FDA 21 CFR Part 177, Section 177.1520, is the specific regulation that governs the two plastics found in virtually every commercial bread tray in North American bakeries: high-density polyethylene (HDPE) and polypropylene (PP). Most quality assurance managers know the tray must be “food grade” – fewer know precisely which regulation says so, what conditions attach to that clearance, and what happens when the documentation trail breaks down. This article covers the current regulatory framework in the detail that compliance actually requires.
How the FDA Regulates Materials That Touch Your Bread
The Federal Food, Drug and Cosmetic Act (FFDCA) is the primary legislation governing food contact materials in the United States, administered by the FDA. Regulations are found in Title 21 of the Code of Federal Regulations, Parts 174-179, which cover indirect food additives and polymers.
Bread trays qualify as indirect food additives under this framework. A food contact substance (FCS) is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food. Because tray materials may migrate into food during storage, handling, or distribution – even in trace amounts – they fall under FDA oversight.
The FDA does not pre-approve individual food contact articles like trays. Instead, each component material – the base resin, colorants, processing aids, any surface treatments – must independently comply with an applicable food additive regulation or other recognized authorization pathway. This is a point that surprises many buyers: FDA clearance applies to the material, not to the finished tray as a product.
The Electronic Code of Federal Regulations (eCFR) at ecfr.gov is the authoritative, real-time source for these regulations. For current regulatory text, verify directly at ecfr.gov, as the eCFR is updated continuously and the specific date of any amendment should be confirmed at the time of any compliance determination.
Food Contact Substance (FCS) Classification for Bread Trays
A food contact substance achieves FDA authorization through one of four pathways. First, it may be listed in 21 CFR as an indirect food additive for the intended use. Second, it may qualify as Generally Recognized as Safe (GRAS) for food contact purposes. Third, it may meet the Threshold of Regulation (TOR) exemption under 21 CFR 170.39. Fourth, it may hold an approved Food Contact Substance Notification (FCN) from FDA.
The FCN program has been operational since 2000. An approved FCN is manufacturer-specific: it is only effective for the specific manufacturer or supplier identified in the notification, per Section 409(h)(2)(C) of the FFDCA. A bakery sourcing a tray from a different manufacturer than the one named in an FCN cannot rely on that FCN for compliance.
For repeated-use articles like commercial bread trays, relevant provisions fall under 21 CFR Part 177 Subpart B and Subpart C, covering substances for single and repeated use respectively. Every component of the tray must find its authorization within this structure.
The TOR exemption pathway allows a food contact substance to be exempt from regulation as a food additive if its migration into food reaches no more than 0.5 parts per billion (ppb) under intended conditions of use, and the substance is not a carcinogen. This threshold was adopted by FDA in 1995 and applies particularly to minor processing aids or additives rather than bulk resin formulations.
HDPE and Polypropylene: FDA Clearance Status and Conditions
Both HDPE and PP are regulated under 21 CFR Section 177.1520 – Olefin Polymers. This single regulation covers both materials, defining them as basic polymers manufactured by catalytic polymerization of ethylene (HDPE) or propylene (PP), respectively.
Section 177.1520 authorizes olefin polymers as articles or components of articles intended for use in contact with food, subject to specifications in paragraph (c) and testing methods in paragraph (d). Copolymers must contain not less than 96 weight-percent of polymer units derived from ethylene and/or propylene, with specific listed exceptions.
Conditions of use are not unlimited. The regulation cross-references 21 CFR 176.170(c) Table 1, which specifies permitted food types and temperature conditions. Certain olefin copolymers are restricted to specific food types at temperatures not exceeding 190 degrees F. Bread is classified as a type VII or similar aqueous/fatty food category, and tray purchasers must confirm that the specific tray material is authorized for that food type under the temperature conditions of intended use.
Extractives testing is a key compliance parameter: total extractives from the food-contact surface must not exceed 0.5 milligrams per square inch (approximately 0.078 mg per square centimeter). Both water and heptane are used as food simulants for bakery products and aqueous products with free fat.
Resin identification code 3 (PVC) carries plasticizer migration concerns and is generally avoided in direct food contact bread tray applications. Code 6 (polystyrene) carries styrene monomer migration concerns and is similarly avoided. Code 7 is a miscellaneous catch-all category that includes polycarbonate (BPA concerns — avoid in food contact) but also includes polylactic acid (PLA), co-polyesters, and other materials with no established food safety concerns and full FDA food contact compliance. Evaluate code 7 materials individually by requesting FDA food contact compliance documentation from the supplier rather than excluding the entire category. HDPE carries recycling code 2; PP carries recycling code 5. Both are accepted food-grade resins alongside PET under the FDA framework.
Good Manufacturing Practices (GMP) Requirements for Tray Producers
FDA clearance for the resin does not eliminate the obligation for the tray manufacturer to comply with Good Manufacturing Practices. The relevant GMP rules are 21 CFR Part 110 (Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food) and 21 CFR Part 117, which is the FSMA-era rule establishing hazard analysis and risk-based preventive controls.
