FDA 21 CFR 177
Strict non-leaching verification for Olefin polymers (PP §177.1520) and Eastman Tritan™ copolyester (§177.1240). Maximum n-hexane extractive limit < 5.5%.
Food Safety Compliance
Comprehensive third-party regulatory validation for North American and European retail shelves: FDA 21 CFR 177, German LFGB, California Prop 65, and zero-PFAS certification.
Core Compliance Pillars
We collaborate with accredited testing bodies (SGS, TÜV Rheinland, Intertek) to ensure every resin batch complies with destination customs requirements.
LFGB 30 & 31
Sensory organoleptic evaluation (taste/odor neutrality grade 0–1). Overall migration limits tested in 3% Acetic Acid, 10% Ethanol, and Olive Oil simulant.
Zero PFAS & Bisphenols
100% free of BPA, BPS, BPF, phthalates (DEHP, DBP, BBP), and heavy metals (Cadmium < 5 ppm, Lead < 10 ppm) satisfying California Prop 65.
Batch Test Reports
Every commercial production run includes raw resin supplier Certificates of Analysis (CoA) and third-party laboratory pass reports for your compliance dossier.
Global Regulatory Standards
Technical test methods and pass criteria applicable to custom injection and blow-molded drinkware.
| Jurisdiction / Standard | Simulant & Test Parameters | Pass Threshold Limit | Accredited Lab Protocol |
|---|---|---|---|
| US FDA 21 CFR 177.1520 Polypropylene (PP5) Drinkware |
Distilled water reflux for 2 hours; n-Hexane extraction at 50°C for 2 hours | Maximum soluble fraction < 9.8%; total extractives < 6.4 mg/sq inch | SGS Food Chemical Lab |
| US FDA 21 CFR 177.1240 Eastman Tritan™ Copolyester |
Distilled water, 8% ethanol, 50% ethanol at reflux temperatures for 2 hours | Total extractives not to exceed 0.05 mg/sq inch of food contact surface | TÜV Rheinland Protocol |
| Germany LFGB §30 & §31 Sensory Organoleptic Test |
Water, tea, or acidic beverage stored at 70°C for 2 hours; triangular sensory panel | Grade ≤ 1.5 on DIN 10955 scale (no discernible taste or odor transfer) | Eurofins Consumer Testing |
| EU Regulation (EU) 10/2011 Overall Migration Limit (OML) |
3% Acetic acid, 10% Ethanol, 20% Ethanol; 2 hours at 70°C (contact duration) | Overall migration < 10 mg/dm² or < 60 mg/kg food simulant | Intertek EU Food Contact |
| California Proposition 65 Heavy Metals & Phthalates |
Acid digestion followed by ICP-OES / GC-MS spectrometer detection | Total Lead < 90 ppm, Cadmium < 100 ppm, 8P Phthalates < 1000 ppm | EPA 3050B / CPSC-CH-C1001 |
| Total Fluorine (PFAS-Free) Waterproof & Greaseproof Coatings |
Combustion Ion Chromatography (CIC) screening for total organic fluorine | Total Fluorine < 50 ppm (indicates zero intentional PFAS addition) | EN 14582 / ISO 21675 |
Request Compliance Dossier
Planning distribution in the US, EU, UK, or Australia? We supply pre-tested resin declarations and prepare test samples for direct lab dispatch.