Migration testing for exported food packaging measures the transfer of chemical substances from packaging materials into food under simulated real-world conditions, and it is a mandatory conformity requirement for entering major international markets. This technical guide explains overall and specific migration limits, the applicable regulatory frameworks such as EU Regulation 10/2011, FDA 21 CFR and the GB 4806 series, food simulants, test conditions and analytical methods used by accredited third-party laboratories to support customs clearance and market access.
Technical Overview
Migration refers to the transfer of substances from food contact materials—such as residual monomers, additives, plasticizers, printing ink components, heavy metals and degradation products—into the packaged food during production, storage, transportation and use. Because these migrating substances may pose potential health risks and alter food quality, virtually all major economies have established strict legal limits on migration levels for food packaging intended for their markets.
Migration testing for exported food packaging is typically divided into two categories. Overall migration (OM), also known as total migration or total extractives, measures the total quantity of all non-volatile substances that transfer from the packaging into food simulants. Specific migration (SM) quantifies individual target substances, such as bisphenol A, phthalates, primary aromatic amines or heavy metals, and compares the results against substance-specific migration limits (SMLs).
For exporters, non-compliant migration results can lead to border rejections, product recalls, notification in the Rapid Alert System for Food and Feed (RASFF), and significant commercial and reputational losses. Partnering with accredited third-party laboratories that operate in accordance with ISO/IEC 17025 ensures that migration data is technically defensible and accepted by regulatory authorities in destination markets.
Regulatory Frameworks for Major Export Markets
European Union
Framework Regulation (EC) No 1935/2004 establishes the general safety principle that food contact materials must not transfer substances to food in quantities that could endanger human health. Commission Regulation (EU) No 10/2011, as amended, governs plastic materials in contact with food and specifies the positive list of authorized substances, food simulants, migration test conditions, and the overall migration limit of 10 mg/dm² (or 60 mg/kg for containers between 500 mL and 10 L, and for infant packaging). Supporting harmonized methods include the EN 1186 series for overall migration and the EN 13130 series for specific migration.
United States
The U.S. Food and Drug Administration (FDA) regulates food contact substances under 21 CFR Parts 174–179, including indirect food additive provisions for polymers, coatings, adhesives and paper. Migration testing follows the FDA chemistry guidance protocols, which assign extraction conditions based on the intended conditions of use (high-temperature sterilized, boiled, hot-filled, room-temperature long-term storage, refrigerated or frozen) and use 8% or 50% aqueous ethanol and n-heptane as food simulants.
China and Other Asian Markets
China's national food safety standards system includes GB 4806.1 (general safety requirements), GB 4806.7 (plastic materials), GB 4806.8 (paper and board), GB 4806.9 (metals), GB 4806.10 (coatings), GB 4806.11 (rubber) and GB 4806.4 (bamboo and wood), with migration test methods specified in the GB 31604 series and pretreatment rules in GB 5009.156. Japan enforces the Food Sanitation Act and its specification notices for apparatus, containers and packaging, while South Korea applies the Korean Food Code and Japan and Korea both reference JIS and national notice methods where applicable.
Germany and Other National Requirements
Germany applies the LFGB framework and the BfR recommendations (such as BfR Recommendation XXXVI for paper and board and XV for silicone), which frequently impose stricter or additional requirements—such as sensory testing and specific substance limits—beyond the harmonized EU rules. Exporters should verify destination-specific national derogations before shipment.
Testing Samples
Plastic Packaging Materials and Articles
Plastic is the most extensively regulated material category. Typical samples include films, pouches, trays, bottles, caps, closures, liners and laminated multilayer structures made from PP, PE, PET, PS, PVC, PC, PA and bioplastics. Testing covers overall migration, monomer migration (e.g., styrene, vinyl chloride, acrylonitrile, caprolactam, terephthalic acid), and additive migration (antioxidants, UV stabilizers, plasticizers, slip agents).
Paper and Paperboard
Paper-based packaging such as cartons, cups, bags, mold pulp trays and wrapping papers is tested for overall migration, heavy metals (lead, cadmium, mercury, chromium VI), pentachlorophenol, formaldehyde, fluorescent whitening agents, polychlorinated biphenyls, and increasingly mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH) from recycled fibers and printing inks.
Metal and Metallized Packaging
Cans, drums, foils, closures and metalized films are evaluated for migration of heavy metals—particularly lead, cadmium, arsenic, chromium and nickel—along with coating-related substances such as bisphenol A diglycidyl ether (BADGE), bisphenol F diglycidyl ether (BFDGE) and novolac glycidyl ether (NOGE) from epoxy lacquers.
