Statutory Scope
European Union legal frameworks establish specific safety limits for plastic materials and multi-layer packaging components intended for contact with foodstuffs. Enacted under framework legislation, food contact regulation 10 2011 defines overall migration limits and specific migration limits for chemical substances in plastic packaging layers and functional barriers. Non-plastic layers like paperboard fall outside its direct primary scope, but plastic coatings and polyolefin films bonded to board must comply fully with its migration thresholds.
The regulation applies across all supply chain stages from monomer synthesis to finished packaging conversion.
Compliance Testing
Analytical verification requires exposing packaging materials to official food simulants under standardized temperature and time conditions representing actual storage scenarios. Demonstrating compliance with food contact regulation 10 2011 involves testing with liquid simulants like ethanol solutions, acetic acid, vegetable oil and dry food simulants like polyPPO. Laboratory testing determines total mass transferred into simulants, ensuring overall migration does not exceed ten milligrams per square decimetre of food contact surface.
Specific migration limits apply to individual chemical constituents such as residual monomers, plasticizers, heavy metals and primary aromatic amines evaluated via gas chromatography mass spectrometry.
Union List
Authorized substances appear on an explicit positive list that specifies maximum residual quantities and specific migration limits for each chemical compound. Compliance with food contact regulation 10 2011 prohibits unlisted substances unless separated from food by an effective functional barrier.
