The Regulation on plastic FCMs (10/2011) is part of EU legislation concerning materials and articles in contact with food.

The Regulation covers many industrial sectors and everyday articles, including single-layer (used for films, bottles and caps), multi-layer and multi-material plastics.

The chapter on compositional requirements is one of the most important sections of the document, because it provides a list of substances that may be used in the manufacture of plastic FCMs.

Migrations tests must be performed to ensure the safety of plastic materials in accordance with FCM regulations. Results are then compared against set migration limits.

MIGRATION TESTS FOR FCMs

There are 2 types of migration: overall and specific migration.

The overall migration limit is the maximum permitted amount of a non-volatile substance released from a material into food. The overall migration limit is 10 mg/dm² of material in contact with food, or 60 mg/kg of food.

The specific migration limit is the maximum permitted amount of a given substance which could be released into food. A list of specific migration limits for authorised substances is included in Regulation 10/2011. These limits are established by the European Food Safety Authority (EFSA) on the basis of toxicity data for each substance.

The Regulation on plastic FCMs also sets out how to conduct migration tests, which are generally carried out using "simulants".

Simulants are substances representative of a given food category. For instance, acetic acid 3% is the simulant for the acid food category.

Tests are performed under standardised time and temperature conditions, representative of the use of the food they mimic; testing time depends on the desired shelf life for that specific food.

If you need support with conducting tests and obtaining the FCM certification, you can rely on our training service: besides consultation, we offer practical support, tailored to your business needs!