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Allergen information for US wholesale bakery customers

A US wholesale bakery owes its trade customers the food source of every one of the nine major allergens present in each product, declared on the label that travels with the goods. Selling into trade rather than into retail changes nothing about that duty. FDA's position is that the allergen declaration applies whether a food is packaged in bulk or in retail containers, and that it stays on a bulk container even where the shipment is relieved of the Nutrition Facts panel and most other label elements. What follows is federal law plus Illinois as one named state example, and it is not legal advice.
Wednesday, 4 November 2026
Title card reading "Allergen information for US wholesale bakery customers" over a background of fresh produce crates

The nine major food allergens

Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.

The Food Allergen Labeling and Consumer Protection Act named the first eight in 2004. The FASTER Act, signed 23 April 2021, designated sesame the ninth, effective 1 January 2023. An ingredient list or allergen sheet written before 2023 and not revisited since is out of date for any bakery handling sesame seeds, tahini or sesame oil.

A highly refined oil derived from one of the nine is outside the definition. Whole categories sit outside the Act as well: the meat, poultry and certain processed egg products USDA regulates rather than FDA, alcoholic beverages under TTB rules, and raw agricultural commodities.

Declaring an allergen in the ingredient list or in a "Contains" statement

FDA allows two places, and either satisfies section 403(w)(1) of the Federal Food, Drug and Cosmetic Act. The food source of a major allergen is declared either in the ingredient list or in a "Contains" statement printed immediately after, or adjacent to, the ingredient list.

What gets declared is the food source rather than the ingredient's technical name. A label using both places has to name every major allergen present in the "Contains" statement, including the ones the ingredient list already spells out, so a "Contains" statement listing only the allergens the ingredient list left unclear does not satisfy the requirement.

Illinois guidance is stricter than FDA's on this one point. The IDPH wholesale guide of May 2026 lists the required label elements and says any of the nine allergens must be declared in a "Contains" statement separate from the ingredient list, which reads as a mandate rather than a choice. FDA's guidance and the statute behind it allow either place. FDA is the source to follow here: it administers section 403(w), and the IDPH guide itself defers to FDA labelling requirements.

"May contain" is not a declaration

Section 403(w) does not address advisory statements. "May contain wheat" is voluntary, so it neither discharges the declaration for an allergen that is in the product nor stands in for allergen controls in the bakery.

FDA also treats an advisory statement as inappropriate for an allergen already declared. A product whose "Contains" statement names milk should not also carry "may contain milk".

A bulk or wholesale container carries the allergen declaration

FDA's fifth-edition allergen guidance, final on 6 January 2025, answers this directly. The requirements reach bulk containers such as reusable totes and containers of bulk food moving between manufacturers, repackers and distributors for further processing, labelling or repacking.

Where a shipment is covered by the written-agreement exemption at 21 CFR 101.100(d), FDA's words are that those regulations do not provide an exemption for food allergen labelling requirements, and that major allergen declarations must be prominently placed on the container, conspicuous enough to be likely to be read.

The declaration belongs on the container. Paperwork travelling alongside can repeat it and cannot carry it instead.

The exemptions cover the rest of the label, not the allergens

Two provisions do the relieving, and both carry conditions.

  • 21 CFR 101.100(d) covers a delivery that, in the practice of the trade, is to be processed, labelled or repacked in substantial quantity at an establishment other than the one that processed or packed it. It is conditional: either the same person operates both ends, or there is a written agreement signed by both parties, carrying both addresses and the processing specifications, kept two years and open to inspection.
  • 21 CFR 101.9(j)(9) drops the Nutrition Facts panel for bulk-form product that is not for distribution to consumers in that form and is used solely to make other foods, or goes on to be processed, labelled or repacked elsewhere.

Both are written for product going on for further work at another establishment. A finished loaf a cafe resells as it is does not fit that description, so the arrangement has to match the regulation before the exemption applies to it.

