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A client called us last spring with a container of plastic kitchenware stuck at the port of Rotterdam. He had a thick file of food contact materials test reports from his Chinese supplier — FDA 21 CFR compliant, every page stamped — and he could not understand why the inspector would not release the goods. The answer was simple and expensive: none of that paperwork said anything about European law. An FDA or LFGB report is not an EU Declaration of Conformity, and at the EU border the Declaration is the document that matters.
That scene repeats more often than you would expect. So let us be blunt about what the rules actually demand, because the gap between «we have certificates» and «we are compliant» is where importers lose money.
The Declaration of Conformity is yours to sign, not the lab’s
Under Regulation (EC) No 1935/2004, anyone placing food contact materials on the EU market issues and signs their own Declaration of Conformity (DoC). It is a statement by the business operator, not a certificate granted by a laboratory. Clients confuse the two constantly: a migration test from an ISO 17025 lab is evidence that supports your declaration, but it is not the declaration. Inspectors ask for the DoC first, and a folder of test reports without one does not close the file.
Article 3 of that regulation is the principle everything else hangs on: a material must not transfer its constituents to food in amounts that could harm health or unacceptably change the food’s taste, smell or composition. Simple to state, hard to prove on paper — which is the whole point of the declaration.
Where the obligation lands in the supply chain
Think of it as a relay. The substance supplier declares what they sell; the maker of the finished article writes their own DoC on top, citing the upstream document and pinning down the conditions of use — what food it touches, at what temperature, for how long, single-use or reusable. Each operator hands their declaration downstream, and whoever holds it must produce it on demand.
And the importer? Here is the part our Valencia client learned the hard way. When goods come from outside the Union, the importer inherits the manufacturer’s compliance role outright. The supplier’s home-market statement is a starting point, nothing more. The real question is never whether you trust your supplier — it is whether the data on the table proves conformity with EU positive lists and migration limits. That is exactly what an inspection probes, and what most files cannot answer.
What a plastics declaration must actually contain
For plastic food contact materials, the governing text is Regulation (EU) No 10/2011. Article 16 of Reg. 1935/2004 fixes the skeleton of any DoC — issuer, material identity, date, a statement of compliance, traceability data — and Article 15 of Reg. 10/2011 adds the flesh for plastics: every substance used, its FCM number from the Union positive list, the restrictions that apply, and how compliance was shown (testing, EFSA-endorsed migration modelling, or conservative calculation).
Why does the positive list matter so much? Because a substance that is not on it cannot be intentionally used, however clean the migration looks. We have seen perfectly safe-testing articles rejected for exactly this reason: an additive authorised in the supplier’s country but simply absent from the EU list. No amount of good test data rescues an unlisted substance.
Migration limits: where declarations quietly fail
This is the trap. The overall migration limit is 10 mg/dm² of food contact surface — the sum of everything that can transfer into the food. Layered on top are the specific migration limits (SML) for individual substances; PET, for instance, must respect the SML for ethylene glycol and terephthalic acid, the building blocks of the polymer. None of that means anything unless it is tested under the right food simulants from Annex III of Reg. 10/2011 — simulant A for watery foods, D2 for fatty ones — and at conditions that mirror real use.
In our experience, the most common defect is not a missing report but the wrong one: testing run with simulant A on a tray that will hold hot oil, or at 40 °C when the product survives a microwave. On paper it reads compliant. Under an inspector’s questions it collapses. A declaration is only as good as the test conditions behind it.
Glass, paper, metal: no specific rule is not a free pass
Plenty of food contact materials — glass, metals, paper and board, silicone, coatings — have no harmonised EU regulation like the one for plastics. That tempts people to assume they are off the hook. They are not. Article 3 still applies, and conformity has to be argued from the toxicological data substance by substance. For paper and board, authorities expect the Council of Europe resolutions referenced; ceramics still fall under Directive 84/500/EEC and its lead and cadmium limits. No dedicated regulation means more work, not less.
How we handle a food contact materials file
At ASC Services we start where the inspector will: with the paperwork you already hold from your manufacturer. We check positive-list status for the key substances, confirm the SML and overall migration figures, and test whether the migration data actually matches your declared use rather than some generic scenario. Then we draft the EU-compliant Declaration of Conformity, build the supporting technical file behind it, and surface every gap before a border official does. We keep clients ahead of regulatory shifts through our news section, as part of our wider consultancy services for regulated products.
Two questions we hear every week
Is an accredited lab’s migration report enough on its own?
No. The report supports your Declaration of Conformity; it does not replace it. The DoC is a separate document you issue and sign, and it is the one authorities ask for. You need both — and be aware that FDA, LFGB and Chinese GB 4806 reports do not prove EU food contact compliance; only migration testing against Regulation (EU) 10/2011 does.
Can my non-EU supplier sign the DoC for me?
No. As the importer you take on the manufacturer’s compliance obligations and must issue an EU declaration yourself. The supplier’s documentation can feed into it, but it cannot stand in for it.
If you manufacture or import food contact materials and you are not sure your file would survive an inspection — or you need a compliant Declaration of Conformity drawn up for the first time — send us your product type and your supplier’s paperwork. Contact us and we will tell you precisely what is missing and how fast we can close it.