No. 28
What certifications or regulatory standards apply to food-contact bread trays in commercial bakery operations?
- 6 sections
- 2 tables
Two layers apply, and they answer different questions. The legal layer asks whether the tray’s plastic, colorants and additives are permitted for food contact; in the United States that is FDA’s food additive framework in Title 21 of the Code of Federal Regulations. The customer layer asks whether the tray maker runs a controlled, audited operation; that is where certifications such as SQF, BRCGS Packaging Materials and FSSC 22000 come in. A third question, transport sanitation under FSMA, reaches bagged bread only in specific cases. This guide is general information, not legal advice; confirm your own obligations with your food safety lead or regulatory counsel.
The federal rules that cover the tray material itself
Specify the tray as a food-contact article even if today’s products all travel bagged; the same pool can later carry unwrapped rolls, and a requalification after the fact is harder than a correct first specification. Three sections of 21 CFR do most of the work for an HDPE tray:
- The resin. 21 CFR 177.1520, “Olefin polymers”, states that the listed olefin 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.” The phrase “subject to the provisions” matters: the section sets conditions, it is not a blanket approval.
- The color. 21 CFR 178.3297, “Colorants for polymers”, defines a colorant as a substance that imparts color to a food-contact material “but that does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye,” and requires use levels no higher than “those reasonably required to accomplish the intended coloring effect.” Each pigment in a colored tray should trace to a listing in that section.
- The stabilizers. 21 CFR 178.2010, “Antioxidants and/or stabilizers for polymers”, is where antioxidant and stabilizer packages are listed.
A substance that is not covered by an existing listing can be cleared through a food contact notification. Under 21 U.S.C. 348(h), a notification “shall become effective 120 days after the date of receipt” unless FDA objects within that period. A separate route, the threshold of regulation in 21 CFR 170.39, exempts a substance that migrates at levels below the threshold if the conditions in that section are met.
Recycled resin follows its own path. FDA describes reviewing each proposed use of recycled plastic “on a case-by-case basis” and issuing informal advice; the voluntary no objection letter and what it covers are explained in our guide to recycled HDPE in bread trays.
What to ask the supplier for, in writing: the resin grade and the CFR section it relies on, each colorant and stabilizer with its section, any food contact notification numbers, and the use conditions the supplier assumed (temperature, food type, repeated use).
Does FSMA’s Sanitary Transportation rule apply to bread trays?
For sealed, shelf-stable bread the answer turns on a definition. In 21 CFR 1.904, transportation operations “do not include any activities associated with the transportation of food that is completely enclosed by a container except a food that requires temperature control for safety.” A closed, unvented poly bag of bread fits the plain reading of food completely enclosed by a container.
Three conditions change that answer:
- Vented or perforated bags. The same section defines food “not completely enclosed by a container” with examples that include “a vented plastic bag.” Bread shipped in vented bags, or unwrapped rolls in open trays, can fall inside the rule.
- Temperature-controlled products. The exclusion does not reach food that requires temperature control for safety.
- Business size. The rule’s definitions also carve out a “non-covered business,” one with less than $500,000 in average annual revenue (inflation adjusted).
Outside the transport rule, the tray is still plant equipment. 21 CFR 117.40 requires plant equipment and utensils to be “adequately cleanable” and maintained “to protect against allergen cross-contact and contamination,” and food-contact surfaces to be “made of nontoxic materials and designed to withstand the environment of their intended use.” For a bakery, the tray wash, inspection and retirement records belong in that program even where the transport rule does not apply.
| Situation | Transport rule (21 CFR part 1, subpart O) | What still applies |
|---|---|---|
| Sealed bag, shelf-stable bread | Excluded as completely enclosed food | Plant sanitation and equipment rules, customer audits |
| Vented bag or unwrapped product | Can apply | Plant rules plus transport sanitation duties |
| Product needing temperature control | Can apply | Plant rules plus transport temperature duties |
| Business under the revenue threshold | Non-covered business | Plant rules, customer requirements |
The certifications customers ask tray suppliers to hold
Certifications are contractual, not statutory: a retailer or a large bakery writes them into its supplier requirements. Ask for the scheme, the exact code or issue, the certificate scope (it should name the site that molds your trays) and the expiry date.
| Scheme | What to ask for | What it does not prove |
|---|---|---|
| SQF | A certificate under the SQF code for manufacture of food sector packaging. SQFI anticipates that, pending completion of its review, the first Edition 10 audits could begin "as early as January 2027," so confirm which edition the audit used | That a specific tray formulation meets 21 CFR |
| BRCGS Packaging Materials | Issue 7, which replaced Issue 6; audits from April 28, 2025 are conducted against Issue 7 | Migration compliance of your tray |
| FSSC 22000 | Certificate scope covering packaging manufacture at the molding site | Your own wash program |
The SQF timing comes from SQFI’s announcement of Edition 10; the BRCGS dates come from LRQA’s summary of Packaging Materials Issue 7, which reports that Issue 7 was published on October 28, 2024. Write the requirement with the code name and edition rather than a bare “SQF certified,” because the code and edition determine what the auditor examined.
Allergen cross-contact in a shared tray pool
FDA lists nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame, with sesame labeling required on packaged foods as of January 1, 2023. A bakery tray list that predates 2023 may omit sesame, which matters for seeded buns.
The exposure route depends on the packaging. For sealed bags, the tray touches film, not bread, so the practical risk sits with unwrapped or vented products and with residue carried on bag exteriors. Where a pool carries both unwrapped allergen-containing products and allergen-free products, the controls to consider are a dedicated sub-pool (marked by color or molded code), a wash program the plant has verified for that soil, and documented inspection at the wash exit. The color-marking side of that decision is covered in our guide to bread tray color coding.
Trays that cross into the European Union
The EU uses a different structure. The European Commission’s summary of EU food contact materials legislation describes Regulation (EC) No 1935/2004 as the framework and Regulation (EU) No 10/2011 as the measure for plastics, with a Union List of permitted substances, migration limits and a “Declaration of Compliance” passed along the manufacturing chain. A tray qualified for the U.S. is not automatically documented for the EU; ask for the EU declaration separately if trays will ship there.
A qualification file that holds up in an audit
- Resin, colorant and stabilizer statement with the 21 CFR section for each.
- Notification numbers for any substance cleared by food contact notification.
- For recycled content, the FDA letter or the supplier’s own documented evaluation and its stated use conditions.
- Current certificate (scheme, code or issue, site, expiry).
- Your own records: wash parameters, inspection criteria, retirement decisions, allergen pool rules.
- A change clause: the supplier notifies you before changing resin, colorant, stabilizer or recycled source, because each change can move a tray out of the section it relied on.
Treat item 6 as the control that keeps the other five true over the life of the fleet.