June 10, 1996
NOTICE TO MANUFACTURERS
Label Declaration of Allergenic Substances in Foods
This letter is to make you aware of the Food and Drug Administration's (FDA's) concerns regarding the labeling of foods that contain allergenic substances. Recently, FDA has received a number of reports concerning consumers who experienced adverse reactions following exposure to an allergenic substance in foods. These exposures occurred because the presence of the allergenic substance in the food was not declared on the food label.
The Food, Drug, and Cosmetic Act (the act) requires, in virtually all cases, a complete listing of all the ingredients of a food. Two of the very narrow exemptions from ingredient labeling requirements appear to have been involved in a number of the recent incidents, however. First, section 403(i) of the act provides that spices, flavorings, and colorings may be declared collectively without naming each one. Secondly, FDA regulations (21 CFR 101.100(a)(3)) exempt from ingredient declaration incidental additives, such as processing aids, that are present in a food at insignificant levels and that do not have a technical or functional effect in the finished food.
In some of the instances of adverse reactions, failure to declare an ingredient appears to have been the result of a misinterpretation of the exemption from ingredient declaration provided for incidental additives in 101.100(a)(3). FDA reminds manufacturers that to qualify for the exemption from ingredient declaration provided for incidental additives and processing aids, a substance must meet both of the requirements of 101.100(a)(3), i.e., it must be present in the food at an insignificant level, and it must not have any technical or functional effect in the finished food. Thus, incidental additives may include substances that are present in a food by virtue of their incorporation as an ingredient in another food. However, when an ingredient added to another food continues to have an effect in the finished food (e.g., egg white as a binder in breading used on a breaded fish product), the ingredient is not an incidental additive, and its use must be declared on the label.
The recent adverse reaction reports indicate that some manufacturers have also incorrectly interpreted what constitutes an insignificant level of a substance. Clearly, an amount of a substance that may cause an adverse reaction is not insignificant. Because evidence suggests that some allergenic substances can cause serious allergic responses in some individuals upon ingestion of very small amounts of the substance, it is unlikely that such an allergen, when it is present in a food, can be present at an insignificant level. Thus, it follows that the requirements of 101.100(a)(3) can not be met under such circumstances.
FDA is considering whether it is necessary to clarify its regulations to ensure that manufacturers fully understand the circumstances in which allergenic food ingredients must be declared and to ensure that sensitive individuals are protected by appropriate labeling.
We have also received reports of adverse reactions to foods in which likely allergenic substances were used as flavors, and not declared by name. Therefore, in addition to the exemption in 101.100(a)(3), the agency is also considering whether an allergenic ingredient in a spice, flavor, or color should be required to be declared, 403(i) not withstanding. On a substance-by-substance basis, the agency has required ingredients covered by the exemption in section 403(i) to be declared when necessary to protect individuals who experience adverse reactions to the substance, e.g., FD&C Yellow No. 5. The agency is open to suggestions on how to best address this problem.
While FDA has not formally defined "allergens," it provided examples of foods that are among the most commonly known to cause serious allergenic responses, i.e., milk, eggs, fish, crustacea, mollusks, tree nuts, wheat, and legumes (particularly peanuts and soybeans), in a policy statement dealing with foods derived from new plant varieties published in the FEDERAL REGISTER of May 29, 1992 (57 FR 22984 at 22987).
FDA advises that the issue of declaring allergenic ingredients in food is being discussed on an international level. Several individual governments and the Codex Alimentarius Commission have begun to formulate policy for the labeling of foods containing allergenic ingredients to ensure that consumers are provided sufficient information to avoid substances to which they are allergic. While packaged foods sold in the U.S. are among the most comprehensively labeled foods in the world (some countries provide broader exemptions from ingredient declaration), FDA is studying its labeling requirements, and considering whether rulemaking is necessary, for the labeling of allergenic ingredients.
While the agency does so, FDA asks manufacturers to examine their product formulations for ingredients and processing aids that contain known allergens that they may have considered to be exempt from declaration as incidental additives under 101.100(a)(3), and to declare the presence of such ingredients in the ingredient statement. Where appropriate, the name of the ingredient may be accompanied by a parenthetical statement such as "(processing aid)" for clarity.
The voluntary declaration of an allergenic ingredient of a color, flavor, or spice could be accomplished by simply naming the allergenic ingredient in the ingredient list. Because such ingredients are normally present at very low levels, the name of the ingredient could generally be placed at the end of the ingredient list and be consistent with its descending order of predominance by weight. Other, non-allergenic ingredients t hat are exempt from declaration would remain unlisted.
Another area of concern is the potential, inadvertent introduction of an allergenic ingredient to a food (e.g., in a bakery that is manufacturing two food products on one production line, one product with peanuts and one without, where traces of peanuts, or peanut products, may end up in the product that does not normally contain peanuts). FDA is considering options for providing consumers with information about the possible presence of allergens in these foods.
The agency is aware that some manufacturers are voluntarily labeling their products with statements such as "may contain (insert name of allergenic ingredient)." FDA advises that, because adhering to good manufacturing practice (GMP) is essential for effective reduction of adverse reactions, such precautionary labeling should not be used in lieu of adherence to GMP. The agency urges manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of the identified food. The agency is open to suggestions on how best to address this issue.
Fred R. Shank, Ph.D.
Director, Center for Food Safety and Applied Nutrition
This document was issued on June 10, 1996.
See more recent information on Food Allergens Labeling.