Glass, Ceramics and Enamel
Rigid inorganic packaging is primarily tested for the release of lead and cadmium using 4% acetic acid under reflux or prolonged contact conditions, in accordance with EN 1388, ASTM C738, GB 31604.24 or the ceramic lead/cadmium release limits of the destination market.
Rubber, Silicone and Elastomeric Materials
Seals, gaskets, nipples, tubing and silicone bakeware are tested for overall migration, volatile matter, N-nitrosamines and N-nitrosatable substances, formaldehyde, and specific monomers relevant to silicone such as cyclic siloxanes, in line with EN 12868, EN 14350, BfR XV and GB 4806.11.
Coatings, Adhesives, Inks and Composite Structures
Functional barriers, lacquered surfaces, laminating adhesives and printed layers are assessed for primary aromatic amines (PAAs), photoinitiators (e.g., benzophenone, ITX), plasticizers and set-off transfer from the non-food-contact side, reflecting the principle that the finished article—not only the base material—must comply.
Testing Items
The scope of migration testing is determined by the material type, the formulation of additives used, the intended food type and the target market. Core testing items include:
- Overall migration (total migration limit: 10 mg/dm² under EU rules; corresponding limits under FDA total extractives protocols, GB 4806 series and Japanese specifications)
- Specific migration of heavy metals: lead, cadmium, arsenic, mercury, chromium, nickel, cobalt, manganese and aluminum
- Specific migration of monomers and starting substances: bisphenol A, styrene, vinyl chloride monomer, acrylonitrile, 1,3-butadiene, caprolactam, terephthalic acid and ethylene glycol
- Specific migration of plasticizers: phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP), adipates, citrates and their SML/QM limits
- Primary aromatic amines (sum limit of 0.01 mg/kg for non-listed PAAs under EU 10/2011)
- Formaldehyde, melamine and hexamethylenetetramine migration from melamine-formaldehyde and other thermosetting articles
- Epoxide derivatives: BADGE, BADGE·H₂O, BADGE·2H₂O, BADGE·HCl, BFDGE and NOGE from coated metal and epoxy systems
- Antioxidants and stabilizers: BHT, Irganox-type phenolic antioxidants, Irgafos-type phosphites and UV absorbers
- Per- and polyfluoroalkyl substances (PFAS) from grease-resistant paper and board, including extractable organic fluorine screening
- Mineral oil hydrocarbons (MOSH/MOAH) from recycled board and printed packaging
- Non-intentionally added substances (NIAS), evaluated by risk-based screening using GC-MS and LC-MS/MS non-targeted analysis
- Sensory testing (odor and taste transfer) required under EU and German LFGB provisions for certain article categories
Testing Methods
Selection of Food Simulants
Food simulants are standardized media that mimic the extractive capacity of different food categories. Under EU 10/2011 and the equivalent GB 5009.156 framework, the simulants are assigned as follows:
- Simulant A: 10% ethanol (v/v) — aqueous foods of neutral pH
- Simulant B: 3% acetic acid (w/v) — acidic aqueous foods
- Simulant C: 20% ethanol (v/v) — alcoholic foods up to 20% alcohol
- Simulant D1: 50% ethanol (v/v) — dairy-type foods and alcohol above 20%
- Simulant D2: vegetable oil — fatty and oil-containing foods
- Simulant E: 95% ethanol or iso-octane — alternative screening simulants for fat-simulating extraction where analytical verification against D2 is demonstrated
FDA protocols instead use 8% or 50% aqueous ethanol for aqueous and alcoholic foods, and n-heptane as a fatty-food simulant, with results for n-heptane extraction typically divided by a factor of five for comparison against oil-exposure limits.
Determination of Contact Conditions
The time and temperature of the migration test must reflect the worst foreseeable conditions of use, including processing, filling and storage. Typical EU test regimes include 10 days at 20 °C or 40 °C for long-term ambient storage, 2 hours at 70 °C for hot-fill applications, 1–2 hours at 100 °C or reflux for boiling applications, and 2 hours at 100 °C followed by 10 days at 40 °C for high-temperature filled articles. High-temperature applications such as retort or microwave/oven use may require testing at 121 °C, 130 °C, 150 °C or 175 °C using appropriate pressure vessels and volatile-loss correction factors.
