Food-contact packaging compliance is a documentation problem, not a certification badge. For the EU you need a Declaration of Compliance under Regulation (EC) No 1935/2004 plus supporting test evidence for the exact material structure; for the US you need evidence that each food-contact substance is cleared under FDA's 21 CFR framework, plus Foreign Supplier Verification Program (FSVP) records if you are the food importer. The two systems do not accept each other's paperwork, and neither "approves" a finished pouch or bag. The buyer's job is to request a structure-specific document pack from the supplier and keep it on file.

Why the documents are your responsibility, not a supplier stamp

Both the EU and the US place the compliance burden on the business that places the packaging on the market or imports the food. A supplier can provide evidence, but it cannot transfer that responsibility.

In the EU, Regulation (EC) No 1935/2004 sets the general safety and inertness principles for all food-contact materials. In the US, FDA regulates food-contact substances through 21 CFR, and imported food products are reviewed at entry — see FDA's Import Basics. A pouch that is fine for dry coffee may be inadequate for a hot-filled soup, so the same material can be compliant in one use and not in another.

The EU document pack (Regulation (EC) No 1935/2004)

Declaration of Compliance (DoC)

The DoC is the core EU document. It is a written statement that a specific material or article complies with the applicable EU rules. It must identify the material or structure, the manufacturer or importer, and the applicable rules.

Supporting evidence: migration testing and GMP

A DoC is only as strong as the file behind it. For flexible pouches and bags, that file usually includes:

  • Migration test reports for the specific film structure and the relevant food simulant (fatty, aqueous, acidic or dry).
  • Evidence that the film, adhesives, inks and coatings are authorised for food contact.
  • A statement that manufacturing follows EU good manufacturing practice (GMP) rules for food-contact materials.
  • For some structures, a review of non-intentionally added substances (NIAS) where relevant.

What to check before you accept a DoC

  • Does it name the exact structure you are buying, layer by layer?
  • Do the stated conditions of use match your product (fill temperature, shelf life, fat or acid content)?
  • Is it issued by the party actually placing the packaging on the market in the EU?
  • Is the test report current and issued by a recognised laboratory for your market?

The European Commission maintains an overview of food-contact material legislation on its Legislation page.

The US document pack (FDA, 21 CFR)

Food-contact substance clearance under 21 CFR

FDA regulates food-contact substances through 21 CFR. Rather than approving a finished package, the framework clears individual substances and their conditions of use. For a pouch this means each film layer, adhesive, ink and coating must be supported by a clearance — a 21 CFR citation, a Food Contact Notification (FCN), or another permitted status.

Conditions of use and migration testing

Clearance is always tied to conditions of use: food type, temperature, time and whether the contact is direct or behind a functional barrier. The documentation should state those conditions and include migration data where the clearance requires it.

FSVP if you import food

If you are importing food into the US — not just packaging — the importer must maintain a Foreign Supplier Verification Program under 21 CFR Part 1 Subpart L, published in eCFR. FSVP covers the food and its packaging as part of the hazard analysis, so your packaging evidence can be pulled into that review.

Checklist: the document pack to request

Document EU US What it proves
Declaration of Compliance Required Not used Structure complies with 1935/2004
Food-contact substance clearance Supporting Required Each substance is cleared under 21 CFR
Migration test report Supporting Supporting Substance transfer stays within limits for the use
GMP statement Supporting — Manufacturing follows EU GMP rules
FSVP records — If food importer Supplier verification for imported food
Conditions-of-use statement Required Required Clearance matches your product and process

Mistakes that delay clearance

  • Asking for an "FDA approved" certificate instead of structure-specific clearance evidence.
  • Reusing one DoC across different films, sizes or products.
  • Ignoring fill temperature, fat content or shelf life when checking the documents.
  • Collecting a certificate but never keeping it on file for an audit.

How Foldveil handles food-contact documentation

For food-contact pouches, bags and rollstock, Foldveil treats documentation as part of the quote, not an afterthought. Certification and test-document scope is verified for the selected factory, material and production run; available certificate numbers are shared with the quote. That means we do not offer a blanket "FDA approved" or "food safe" statement — we confirm the exact structure, your product's conditions of use, and the target market, then match the document pack to it.

Start with a spout pouch, flat-bottom pouch or side-gusset bag specification, or request a quote with your product, fill method and target market.

Related reading

Sources

This is a buyer's checklist, not legal advice. Confirm the specifics of your product and market with your compliance counsel.