The Federal Food, Drug, and Cosmetic Act provides for the use of chemical preservatives in foods if the chemical is:
- Generally recognized as safe for such use; or if a food additive is covered by food additive regulations prescribing conditions of safe use;
- Not used in such a way as to conceal damage or inferiority or to make the food appear better or of greater value than it is;
- Properly declared on the label of the food in which used.
In addition, the preservative should be food grade, perform its intended function, and be used in accord with good manufacturing practices and, where applicable, in accord with existing food additive regulations.
In recent years, we have held that the statutory words "chemical preservative" are not necessary in order to satisfy the 403(k) provisions of the act, so long as the declaration on the label does reflect the fact that a chemical preservative is present. Thus, when the precise preservative function of the chemical is known, the statutory phrase can be replaced by words which describe this function. It is believed that in many situations this designation of the precise chemical function, coupled with the common or usual name of the chemical, results in a statement more informative to the consumer. This manner of label declaration is permitted by many standards.
The term "chemical preservative" as defined by 2l CFR 101.22(a)(5), "means any chemical that, when added to food tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices or oils extracted from spices, substances added to food by direct exposure thereof to wood smoke, or chemicals applied for their insecticidal or herbicidal properties".
A "chemical preservative" may be used in nonstandardized foods, if the preservative is a suitable substance that is not a food additive as this term is defined in Section 201(s) of the Federal Food, Drug, and Cosmetic Act; or if a food additive, it is used in conformity with the regulations of 21 CFR 172 and with good manufacturing practices.
To be in accord with good manufacturing practices, the use of a preservative should not: (1) result in deception, (2) adversely affect the nutritive value of the food, or (3) permit continued growth of food poisoning organisms while suppressing growth of others that would make spoilage evident.
To be acceptable for food use, a chemical preservative should comply with purity specifications in regulations in 21 CFR 172, or in the Food Chemicals Codex.
Preservatives should never be substituted for sanitation and selection of good raw materials.
Foods containing preservatives must bear labeling in accordance with the requirements of Sections 403(i) and 403(k) of the Act. To satisfy both provisions, the statement used must indicate the common or usual name of the chemical and that it is a preservative. This can without question be accomplished by a statement such as, "___________ added as a preservative," or "preserved with __________," the blank being filled in with the common or usual name of the preservative ingredient.
In lieu of the preceding declaration, the common or usual name of the chemical may be coupled with a description of its precise preservative function, for example, " _________ to retard (inhibit) mold growth," or "________ to retard spoilage," or " _________ to promote color retention," the blank being filled in with the common or usual name of the preservative ingredient.
Reissued: 12/3/73, 10/1/80, 2/1/89
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.