Exporting plastic packaging bags to overseas markets involves navigating a comprehensive regulatory landscape. Different target markets-such as the European Union and the United States-each have their own independent regulatory frameworks, and missing any required compliance document can result in cargo detention, return, or even destruction. Below is a detailed breakdown of the specific purpose and applicable scenarios for each major export certification.
I. European Union Market: Food Contact Regulations and Recycled Plastic Certification
The EU maintains a rigorous regulatory system for food contact materials. The core framework, combined with tax-related recycling certifications, forms two essential thresholds that must be met for exports to the EU.
1. EU Food Contact Material Regulations: (EC) 1935/2004 and (EU) 10/2011
Purpose: This serves as the fundamental entry barrier for all plastic packaging that comes into direct or indirect contact with food products entering the EU market. The regulation mandates that packaging materials must not transfer substances harmful to human health into food, nor alter the composition, odor, or flavor of the food.
Among these, (EU) No 10/2011 is the dedicated standard specifically for plastic materials and is currently the most widely applied sub-regulation. It covers all plastic-based products including plastic packaging bags, storage containers, and composite film bags, establishing clear limits for overall migration (global migration) and specific migration of hazardous substances.
Key Testing Items and Thresholds:
| Testing Parameter | EU Requirement (EU 10/2011) | Purpose/Meaning |
|---|---|---|
| Overall Migration (OM) | ≤ 10 mg/dm² (food contact surface) | Measures the total amount of non-volatile substances that leach from packaging materials; serves as the most basic "passing grade" |
| Specific Migration Limit (SML) | Strictly controlled per regulatory list; includes limits for primary aromatic amines (PAAs) | Targets specific monomers (e.g., BPA) or additives; standards are often stricter than Chinese national standards |
| Testing Conditions | Gradient temperature testing based on actual use, e.g., 40°C/10 days or 100°C/2 hours | Simulates the most severe temperature and contact duration conditions for migration risk assessment under real-use scenarios |
Special Note: EU regulations also cover non-intentionally added substances (such as oligomers and residual solvents), which is precisely a major reason for frequent returns of exported products. Additionally, the amendment (EU) 2025/351, effective from March 16, 2025, further tightens requirements for the use of recycled plastics and labeling. For plastic materials designed for repeated use, aging mitigation instructions and wear-and-tear warnings must be provided.
2. EN 15343 / UNE-EN 15343 Recycled Plastic Certification (Linked to Spanish Plastic Tax)
Purpose: This certification is used to verify the recycled plastic content in products and serves as the core technical basis for applying for Spanish "Plastic Tax" exemptions. Under Spanish regulations, for non-reusable plastic packaging exported to Spain, the recycled plastic content must be certified in accordance with the UNE-EN 15343 standard in order to claim tax exemption.
Core Certification Requirements:
Traceability Certification: A closed-loop traceability chain must be established from waste collection to recycled pellet production, with documented records of waste sources, production and sales logs, and quality test data for recycled materials.
Content Calculation: Only pre-consumer or post-consumer materials can be counted toward recycled content; internal rework/scrap is not eligible.
Scope of Application: Covers nearly all plastic packaging, including PE bags, PET trays, and daily chemical packaging bottles.
Currently, certification bodies such as SGS have launched EN 15343 certification services in the Chinese market to help companies meet EU compliance requirements and benefit from tax incentives.
II. United States Market: FDA Food Contact Material Regulations
FDA 21 CFR Regulations (Core Reference: 21 CFR 177.1520, etc.)
Purpose: Plastic packaging bags exported to the United States that come into contact with food must comply with the corresponding material-specific clauses under Title 21 of the U.S. Code of Federal Regulations (21 CFR) . This constitutes the mandatory access standard set by the U.S. FDA for food contact materials. The core purpose is to verify that packaging materials will not migrate chemicals harmful to human health into food under foreseeable use conditions.
Key Control Points:
Migration Control for Materials: For PE materials as an example, compliance with 21 CFR 177.1520 is required, which governs overall migration limits and specific monomer migration (e.g., ethylene, propylene).
