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Every week a manufacturer sends us a thick folder of test reports and asks the same question: my products are FDA compliant and LFGB tested, so why is the EU importer asking for more? The short answer is that food contact compliance in the EU is not a test result you can buy in another jurisdiction. It is a legal declaration, backed by testing carried out against Europe’s own rules. An FDA, LFGB or Chinese GB 4806 report answers a different law, so it cannot, on its own, prove that a product is safe to place on the EU market.
In the European Union, food contact materials are governed by Regulation (EC) No 1935/2004 (the framework for all materials) and, for plastics, Regulation (EU) No 10/2011. Article 3 of the framework regulation sets the core rule: a material must not transfer its constituents into food in quantities that could endanger health, change the composition of the food, or spoil its taste or smell. Everything else — positive lists, migration limits, test conditions — exists to prove that this rule is met. A report written for another country does not.
Does an FDA 21 CFR report make my product EU compliant?
No. The US system under Title 21 of the Code of Federal Regulations (21 CFR 170–190) works from a different inventory of cleared substances and a different approach to migration. A food contact substance cleared by the FDA — through 21 CFR listing or a Food Contact Notification — may not appear on the EU’s authorised list at all. The simulants, the test temperatures and times, and the acceptance limits are not the same. A stamp saying “FDA 21 CFR compliant” tells an EU inspector nothing about whether the article respects the EU’s specific migration limits.
Is a German LFGB certificate enough for the EU?
Not by itself, and this one causes the most confusion. The LFGB (the German Food and Feed Code) is national law of an EU member state, and the associated BfR recommendations are respected across Europe. But a typical “LFGB test” from a laboratory covers sensory analysis and overall migration for a specific material, often materials such as silicone, rubber or paper for which no EU-harmonised measure exists. For plastics, Regulation (EU) No 10/2011 is fully harmonised and directly applicable in every member state. An LFGB certificate does not test against the EU Union list of authorised substances, does not cover every specific migration limit, and is not the Declaration of Conformity that EU law requires. It can be a useful supporting document; it is not the compliance itself.
What about Chinese GB 4806 testing?
The GB 4806 series (GB 4806.1 general safety, GB 4806.6 and 4806.7 for plastic resins and articles, with migration methods in the GB 31604 series) is China’s national standard. It has its own positive lists, its own limits and its own test conditions. None of these are recognised as proof of conformity in the EU. A product can pass GB 4806 in full and still breach a specific migration limit set by Regulation (EU) No 10/2011, because the two systems authorise different substances at different thresholds.
Why can’t one good test simply cover all markets?
Because food contact rules differ on four points that decide compliance:
- The positive list. Each region authorises a different set of substances. A monomer or additive on the FDA or GB list may not be on the EU Union list (Annex I of Regulation 10/2011).
- Migration limits. The EU applies an overall migration limit of 10 mg/dm² plus substance-specific limits (SMLs). Other systems use different values.
- Simulants and conditions. The EU prescribes its own food simulants and time/temperature conditions (Annexes III and V of Regulation 10/2011). A test run under US or Chinese conditions is not comparable.
- The legal instrument. EU compliance is stated in a signed Declaration of Conformity, supported by documentation. A test report is one input to that file — never a substitute for it.
What does the EU actually require?
For a plastic food contact article, compliance means: the materials use only substances on the EU authorised list; migration testing is carried out with EU simulants and conditions and stays within the overall and specific limits; the product is made under Good Manufacturing Practice (Regulation (EC) No 2023/2006); and all of this is captured in a Declaration of Conformity with supporting documentation that follows the product down the supply chain. We explain how that declaration is built in our guide to the EU Declaration of Conformity for food contact materials.
What should a non-EU manufacturer do?
Keep your FDA, LFGB or GB reports — they show the product has been tested and are useful background. But before shipping to the EU, have the product assessed and, where needed, re-tested against Regulation (EU) No 10/2011, and prepare the Declaration of Conformity that the EU importer is legally required to hold. Doing this before the goods leave the factory is far cheaper than doing it with a container held at Rotterdam or Valencia.
In the EU, food contact compliance is governed by Regulation (EC) No 1935/2004 and, for plastics, by Regulation (EU) No 10/2011 — which require a Declaration of Conformity backed by migration testing against the EU’s own limits and simulants. No FDA, LFGB or GB 4806 report, however thick the folder, can replace it.