coloringInsufficient economic importance to be tested (1965)
Orange 1artificial coloringOrgan damage (1956)
Orange 2artificial coloringOrgan damage (1960)
Orange Bartificial coloringContained low levels of a cancer-causing contaminant. Orange B was used only in sausage casings to color sausages, but is no longer used in the United States (1978, ban never finalized).
Red 1artificial coloringLiver cancer (1961)
Red 2artificial coloringPossible carcinogen (1976)
Red 4artificial coloringHigh levels damaged adrenal cortex of dog; after 1965 it was used only in maraschino cherries and certain pills; it is still allowed in externally applied drugs and cosmetics (1976).
Red 32artificial coloringDamages internal organs and may be a weak carcinogen; since 1956 it continues to be used under the name Citrus Red 2 only to color oranges (2 ppm) (1956).
Sudan 1artificial coloringToxic, later found to be carcinogenic (1919).
Violet 1artificial coloringCancer (it had been used to stamp the Department of Agriculture’s inspection mark on beef carcasses) (1973).
Yellow 1 & 2artificial coloringIntestinal lesions at high dosages (1959).
Yellow 3artificial coloringHeart damage at high dosages (1959).
Yellow 4artificial coloringHeart damage at high dosages (1959).
Other Additives:
agene (nitrogen trichloride)flour bleaching and aging agentDogs that ate bread made from treated flour suffered epileptic-like fits; the toxic agent was methionine sulfoxime (1949).
cinnamyl anthranilateartificial flavoringLiver cancer (1982)
cobalt saltsstabilize beer foamToxic effects on heart (1966)
coumarinnatural flavoringLiver poison (1970)
cyclamateartificial sweetenerBladder cancer, damage to testes; now not thought to cause cancer directly, but to increase the potency of other carcinogens (1969).
diethyl pyrocarbonate (DEPC)preservative (beverages)Combines with ammonia to form urethane, a carcinogen (1972)
dulcin (p-ethoxy-phenylurea)artificial sweetenerLiver cancer (1950)
ethylene glycolsolventKidney damage (1998)
monochloroacetic acidpreservativeHighly toxic (1941)
nordihydroguaiaretic acid (NDGA)plant-derived antioxidantKidney damage (1968 by FDA, 1971 by USDA)
oil of calamusnatural flavoringIntestinal cancer (1968)
polyoxyethylene-8-stearate (Myrj 45)emulsifierHigh levels caused bladder stones and tumors (1952)
safrolenatural flavoring (root beer)Liver cancer (1960)
thioureapreservativeLiver cancer (c. 1950)
[Source: Center for Science in the Public Interest 12)]

List of food additives

Table 2. Approved Food additives – alphabetical list 13)

