Introduction: The Regulatory Framework for Migration Testing of Packaging Materials That Come into Contact with Food
When assessing the chemical safety of packaging materials that come into contact with food, migration testing forms the foundation for regulatory compliance. In addition to the European Union’s Packaging and Packaging Waste Regulation (PPWR), the Framework Regulation 1935/2004/EC and, in particular, Regulation 10/2011/EU for plastic materials stipulate that substances that may migrate from the packaging into food must be quantified and limited. Migration tests are conducted in two basic categories: the overall migration test, which measures the general inertness of the packaging, and specific migration tests, which quantitatively determine the migration of specific chemical substances. Nano-Test Labor Services conducts all migration tests in accordance with the PPWR and relevant EU regulations, in full compliance with GLP principles, using validated methods and appropriate food simulants; in addition to analytical measurements, we also offer our customers an assessment of regulatory compliance as well as technical consulting.
Overall Migration Test: Quantitative Measurement of the Packaging's Chemical Inertness
The total migration test is a fundamental safety parameter designed to measure the total mass of all non-volatile substances that migrate from the packaging material into the food. This test serves as an indicator of the packaging’s chemical inertness and is mandatory for all plastic materials that come into contact with food. The general overall migration limit (OML) specified in Regulation 10/2011/EU is defined as 10 mg/dm² per surface area in contact with food. In specific applications involving infant and toddler food, this limit may be applied as 60 mg/kg (per food or simulant).
Food Simulants: Standardized Test Media
Due to the analytical complexity of real food matrices, migration tests are conducted using standardized food simulants. These simulants are designed to represent food categories with different chemical properties. The following table provides details on the food simulants defined in Regulation (EU) No. 10/2011, their chemical composition, and the food types they represent:
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| Simulans code | Chemical Composition | Food Category Shown | Examples of typical foods |
|---|---|---|---|
| Simulans A | 10% ethanol (v/v) | Hydrophilic Aqueous Foods | Water, fruit juices, non-alcoholic beverages |
| Simulans B | 3% acetic acid (v/v) | Saure wässrige Lebensmittel (pH < 4,5) | Vinegar, pickled vegetables, citrus juices, ketchup |
| Simulans C | 20% ethanol (v/v) | Foods containing alcohol (alcohol content up to 20%) | Beer, wine, low-alcohol beverages |
| Simulans D1 | 50% ethanol (v/v) | Alternative simulant for fatty foods; high-alcohol foods; water-in-oil emulsions | Liqueur, cream sauces, dairy products |
| Simulans D2 | Vegetable oil (olive oil or sunflower oil) | Reference simulant for fatty foods | Olive oil, butter, frying oils, greasy sauces |
| Simulans E | Poly(2,6-diphenyl-p-phenylene oxide) – Tenax® | Dry Foods | Flour, sugar, grains, dried legumes, cookies |
Note: The appropriate simulant is selected in accordance with the simulant assignment tables in Annex III of Regulation (EU) No. 10/2011, based on the chemical properties and physical form of the food with which the packaging comes into contact. For packaging that is expected to come into contact with more than one category of food, testing with multiple simulants may be required.
Standard Test Conditions and Application Scenarios
The temperature and time parameters for migration tests are selected to reflect the anticipated worst-case scenario for the use of the packaging. The standardized test conditions defined in Annex V of Regulation (EU) No. 10/2011 are assigned to the application scenarios in the following table:
| Test Condition Code | Temperature | Duration | Anticipated Food Contact Conditions |
|---|---|---|---|
| OM1 | 40 °C | 10 days | Long-term storage at room temperature and below (including frozen and refrigerated products) |
| OM2 | 70 °C | 2 hours | Brief exposure to heat (pasteurization-like applications) |
| OM3 | 100 °C | 1 hour | Brief contact at boiling temperature (hot filling, applications involving boiling water) |
| OM4 | 121 °C | 30 minutes | Contact under sterilization conditions (retort, autoclave) |
| OM5 | 175 °C | 1 hour | High-temperature applications (furnace vessels, microwave applications) |
Total Migration Analysis at Nano-Test: Gravimetric Determination Method
Total migration is determined at the Nano-Test laboratory in accordance with international standard methods (EN 1186 series). The analytical procedure includes the following steps:
Contact test: The packaging sample is brought into contact with the selected simulant using standard contact cells or by immersion at the specified temperature and for the specified duration.
Evaporation of the simulant: The simulant extract obtained after contact is evaporated under controlled conditions (under vacuum or in an inert gas atmosphere) until it is completely dry.
Gravimetric weighing: The remaining non-volatile residue is weighed using a high-precision analytical balance (with a resolution of 0.01 mg).
Calculation and evaluation of results: The determined mass value is expressed as a ratio to the surface area of the packaging that comes into contact with the food (dm²), reported in mg/dm², and compared with the legal limit of 10 mg/dm².
Specific Migration Tests: Determination of Specific Compounds
While the total migration test evaluates the overall chemical inertness of the packaging, specific migration tests are required to demonstrate the safety of specific chemical substances. Specific migration refers to the quantitative determination of the amount of a defined chemical substance (monomer, additive, plasticizer, antioxidant, etc.) that migrates from the packaging into the food or simulant. For each regulated substance, a specific migration limit (SML) was established as part of a toxicological risk assessment conducted by the European Food Safety Authority (EFSA). The SML value indicates the maximum permissible concentration of the substance in question in the food and is expressed in mg/kg (per food or simulant).
