FDA Food Contact Requirements for Commercial Bread Trays

FDA does not approve bread trays. It authorizes the substances a tray is made of, and each authorization covers a particular use. The regulation that lists HDPE and polypropylene for food contact is 21 CFR 177.1520, and the colorants and additives need their own authorization. What you need is a written statement from the supplier that names the exact tray model, the authorization for each component, and the food types and temperatures it covers. NSF certification is one way to meet retail food codes; it is not a federal requirement for the tray.

These documents matter where the tray touches food: under unwrapped product, the direct-contact class among the three tray use classes. A tray that only ever carries sealed packages does not hold food against its surface, but this guide suggests getting the documents for every model anyway, because a fleet that can put any tray under unwrapped product on any route is a direct-contact fleet.

What should you ask a tray supplier for?

For every tray model you run, get these in writing:

1. The base resin and its authorization. The resin type and grade, and the regulation that covers it, down to the paragraph and item of 21 CFR 177.1520, or the number of the Food Contact Notification (FCN) and the company it names. “Food grade” on its own cites nothing.
2. The same for colorants and additives. Ask the supplier to confirm that every colorant, processing aid and additive in the formulation is authorized, and under what.
3. The conditions of use covered. Which food types and which storage conditions the authorization covers: room temperature, refrigerated, frozen. Match this to what your trays actually do.
4. Recycled content. Whether the tray contains recycled resin and, if it does, how the supplier addresses FDA’s recycled plastics guidance. What to ask about recycled resin covers the questions.
5. A guaranty. Ask whether the supplier will sign a continuing guaranty that its trays are “not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act,” the wording FDA suggests (21 CFR 7.13). The statute lets a person who received goods “in good faith” under such a guaranty rely on it (21 U.S.C. 333(c)(2)); what that covers in your case is a question for counsel.
6. Certification, if your inspector expects it. For an in-store bakery, the certification listing that shows the exact model.
7. A change commitment. A written promise to tell you before the resin, a colorant, the resin source or the manufacturing plant changes. A formulation change you never hear about can leave your file describing a tray you no longer buy.

File these by model, and pull them out again whenever you add a model or change supplier.

What does FDA actually authorize?

A substance, for a use. The Act defines a food contact substance as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food” (21 U.S.C. 348(h)(6)). A bread tray holds and transports food, so the substances in it fall under this definition.

A food additive is deemed unsafe “with respect to any particular use or intended use” unless an authorization covers that use (21 U.S.C. 348(a)). FDA lists the routes to authorization for a component of a food contact material: a regulation in Title 21 of the CFR, GRAS status, a prior sanction letter, a Threshold of Regulation exemption, or an effective FCN (FDA, Determining the Regulatory Status of Components of a Food Contact Material).

One route works differently, and it matters to a buyer. An FCN belongs to one manufacturer. FDA says an FCN is “not effective for a similar or identical substance produced or prepared by a manufacturer other than a manufacturer identified in the prior notification.” If your supplier’s compliance rests on an FCN, the resin has to come from the company the notification names.
A listing is not the end of the question either: FDA’s general rule for indirect additives says a component “shall be of a purity suitable for its intended use,” and that a listing does not relieve the use from “compliance with any other provision” of the Act (21 CFR 174.5).

Authorization matters because the legal consequence attaches to the food: under the Act, food that contains a food additive “unsafe within the meaning of section 348” is adulterated (21 U.S.C. 342(a)).

If product has to be recalled, FDA classifies the recall by health risk, from Class I to Class III (21 CFR 7.3); a tray problem is classified on its own facts.

Which rules cover an HDPE or polypropylene tray?

The resin. 21 CFR 177.1520 covers olefin polymers, including polypropylene and polyethylene, and says the listed polymers “may be safely used as articles or components of articles intended for use in contact with food, subject to the provisions of this section” (eCFR 177.1520). A copolymer qualifies only if it contains “not less than 96 weight-percent of polymer units derived from ethylene and/or propylene,” with the exceptions the section lists. The specifications in paragraph (c) differ from one polymer item to the next, and some items are limited to named conditions of use, which is why the supplier’s letter should name the item and not only the section. HDPE and polypropylene stand on equal footing here; the trade-offs between them are about heat, cold and impact, not FDA status.

The color. Colorants for plastics have their own regulation, 21 CFR 178.3297, which defines a colorant as a substance that “does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye” (eCFR 178.3297). A colorant can also be authorized another way, so the letter should say how. If you color code trays for allergen control, the colored trays need this documentation as much as the plain ones; building an allergen color scheme with one meaning per color covers the scheme itself.

The food and the temperature. FDA describes uses by food type and condition of use (FDA, Food Types and Conditions of Use):

Sources for the table: FDA, Food Types and Conditions of Use for Food Contact Substances.

If product goes onto trays while still warm, ask the supplier which condition covers that. A letter written for room temperature does not tell you about the freezer; checking a tray’s cold rating before freezer use covers the rest.

Where does NSF certification fit?

Retail food codes and FDA’s food additive rules answer different questions, and NSF certification belongs to the retail codes.

FDA says regulators “use the FDA Food Code as a model to develop or update their own food safety rules,” and the code addresses “the retail and food service segment of the industry” (FDA Food Code). Its materials section says food-contact materials “may not allow the migration of deleterious substances or impart colors, odors, or tastes to food” (Food Code 4-101.11, as adopted in Washington at WAC 246-215-04100).

The code then offers a shortcut. Washington’s version says food equipment certified or classified for sanitation under a recognized American National Standards Institute (ANSI) accredited certification program “is deemed to comply with Subparts A and B of this part,” which hold the materials and design requirements (Food Code 4-205.10, as adopted in Washington at WAC 246-215-04272). NSF lists ANSI and its accreditation board, ANAB, among the organizations that accredit it (NSF). Certification is a way to show compliance, and the rules quoted on this page do not require it. Your state’s adoption of the Food Code, and your local inspector, decide what an in-store bakery must show; tray choices for an in-store bakery covers retail settings.

A wholesale plant registered with FDA works under the manufacturing rule instead, which requires food-contact surfaces to be “made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds, sanitizing agents, and cleaning procedures” (21 CFR 117.40). For a plant, the supplier’s authorization letter is what answers the food additive question.

What does the bakery itself have to do?

Supplier paperwork covers the tray as delivered. How you use it is your part. The manufacturing rule requires food-contact surfaces to be “maintained to protect food from allergen cross-contact and from being contaminated by any source, including unlawful indirect food additives” (21 CFR 117.40(a)(6)). In practice:

• Use trays inside their authorization. Keep each model within the food types and conditions its letter covers.
• Keep chemistry inside the tray’s rating. Sanitizers and wash temperatures have limits of their own, and the tray has to withstand them; sanitizer strengths and wash temperatures for trays lists them.
• Retire damaged trays. The resin letter says nothing about a tray’s condition. Take trays with cracked food-contact surfaces out of food contact; why a crack in a food surface ends a tray’s food-contact life explains where that rule comes from and where it is our recommendation.
• Put trays in the supplier approval part of your food safety plan. How trays fit the plan, and how long the records are kept, is covered in adding trays to your food safety plan.

Which documents are you missing?

List every tray model in your plant, and next to each one write the resin authorization, the colorant authorization and the conditions of use you have on paper. Any blank is the first supplier request. Any condition your trays see that the paperwork does not cover, such as a freezer or warm product, is the second.