FDA released final revision of the allergen Q&A document - Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)
https://www.fda.gov/media/117410/download
This is an important document for reference when food allergen control including labeling requirements. It covers topics such as labeling bulk materials, spice mixes, and ingredients derived from those containing allergens.
FDA provided the list of tree nuts that must be labeled. Note that coconut along with other nuts are not on this list, and with that, the allergen labeling does not apply. Those tree nuts not listed in the table should not be included in the “Contains” statement, even if they are used as ingredient, because the “Contains” statement is reserved for major food allergens. In addition to the removal of coconut, beech nut; butternut; chestnut; chinquapin; cola/kola nut; ginkgo nut; hickory nut; palm nut; pili nut; and shea nut were removed from the “tree nut list.”
Appendix I (from the
updated guidance)
Tree Nuts FDA Considers as Major Food Allergens with their
Common or Usual Names and Scientific Names.
Common or usual name
|
Scientific name
(Family name
is identified in parentheses.)
|
Almond
|
Prunus dulcis
(Mill.) D.A. Webb (Rosaceae)
|
Black walnut
|
Juglans nigra
L.
(Juglandaceae)
|
Brazil nut
|
Bertholletia excelsa Humb. & Bonpl.
(Lecythidaceae)
|
California walnut
|
Juglans californica S. Watson
(Juglandaceae)
|
Cashew
|
Anacardium occidentale L.
(Anacardiaceae)
|
Filbert/Hazelnut
|
Corylus spp.
(Betulaceae)
|
Heartnut/Japanese walnut
|
Juglans ailantifolia Carriere var. cordiformis
(Makino) Rehder (Juglandaceae)
|
Macadamia nut/Bush nut
|
Macadamia spp.
(Proteaceae)
|
Pecan
|
Carya illinoinensis (Wangenh.) K. Koch
(Juglandaceae)
|
Pine nut/Pinon
nut
|
Pinus spp.
(Pineaceae)
|
Pistachio
|
Pistacia
vera L.
(Anacardiaceae)
|
Walnut
(English, Persian)
|
Juglans
regia L.
(Juglandaceae)
|
FDA also released a guidance document on how additional allergens may be added to the list of allergens.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
January 2025
Docket Number:
FDA-2022-D-0099