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FDA Food Contact Material: Compliance Guide

In 2023, the FDA issued warning letters to multiple manufacturers of food contact articles — including a major manufacturer of reusable plastic food containers — for failing to provide adequate documentation that their food contact substances were approved for their intended use. The common thread in all the letters: the companies had test data showing their products were safe, but they could not produce a properly structured Declaration of Compliance that mapped each substance in the material to its regulatory clearance. The FDA's position was unambiguous: data without a properly structured declaration is not compliance documentation.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA) and 21 CFR Parts 170–199, any material intended to contact food during manufacturing, packaging, storage, or preparation must be approved by the FDA or be Generally Recognized as Safe (GRAS). The manufacturer or supplier issues a Declaration of Compliance (DoC) — a self-declared document that certifies the material meets FDA regulatory requirements. On the Sustalium platform, food-contact declarations are one of the most cross-referenced document types we see: a food packaging supplier issues a Declaration of Compliance to its downstream customer, who must then present it to their own buyer or retailer audit.

What the FDA Requires for Food Contact Materials

The FDA regulates food contact materials through a framework of food additive regulations, GRAS determinations, and Food Contact Notifications (FCNs). The three primary pathways to market clearance are:

1. Food Additive Regulation (21 CFR Parts 174–178)

A substance listed in an FDA food additive regulation has been evaluated and cleared for specific food contact uses. The regulation specifies the permitted use conditions — type of food, temperature limits, maximum thickness, and other constraints the manufacturer must respect.

Key sections: | 21 CFR Part | Covers | |-------------|--------| | Part 175 | Adhesives and components of coatings | | Part 176 | Paper and paperboard components | | Part 177 | Polymers (polyethylene, polypropylene, PET, nylon, etc.) | | Part 178 | Adjuvants, production aids, and sanitizers |

If your material falls within a listed 21 CFR regulation and meets all specified conditions of use, it is cleared for food contact and you can issue a Declaration of Compliance referencing the specific regulation.

2. Food Contact Notification (FCN)

For new food contact substances not already covered by a regulation, the manufacturer submits a Food Contact Notification to the FDA. If the FDA does not object within 120 days, the notification becomes effective and the substance is cleared — but only for the manufacturer who submitted the FCN and for the specific uses described in the notification. FCNs are proprietary, meaning a downstream manufacturer cannot rely on someone else's FCN unless they are specifically authorized to do so.

As of 2026, the FDA's Inventory of Effective FCNs contains over 1,000 cleared substances.

3. Generally Recognized as Safe (GRAS)

A substance determined by qualified experts to be GRAS for its intended use does not require pre-market FDA approval. A GRAS determination can be self-affirmed by the manufacturer (independent GRAS conclusion) or submitted to the FDA for a "no questions" letter (FDA-notified GRAS). Either pathway requires that the manufacturer maintain robust scientific documentation supporting the GRAS conclusion.

What a Declaration of Compliance Must Contain

The FDA does not prescribe a specific DoC format, but the document must be sufficiently detailed to demonstrate regulatory clearance. Based on industry practice and FDA enforcement precedent, a compliant DoC should include:

  1. Supplier identification: Legal name, address, contact information of the entity issuing the declaration.
  2. Material identification: Trade name, grade, and a complete list of all components and additives in the material, including CAS numbers where available.
  3. Regulatory citation for each substance: The specific 21 CFR section and paragraph, FCN number, or GRAS conclusion that clears each substance for food contact use.
  4. Conditions of use: The specific food types, temperature limits, and usage conditions under which the material is cleared.
  5. Limitations: Any restrictions — for example, "suitable for aqueous foods up to 212°F but not for fatty foods above 120°F."
  6. Statement of compliance: A clear statement that the material complies with FDA requirements for its intended food contact use.
  7. Date and signature: The date of issue and the signature of an authorized representative.

The Proprietary FCN Trap

An FCN is proprietary to the notifier. If your supplier uses a substance cleared under their FCN, that clearance does not extend to you unless the notifier has explicitly authorized you to rely on it — typically through a letter of authorization. In practice, this means that companies further down the supply chain often unknowingly rely on FCNs they have no legal right to reference. This is a recurring issue flagged in FDA warning letters and buyer audits.

Enforcement and Market Access

The FDA does not pre-approve individual DoCs. However, enforcement occurs through:

  • FDA facility inspections: If your DoC is incomplete or cannot be supported by underlying documentation, the FDA may issue a Form 483 observation or a warning letter.
  • CBP import holds: US Customs and Border Protection may detain food contact articles if the importer cannot produce adequate FDA compliance documentation.
  • Buyer and retailer audits: Major food brands and retailers increasingly require Declaration of Compliance documentation as part of supplier approval programs — often in a structured, verifiable format rather than a static PDF.
  • EU–US divergence: An EU FCM Declaration of Compliance (under Regulation [EC] No 1935/2004) is not automatically valid in the US. The frameworks are structurally similar but the regulatory citations and testing standards differ. We see companies on the Sustalium platform regularly needing to maintain both an EU FCM declaration and a US FDA DoC for the same product.

How Sustalium Supports FDA FCM Compliance

Maintaining FDA Declarations of Compliance across changing material formulations, supplier changes, and multi-market requirements creates significant documentation overhead.

Sustalium's FDA food contact material compliance platform addresses this:

  • Component-Mapped DoC Generator: Enter your material composition once — including each substance's regulatory pathway (21 CFR citation, FCN number, or GRAS basis), CAS numbers, and conditions of use. Sustalium generates a complete Declaration of Compliance that maps every individual component to its clearance.
  • Dual-Market FCM Declarations: For companies supplying both the EU and US markets, Sustalium maintains your EU Declaration of Compliance (under Regulation [EC] 1935/2004 and Regulation [EU] 10/2011 on plastic FCMs) alongside your FDA DoC — using the same material data, with correct citations for each jurisdiction.
  • Buyer-Ready Sharing: Instead of emailing static PDFs to every downstream customer, generate a public-facing compliance page that food brands and retailers can verify directly. When the customer's next audit asks for your food contact compliance documentation, send a link, not an attachment.

Build Your FDA Food Contact Declaration Today

An incomplete or missing Declaration of Compliance can trigger FDA observations, buyer rejections, and CBP import holds. Centralize your material data and generate a properly structured FDA DoC in minutes.

With Sustalium, generate your FDA food contact compliance documentation for just €10 per document.

Build Your FDA DoC Now →

Frequently Asked Questions

Is an FDA Declaration of Compliance the same as an EU FCM Declaration?

No. While both certify food contact safety, the regulatory frameworks differ. The FDA DoC cites 21 CFR regulations, FCNs, or GRAS determinations. The EU FCM Declaration cites Regulation [EC] 1935/2004 and specific material-specific measures like Regulation [EU] 10/2011 for plastics. The testing standards and migration limits also differ.

Can I use a single DoC for all my food contact products?

A DoC is specific to a material formulation and its intended conditions of use. Different materials, different formulations, or different use conditions require separate declarations. However, a single DoC can cover multiple products if they use the same material under the same conditions.

What happens if my supplier refuses to provide a DoC?

Without a DoC from your supplier, you cannot verify that the material is FDA-cleared — and you cannot issue your own DoC to your downstream customer. In practice, food brands will generally not accept a supplier that cannot produce food contact compliance documentation.

Does the FDA pre-approve Declarations of Compliance?

No. The FDA does not review or approve individual DoCs. The declaration is a self-certification, but it must be supported by underlying regulatory clearances, test data, and documented GRAS determinations. The FDA verifies the substance of the DoC during facility inspections and in response to compliance concerns.

Last updated: July 17, 2026