ADDITIVE

NUMBER

Acacia or gum Arabic

414

Acesulphame potassium

950

Acetic acid, glacial

260

Acetic and fatty acid esters of glycerol

472a

Acetylated distarch adipate

1422

Acetylated distarch phosphate

1414

Acetylated oxidised starch

1451

Acid treated starch

1401

Adipic acid

355

Advantame

969

Agar

406

Alginic acid

400

Alitame

956

Alkaline treated starch

1402

Alkanet or Alkannin

103

Allura red AC

129

Aluminium

173

Aluminium silicate

559

Amaranth

123

Ammonium acetate

264

Ammonium adipates

359

Ammonium alginate

403

Ammonium carbonate

503

Ammonium chloride

510

Ammonium citrate

380

Ammonium fumarate

368

Ammonium hydrogen carbonate

503

Ammonium lactate

328

Ammonium malate

349

Ammonium phosphate, dibasic

342

Ammonium phosphate, monobasic or Ammonium dihydrogen phosphates

342

Ammonium salts of phosphatidic acid

442

α-Amylase

1100

Annatto extracts

160b

Anthocyanins or Grape skin extract or Blackcurrant extract

163

Arabinogalactan or larch gum

409

Ascorbic acid

300

Ascorbyl palmitate

304

Aspartame

951

Aspartame-acesulphame salt

962

Azorubine or Carmoisine

122

b-apo-8′-Carotenoic acid methyl or ethyl ester

160f

b-apo-8′-Carotenal

160e

Beeswax, white and yellow

901

Beet red

162

Bentonite

558

Benzoic acid

210

Bleached starch

1403

Bone phosphate

542

Brilliant black BN or Brilliant Black PN

151

Brilliant Blue FCF

133

Brown HT

155

Butane

943a

Butylated hydroxyanisole

320

Butylated hydroxytoluene

321

Calcium acetate

263

Calcium alginate

404

Calcium aluminium silicate

556

Calcium ascorbate

302

Calcium benzoate

213

Calcium carbonate

170

Calcium chloride

509

Calcium citrate

333

Calcium disodium ethylenediaminetetraacetate or calcium disodium EDTA

385

Calcium fumarate

367

Calcium gluconate

578

Calcium glutamate

623

Calcium hydroxide

526

Calcium lactate

327

Calcium lactylate

482

Calcium lignosulphonate (40-65)

1522

Calcium malate

352

Calcium oleyl lactylate

482

Calcium oxide

529

Calcium phosphate, dibasic or calcium
hydrogen phosphate

341

Calcium phosphate, monobasic or calcium dihydrogen phosphate

341

Calcium phosphate, tribasic

341

Calcium propionate

282

Calcium silicate

552

Calcium sorbate

203

Calcium stearoyl lactylate

482

Calcium sulphate

516

Calcium tartrate

354

Caramel I

150a

Caramel II

150b

Caramel III

150c

Caramel IV

150d

Carbon blacks or Vegetable carbon

153

Carbon dioxide

290

Carnauba wax

903

Carotene

160a

Carrageenan

407

Cellulose microcrystalline

460

Cellulose, powdered

460

Chlorophyll

140

Chlorophyll-copper complex

141

Chlorophyllin copper complex, sodium and potassium salts

141

Choline salts

1001

Citric acid

330

Citric and fatty acid esters of glycerol

472c

Cochineal or carmines or carminic acid

120

Cupric sulphate

519

Curcumin or turmeric

100

Cyclamate or calcium cyclamate or sodium cyclamate

952

Dextrin roasted starch

1400

Diacetyltartaric and fatty acid esters of glycerol

472e

Dioctyl sodium sulphosuccinate

480

Disodium-5′-ribonucleotides

635

Disodium-5′-guanylate

627

Disodium-5′-inosinate

631

Distarch phosphate

1412

Dodecyl gallate

312

Enzyme treated starches

1405

Erythorbic acid

315

Erythritol

968

Erythrosine

127

Ethyl lauroyl arginate

243

Ethyl maltol

637

Fatty acid salts of aluminium, ammonia, calcium, magnesium, potassium and sodium

470

Fast green FCF

143

Ferric ammonium citrate

381

Ferrous gluconate

579

Flavoxanthin

161a

Fumaric acid

297

Gellan gum

418

Glucono δ-lactone or Glucono
delta-lactone

575

Glucose oxidase

1102

L-glutamic acid

620

Glycerin or glycerol

422

Glycerol esters of wood rosins

445

Glycine

640

Gold

175

Green S

142

Guar gum

412

4-hexylresorcinol

586

Hydrochloric acid

507

Hydroxypropyl cellulose

463

Hydroxypropyl distarch phosphate

1442

Hydroxypropyl methylcellulose

464

Hydroxypropyl starch

1440

Indigotine

132

Iron oxide

172

Isobutane

943b

Isomalt

953

Karaya gum

416

Kryptoxanthin

161c

L-cysteine monohydrochloride

920

L-Leucine

641

Lactic acid

270

Lactic and fatty acid esters of glycerol

472b

Lactitol

966

Lecithin

322

Lipases

1104

Locust bean gum or carob bean gum

410

Lutein

161b

Lycopene

160d

Lysozyme

1105

Magnesium carbonate

504

Magnesium chloride

511

Magnesium gluconate

580

Magnesium glutamate

625

Magnesium lactate

329

Magnesium oxide

530

Magnesium phosphate, dibasic

343

Magnesium phosphate, monobasic

343

Magnesium phosphate, tribasic

343

Magnesium silicate or Talc

553

Magnesium sulphate

518

Malic acid

296

Maltitol and maltitol syrup or hydrogenated glucose syrup

965

Maltol

636

Mannitol

421

Metatartaric acid

353

Methyl ethyl cellulose

465

Methyl cellulose

461

Methylparaben or Methyl-p-hydroxy-benzoate

218

Mixed tartaric, acetic and fatty acid esters of glycerol or tartaric, acetic and fatty acid esters of glycerol (mixed)

