Cross Border Polymer Migration Testing Standard Parameters
Cross-border polymer migration compliance requires testing finished articles under verified worst-case simulants, contact times, and surface-to-volume ratios.
European Union Regulation 10/2011
Meaning
Specific legal frameworks govern the composition and testing of plastic materials intended to come into contact with food within the European single market. Officially designated as European Union Regulation 10/2011, this legislation establishes a positive list of authorized monomers, additives, and polymer production aids. It sets out the overall migration limit of ten milligrams per square decimeter and defines specific migration limits for individual restricted substances.
Every supplier of plastic packaging must provide a detailed declaration of compliance to verify adherence to these requirements.
Union List
The annex contains all authorized substances that may be used in the manufacture of plastic layers in materials and articles. No substance may be used if it is not included in this positive list, unless it falls under specific exemptions like functional barriers. The list is updated periodically to reflect new scientific assessments of chemical safety.
Migration Testing
Packaging must be tested using specified food simulants and exposure times that represent the worst foreseeable conditions of use. For example, 3 percent acetic acid simulates acidic foods, while rectified olive oil simulates fatty substances. Modern laboratories often substitute ethanol or isooctane to simplify the testing process.
Compliance Documentation
Every step of the supply chain requires a declaration of compliance. This document ensures traceability and provides the next user with necessary information regarding restricted substances. It must be updated whenever the formulation changes.