Plastic food contact material regulations and testing in the EU

Published August 15, 2022

Niko Markkinen

Niko Markkinen – PhD, food development

Food & food contact materials, Measurlabs

All food contact materials (FCMs) sold, imported or manufactured in the EU must comply with the Framework Regulation (EC) 1935/2004 on materials and articles intended to come into contact with food. Some FCMs, for example plastics, regenerated cellulose and ceramics, and are covered by additional EU regulations that set specific rules for the material in contact with food. Here we give an overview of the testing requirements concerning plastics.

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What is the regulation and what does it concern?

The EU Commission Regulation No 10/2011 lays the principles for manufacturing, testing and assessing the safety of plastic food contact materials. It includes the list of raw materials allowed in the production of plastic food contact materials and the test methods that must be used to demonstrate the compliance of plastic FCMs.

The regulation states that FCMs may not release any constituents into the food in such quantity that could endanger human health or cause unacceptable change in the composition, taste or smell of the food. In addition, all FCMs should be manufactured by good manufacturing practices (GMPs) that are given in Regulation (EC) 2023/2006. A specific testing plan must be prepared for each material specifically, based on the intended end use of the product and the raw materials used to manufacture it. The testing consists of overall migration tests, specific migration tests, and tests to for heavy metals and primary aromatic amines.

Overall migration testing by EU regulation

The overall migration limit (OML) is the sum of all the compounds that might migrate from the material into food. The OML shows how inert the material is towards food, and is most often tested by placing the FCM in contact with a specific solvent that mimics food. You can find more information about the solvents and testing specifications in our article about overall migration testing. The total amount of migrated substances is then determined and compared to the limit given in Regulation (EU) No 10/2011. Overall migration testing is performed according to EN 1186 standard.

Specific migration testing by EU regulation

Specific Migration Limits (SMLs) apply to individual substances or groups of similar substances that are used as raw material in plastic FCMs. The limitations for each allowed raw material substance are given in Regulation (EU) No 10/2011. These limits are based on the toxicological risks that different substances cause. Specific migrations are tested according to EN 13130 by placing the material in contact with a specific food-mimicking solvent, after which the migration of each substance is determined using suitable analytical techniques.

Heavy metals and primary aromatic amines

Raw materials used in plastics, such as colorants and pigments, might contain traces of heavy metals or primary aromatic amines (PAAs). Possible migration of these substances into food must be tested and the compliance assessed according to the criteria given in Regulation (EU) No 10/2011.

Do you need tests for food contact materials?

Measurlabs offers all tests required for writing the Declaration of Conformity for food contact materials, and our experts are happy to help you define the correct testing conditions. Order the analyses you need directly from our webshop or contact us at to get your testing started!

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