Selling food products in the European Union requires packaging that complies with Regulation No 10/2011 on plastic materials and articles intended to come into contact with food. This regulation establishes specific rules for migration limits, material composition, and documentation. Brands sourcing flexible pouches from international manufacturers must verify that their packaging meets these requirements before placing products on the EU market.
This guide explains the key aspects of EU 10/2011 compliance for food contact pouches, covering migration testing, approved materials, declarations of compliance, and supplier responsibilities. Each section provides practical information to help procurement teams navigate EU regulatory requirements and work effectively with packaging suppliers.
EU Regulation No 10/2011 is the primary European regulation governing plastic food contact materials. It applies to plastic materials and articles intended to contact food directly or indirectly, including the plastic layers in multi-layer flexible packaging. The regulation specifies an overall migration limit of 10 milligrams per square decimeter of food contact surface, meaning no more than 10 mg of substances may transfer from the packaging into food.
Specific migration limits apply to individual substances listed in the regulation's Union List of authorized monomers, additives, and other starting substances. The regulation also specifies simulation conditions based on food type and contact temperature. Brands must ensure that their packaging structure uses only authorized substances and that migration stays within the prescribed limits under intended use conditions.
Migration testing under EU 10/2011 uses food simulants that represent different food categories. Ten percent ethanol simulates aqueous and acidic foods. Twenty percent ethanol simulates alcoholic foods. Vegetable oil or substitute simulants represent fatty foods. Iso-octane and 95 percent ethanol may be used as substitute simulants for compliance testing under specific conditions.
Test conditions combine time and temperature to simulate actual use. For example, long-term storage at room temperature is typically tested at 40 degrees Celsius for 10 days. Hot-fill applications require testing at the fill temperature followed by 10 days at 40 degrees. The specific test conditions depend on the intended use of the packaging. Brands should confirm that migration testing covers the food type, contact time, and temperature that match their product's actual use conditions. Documentation can be produced to meet EU 10/2011 requirements upon request from experienced manufacturers.
The Union List in EU 10/2011 specifies the monomers, other starting substances, and additives authorized for use in plastic food contact materials. Only substances on this list may be used, unless they are subject to a specific national authorization or are covered by a functional barrier that prevents migration above detectable levels.
Common materials used in EU compliant pouch structures include polyethylene, polypropylene, polyethylene terephthalate, polyamide, and ethylene vinyl alcohol. Aluminum foil is used as a barrier layer in many structures. Each material must be evaluated against the Union List and any specific migration limits that apply. Additives such as antioxidants, slip agents, and antistatic agents are also subject to the Union List restrictions. Brands should verify with their supplier that all layers and additives in the proposed structure are authorized under the regulation.
Article 15 of EU 10/2011 requires that a declaration of compliance accompany plastic food contact materials at all stages of the supply chain except the retail stage. This declaration must identify the manufacturer, identify the materials and articles covered, confirm compliance with relevant rules, and specify any restrictions or special conditions of use.
The declaration must include information about the substances used that are subject to restrictions, the dual-use additives used in amounts above the applicable limits, and the food types and contact conditions for which the material is suitable. Supporting documentation must be available to demonstrate the basis for the declaration. This documentation includes formulation details, test reports, and risk assessments. Brands should request the declaration of compliance from their packaging supplier and verify that the supporting documentation is available for review by competent authorities.
Packaging suppliers are responsible for ensuring that the materials they produce comply with EU 10/2011. This includes using only authorized substances, conducting migration testing, providing declarations of compliance, and maintaining supporting documentation. Suppliers must also communicate any restrictions on use to their customers.
For international suppliers, the brand or importer placing the packaging on the EU market is responsible for ensuring compliance. This means the brand must obtain the declaration of compliance and supporting documentation from the supplier and verify that it covers the intended use. The brand should also confirm that the supplier maintains traceability records and can provide test reports upon request. Third-party inspection services can help verify that the supplier's processes and documentation meet regulatory expectations.
Printing inks used on food contact packaging are regulated separately from the plastic material regulation. The EU does not have a single harmonized regulation for printing inks in food contact applications, but several member states have national regulations. Germany's printed mineral ordinance and the Swiss printing ink ordinance are commonly referenced standards.
In practice, brands should request low-migration inks that comply with applicable European regulations and national requirements. The ink supplier should provide a declaration of compliance confirming that the inks are suitable for the intended application. Coatings used on food contact surfaces must also comply with applicable regulations. For laminated structures, adhesives must be fully cured and tested for migration. Brands should obtain compliance documentation for all inks, coatings, and adhesives used in the packaging structure.
