FDA 21 CFR and EU 1935/2004: The Food-Contact File to Demand Before a Pallet Ships

A UK importer took delivery of 40 pallets of absorbent pads in March, then spent six weeks trying to obtain a Declaration of Compliance from a trading company that had bought them from a converter who had bought the film from a third party. The pads were almost certainly fine. The paperwork chain was four companies long and nobody at the far end would put a signature on a document naming the correct regulation. The pallets sat in a warehouse for the whole of Q2.

Food-contact compliance for a pad is not one certificate. It is a short set of documents that must match each other, name the right regulations, and be issued by someone with the standing to issue them. Here is the file to request before purchase, and how to read it.

The Difference Between a Certificate and a Declaration of Compliance

An ISO 9001 certificate proves a factory runs a quality system. It says nothing about whether the pad may touch food. A food-grade certificate from a third-party body is closer but still describes a process, not a material. The document that matters is a Declaration of Compliance, or DoC, issued against a specific regulation for a specific article, listing the substances used and the migration test results.

In the EU the DoC is required by Article 16 of Regulation 1935/2004 and, for plastic components, by Regulation 10/2011. In the US the equivalent evidence is a statement that the components are covered by one or more indirect food additive regulations in 21 CFR 174 to 178, or by an effective food contact notification, with the citation given for each component.

What the Two Regimes Actually Require of a Pad

A pad has at least three components that need separate coverage: the film backing, the tissue or nonwoven carrier, and the SAP core, plus any adhesive used in lamination. Under EU rules each must appear in the DoC with its FCM substance number, and the finished article must meet an overall migration limit of 10 milligrams per square decimetre.

Under US rules the film is typically covered by 21 CFR 177.1520 for olefin polymers, paper and board by 176.170 and 176.180, and the adhesive by 175.105. The SAP core is the component most often left vague, and it is the one to press on, because a supplier who cannot cite a regulation or an FCN for the polymer has not finished the work.

• Declaration of Compliance naming the regulation, the article, and the issue date.
• Migration test report from an accredited laboratory, with the food simulant used.
• Component list with CAS numbers or FCM numbers for film, carrier, core and adhesive.
• Certificate of analysis per production lot, including absorbency and grammage.
• Statement on heavy metals and on primary aromatic amines where polyurethane adhesive is used.
• Safety data sheet, plus a written statement on nano-material content if any is claimed.

Reading a Migration Report Without a Chemistry Degree

Three things to check. First, the simulant: a pad used under raw meat should be tested with simulant D2, vegetable oil, or with the appropriate substitute, not only with water. Second, the test conditions: 4 °C for 24 hours is closer to a thaw room than 70 °C for 2 hours, and a report using only the harsh condition tells you little about your application. Third, whether the result is overall migration or specific migration, because the two have different limits and only specific migration addresses individual substances.

A report that states only a pass, with no simulant, no temperature and no duration, should be returned.

Building the File Before the First Order

Ask for the DoC and the migration report at quotation stage, not at delivery. A supplier who can produce them in a week is a manufacturer or a well-briefed converter. One who needs a month is passing the request up a chain that may not answer.

Keep the file with the purchase specification so that a formulation change triggers a document update rather than a surprise at audit. Our food-contact certified SAP pad materials ship with a DoC, lot-level CoA and migration data referenced to the exact film and core used.