Allergen management is a constantly evolving field. Whether you’re making food (or beverages, or anything else) — if you’re working with the US market, you need to have a thorough plan for allergens in your facility. This month’s new FDA guidance brings several important changes that will impact many manufacturer’s allergen control plans as well as product labeling. While these are nonbinding recommendations, it’s always a good idea to take them seriously to protect your brand and your consumer.
Read on for the most notable changes — or skip to to the bottom for a link to the January 2025 guidance itself.
A tree nut by any other name
The definition of “tree nut” varies from country to country. This month, the FDA has
quietly streamlined the list of tree nuts considered major food allergens. Perhaps the biggest change: coconut is no longer considered a tree nut. This means coconut is no longer subject to mandatory allergen management protocols.
The list of nuts removed from the list of tree nuts include: beech, butternut, chestnut, chinquapin, coconut, cola/kola, ginkgo, hickory, palm, pili, and shea.
If your labeling currently has Contains statements including any of these nuts — they should be revised. The Contains statement is reserved only for major food allergens. It is still imperative that you list these nuts in the ingredient list, by their common or usual name.
The current list of tree nuts which must still be handled as major food allergens — and included in any Contains statement — has been reduced to:
- Almond
- Brazil Nut
- Cashew
- Filbert/Hazelnut
- Macadamia Nut / Bush nut
- Pecan
- Pine Nut / Pinon Nut
- Pistachio
- Walnut (Black Walnut, California Walnut, English Walnut, Japanese Walnut/Heartnut, and Persian Walnut)
Got Milk?
Milk remains a major food allergen, but with an expanded definition. Previously only milk from cows required allergen protocols and labeling. Now, milk from domesticated cows, sheep, goats and other ruminants must all be labeled and managed as a major food allergen.
Additionally, “animal-free” or “precision-fermented” casein and other products must also be labeled as milk. To quote the guidance document directly:
Food ingredients that include proteins derived from a major food allergen (e.g., through chemical, biochemical, mechanical, fermentation, or bioengineering processes) may be capable of eliciting an allergic reaction, and their presence is not obvious without declaration of the allergen. An example would be protein that is derived from cow milk but produced via fermentation in a non-milk food source, such as a genetically engineered strain of yeast. In this example, the protein produced by fermentation may be identical (or sufficiently similar) to the protein in milk such that it could be … causing allergic reactions to people sensitive to proteins in milk.
The Incredible Egg
Similar to milk, egg remains a major food allergen. However, the definition of egg has expanded to include eggs from not just chickens, but chickens, ducks, geese, quail, and other fowl.
As above, any protein derived from egg — including a protein produced via fermentation — could trigger an allergic reaction and must be labeled and handled as an allergen.
Other Notable Updates
The Q&A format of the guidance document covers a lot of ground. Several questions focus on label appearance. Because consumers can make the best decisions when information is presented in a uniform format, the FDA has detailed examples regarding the correct phrasing, placement, and content of allergen information on labels.
In terms of which items are subject to this guidance — the FDA clarified its thinking around packaged foods. Any facility that serves packaged food to humans is covered. If you put it in a package before the customer walks in the door — that package must have correct labeling. That includes packaged meals served on airlines.
The guidance is not meant for food for animals, nor for USDA-regulated items or TTB-regulated items. It does not cover OTC medications, cosmetics, or cleaning products.
The full guidance is worth a read, regardless of which allergens your facility works with. You can read it online, here:
