Polymer Migration Testing Parameters for European Food Contact Compliance
European food contact polymer compliance mandates measuring total migration below 10 mg/dm² and specific migration limits using exact simulants and conditions.
Triple Extraction Protocol
Meaning
Sequential washing steps remove residual chemicals from a plastic sample for purity testing. Laboratory staff follow a triple extraction protocol to ensure all potential migrants are captured from a polymer before it is approved for medical use. The process involve soaking the sample in three separate batches of solvent under controlled conditions.
This ensures that even the most stubborn additives are removed for analysis.
Solvent Sequence
Different liquids are used to target a wide range of chemical properties. The first solvent might target non-polar oils while the final solvent targets polar residues. This multi stage approach is more effective than a single long soak.
Leachate Analysis
Extracted liquids are tested using chromatography to identify the concentration of each substance. The triple extraction protocol provides a worst case scenario for how many chemicals might leak out of a part in the field. It is a standard requirement for materials that will be in long term contact with the human body.
Regulatory Approval
Data from these tests is submitted to authorities like the FDA to prove the safety of the resin. A material that passes the protocol is considered low risk for leaching harmful additives. The test results help set the shelf life and usage limits for the final product.