Analytical Techniques
Quantification of migrated substances requires validated instrumental methods appropriate to each analyte class:
- Gravimetric analysis (EN 1186 series) for overall migration, with correction for simulant volatile loss
- Gas chromatography–mass spectrometry (GC-MS) and headspace GC-MS for volatile monomers, solvents and mineral oil fractions
- Liquid chromatography with fluorescence or UV detection (HPLC-FLD/UV) for bisphenol A, melamine, photoinitiators and antioxidants
- Liquid chromatography–tandem mass spectrometry (LC-MS/MS) for trace-level PAAs, PFAS and complex additive packages
- Inductively coupled plasma mass spectrometry or optical emission spectrometry (ICP-MS/ICP-OES) for heavy metal migration
- UV-Visible spectrophotometry and colorimetric methods for formaldehyde and certain derivatized amines
Quality Assurance and Method Validation
Testing is performed under ISO/IEC 17025-accredited quality systems with method validation covering linearity, limit of quantification (typically at or below 0.01 mg/kg for regulated SM substances), recovery, repeatability and measurement uncertainty. Where migration exceeds an SML, confirmation testing of the residual content in the material (QM or QMA) is used to support a dilution calculation under the partition-based approach permitted by EU 10/2011 Annex IV for fat-reduction factors and simulant substitution.
Applications
Migration testing data for exported food packaging supports multiple commercial and regulatory objectives across the supply chain:
- Export customs clearance and market access documentation for the EU, the United States, Japan, South Korea, Southeast Asia, the Middle East, Australia and other destinations
- Compliance declarations of conformity (DoC) and supporting documentation required under Article 16 of Regulation (EC) No 1935/2004 and downstream customer audits
- New product development and material selection studies comparing candidate resins, coatings and laminate structures under accelerated storage scenarios
- Supplier qualification and incoming-material control programs for brand owners and converters
- Food Contact Notification (FCN) submissions to the FDA and dossier support for EFSA evaluation of new substances
- Risk assessment of non-intentionally added substances (NIAS) and safety justifications for recycled content and functional barrier designs
- Response to RASFF notifications, market surveillance actions and customer complaints, including root-cause migration analysis
FAQ
What is the difference between overall migration and specific migration?
Overall migration measures the total mass of all substances transferring into a food simulant and is compared with a single limit (typically 10 mg/dm² in the EU). Specific migration targets individual regulated substances and is compared against substance-specific migration limits (SMLs) listed, for example, in Annex I of EU 10/2011 or the FDA indirect additive regulations. Both tests are usually required for a complete compliance assessment.
How are food simulants selected for my product?
Simulant selection depends on the actual food to be packaged—aqueous, acidic, alcoholic, dairy or fatty—and on the regulatory regime of the destination market. A single packaging article used for several food categories may require testing in multiple simulants to cover the full range of foreseeable use.
Which test condition applies to hot-filled or retorted packaging?
Hot-filled articles are generally tested at 2 hours at 70 °C or equivalent, while retorted or high-temperature sterilized articles are tested at 121 °C or higher for the actual process duration, followed by the long-term storage condition. The chosen regime must represent the worst foreseeable use of the finished article.
Do I need separate test reports for each export destination?
In many cases yes. Although the underlying science is similar, the EU, the United States, Japan, China, Korea and Germany each define their own simulants, test conditions, analyte lists and limits. A technical file therefore often includes multiple test suites, each mapped to the specific regulation of the target market.
What are NIAS and do they require testing?
Non-intentionally added substances include impurities, reaction intermediates and degradation products that are not deliberately added to the packaging. EU Regulation 10/2011 requires that NIAS be assessed in accordance with internationally recognized scientific risk assessment principles, which is usually fulfilled through targeted screening plus non-targeted GC-MS and LC-MS/MS analysis of the worst-case migration extract.
How much sample is needed and how long does testing take?
Typical requirements are 20 to 60 finished articles or one to two square meters of film/laminate per test set, depending on the surface-area-based or volume-based test design. Standard overall migration testing takes approximately three to four weeks because of the mandatory 10-day contact period, while specific migration programs depend on the number of analytes and typically require two to six weeks including validation.
Can migration limits be exceeded even if the raw material complies?
Yes. Compliance must be demonstrated on the finished article after all processing steps—printing, lamination, coating, curing and sterilization—because these steps can generate new migrants or change migration behavior. Testing the finished packaging in its real configuration is the only reliable basis for a compliance declaration.