Article 16 of EU 10/2011 requires that supporting documentation be retained for at least five years after the materials are placed on the market. This documentation must include the formulation of the material, test reports, and risk assessments that demonstrate compliance with the regulation.
Brands should maintain a compliance file that includes the declaration of compliance, supporting documentation from the packaging supplier, declarations from raw material and ink manufacturers, migration test reports, and any third-party inspection reports. This file should be updated whenever materials, formulations, or suppliers change. The documentation must be available for review by competent authorities upon request. Maintaining organized and complete records is essential for demonstrating compliance and managing any regulatory inquiries.
Minimum order quantities for custom-printed EU 10/2011 compliant pouches typically range from 1,000 to 5,000 units for simple designs and 5,000 to 10,000 units for multi-color or complex structures. Stock formats may be available in smaller quantities for brands testing the market.
Sampling is an important step before full production. A physical sample allows the brand to evaluate the material quality, printing, and construction of the pouch. It also provides material for migration testing if needed. Brands should request samples and allow time for any required testing before committing to a production run. Lead time for production is typically 15 to 25 working days after artwork approval, with 7 to 20 days for shipping. Brands should plan their timeline to accommodate sampling, testing, documentation review, and production.
EU 10/2011 differs from US FDA regulations in several key areas. The EU regulation establishes a single overall migration limit of 10 mg per square decimeter, while the FDA evaluates migration based on estimated dietary intake and allowable daily intake levels. The EU maintains a positive Union List of authorized substances for plastics, while the FDA uses a broader system of regulations, notifications, and GRAS determinations.
The EU requires a formal declaration of compliance document, while the FDA relies on letters of guarantee from suppliers. The EU regulation specifies standard simulants and test conditions, while FDA guidance allows more flexibility in test design. These differences mean that a packaging structure compliant in one market may not automatically be compliant in the other. Brands selling in both markets should verify compliance separately for each jurisdiction and request appropriate documentation from their supplier for each market.
When evaluating a supplier for EU 10/2011 compliant pouches, brands should request the declaration of compliance and supporting documentation for the proposed packaging structure. The supplier should demonstrate knowledge of EU regulatory requirements and the ability to produce structures using authorized substances from the Union List.
A supplier operating under an ISO 9001 quality system provides assurance that incoming inspection, in-process control, and finished goods testing are conducted systematically. Migration testing should be available or arranged through accredited laboratories. Traceability records should link each production batch to specific raw material lots. The supplier should also provide compliance documentation for inks, adhesives, and coatings used in the structure. Third-party inspection support offers additional verification. Evaluating these capabilities helps brands select a supplier capable of meeting EU 10/2011 requirements consistently.
EU 10/2011 compliance for food contact pouches requires authorized materials, migration testing within regulatory limits, declarations of compliance, and comprehensive documentation. Brands must verify that every component of their packaging structure meets the regulation's requirements for the intended food type and use conditions. Working with a supplier that understands EU requirements and maintains structured quality systems simplifies the compliance process and supports consistent production of compliant packaging for European markets.
The overall migration limit is 10 milligrams per square decimeter of food contact surface. This means that the total amount of all substances transferring from the packaging into food must not exceed this limit under the intended use conditions specified for the packaging.
Yes, Article 15 of EU 10/2011 requires a declaration of compliance for plastic food contact materials at all stages of the supply chain except retail. The declaration must confirm compliance, identify authorized substances with restrictions, and specify suitable food types and contact conditions.
Yes. International manufacturers can produce packaging using materials authorized under the Union List and conduct migration testing to EU 10/2011 conditions. The brand or importer placing the packaging on the EU market is responsible for obtaining and verifying the declaration of compliance and supporting documentation.
Supporting documentation must be retained for at least five years after the plastic materials are placed on the market. This includes formulations, test reports, and risk assessments. The documentation must be available for review by competent authorities upon request throughout the retention period.
EU 10/2011 covers the plastic layers in food contact materials. Printing inks are regulated separately, and the EU does not have a single harmonized regulation for inks. National regulations such as the Swiss printing ink ordinance apply. Brands should request low-migration inks with compliance declarations from ink manufacturers.
Custom-printed pouches typically require 1,000 to 5,000 units for simple designs and 5,000 to 10,000 units for multi-color or complex structures. Stock formats may be available in smaller quantities. Production lead time is generally 15 to 25 working days after artwork approval.