In Illinois, IDPH inspects wholesale and local health departments inspect retail

The Illinois Department of Public Health regulates food processed, packaged, labelled, stored and distributed for wholesale in the state, other than the meat, poultry and egg products that USDA and the Illinois Department of Agriculture take. Sales direct to consumers, including online and at farmers markets, count as retail and sit with local health departments instead. FDA also has jurisdiction where a business is primarily wholesale or sells across state lines.

A wholesale operation needs a Manufactured Food Permit from IDPH. The application carries fees, an inspection questionnaire, a floor plan drawing and product labels, and a new firm cannot start before IDPH has inspected and approved it. The rules are 77 Ill. Adm. Code 730, and IDPH has adopted 21 CFR Part 117 on top.

Labelling is one of two allergen duties there. The second is controlling cross-contact: an Allergen Control Plan is a required element of the Food Safety Plan, separating different allergens from ingredient storage through process, packaging, labelling and final product storage, and inspectors review allergen control procedures for unintentional cross-contact.

What the trade customer does with the label

IDPH's allergen page devotes one question to wholesale, and the duty is one sentence of it: wholesale products are required to include allergen information on labels. The sentence after that is addressed to the other end of the delivery, telling a food establishment handed product with no labelling and no product sheet to file an incident report with the state.

The rest of that page is the cafe's or deli's own duty, under the retail food code. Food the retailer packages itself must list the allergen as an ingredient. Unpackaged food sold or served needs a written notification of the major allergens in it, which can be a brochure, a deli-case or menu notice, a placard or a QR code. Bulk food a customer self-dispenses needs either the manufacturer's label or a card naming the food source of each allergen.

Bakery and deli cases are named explicitly, and each item in the case needs its own notification rather than one sign covering everything, though items sharing the same allergens can be listed together. The cafe writes that notification from whatever arrived with the delivery, so a wholesale box landing without a declaration stops the cafe labelling its case.

State requirements sit on top of the federal nine

Federal law sets the minimum and each state adds to it. Illinois appears here as one worked example, and the other forty-nine states each run their own wholesale permitting and their own adoption of the retail food code. A bakery selling into more than one state has more than one set of state requirements to read.

The state health department publishes the rest. For a wholesale bakery that means the agency licensing or permitting the production premises, which in Illinois is IDPH rather than the local health department.

Wholesale Handler holds no allergen data

Wholesale Handler is an order desk. It holds no recipes, no ingredient stock, no costing and no allergen or nutrition data, so a product has no allergen field and nothing in the product form asks for one. Ingredient declarations belong with bakery production software, or with the labels the baker prints. Microbakery wholesale cafe order management covers the ordering cutoff and the make list at three or four cafe accounts.

A product does carry a free-text description, alongside its unit label, pack size, tax rate, barcode and SKU. The description prints on the packing slip under the product name, shows in full on the public storefront card, and appears on the customer's order form truncated to one line with the whole text as the hover title. It is copied onto the order line when the order is placed, so a packing slip prints the wording as it stood at that moment rather than as it reads today.

Nothing validates that text and nothing checks it against a recipe, and the single line on the order form clips a long one. Anything written there repeats the declaration rather than standing in for it. How to make packing slips for wholesale bakery deliveries covers generating a slip from a confirmed order instead of handwriting it.

Every packing slip also carries one block of standing text, set once in Settings and identical on each slip. It is per business rather than per product, so it can hold a line saying where a customer gets allergen information rather than the information itself.

Wholesale Handler pricing

Three plans, and the only difference between them is how many customers you trade with. Every feature is on all three, so nothing is held back on the free one.

  • Free - up to 3 customers, no card
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  • Pro - up to 50 customers, US$109/month

Up to 500 products and unlimited orders and invoices on every plan. One fee for the whole business - no per-user charge, and no cut of what you sell. No contract, and cancel anytime.

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