The short answer
Biscuits, cookies, crackers, cakes, wafers and breads are FDA-regulated foods. The bakery needs FDA food facility registration with a U.S. Agent, every shipment needs Prior Notice, and the U.S. importer needs an FSVP. Most problems at the border are label problems: undeclared allergens, non-U.S. Nutrition Facts, and colors or fats not allowed in the U.S.
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The top label issues for bakery products
| Issue | What to check |
|---|---|
| Allergens | Wheat, milk, egg, soy, tree nuts, peanuts and sesame (since January 1, 2023) — declared in U.S. form, including allergens hidden in fillings, creams, chocolate and toppings |
| Partially hydrogenated oils | PHOs are no longer GRAS; after the final compliance dates passed (January 1, 2020 and January 1, 2021), they cannot be added to food. Check margarines, shortenings and fillings from suppliers |
| Colors | Only FDA-permitted colors; Red No. 3 is banned from January 15, 2027 — common in decorations, sprinkles and pink fillings |
| Nutrition Facts | U.S. format and U.S. serving sizes (for cookies, cakes and crackers these differ from EU/Asian “per 100 g” panels) |
| Ingredient names | Common names in English; sub-ingredients of compound ingredients listed |
| Claims | “Healthy”, “low sugar”, “high fiber”, “gluten-free” all have FDA definitions |
Food safety points importers check
- Allergen control in plants that run several recipes on the same line (cleaning validation, scheduling)
- Fillings and creams that need temperature control or water activity control
- Mycotoxins in wheat flour (FDA’s October 2026 draft guidance uses a bakery controlling DON in wheat flour as an example)
- Foreign matter — metal detection and sieving
- Supplier approval for flour, nuts, chocolate and colors
Shelf-stable vs refrigerated
Most biscuits and crackers are low-moisture and shelf-stable. Cream cakes, cheesecakes and filled pastries may need refrigeration and a validated shelf life. Ship them frozen or chilled, with storage instructions on the pack.
Example: butter cookies from Denmark and cream wafers from Türkiye
A Danish butter cookie maker uses a U.S. Nutrition Facts panel with the U.S. serving size, declares “Contains: wheat, milk, egg”, and confirms its sprinkles contain no Red No. 3. A Turkish wafer maker checks that its hazelnut cream filling declares hazelnut (a tree nut) and milk, that its shortening has no PHOs, and that the wafer line’s sesame products are separated. Both register with FDA, file Prior Notice and work with an importer that has an FSVP.
Checklist
- 1Register the bakeryFDA food facility registration with a U.S. Agent.
- 2Review every ingredientNo PHOs, only permitted colors (no Red No. 3 from January 15, 2027).
- 3Build the U.S. labelAllergens including sesame, Nutrition Facts with U.S. serving size, English ingredients.
- 4Control allergens in the plantCleaning and scheduling between recipes.
- 5Prior Notice and FSVPEvery shipment, every importer.
FDA food facility registration with U.S. Agent from $300. Standard label review with Nutrition Facts $550. Prior Notice $15 per shipment.
Frequently asked questions
Can biscuits contain partially hydrogenated oil in the US?
No. FDA determined in 2015 that PHOs are not GRAS, and the final compliance dates passed on January 1, 2020 and January 1, 2021. PHOs cannot be added to food.
Do imported cookies need a US Nutrition Facts label?
Yes, unless an exemption applies. EU or Asian “per 100 g” panels do not meet U.S. rules. See the small business exemption.
Is sesame a major allergen for bakery products?
Yes. Since January 1, 2023, sesame is the ninth major food allergen and must be declared.
Can I use Red No. 3 in cake decorations?
Not after January 15, 2027, when its authorization for food ends.
Sources
- FDA — Final determination regarding partially hydrogenated oils
- FDA — FASTER Act: sesame is the ninth major food allergen
- Federal Register — Red No. 3 revocation, FR Doc. 2025-00830
Rules and dates checked on November 11, 2026. This article is general information, not legal advice.