472f

Mono- and di-glycerides of fatty acids

471

Monoammonium L-glutamate

624

Monopotassium L-glutamate

622

Monosodium L-glutamate or MSG

621

Monostarch phosphate

1410

Natamycin or pimaricin

235

Neotame

961

Nisin

234

Nitrogen

941

Nitrous oxide

942

Octafluorocyclobutane

946

Octyl gallate

311

Oxidised polyethylene

914

Oxidised starch

1404

Paprika oleoresins

160c

Pectin

440

Petrolatum or petroleum jelly

905b

Phosphated distarch phosphate

1413

Phosphoric acid

338

Polydextrose

1200

Polydimethylsiloxane or Dimethylpolysiloxane

900a

Polyethylene glycol 8000

1521

Polyglycerol esters of fatty acids

475

Polyglycerol esters of interesterified ricinoleic acid

476

Polyoxyethylene (40) stearate

431

Polysorbate 60 or Polyoxyethylene (20)    sorbitan monostearate

435

Polysorbate 65 or Polyoxyethylene (20)     sorbitan tristearate

436

Polysorbate 80 or Polyoxyethylene (20)     sorbitan monooleate

433

Polyvinylpyrrolidone

1201

Ponceau 4R

124

Potassium acetate or Potassium diacetate

261

Potassium adipate

357

Potassium alginate

402

Potassium aluminium silicate

555

Potassium ascorbate

303

Potassium benzoate

212

Potassium bicarbonate

501

Potassium bisulphite

228

Potassium carbonate

501

Potassium chloride

508

Potassium citrate

332

Potassium dihydrogen citrate

332

Potassium ferrocyanide

536

Potassium fumarate

366

Potassium gluconate

577

Potassium lactate

326

Potassium malate

351

Potassium metabisulphite

224

Potassium nitrate

252

Potassium nitrite

249

Potassium phosphate, dibasic

340

Potassium phosphate, monobasic

340

Potassium phosphate, tribasic

340

Potassium polymetaphosphate

452

Potassium propionate

283

Potassium pyrophosphate

450

Potassium silicate

560

Potassium sodium tartrate

337

Potassium sorbate

202

Potassium sulphate

515

Potassium sulphite

225

Potassium tartrate or Potassium acid tartrate

336

Potassium tripolyphosphate

451

Processed eucheuma seaweed

407a

Propane

944

Propionic acid

280

Propyl gallate

310

Propylene glycol

1520

Propylene glycol alginate

405

Propylene glycol mono- and di-esters or Propylene glycol esters of fatty acids

477

Propylparaben or Propyl-p-hydroxy-benzoate

216

Proteases (papain, bromelain, ficin)

1101

Quillaia extract (type 1)

999(i)

Quillaia extract (type 2)

999(ii)

