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Food Contact ingredients

The Food and Drug Administration (FDA) Data Standards Council is standardizing vocabulary across the FDA. Therefore, the wording in some terms below may change slightly in the future.

Biotechnology - refers to techniques used by scientists to modify deoxyribonucleic acid (DNA) or the genetic material of a microorganism, plant, or animal in order to achieve a desired trait. In the case of foods, genetically engineered plant foods are produced from crops whose genetic makeup has been altered through a process called recombinant DNA, or gene splicing, to give the plant desired traits. Genetically engineered foods are also known as biotech, bioengineered, and genetically modified, although "genetically modified" can also refer to foods from plants altered through methods such as conventional breeding. While in a broad sense biotechnology refers to technological applications of biology, common use in the U.S. has narrowed the definition to foods produced using recombinant DNA.

Color Additive - A color additive is a dye, pigment, or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetics, or to the human body. The legal definition can be found in Section 201(t) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provides exclusions as well. Color additives for use in food, drugs, and cosmetics require premarket approval. Color additives for use in or on a medical device are subject to premarket approval if the color additive comes in direct contact with the body for a significant period of time. For additional information, consult the Color Additive Program on the CFSAN Internet.

Colorant - A colorant is a dye, pigment, or other substance that is used to impart color to or to alter the color of a food-contact material, but that does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye. The term 'colorant' includes substances such as optical brighteners and fluorescent whiteners, which may not themselves be colored, but whose use is intended to affect the color of a food-contact material. (21 CFR 178.3297(a)).

EAFUS - The "Everything Added to Food in the United States" (EAFUS) database is an informational database maintained by CFSAN under an ongoing program known as the Priority-based Assessment of Food Additives (PAFA). PAFA contains an administrative, chemical, and toxicological information on over 2000 substances directly added to food, including substances regulated by the FDA as a direct food additive, secondary direct food additive, color additive, GRAS, and prior-sanctioned substance. In addition, the database contains only administrative and chemical information on approximately 1000 such substances. Information about the more than 3000 total substances comprises EAFUS. For a complete listing of EAFUS substances, see the EAFUS list.

Food Additive - A food additive is defined in Section 201(s) of the FD&C Act as 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 characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding the food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives1.

Food Contact Substance (FCS) - Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.