How are Food Additives Regulated? Home News Industry News
How are Food Additives Regulated?

Food Additives are not always byproducts of 20th century technology or modern know-how. 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 cucumbers in a vinegar solution.
Over the years, however, improvements have been made in increasing the efficiency and ensuring the safety of all food additives. Today food and color additives are more strictly regulated that at any other time in history. The basis of modern food law is the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938, which gives the Food and Drug Administration (FDA) authority over food and food ingredients and defines requirements for truthful labeling of ingredients.


The Food Additives Amendment to the FD&C Act, 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 additives safety for the ways it will be used.


The Food Additives Amendment exempted two groups of substances from the food additive regulation process. All substances that FDA or the U.S. Department of Agriculture (USDA) had determined were safe for use in specific food prior to the 1958 amendment were designated as prior-sanctioned substances. Examples of prior-sanctioned substances are sodium nitrite and potassium nitrite used to preserve luncheon meats.


A second category of substances excluded from the food additive regulation process are generally recognized as safe or GRAS substances. GRAS substances are those whose use is generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific evidence. Salt, sugar, spices, vitamins and monosodium glutamate are classified as GRAS substances, along with several hundred other substances. Manufacturers may also request FDA to review the use of a substance to determine if it is GRAS.


Since 1958, FDA and USDA have continued to monitor all prior sanctioned and GRAS substances in light of new scientific information. If new evidence suggests that a GRAS or prior sanctioned substance may be unsafe, federal authorities can prohibit its use or require further studies to determine its safety.


In 1960, Congress passed similar legislation governing color additives. The Color Additives Amendments to the FD&C Act require dyes used in foods, drugs, cosmetics and certain medical devices to be approved by FDA prior to their marketing.


In contrast to food additives, colors in use before the legislation were allowed continues use only if they underwent further testing to confirm their safety. Of the original 200 provisionally listed color additives, 90 have been listed as safe and the remainder have either been removed from use by FDA or withdrawn by industry.


Both the Food Additives and Color Additives Amendments include a provision which prohibits the approval of an additive if it is found to cause cancer in humans or animals. This clause is often referred to as the Delaney Clause, named for its Congressional sponsor, Rep. James Delaney (D-N.Y.).


Regulations known as Good Manufacturing Practices (GMP) limit the amount of food and color additives used in foods. Manufacturers use only the amount of an food additive necessary to achieve the desired effect.

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