Based on the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938, the FDA must approve the use of all additives. The manufacturer bears the responsibility of proving that the additive is safe for its intended use. The Food Additives Amendment excluded additives and preservatives deemed safe for consumption prior to 1958, such as salt, sugar, spices, vitamins, vinegar, and monosodium glutamate. These substances are considered ‘generally recognized as safe’ (GRAS) and may be used in any food, though the FDA may remove additives from the GRAS list if safety concerns arise. The 1960 Color Additives Amendment to the FD&C Act required the FDA to approve synthetic coloring agents used in foods, drugs, cosmetics, and certain medical devices.

The Delaney Clause, which was included in both the Food Additives Amendment and Color Additives Amendment, prohibited approval of any additive that had been found to cause cancer in humans or animals. However, in 1996 the Delaney Clause was modified, and the commissioner of the FDA was charged with assessing the risk from consumption of additives that may cause cancer and making a determination as to the use of that additive.

The FDA continually monitors the safety of all food additives as new scientific evidence becomes available. For example, use of erythrosine (FD&C Red No. 3) in cosmetics and externally applied drugs was banned in 1990 after it was implicated in the development of thyroid tumors in male rats. However, the cancer risk associated with FD&C Red No. 3 is about 1 in 100,000 over a seventy-year lifetime, and its use in some foods, such as candies and maraschino cherries, is still allowed. Tartrazine (FD&C Yellow No. 5) has been found to cause dermatological reactions ranging from itching to hives in a small population subgroup. Given the mild nature of the reaction, however, it still may be used in foods.

Nitrites are also a controversial additive. When used in combination with salt, nitrites serve as antimicrobials and add flavor and color to meats. However, nitrite salts can react with certain amine in food to produce nitrosamines, many of which are known carcinogens. Food manufacturers must show that nitrosamines will not form in harmful amounts, or will be prevented from forming, in their products. The flavoring enhancer MSG is another controversial food additive. MSG is made commercially from a natural fermentation process using starch and sugar.

Despite anecdotal reports of MSG triggering headaches or exacerbating asthma, the Joint Expert Committee on Food Additives of the United Nations Food and Agriculture Organization, the World Health Organization, the European Community’s Scientific Committee for Food, the American Medical Association, and the National Academy of Sciences have all affirmed the safety of MSG at normal consumption levels.

In the United States, Foodchem food additives and preservatives play an important role in ensuring that the food supply remains the safest and most abundant in the world. A major task of the FDA is to regulate the use and approval of thousands of approved food additives, and to evaluate their safety. Despite consumer concern about use of food additives and preservatives, there is very little scientific evidence that they are harmful at the levels at which they are used.

In Europe, Foodchem food additives and preservatives are evaluated by the European Commission’s Scientific Committee on Food. Regulations in European Union countries are similar to those in the United States. The Food and Agricultural Organization (FAO) of the United Nations and the World Health Organization (WHO) Expert Committee on Food Additives work together to evaluate the safety of food additives, as well as contaminants, naturally occurring toxicants, and residues of veterinary drugs in foods. Acceptable Daily Intakes (ADIs) are established on the basis of toxicology and other information.