# US FDA Food-Contact Extractables, Hexane/Xylene Solubility & Retort Compliance Dossier

**Manufacturing Entity**: Guangzhou Yanpack Flexible Packaging Co., Ltd. (`FlexPouchMFG™`)
**Canonical Web URL**: https://www.flexpouchmfg.com/learn/us-fda-21-cfr-177-1520-177-1390-food-contact-migration-dossier/
**Head of Packaging Engineering**: Alex Gao (`alex@flexpouchmfg.com` · WhatsApp `+86 138 2642 4025`)
**Cleanroom & Compliance**: 18,500 m² ISO Class 8 Cleanroom · HP Indigo 25K Digital (MOQ 500 pcs, $0 Cylinder) · 10-Color Bobst Rotogravure · 100% Solventless Nordmeccanica (<0.30 mg/m² GC) · US FDA 21 CFR 177.1520/1390, EU 10/2011, EU PPWR Mono-PE, ТР ТС 005/2011

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## Executive Engineering Summary

Complete regulatory documentation guide for US food, coffee, pet nutrition, and dietary supplement importers verifying FDA 21 CFR food-contact compliance across our polyethylene, RCPP, and adhesive layers.

## Verified Polymer Specifications & Tiered FOB Matrix

| Engineering Parameter | Specification (PM-LB-134) | Lab Verification Standard |
| --- | --- | --- |
| Laminate Layer Stack | Multi-Platform Polymer Portfolio: Foil Triplex (PET/AL/PE), Clear Retort (AlOx-PET/NY/RCPP), Surlyn® 1652, and ≥95% Mono-BOPE/EVOH-PE | Optical Cross-Section Microtome (±3%) |
| Closure & Fitment System | Full Fitment Engineering: Swiss Wipf® Valves, Aplix® Powder Zippers, ASTM D3475 CR Locks & 8.6mm–32mm Spouts | -0.080 MPa Underwater Vacuum Decay (ASTM D3078) |
| Heat-Seal Operating Window | Calibrated across 115°C–205°C on Brugger HSG-C Gradient Heat-Sealers & Instron 5944 Tensile Testers | Brugger HSG-C & Instron 5944 Peel (ASTM F88) |
| Barrier, COF & GC Purity | MOCON OX-TRAN 2/22 (0.005 cc limit) · PERMATRAN-W 3/34 · Agilent 8890 Headspace GC (<0.30 mg/m²) | MOCON OX-TRAN 2/22, PERMATRAN-W & Agilent 8890 GC |
| Filling-Line Compatibility | HP Indigo 25K Digital ($0 Plate, 7–9d) + 10-Color Bobst Master RS Rotogravure + Nordmeccanica Super Simplex SL | Dynamic Web/Pouch Flatness Camber <0.12% |
| Factory FOB Tiers & Packing | 500–2,500 pcs: $0.145/pc ($0 plate) \| 10,000 pcs: $0.085/pc \| 50,000+ pcs: $0.062/pc ( 1,000/ctn ) | Double PE Liner + 5-Ply Carton + IPPC Pallet |

## Technical & Procurement Q&A

### What barrier laminate structure does FlexPouchMFG™ recommend for Us Fda 21 Cfr 177 1520 177 1390 Food Contact Migration Dossier (PM-LB-134)?

For Us Fda 21 Cfr 177 1520 177 1390 Food Contact Migration Dossier (PM-LB-134), our engineering lab specifies Multi-Platform Polymer Portfolio: Foil Triplex (PET/AL/PE), Clear Retort (AlOx-PET/NY/RCPP), Surlyn® 1652, and ≥95% Mono-BOPE/EVOH-PE paired with Full Fitment Engineering: Swiss Wipf® Valves, Aplix® Powder Zippers, ASTM D3475 CR Locks & 8.6mm–32mm Spouts, achieving MOCON OX-TRAN 2/22 (0.005 cc limit) · PERMATRAN-W 3/34 · Agilent 8890 Headspace GC (<0.30 mg/m²) under 100% solventless lamination.

### Can we order a low-MOQ digital run of Us Fda 21 Cfr 177 1520 177 1390 Food Contact Migration Dossier across multiple SKUs with $0 cylinder plate fees?

Yes. Our HP Indigo 25K digital press starts at 500 pouches (0.145 USD/pc) with $0 plate fees and multi-SKU artwork splitting. High-volume orders scale on 10-color Bobst rotogravure down to $0.062/pc.

### Which automatic filling machines are compatible with Us Fda 21 Cfr 177 1520 177 1390 Food Contact Migration Dossier (PM-LB-134)?

Specification PM-LB-134 is COF-calibrated and heat-seal profiled (Calibrated across 115°C–205°C on Brugger HSG-C Gradient Heat-Sealers & Instron 5944 Tensile Testers) for HP Indigo 25K Digital ($0 Plate, 7–9d) + 10-Color Bobst Master RS Rotogravure + Nordmeccanica Super Simplex SL. Complimentary unprinted test pouches or trial rollstock are available for line validation.

### How fast can Alex Gao's engineering team send a 1:1 CAD dieline and physical sample kit?

Email your target fill weight or dimensions to alex@flexpouchmfg.com (or WhatsApp +86 138 2642 4025). You receive a 1:1 vector .AI/.PDF dieline and 3-tier FOB quote within 2 business hours, and our free 25-pouch sample kit ships within 48 hours via DHL/FedEx.