Quinoline yellow

104

Rhodoxanthin

161f

Riboflavin

101

Riboflavin-5′-phosphate sodium

101

Rubixanthin

161d

Saccharin or calcium saccharine or sodium saccharine or potassium saccharine

954

Saffron or crocetin or crocin

164

Shellac

904

Silicon dioxide, amorphous

551

Silver

174

Sodium acetate

262

Sodium acid pyrophosphate

450

Sodium alginate

401

Sodium aluminium phosphate

541

Sodium aluminosilicate

554

Sodium ascorbate

301

Sodium benzoate

211

Sodium bicarbonate

500

Sodium bisulphite

222

Sodium carbonate

500

Sodium carboxymethylcellulose

466

Sodium citrate

331

Sodium diacetate

262

Sodium dihydrogen citrate

331

Sodium erythorbate

316

Sodium ferrocyanide

535

Sodium fumarate

365

Sodium gluconate

576

Sodium hydrogen malate

350

Sodium hydrosulphite

Sodium lactate

325

Sodium lactylate

481

Sodium malate

350

Sodium metabisulphite

223

Sodium metaphosphate, insoluble

452

Sodium nitrate

251

Sodium nitrite

250

Sodium oleyl lactylate

481

Sodium phosphate, dibasic

339

Sodium phosphate, monobasic

339

Sodium phosphate, tribasic

339

Sodium polyphosphates, glassy

452

Sodium propionate

281

Sodium pyrophosphate

450

Sodium sorbate

201

Sodium stearoyl lactylate

481

Sodium sulphate

514

Sodium sulphite

221

Sodium tartrate

335

Sodium tripolyphosphate

451

Sorbic acid

200

Sorbitan monostearate

491

Sorbitan tristearate

492

Sorbitol or sorbitol syrup

420

Stannous chloride

512

Starch acetate

1420

Starch sodium octenylsuccinate

1450

Stearic acid or fatty acid

570

Steviol glycosides

960

Succinic acid

363

Sucralose

955

Sucrose acetate isobutyrate

444

Sucrose esters of fatty acids

473

Sulphur dioxide

220

Sunset yellow FCF

110

Tannic acid or tannins

181

Tara gum

417

Tartaric acid

334

Tartrazine

102

tert-Butylhydroquinone

319

Thaumatin

957

Titanium dioxide

171

α-Tocopherol

307

δ-Tocopherol

309

γ-Tocopherol

308

Tocopherols concentrate, mixed

307b

Tragacanth gum

413

Triacetin

1518

Triammonium citrate

380

Triethyl citrate

1505

Violoxanthin

161e

Xanthan gum

415

Xylitol

967

Yeast mannoproteins

455

Symbols used in this list: A or α = alpha; β = beta; δ = delta; γ = gamma.

Color Additives Approved for Use in Human Food

Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except for coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time 14).

Table 3. Color Additives Exempt from Batch Certification – Color Additives Approved for Use in Human Food

21 CFR SectionStraight ColorEEC#Year(2)ApprovedUses and Restrictions
§73.30Annatto extractE160b1963Foods generally.
§73.40Dehydrated beets (beet powder)E1621967Foods generally.
§73.75Canthaxanthin(3)E161g1969Foods generally, NTE(7) 30 mg/lb of solid or semisolid food or per pint of liquid food; May also be used in broiler chicken feed.
§73.85CaramelE150a-d1963Foods generally.
§73.90β-Apo-8′-carotenalE160e1963Foods generally, NTE(7): 15 mg/lb solid, 15 mg/pt liquid.
§73.95β-CaroteneE160a1964Foods generally.
§73.100Cochineal extractE1201969Foods generally
2009Food label must use common or usual name “cochineal extract”; effective January 5, 2011
CarmineE1201967Foods generally
2009Food label must use common or usual name “carmine”; effective January 5, 2011
§73.125Sodium copper chlorophyllin(3)E1412002Citrus-based dry beverage mixes NTE(7) 0.2 percent in dry mix; extracted from alfalfa.
§73.140Toasted partially defatted cooked cottonseed flour—-1964Foods generally.
§73.160Ferrous gluconate—-1967Ripe olives.
§73.165Ferrous lactate—-1996Ripe olives.
§73.169Grape color extract(3)E163?1981Nonbeverage food.
§73.170Grape skin extract (enocianina)E163?1966Still & carbonated drinks & ades; beverage bases; alcoholic beverages (restrict. 27 CFR Parts 4 & 5).
§73.200Synthetic iron oxide(3)E1721994Sausage casings NTE(7) 0.1 percent (by wt).
2015Hard and soft candy, mints and chewing gum.
2015For allowed human food uses, reduce lead from ≤ 20 ppm to ≤ 5 ppm.
§73.250Fruit juice(3)—-1966Foods generally.
1995Dried color additive.
§73.260Vegetable juice(3)—-1966Foods generally.
1995Dried color additive, water infusion.
§73.300Carrot oil—-1967Foods generally.
§73.340PaprikaE160c1966Foods generally.
§73.345Paprika oleoresinE160c1966Foods generally.
§73.350Mica-based pearlescent pigments—-2006Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum.
2013Distilled spirits containing not less than 18 % and not more than 23 % alcohol by volume but not including distilled spirits mixtures containing more than 5 % wine on a proof gallon basis.
2015Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, nonalcoholic cocktail mixers and mixes and in egg decorating kits.
§73.450RiboflavinE1011967Foods generally.
§73.500SaffronE1641966Foods generally.
§73.530Spirulina extract—-2013Candy and chewing gum.
2014Coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals (excluding extruded cereals).
§73.575Titanium dioxideE1711966Foods generally; NTE(7) 1 percent (by wt).
§73.585Tomato lycopene extract; tomato lycopene concentrate(3)E1602006Foods generally.
§73.600TurmericE1001966Foods generally.
§73.615Turmeric oleoresinE1001966Foods generally.
[Source: U.S. Food and Drug Administration 15)]

Notes: (2) The year approved is based on the date listed in the “Confirmation of Effective Date” notice for the action as published in the Federal Register. (3) Petitioned for use after the 1960 amendments; not provisionally listed. (7) NTE – not to exceed.

