Guidance on FCM test conditions

How laboratories decide on conditions for Food Contact Materials (FCM) migration tests

The answer to this question can be found in the food contact materials (FCM) regulation for plastics (EU) 10/2011 and in the Council of Europe (CoE) resolutions for silicones and rubbers or metals and alloys. These legislative acts provide guidance how to choose the right test conditions for the migration tests.

Migration is the transfer of chemical substances from food contact materials into food. Migration is dependent on the temperature (of the food), the expected duration of the food with the material and the type of food. 

Overall and Specific Migration Limits are applicable. The Overall Migration Limit (OML) applies to the sum of all substances that can migrate from the FCM into food (or food simulant). The OML is a measure for the inertness of the material.  Specific Migration Limits (SML) apply only to individual substance (groups). 

Simulants, temperature and duration

For laboratories it is impractical to perform migration tests on all the actual types of food under normal and foreseeable use conditions. The tests are therefore performed with simulants that replace or substitute actual food. 
There are several simulants that can be chosen, depending on the type of food (dry, aqueous, acidic and alcoholic, dairy). 
The test conditions are a combination of contacttime, temperature and simulants that will simulate the actual usage of the product as closely as practical. The test conditions will vary based on the food contact applications, intended use, as well as the regulation that it is tested against.

Although legislation provides some guidance, determining the correct parameters for testing remains a challenge. To address this, an EU guidance document has been published, which is widely used by laboratories to select the appropriate testing parameters. You can access the document here.

This guidance categorizes various types of kitchenware articles made from plastics, metals, silicone & rubber and paper & board, providing the correct test parameters for each category. For articles made from other materials, the document can still be used to determine the applicable contact time and temperature for testing.