The Regulatory Significance of Migration Testing for Packaging That Comes into Contact with Food
The safety of packaging materials that come into contact with food is strictly regulated by a series of specific regulations, including the European Union’s Packaging and Packaging Waste Regulation (PPWR), Framework Regulation 1935/2004/EC, and Regulation 10/2011/EU on plastic materials. At the heart of this regulatory framework are migration tests, which aim to quantitatively determine the substances that may migrate from the packaging into food. Migration tests serve to protect consumer health and demonstrate the product’s compliance with regulations by determining how much of a substance migrates into food under the conditions of use of the packaging material (total migration) and which specific substances migrate in what concentrations (specific migration). Nano-Test Labor Services conducts total and specific migration tests in accordance with the PPWR and relevant EU regulations, in full compliance with GLP principles, using validated methods and appropriate food simulants.
Overall Migration Assessment: Quantitative Evaluation of Mass Migration
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 inertness (chemical unreactivity) and is limited by the general limit of 10 mg/dm² (per surface area in contact with food) established in Regulation 10/2011/EU for all plastic materials that come into contact with food.
Food Simulants and Test Conditions
Conducting migration tests using actual foods is not feasible due to analytical complexities and matrix effects. Therefore, Regulation (EU) No. 10/2011 defined standardized food simulants that represent various food categories. The following table summarizes these simulants and the types of foods they represent:
| Simulans code | Composition of the Simulant | Type of Food Shown |
|---|---|---|
| Simulans A | 10% ethanol (v/v) | Hydrophilic Aqueous Foods |
| Simulans B | 3% acetic acid (w/w) | Saure wässrige Lebensmittel (pH < 4,5) |
| Simulans C | % 20% ethanol (m/m) | Foods containing alcohol (up to 20% alcohol) |
| Simulans D1 | 50% ethanol (m/m) | Fatty foods (alternative simulant); alcoholic foods (more than 20% alcohol); water-in-oil emulsions |
| Simulans D2 | Vegetable oil (default: olive oil or sunflower oil) | Fatty foods (reference simulant) |
| Simulans E | Poly(2,6-diphenyl-p-phenylene oxide) – Tenax® | Dry Foods |
Note: The selection of the simulant depends on the chemical properties of the food with which the packaging comes into contact, as well as on the conditions of use. Detailed tables on simulant assignment can be found in Annex III of Directive 10/2011/EU.
The test conditions (temperature and duration) are selected to reflect the most unfavorable anticipated usage scenario for the packaging. The following table shows the standard test conditions and the corresponding usage scenarios:
| 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) |
| OM2 | 70 °C / 2 hours | Brief exposure to heat (similar to pasteurization) |
| OM3 | 100 °C / 1 hour | Brief contact at boiling temperature |
| OM4 | 121 °C / 30 minutes | Contact under sterilization conditions (autoclave) |
Gravimetric Determination and Evaluation of Threshold Values
The determination of total migration in the Nano-Test laboratory is based on the principle that, after contact under controlled conditions, the simulant evaporates and the remaining non-volatile residue is weighed gravimetrically using a high-precision analytical balance.
For aqueous simulants (A, B, C, D1), the direct evaporation method is used; for oily simulants (D2), however, the principle of oil recovery and measurement of the mass difference is applied. The result obtained is normalized by the surface area of the packaging that comes into contact with the food (dm²) and compared with the legal limit of 10 mg/dm². For certain applications where a volume-based limit applies (e.g., contact with baby food), the result is also evaluated based on the simulant limit of 60 mg/kg.
Specific Migration Tests: Full Compliance Through Targeted Identification of Compounds
While the total migration test evaluates the overall inertness of the packaging, specific migration tests are essential for demonstrating the safety of certain substances. Specific migration refers to the quantitative determination of the amount of a specific chemical substance (monomer, additive, initiator, etc.) that migrates from the packaging into the food. For each substance, there is a specific migration limit (SML) established on the basis of a toxicological assessment by the European Food Safety Authority (EFSA).
Key Regulated Substances and SML Values
The following table summarizes some specific substances for which analysis is frequently required in packaging that comes into contact with food, as well as their SML values in accordance with Regulation (EU) No. 10/2011:
| Substance Group / Specific Substance | Abbreviation / Chemical Name | SML (mg/kg of food or simulant) | Typical reason for its occurrence |
|---|---|---|---|
| Bisphenol A | BPA | 0.05 (in proceedings to revoke a license) | Polycarbonate plastics, epoxy resin coatings |
| Phthalates (DEHP) | Di(2-ethylhexyl) phthalate | 1,5 | PVC plasticizers, flexibility agents |
| Phthalates (DBP) | Dibutyl phthalate | 0, 3 | PVC plasticizers, adhesives |
| Primary Aromatic Amines | PAA (total) | 0.01 (not detectable) | Degradation products of azo dyes, polyurethane adhesives |
| Formaldehyde | CH₂O | 15 | Melamine resins, paper coatings |
| Ethylene glycol | EG | 30 | PET-Monomer, Polyesterharze</ td> |
| Styrene | C₈H₈ | Limited in certain applications | Polystyrene (PS) monomer |
Specific Analytical Workflow for Migration Testing in the Nano-Test Laboratory
Specific migration tests in the Nano-Test laboratory are conducted according to the following systematic procedure:
Determination of suitable simulants and test conditions: Based on the usage 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.
Migration test: The packaging sample is exposed to the selected simulant in standardized contact cells or via an immersion method at the specified temperature and for the specified duration.
Analysis of the Simulant Extract: The simulant extract obtained after contact is analyzed using an analytical method validated for the target substance. The most important instrument platforms used by Nano-Test for this purpose include:
LC-MS/MS: For the determination of bisphenols, phthalates, primary aromatic amines, and other polar/semi-polar organic compounds in the ultra-trace range.
GC-MS / GC-MS/MS: For the determination of volatile and semi-volatile organic compounds, phthalates, and NIAS compounds.
HPLC-DAD / UV-Vis: For the determination of specific additives and substances with known chromophore groups.
Comparison of Results with the SML and Reporting: The quantitative results obtained are compared with the statutory SML value for the respective substance and evaluated for compliance or non-compliance. The results are presented to the customer in the form of a GLP-compliant analysis report.
Nano-Test's Integrated Service Approach to Migration Testing
At Nano-Test Labor Services, we do not offer migration testing as a standalone service, but rather as an integral part of the process for ensuring compliance with PPWR and food contact regulations. Our scope of services includes the following phases:
| Service Phase | Scope |
|---|---|
| Regulatory Consulting | Determining the appropriate simulant, test conditions, and analytical parameters based on your product’s intended use and the types of food with which it comes into contact |
| Analytical Testing | Conducting general and/or specific migration tests using GLP-compliant, validated methods |
| Conformity Assessment | Preparation of a declaration of conformity or nonconformity by comparing the results with the statutory limit values (OML, SML) |
| Technical Reporting | Assistance in preparing a comprehensive analysis report and a Declaration of Conformity (DoC) for regulatory submissions |
| Advice on Nonconformity | Identification of the cause when limit values are exceeded and recommendations for corrective actions |
To ensure that your packaging materials that come into contact with food and are exported to the European market are fully compliant with the PPWR and relevant EU regulations, and to conduct your general and specific migration tests with a reliable partner, you can contact our team of experts to receive detailed information about Nano-Test’s accredited laboratory services and technical consulting.