Migrationstests für Lebensmittelkontaktkunststoffe: EU and FDA Requirements
Migration testing ensures that plastic packaging materials do not transfer harmful substances to food products. Dieser Artikel vergleicht die EU 10/2011 und FDA-Migrationstestanforderungen.
EU 10/2011 Regulation Requirements
- Overall Migration Limit (OML): 10 mg/dm² or 60 mg/kg food
- Specific Migration Limits (SML): Substance-specific limits
- Test Conditions: Time/temperature based on intended use
- Food Simulants: Ethanol, acetic acid, olive oil, Tenax
FDA Migration Testing Protocol
- Extraction Solvents: n-Hexane, distilled water, 8% ethanol
- Extraction Conditions: 60°C for 2 Std. (typical)
- Acceptance Criteria: ≤0.5 mg/in² surface area
- Heavy Metals: ≤1 ppm total
Test Methodology
EN 1186 series for overall migration:
- Teil 2: Gravimetric method for simulants
- Teil 5: Cell for liquid foods at elevated temperatures
- Teil 11: Total immersion method
Specific Migration Analysis
GC-MS and HPLC analysis for:
- Antimony (catalyst residue): SML 0.04 mg/kg
- Acetaldehyd: ≤10 ppm for beverages
- Phthalates: SML 0.3-1.5 mg/kg depending on type
- Primary aromatic amines: NDL (not detectable)
Declaration of Compliance (DoC)
✓ EU DoC per Article 16 of Regulation 10/2011
✓ FDA Letter of Guarantee
✓ Test reports from accredited laboratories (ISO 17025)
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