(effiective jan. l, 2023)
The declaration that a food contains a major food allergen must be met by one of the following:
1 Stating the common or usual name of the food allergen in the list of ingredients followed in parentheses by the name of the food source from which the major food allergen is derived (unless the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list); or
2 Stating immediately after or is adjacent to the list of ingredients, “Contains,” followed by the name of food source from which the major food allergen is derived.73
If the labeling includes an allergen “Contains” statement, then all major allergens must be included in the statement even if the common name of the allergen is already listed in the ingredient statement. This is designed to protect against consumer misunderstanding and confusion from the omission.
Note that the list of “major food allergens” consists of five individual food sources, such as milk and peanuts, and three categories of foods, fish, crustacea, and tree nuts. These categories include many individual foods, so the list of major food allergens contains more than eight allergens. In addition, FDA interprets the categories broadly. Thus, by FDA’s count there are twenty‐nine major allergens under FALCPA.
The act requires allergens in flavoring, coloring, or incidental additives to also be labeled in accordance with these requirements. Thus, although flavorings or colorings may be listed generically, a major allergen source must be specifically declared. Similarly, the incidental additive exception from ingredient labeling does not apply to major allergens.
To gain an exemption from the FALCPA labeling requirements, the law provides for a petition for exemption and for a notification of exemption.
3.8.1 Petitions for Exemption
FALCPA establishes a process by which a person may petition FDA with scientific evidence that demonstrates that an ingredient as derived by the method specified in the petition does not cause an allergenic response that poses a risk to human health. FDA has 180 days to approve or deny the petition.74
3.8.2 Notifications for Exemption
FALCPA establishes a process by which a person may file a notification containing scientific evidence demonstrating that an ingredient “does not contain allergenic protein.”75 The scientific evidence must include the analytical method used and the ingredient must be derived by the specified method. FDA has ninety days to object to a notification. Absent an objection, the food ingredient is exempt from FALCPA’s labeling requirements for major food allergens.
NOTES
3.30 Tree Nuts. Section 201(qq) of the FD&C Act defines “major food allergen” to include “tree nuts.” Three examples are provided in section 201(qq): almonds, pecans, and walnuts. A nut is a fruit composed of a hard shell and a seed, but a number of hard kernels from plants are also called “nuts.” FDA has taken a broad approach to the category of “tree nuts,” which includes some, but not all, plant seeds that are commonly called “nuts.” Therefore, coconuts (a one‐seeded fruit or drupe), pine nuts or pinyons (seeds), ginkos (seeds), and dried lychees (fruit) are deemed to be “tree nuts” by FDA. However, surprisingly FDA does not consider annatto to be a tree nut even though the seeds are sometimes called annatto nuts and comes from trees, and they are a known allergen.
3.31 “The Common Name Identification of Major Allergens Law.” The food allergen labeling law is not the sole law on allergen labeling, and this imprecision in naming the law sometimes creates confusion. This law would more precisely be called something like, “The Common Name Identification of Major Allergens Law.” For example, peas are not a major allergen under the FALCPA. Nonetheless, peas are still required to be listed in the ingredient statement. That is, the pea allergen is still disclosed. It simply is not highlighted as a major allergen.
3.32 Sulfites are not allergens. Sulfite intolerance creates a reaction similar to an allergic reaction, but sulfite is not a true allergen. Sulfite labeling is regulated in the United States similar to that of allergens, but the law is not part of the allergen labeling law. Basically, sulfites must be declared when the concentration in the food is ≥10 ppm total SO2. The specific name of the additive (e.g., sodium bisulfite) must be declared in the case of use as an intentional ingredient. 21 C.F.R. § 101.100 (a)(4). Sulfites are prohibited on meats and also on fruits and vegetables intended to be served raw or presented fresh to the public. 51 Fed. Reg. 51, 25021‐25026 (July 9, 1986).
* * * * *
Notice to Manufacturers
Label Declaration of Allergenic Substances in Foods
Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, FDA, June 10, 1996.
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 C.F.R. 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) cannot
