Cover Image

PAPERBACK
$27.00



View/Hide Left Panel

Chemical preservatives not exempted by 21 CFR §101.100 must be labeled with both the common or usual name of the ingredient and a separate identification of the function of the preservative [21 CFR §101.22(j)]. Certain color additives that are of health significance (e.g., that may cause allergic reactions) must be identified by their specific names [21 CPR Part 74 and 21 CFR §101.22(c)].

In 1986, FDA adopted a regulation limiting the use of sulfiting agents (21 CFR §182.3739 through §3862) but did not declare a preemptive policy. The agency stated that it would not preempt in the absence of a "genuine need to stop the proliferation of inconsistent requirements" (FDA, 1986). The existing FDA regulation states that sulfites must be declared on food labels if they are present above a given level. Below that level, they are considered an incidental additive and not required to be listed in the ingredient statement [21 CFR §101.100(a)(4)].

The Committee examined TC and administrative information letters regarding implementation, including specific interpretations of FDCA Section 403(k). There are several TC letters dating from 1940 that deal specifically with the determination that vanillin is an artificial flavoring and products (chocolate, in this case) containing it should be so labeled (TC-176, 1940). Likewise, caramel was determined to be an artificial color. Another TC letter details the methods of label declaration of its content (TC-203, 1940). During this period, nitrogen and carbon dioxide in canned foods were not considered chemical preservatives (TC-198, 1940).

In an information letter, the use of the words "color added" or "certified color added" was determined by FDA to be in compliance with FDCA Section 403(k) (Administrative Information Letter No. 87, 1949). With respect to label declarations of preservatives, the agency took the position in a 1963 Bureau of Enforcement Guideline that for finished foods in which flavorings such as spices have been treated with a chemical preservative, no label designating this practice is required if that chemical preservative was not intended to nor did it have any preservative effect on the finished food (BE-145, 1963). Active enforcement has occurred on labeling requirements for FD&C Yellow Dye No. 5 in foods has been active, due to the allergic reaction experienced by some consumers (21 CFR §74.705).

In a related section, FDCA Section 402(c) provides that a food is adulterated "if it is, or it bears or contains, a color additive which is unsafe" within the meaning of FDCA Section 706(a) dealing with certified or coal-tar colors.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement