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Guidance on FCM test conditions

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

How do 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 itself gives certain guidance,  it is still a challenge to determine how to choose the correct parameters for testing. Therefore a EU guidance document is published which most laboratories will use for choosing the correct testing parameters: Read here

This guidance document has categorised all kind of kitchenware articles made from plastic and metals.
For each category the correct test parameters are given. For articles which are not made from plastic or metal this guidance document can still be used for the applicable contacttime and temperature. 
The food simulants must be chosen based on the applicable legislation or CoE resolutions.

The list of food simulants defined in Regulation (EU) 10/2011:

Simulant A

Ethanol 10 % (volume/volume)

Simulant B

Acetic acid 3 % (weight/volume);

Simulant C

Ethanol 20 % (v/v); 

Simulant D1

Ethanol 50 % (v/v); 

Simulant D2

Any vegetable oil containing less than 1 % unsaponifiable matter;

Simulant E

Poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm.

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