Meaning
Regulatory standards for plastic materials intended to come into contact with food establish strict limits on chemical substances that can migrate from packaging into food products. This comprehensive European regulation, known officially as EU 10 2011 food contact, specifies the authorized substances that may be used in the manufacture of plastic food contact materials. It defines the rules for testing migration using food simulants under specific time and temperature conditions.
The boundary of this regulation applies to any plastic layer in multi-material assemblies that directly contacts food or is separated by a functional barrier.
Migration Limit
Maximum allowable limits for the release of chemical constituents are set to protect human health. Under the framework of EU 10 2011 food contact, substances are subject to both overall migration limits and specific migration limits. Overall migration measures the total amount of non-volatile substances that transfer from the plastic.
Material Testing
Laboratory analyses must simulate the real-world conditions that a moulded part will encounter during its life cycle. Compliance with EU 10 2011 food contact requires testing the finished article with simulants representing acid, alcohol, water or fatty foods. The testing protocol uses temperature exposures that mimic hot-fill conditions, long-term storage or microwave heating.
If a moulded container fails these rigorous tests, the resin formulation or the injection moulding process must be modified to reduce chemical leaching.
Compliance Documentation
A formal declaration of compliance must accompany food-grade resins throughout the entire manufacturing chain from resin producer to the final packer. Within the context of EU 10 2011 food contact, this document certifies that all raw materials are on the union list of authorized substances. Injection moulders must review these declarations to ensure that process additives, colorants or slip agents used during production do not violate the approved limits.
Keeping these records up to date is crucial for passing regulatory audits, avoiding product recalls and maintaining corporate credibility in highly regulated consumer goods markets.