Source review: 5 October 2026. Editorial guidance; not FDA approval or a substitute for a product-specific assessment.
FDA’s major-allergen labeling rules apply to covered FDA-regulated packaged foods, including dietary supplements. They do not replace ordinary ingredient labeling or a safety assessment. Determine jurisdiction first: most meat, poultry, Siluriformes fish and certain processed egg products fall under USDA rules; raw agricultural commodities are excluded from these major-allergen labeling requirements. Covered bulk food packages can also need declarations; a further-processing agreement is not itself an allergen-labeling exemption.
Nine sources; current tree-nut scope
The nine major food-allergen sources are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Crustacean shellfish is not a synonym for every shellfish: shrimp, crab and lobster differ from molluscan shellfish such as oysters. Identify each relevant fish species, Crustacean species and tree-nut type rather than using an undifferentiated category.
Edition 5 Table 1 lists almond; black walnut; Brazil nut; California walnut; cashew; filbert/hazelnut; heartnut/Japanese walnut; macadamia/bush nut; pecan; pine nut/pinon nut; pistachio; and English/Persian walnut. Chestnut and coconut are not on that list and are not major tree-nut allergens under this guidance. Neither is argan. FDA’s current FAQ also identifies beech nut, butternut, chinquapin, cola/kola, ginkgo, hickory, palm, pili, shea and lichee as excluded. Do not put these non-major sources in a major-allergen Contains statement merely because they are ingredients.
Ordinary ingredient requirements still apply: use appropriate common or usual names unless a specific ingredient-labeling exemption applies. A non-major ingredient can still cause an allergic reaction; absence from Table 1 is not a safety guarantee. FDA acknowledges previously labeled coconut-containing products may remain in commerce during transition, without establishing a universal relabeling deadline in its FAQ.
Milk includes milk from domesticated cows, goats, sheep and other ruminants; eggs include eggs from domesticated chickens, ducks, geese, quail and other fowl. Identify a non-cow or non-chicken source appropriately. FDA examples include ingredients “milk, goat milk” and “eggs, duck eggs”; if Contains is used, include “milk, goat milk” or “eggs, duck eggs” as applicable and every other major-allergen source present. Cow milk and chicken eggs do not require an additional animal name.
Declaration methods and evidence
A source already identified in an ingredient’s common or usual name, such as wheat flour or milk, does not need a redundant parenthetical solely for that source. Otherwise identify the source parenthetically, for example sodium caseinate (milk), or use a Contains statement immediately after or adjacent to the ingredient list. Contains must be at least the ingredient-list type size and must identify all major-allergen sources present, even those already named in the ingredients. Do not add non-major allergens to this reserved statement.
The statutory repetition exception can avoid repeating a source already named elsewhere in the ingredient list, unless that name appears as part of an ingredient that is not a major food allergen. Review the actual complete list, not an isolated word. Compound ingredients, flavorings, colors and incidental additives must be assessed for major-allergen protein: an ordinary incidental-additive exemption does not automatically exempt allergen disclosure. Identify every applicable type/species in a mixed-source ingredient.
Highly refined oils (refined, bleached and deodorized) and ingredients derived from those oils are excluded from the major-allergen definition. Cold-pressed, expeller-pressed or otherwise unrefined oil is not automatically exempt. Ordinary oil naming generally identifies the source, such as soybean oil. Obtain processing and protein evidence; ingredients without major-allergen protein, or an ingredient covered by a valid FDA exemption petition/notification, require an ingredient-specific assessment. Do not infer a blanket exemption from a supplier’s “allergen-free” claim.
Sesame timing and foreign-language labels
The FASTER Act’s sesame requirements took effect on 1 January 2023. The relevant rule is not the date labels were printed. FDA explains that foods already in interstate commerce before 2023, including retail stock, did not have to be removed or relabeled for sesame; some could remain depending on shelf life. This does not exempt newly introduced food merely because old label stock was printed earlier, and FDA did not announce the invented 2026 transition cutoff previously described here.
Under 21 CFR 101.15(c), required label and labeling information generally appears in English. For articles distributed solely in Puerto Rico or a territory whose predominant language is not English, that predominant language may substitute. A foreign-language representation on a label generally triggers all required label information in that language as well, not only the allergen statement. The narrow exception concerns meal-service packages of no more than 1½ ounces or 1½ fluid ounces, not for retail sale, whose only foreign-language representation is the food name. Paragraph (c)(3) separately covers non-label articles of labeling. Assess the entire artwork and applicable exceptions.
Cross-contact and claims
Voluntary advisory statements must be truthful and not misleading and cannot substitute for appropriate manufacturing controls. Cross-contact is not an intentionally added ingredient and should not be entered in the ingredient list or Contains statement as if it were one. FDA considers an allergen-free claim alongside a may-contain warning for that same allergen inappropriate; it also considers Contains plus may-contain for the same allergen misleading. Assess cleaning, segregation and supplier controls before selecting wording.
Exporter ingredient-to-label worksheet — recommended workflow
Record one row per ingredient or compound sub-ingredient: product and regulatory jurisdiction; recipe/version date; supplier and evidence reference; all sub-ingredients; oil processing and residual-protein evidence; major-allergen source and exact type/species; proposed ingredient name and declaration method; complete Contains cross-check; cross-contact assessment and controls; conflicting claims; reviewer and review date; unresolved evidence and owner. Keep the finished artwork version alongside this record. This is an editorial workflow, not an FDA form or an approved label.
Illustrative example: wheat flour, eggs, cheese (milk) and butter (milk) identify wheat, egg and milk in the ingredients. A separate Contains statement is not mandatory solely because those sources are present. If chosen, “Contains: wheat, eggs, milk” must remain complete after recipe changes. This example does not certify all other labeling requirements.
Illustrative example: coconut oil and chestnut flour need appropriate ingredient names; neither should be added to a major-allergen Contains statement merely as a tree nut under Edition 5. Separately assess an almond ingredient and any credible cross-contact risk; do not use “almond-free” with “may contain almonds”.
Registration is a separate task
Label compliance is distinct from facility registration and renewal. An applicable food facility must renew between 1 October and 31 December 2026, even if registered or updated before 1 October. FDA charges no food-registration/renewal filing fee; independently agreed professional service fees are separate. Registration does not approve a label or guarantee import release. Renewal guide: https://fdabridge.com/blog/fda-food-facility-registration-renewal-2026
For an enquiry about available assistance and a defined scope, use https://fdabridge.com/contact . Food services: https://fdabridge.com/food . Do not infer a guaranteed review outcome or specialist credential from this article.
Primary sources: FDA current FAQ: https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/frequently-asked-questions-food-allergen-labeling-guidance-industry
FDA Edition 5, especially scope, Table 1 and declaration questions: https://www.fda.gov/media/117410/download
FDA sesame effective-date reminder: https://www.fda.gov/food/hfp-constituent-updates/fda-reminds-manufacturers-effective-date-sesame-major-food-allergen
Foreign-language label rule: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.15