Introduction: The regulatory framework for migration testing of food contact materials
When assessing the chemical safety of packaging materials that come into contact with food, migration testing forms the cornerstone of regulatory compliance. In addition to the European Union Packaging and Packaging Waste Regulation (PPWR), Framework Regulation 1935/2004/EC and in particular Regulation 10/2011/EU for plastic materials stipulate that substances that can migrate from the packaging into food must be quantitatively determined and limited. Migration tests are carried out in two fundamental categories: the overall migration test (Overall Migration), which measures the general inertness of the packaging, and specific migration tests (Specific Migration), which quantitatively determine the migration of specific chemical substances. Nano-Test Lab Services performs all migration tests within the framework of PPWR and the relevant EU regulations in full compliance with GLP principles, using validated methods and appropriate food simulants; in addition to analytical measurement, we also offer our customers an assessment of regulatory compliance and technical consulting.
Overall migration test (Overall Migration): Quantitative measurement of the chemical inertness of the packaging
The overall migration test is a fundamental safety parameter that aims 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 chemical inertness of the packaging and is mandatory for all plastic materials that come into contact with food. The overall migration limit (Overall Migration Limit – OML) set in Regulation 10/2011/EU is defined as 10 mg/dm² per surface area in contact with food. This limit can be applied in special cases for infant and young child food 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 carried out using standardized food simulants. These simulants are designed to represent food categories with different chemical properties. The following table contains details of the food simulants defined in Regulation (EU) No 10/2011, their chemical composition and the food types they represent:
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| Simulant code | Chemical composition | Represented food category | Typical food examples |
|---|---|---|---|
| Simulant A | 10 % Ethanol (v/v) | Hydrophilic aqueous foods | Water, fruit juices, non-alcoholic beverages |
| Simulant B | 3 % acetic acid (v/v) | Acidic aqueous foods (pH < 4,5) | Vinegar, pickled vegetables, citrus juices, ketchup |
| Simulant C | 20 % ethanol (v/v) | Alcoholic foods (alcohol content up to 20 %) | Beer, wine, low-alcohol beverages |
| Simulant D1 | 50 % ethanol (v/v) | Alternative simulant for fatty foods; high-alcohol foods; water-in-oil emulsions | Liqueur, cream sauces, dairy products |
| Simulant D2 | Vegetable oil (olive oil or sunflower oil) | Reference simulant for fatty foods | Olive oil, butter, frying oils, fatty sauces |
| Simulant E | Poly(2,6-diphenyl-p-phenylene oxide) – Tenax® | Dry foods | Flour, sugar, cereals, dried legumes, biscuits |
Note: The selection of the appropriate simulant is made according to the simulant assignment tables in Annex III of Regulation (EU) No 10/2011 based on the chemical properties and the physical form of the food with which the packaging comes into contact. In the case of packaging that is expected to come into contact with more than one food category, testing with multiple simulants may be required.
Standard test conditions and application scenarios
The temperature and time parameters for migration tests are chosen to reflect the expected 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 | Expected food contact condition |
|---|---|---|---|
| OM1 | 104 °F | 10 days | Long-term storage at room temperature and below (including frozen and chilled products) |
| OM2 | 158 °F | 2 hours | Brief contact with heat (pasteurisation-like applications) |
| OM3 | 100 °C | 1 hour | Short-term contact at boiling temperature (hot filling, applications with boiling water) |
| OM4 | 121 °C | 30 minutes | Contact under sterilization conditions (retort, autoclave) |
| OM5 | 175 °F | 1 hour | High temperature applications (oven containers, microwave applications) |
Overall migration analysis in Nano-Test: Gravimetric determination method
The determination of overall migration in the Nano-Test laboratory is carried out according to 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 at the specified temperature and duration using standard contact cells or by immersion method.
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 dried.
Gravimetric weighing: The remaining non-volatile residue is weighed with a high-precision analytical balance (with a resolution of 0.01 mg).
Calculation and evaluation of results: The determined mass value is related to the surface area of the packaging that comes into contact with the food (dm²), expressed in mg/dm² and compared with the legal limit of 10 mg/dm².