Frequently Requested Specific Migration Parameters and SML Values
The following table summarizes the most important specific substances, their chemical groups, and the current SML values in accordance with 10/2011/EU (consolidated version), for which analysis is frequently required for packaging that comes into contact with food:
| Substance Group | Specific substance(s) | Abbreviation | SML (mg/kg) | Typical source included in the package |
|---|---|---|---|---|
| Bisphenols | Bisphenol A | BPA | 0,05 | Polycarbonate plastics, epoxy resin coatings |
| Bisphenol S | BPS | 0,05</ td> | BPA-free alternative, coatings for thermal paper | |
| Phthalates | Di(2-ethylhexyl) phthalate | DEHP | 1,5 | PVC plasticizers, gaskets, fasteners |
| Dibutyl phthalate | DBP | 0,3 | Adhesives, printing inks, PVC films | |
| Butylbenzyl phthalate | BBP | 30</ td> | Vinyl coatings, printing inks | |
| Primary Aromatic Amines | Total PAA (specific list) | PAA | 0.01 (total, not detectable) | Degradation products of azo dyes, PU adhesives |
| Aldehydes | Formaldehyde | FA | 15 | Melamine resins, paper coatings, adhesives |
| Monomers | Ethylene glycol | EG | 30 | PET monomer, polyester resins |
| Styrene | -</ td> | Depending on the application | Polystyrene (PS) monomer, ABS copolymers | |
| Metals | Lead, cadmium, mercury (specific migration) | Pb, Cd, Hg | Varies depending on the fabric | Pigments, stabilizers, recycled components |
Note: The SML values listed above are based on the consolidated version of Regulation (EU) No. 10/2011. Regulatory changes (e.g., the planned complete ban on BPA) are closely monitored and proactively communicated to our customers.
Analytical Workflow for the Specific Migration Test in the Nano-Test Laboratory
Specific migration tests in the Nano-Test laboratory are performed using validated analytical methods that are optimized according to the chemical properties of the target substance. The workflow consists of four main phases:
| Phase | Step | Explanation |
|---|---|---|
| 1. Experimental Setup | Determination of the Simulant and Test Conditions | Appropriate simulants and test conditions are selected in accordance with Annexes III and V of Regulation (EU) No. 10/2011, based on the application scenario and food type specified by the customer. |
| 2. Migration Attempt | Controlled Contact | The packaging sample is exposed to the selected simulant in standard contact cells using the immersion or filling method at the specified temperature and for the specified duration. |
| 3. Instrumental Analysis | Substance-Specific Determination | The Simulans extract is analyzed using a method validated for the target substance. Main platforms used: LC-MS/MS (bisphenols, PAA, phthalates), GC-MS/MS (volatile organic compounds, phthalates), HPLC-DAD (specific additives). |
| 4. Analysis and Reporting | Comparison with the SML and Declaration of Conformity | The quantitative results obtained are compared with the statutory SML value for the respective substance. The results are presented to the client in the form of a comprehensive, GLP-compliant analysis report, and an assessment of compliance or non-compliance is provided. |
Nano-Test's Integrated Service Model for Migration Testing
At Nano-Test Labor Services, we do not offer migration testing as standalone analyses, but rather as an integral part of the conformity assessment process in accordance with the PPWR and food contact regulations. Our service model is based on the four cornerstones summarized in the following table:
| Service Pillar | Scope | Benefits for the Customer | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Regulatory Consulting | Determining the appropriate simulant, test conditions, and analytical parameters | Avoiding Unnecessary Testing, Saving Time and Money Through the Right Testing Strategy | |||||||||||||||||||||||||||||||||||||||||||
| Analytical Testing Services | Conducting total and specific migration tests using GLP-compliant, validated methods for conducting total and specific migration tests | Analytical data that is accepted, reasonable, and verifiable by regulatory authorities | |||||||||||||||||||||||||||||||||||||||||||
| Conformity Assessment | Preparation of a declaration of conformity or nonconformity by comparing the results with the OML and SML values | Nonconformity | A clear and definitive assessment of the product's legal status | ||||||||||||||||||||||||||||||||||||||||||
| Support for Technical Documentation | Bereitstellung der für behördliche Anträge erforderlichen Daten sowie eines umfassenden Analyseberichts und der für die Konformitätserklärung (Declaration of Compliance – DoC) notwendigen Daten</ td> | Assisting the customer in preparing their own declaration of conformity completely and correctly |
In the event of a limit value being exceeded or nonconformity, Nano-Test’s team of experts also provides its customers with technical advice on root cause analysis to identify the source of the problem, as well as on planning corrective actions.
To ensure that your food-contact packaging, which you export to the European market, is fully compliant with the PPWR and relevant EU regulations, and to conduct your total and specific migration tests with a reliable and experienced partner, you can contact our team of experts to receive detailed information about Nano-Test’s accredited laboratory services and technical consulting.