Overall Migration Limit (OML): The total amount of non-volatile substances extracted in food simulants (water, acidic solutions, oils, etc.) must not exceed 10 mg/dm².
Specific Migration Limit (SML): The usage levels of additives such as antioxidants (e.g., BHT, Irganox 1010) and slip agents (e.g., erucamide) must be controlled within their respective SML ranges.
Prohibition on Unverified Recycled Materials: FDA explicitly prohibits the use of recycled materials that have not been fully validated in the food-contact layer. The use of PCR (post-consumer recycled) materials requires prior issuance of a No-Objection Letter (NOL) from the FDA.
Testing Conditions: FDA requires migration testing to be conducted under the most severe temperature and longest contact time expected for the product's intended use. For conventional room-temperature products, an accelerated testing protocol of 40°C for 10 days is typically adopted.
III. Environmental and Sustainability Attribute Certifications (Value-Added for Exports)
1. FSC Certification (Essential for Paper-Plastic Composite Bags)
Purpose: For paper-plastic composite packaging bags containing a paper component, FSC (Forest Stewardship Council) Chain of Custody (CoC) certification is a de facto requirement for exports to European and American markets. It is used to prove that the paper fiber originates from sustainably managed forests. As of 2026 data, approximately 35% of returned shipments are linked to missing FSC documentation.
Specific Requirements:
CoC (Chain of Custody) Certificate: A continuous and traceable chain must be maintained from the forest to the paper mill to the packaging manufacturer.
Label Proportions: For example, FSC Mix 70% requires that at least 70% of the fiber comes from FSC-certified forests, with the remaining portion from controlled sources.
2. Compostability/Biodegradability Certification
Purpose: Applicable to biodegradable plastic bags that emphasize environmental friendliness. Certifications for "industrial compostability" issued by Germany's DIN CERTCO or Belgium's TÜV AUSTRIA are highly recognized in international markets and serve as important credentials for products to be included in eco-procurement lists.
Important Note: Compostability certifications (such as ASTM D6400) cannot replace food contact safety certifications. Even if a product meets compostability requirements, if its overall migration exceeds limits, it will still be deemed non-compliant.
3. PCR Recycled Content Certification
Purpose: For packaging bags using post-consumer recycled (PCR) plastics, third-party certification of recycled content-provided by organizations such as SCS Global Services-offers transparent and credible verification of the recycling percentage. This is a key credential for meeting brand owners' sustainable sourcing requirements.
Summary: Complete Certification Checklist for Exports
| Target Market | Certificate/Regulation | Specific Purpose | Mandatory/Voluntary |
|---|---|---|---|
| European Union | (EC) 1935/2004 + (EU) 10/2011 | Food contact safety access; overall migration ≤ 10 mg/dm² | Mandatory |
| EU (Spain) | EN 15343 / UNE-EN 15343 | Verify recycled plastic content for plastic tax exemption | Mandatory (tax-related) |
| United States | FDA 21 CFR (e.g., 177.1520) | Food contact safety access; migration control | Mandatory |
| EU/US | FSC Certification | Prove sustainable sourcing of paper component (paper-plastic composite bags) | Mandatory for EU/US exports |
| International | DIN CERTCO / TÜV AUSTRIA | Prove industrial compostability and biodegradability | Voluntary (value-added) |
| International | SCS/GRS Recycled Content Certification | Verify PCR recycling percentage | Voluntary (commonly required by brands) |
Practical Recommendations
Exporters are advised to first clearly identify the regulatory framework applicable to their target market (EU EC series or U.S. FDA CFR), and then engage accredited third-party testing organizations with CNAS/CMA qualifications-such as SGS, Intertek, or TÜV-to conduct a comprehensive compliance assessment.
It is critically important to note that EU and U.S. standards are not interchangeable; each market requires separate and complete preparation of compliance documentation. Additionally, all product labels, instruction manuals, and Declarations of Conformity (DoC) must be properly annotated in accordance with the specific requirements of the destination country. Early engagement with regulatory authorities and certification bodies will help avoid costly delays and ensure that your packaging is both legally compliant and commercially viable in international markets.