GMP requirements for food contact material producers include control of contamination during manufacturing, proper cleaning and sanitizing of production equipment, personnel hygiene controls, and adequate facility design. Under 21 CFR 175.105(a)(2), food packaging manufacturers must ensure GMP compliance, including that indirect additive contact with aqueous and fatty foods does not exceed trace amounts.
NSF International Standard NSF 51 (Food Equipment Materials) provides independent verification that a material meets food-grade standards, establishing minimum health and sanitation requirements for materials used in commercial food equipment.
GMP compliance by the tray manufacturer does not automatically transfer to the bakery. Bakeries must implement their own GMP controls regarding tray use, cleaning, and maintenance. FSMA extended FDA’s authority and reinforced that food contact materials causing adulteration of food violate the FFDCA.
What Bakeries Must Verify When Purchasing FDA-Compliant Trays
Regulatory compliance on the supplier side does not complete the bakery’s obligation. Bakeries must conduct their own verification and retain documentation supporting that their trays are made from FDA-compliant materials.
Request a Certificate of Conformance (CoC) from the tray supplier. This document should state that the tray materials comply with applicable FDA regulations, specifying which CFR sections apply. It is not sufficient for a supplier to assert “food grade” without citing the specific regulatory basis.
Additional documentation to obtain from suppliers:
- Material specifications including resin type and grade
- The FCN number or CFR citation authorizing the resin for food contact use
- Safety Data Sheets (SDS) for all chemical components
- Any GRAS determinations or TOR exemptions if applicable
Colorants and additives in the tray must be separately authorized. Base resin compliance does not automatically extend to color pigments or processing aids mixed into the formulation. Request specific confirmation that all non-resin components are also covered by appropriate FDA authorization.
Confirm that the tray material is authorized for the specific food type (bread, as an aqueous/fatty food) and the temperature conditions of use. If a supplier holds an FCN, verify that the tray is sourced specifically from the notifier named in the FCN – authorization does not transfer to other manufacturers of the same resin type.
Bakeries operating in Maine, Oregon, Vermont, or Washington should also check state-level requirements. These states have adopted additional reporting or restriction rules for food contact materials that may impose obligations beyond the federal FDA baseline.
Record-Keeping and Documentation for FDA Compliance
Without records, policy is unenforceable. Every documented wash parameter, inspection result, and corrective action is what transforms a stated compliance program into a defensible one. During both announced and unannounced inspections, auditors expect to see documentation, not assurances.
Core records to maintain: supplier Certificates of Conformance, FCN or CFR citations for each tray model in use, Safety Data Sheets, migration and extractives test results where available, and purchase records linking specific tray lots to specific suppliers.
Update records any time a tray supplier changes, a new tray model is introduced, or a supplier notifies the bakery of a formulation change. A formulation change that is not flagged to the bakery can invalidate prior compliance documentation without the bakery knowing.
The bakery’s HACCP plan or FSMA preventive controls documentation should include a supplier approval program that addresses food contact materials, including trays. The hazard analysis should explicitly address physical and chemical hazards from packaging materials.
Under FSMA, FDA generally requires food facility records to be retained for a minimum of two years. Compliance documentation for food contact materials should align with this minimum, and records should be stored in an accessible location, current and retrievable on short notice.
Digital record systems with search capability significantly improve the speed at which compliance documentation can be produced during an inspection, which reduces the risk of an auditor characterizing a documentation gap as a compliance failure.
Consequences of Using Non-Compliant Trays in Your Operation
The legal consequence is direct: using non-compliant food contact materials causes the food itself to be legally “adulterated” under the FFDCA, regardless of whether actual harm to a consumer has occurred or can be demonstrated.
FDA enforcement follows a defined escalation sequence. A warning letter is the initial step, identifying violations and requiring corrective action. If the warning letter response is inadequate, civil monetary penalties follow. FSMA gave FDA mandatory recall authority when there is a reasonable probability of serious adverse health consequences, classified as a Class I recall. Beyond recalls, FDA can suspend a facility’s registration, which prevents shipment of all food products from that facility. Injunctions and seizures coordinated with the US Marshals Service are available at the most serious end of the enforcement spectrum.
Recall classification depends on severity. Class I indicates a reasonable probability of serious adverse health consequences or death. Non-food-grade plastic fragments in food typically trigger Class I recall consideration. Class II indicates temporary or medically reversible adverse health consequences.
All recalls are published in the FDA weekly Enforcement Report. Public disclosure of a recall involving non-compliant tray materials creates reputational damage that extends well beyond the regulatory penalty.
Non-compliant trays discovered during a third-party food safety audit – whether SQF, BRC, or a GFSI-recognized scheme – will generate critical non-conformances that directly jeopardize facility certification. The audit consequence can arrive before the regulatory consequence and carries its own set of commercial penalties with retail customers who require GFSI certification as a condition of doing business.
The documentation disciplines required for FDA compliance are not bureaucratic overhead. They are the difference between a traceable, defensible supply chain and a liability that surfaces during an FDA inspection, a GFSI audit, or a product recall investigation.