PrecautionsRegulating Safety of Food Additives
and Preservatives
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 addi-
tives. 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 con-
cerns 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 appro-
val 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 con-
sumption of additives that may cause cancer and mak-
ing 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 reac-
tions ranging from itching to hives in a small popula-
tion 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 anti-
microbials and add flavor and color to meats. How-
ever, 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 Agri-
culture 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, food additives and preserva-
tives 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 addi-
tives, 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, 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.KEY TERMS
Bacteria—Single-celled organisms without nuclei,
some of which are infectious.
Bactericidal—A state that prevents growth of
bacteria.
Bateriostatic—A substance that kills bacteria.
Carcinogen—A cancer-causing substance.
Enrichment—The addition of vitamins and miner-
als to improve the nutritional content of a food.
Fermentation—A reaction performed by yeast or
bacteria to make alcohol.
Fortification—The addition of vitamins and miner-
als to improve the nutritional content of a food.
Leavening—Yeast or other agents used for rising
bread.
Microorganism—Bacteria and protists; single-
celled organisms.Food additives