Specific migration tests: Determination of certain compounds
While the overall migration test evaluates the general chemical inertness of the packaging, specific migration tests (Specific Migration) are required to demonstrate the safety of certain 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) has been established within the framework of a toxicological risk assessment carried out by the European Food Safety Authority (EFSA). The SML value indicates the maximum permitted concentration of the substance in question in the food and is given 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 according to 10/2011/EU (consolidated version), the analysis of which is frequently requested for packaging in contact with food:
| Substance group | Specific substance(s) | Abbreviation | SML (mg/kg) | Typical source in the packaging |
|---|---|---|---|---|
| Bisphenols | Bisphenol A | BPA | 0,05 | Polycarbonate plastics, epoxy resin coatings |
| Bisphenol S | BPS | 0.05 | BPA alternative, coatings for thermal paper | |
| Phthalates | Di(2-ethylhexyl)phthalate | DEHP | 1,5 | PVC plasticizer, seals, closures |
| Dibutyl phthalate | DBP | 0,3 | Adhesives, printing inks, PVC films | |
| Butylbenzylphthalate | BBP | 30 | Vinyl coatings, printing inks | |
| Primary aromatic amines | Total PAA (specific list) | PAA | 0.01 (total, not detectable) | Decomposition products of azo dyes, PU adhesives |
| Aldehydes | Formaldehyde | FA | 15 | Melamine resins, paper coatings, adhesives |
| Monomers | Ethylene glycol | EC | 30 | PET Monomer, Polyester Resins |
| Styrene | -</ td> | Application-dependent | Polystyrene (PS) monomer, ABS copolymers | |
| Metals | Lead, cadmium, mercury (specific migration) | PB, CD, HG | Varies by fabric | Pigments, stabilizers, recycled components |
Note: The above SML values are based on the consolidated version of Regulation (EU) No. 10/2011. Regulatory changes (e.g. the planned complete ban on BPA) will be closely monitored and proactively communicated to our customers.
Analytical Workflow for Specific Migration in the Nano Test Laboratory
Specific migration tests in the nano-test laboratory are carried out 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. Test setup | Determination of the simulant and test conditions | According to the application scenario specified by the customer and the type of food, suitable simulants and test conditions are selected in accordance with Annexes III and V of Regulation (EU) No. 10/2011. |
| 2. Migration test | Controlled contact | The package sample is brought into contact with the selected simulant in standard contact cells by means of immersion or filling methods at the specified temperature and over the specified period of time. |
| 3. Instrumental analysis | Substance-specific determination | The simulants extract is analyzed with 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. Evaluation and reporting | Comparison with the SML and declaration of conformity | The quantitative results obtained are compared with the legal SML value of the respective substance. The results are presented to the customer in the form of a GLP-compliant, comprehensive analysis report, and an assessment of conformity or non-conformity is carried out. |
Nano-Test's integrated service model for migration testing
As Nano-Test Lab Services, we offer migration tests not as individual analyses, but as an integral part of the conformity process according to PPWR and the regulations on food contact. Our service model is based on the four pillars summarized in the following table:
| Service pillar | Scope | Benefits for the customer | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Regulatory consulting | Determination of the correct simulance, test conditions and analytical parameters | Avoidance of unnecessary tests, cost and time savings through the right testing strategy | |||||||||||||||||||||||||||||||||||||||||||
| Analytical Testing Services | Perform overall and specific migration checks using GLP-compliant, validated methodologies to perform overall and specific migration checks | Analytical data accepted, justifiable and comprehensible by the regulatory authorities | |||||||||||||||||||||||||||||||||||||||||||
| Conformity assessment | Preparation of a declaration of conformity or non-conformity by comparing the results with the OML and SML values | Non-conformity | A clear and binding assessment of the legal status of the product | ||||||||||||||||||||||||||||||||||||||||||
| Support with technical documentation | Provision of the data required for regulatory applications, as well as a comprehensive analysis report and the data required for the Declaration of Compliance (DoC | Support for the customer in the complete and correct creation of their own declaration of conformity |
In the event of a limit value being exceeded or non-conformity, Nano-Test's team of experts also offers its customers technical advice on root cause analysis to identify the source of the problem and on planning corrective actions.
To ensure the full conformity of your packaging that comes into contact with food that you export to the European market with PPWR and the relevant EU regulations, and to carry out your overall and specific migration tests with a reliable and experienced partner, you can contact our expert team to obtain detailed information about the accredited lab services and technical consulting of Nano-Test.