Table 4. Color Additives Subject To Certification – Color Additives Approved for Use in Human Food

21 CFR SectionStraight ColorEEC#Year(2)ApprovedUses and Restrictions
§74.101FD&C Blue No. 1E1331969Foods generally.
1993Added Mn spec.
§74.102FD&C Blue No. 2E1321987Foods generally.
§74.203FD&C Green No. 3—-1982Foods generally.
§74.250Orange B(3)—-1966Casings or surfaces of frankfurters and sausages; NTE(7) 150 ppm (by wt).
§74.302Citrus Red No. 2—-1963Skins of oranges not intended or used for processing; NTE(7) 2.0 ppm (by wt).
§74.303FD&C Red No. 3E1271969Foods generally.
§74.340FD&C Red No. 40(3)E1291971Foods generally.
§74.705FD&C Yellow No. 5E1021969Foods generally.
§74.706FD&C Yellow No. 6E1101986Foods generally.
[Source: U.S. Food and Drug Administration 16)]

Note: Color additives listed in table 4 must be analyzed and batch certified by FDA before they can be used in any FDA-regulated product marketed in the U.S. This requirement applies to products imported into this country as well as those manufactured domestically. Manufacturers of certified color additives must include on the label the name of the certified color additive, a statement indicating general use limitations, any quantitative limitations in products, and the certification lot number assigned to the batch. Straight colors required to be certified are listed in 21 CFR Part 74. Most lakes are provisionally listed under 21 CFR 81.1 for use as listed in 21 CFR 82.51 (food, drugs, and cosmetics), 21 CFR 82.1051 (drugs and cosmetics), or 21 CFR 82.2051 (externally applied drugs and cosmetics). All FD&C Red No. 40 lakes are permanently listed under 21 CFR 74.340 (food), 74.1340 (drugs), and 74.2340 (cosmetics). FD&C Blue No. 1 and FD&C Yellow No. 5 aluminum lakes for drug and cosmetic use are permanently listed in 21 CFR sections 74.1101, 74.1705, 74.2101, and 74.2705.

Additional notes: (2) The year approved is based on the date listed in the “Confirmation of Effective Date” notice for the action as published in the Federal Register. (3) Petitioned for use after the 1960 amendments; not provisionally listed. (7) NTE – not to exceed.

Table 5. Approved Food Colours in the European Union

E100Curcumin
E101(i) Riboflavin
(ii) Riboflavin-5′-phosphate
E102Tartrazine
E104Quinoline yellow
E110Sunset Yellow FCF; Orange Yellow S
E120Cochineal; Carminic acid; Carmines
E122Azorubine; Carmoisine
E123Amaranth
E124Ponceau 4R; Cochineal Red A
E127Erythrosine
E129Allura Red AC
E131Patent Blue V
E132lndigotine; Indigo Carmine
E133Brilliant Blue FCF
E140Chlorophylls and chlorophyllins
E141Copper complexes of chlorophyll and chlorophyllins
E142Green S
E150aPlain caramel
E150bCaustic sulphite caramel
E150cAmmonia caramel
E150dSulphite ammonia caramel
E151Brilliant Black BN; Black PN
E153Vegetable carbon
E155Brown HT
E160aCarotenes
E160bAnnatto; Bixin; Norbixin
E160cPaprika extract; Capsanthian; Capsorubin
E160dLycopene
E160eBeta-apo-8′-carotenal (C30)
E161bLutein
E161gCanthaxanthin
E162Beetroot Red; Betanin
E163Anthocyanins
E170Calcium carbonate
E171Titanium dioxide
E172Iron oxides and hydroxides
E173Aluminium
E174Silver
E175Gold
E180Litholrubine BK
[Source 17)]

Note: The list was last updated 21 July 2016.

References   [ + ]

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