The regulatory significance of migration tests for food contact packaging
The safety of packaging materials that come into contact with food is strictly regulated by a series of specific regulations, including the European Union 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 can 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 substance migrates into the food under the conditions of use of the packaging material (overall migration) and which substances specifically migrate at what concentrations (specific migration). Nano-Test Labor Services carry out overall and specific migration tests in accordance with PPWR and the relevant EU regulations, fully complying with the GLP principles, using validated methods and appropriate food simulants.
Overall migration testing (Overall Migration): Quantitative assessment of mass migration
Overall migration testing is a fundamental safety parameter aimed at measuring 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 inertness (chemical non-reactivity) of the packaging and is limited by the general limit of 10 mg/dm² (per unit area of material in contact with food) set out in Regulation 10/2011/EU for all plastic materials in contact with food.
Food simulants and test conditions
Performing migration tests with real foods is not practical due to analytical complexities and matrix effects. Therefore, standardized food simulants representing different categories of food have been defined under Regulation 10/2011/EU. The following table summarizes these simulants and the types of food they represent:
| Simulant code | Simulant composition | Represented food type |
|---|---|---|
| Simulant A | 10 % Ethanol (v/v) | Hydrophilic aqueous foods |
| Simulant B | 3 % Acetic acid (m/m) | Acidic aqueous foods (pH < 4.5) |
| Simulant C | % 20 % Ethanol (m/m) | Alcoholic foods (up to 20 % alcohol) |
| Simulant D1 | 50% Ethanol (m/m) | Fatty foods (alternative simulant); alcoholic foods (more than 20 % alcohol); water-in-oil emulsions |
| Simulant D2 | Vegetable oil (standard: olive oil or sunflower oil) | Fatty foods (reference simulant) |
| Simulant E | Poly(2,6-diphenyl-p-phenylene oxide) – Tenax® | Dry foods |
Note: The choice of simulant is based on the chemical properties of the food with which the packaging comes into contact and the conditions of use. Detailed tables for simulant assignment can be found in Annex III of Directive 10/2011/EU.
The test conditions (temperature and duration) are chosen to reflect the most likely worst-case scenario of the packaging's use. The following table shows the standard test conditions and the corresponding use scenarios:
| Test condition code | Temperature / Duration | Expected food contact condition |
|---|---|---|
| OM1 | 40 °C / 10 days | Long-term storage at room temperature and below (including frozen and chilled) |
| OM2 | 70 °C / 2 hours | Short-term contact with heat (similar to pasteurization) |
| OM3 | 100 °C / 1 hour | Brief contact at boiling temperature |
| OM4 | 121 °C / 30 minutes | Contact under sterilization conditions (retort) |
Gravimetric determination and evaluation of limit values
The determination of total migration in the nano-test laboratory is based on the principle that the simulant evaporates after contact under controlled conditions and the remaining non-volatile residue is weighed gravimetrically with a high-precision analytical balance.
For aqueous simulants (A, B, C, D1), the direct evaporation method is applied; for the oily simulant (D2), however, the principle of oil recovery and measurement of the mass difference is used. The result obtained is related to the surface area of the packaging that comes into contact with the food (dm²) and compared with the legal limit value of 10 mg/dm². For certain applications where a volume-based limit value applies (e.g. in contact with baby food), the result is also evaluated against the simulant limit value of 60 mg/kg.
Specific migration tests: Full compliance through targeted determination of compounds
While the overall migration test evaluates the general inertness of the packaging, specific migration tests are essential to demonstrate the safety of certain substances. Specific migration is the quantitative determination of the amount of a specific chemical substance (monomer, additive, initiator, etc.) that passes from the packaging into the food. There is a specific migration limit (SML) for each substance, which has been established on the basis of a toxicological assessment by the European Food Safety Authority (EFSA).
Most important regulated substances and SML values
The following table summarizes some specific substances, whose analysis is often required for packaging that comes into contact with food, as well as their SML values according to Regulation (EU) No. 10/2011:
| Material group / Specific material | Abbreviation / Chemical Name | SML (mg/kg food or simulant) | Typical reason for occurrence |
|---|---|---|---|
| Bisphenol A | BPA | 0.05 (in the prohibition procedure) | Polycarbonate plastics, epoxy resin coatings |
| Phthalates (DEHP) | Di(2-ethylhexyl)phthalate | 1,5 | PVC plasticizers, flexibilizers |
| Phthalates (DBP) | Dibutyl phthalate | 0, 3 | PVC plasticizers, adhesives |
| Primary aromatic amines | PAA (total) | 0.01 (not verifiable) | Degradation products of azo dyes, polyurethane adhesives |
| Formaldehyde | Ch₂o | 15 | Melamine resins, paper coatings |
| Ethylene glycol | EC | 30 | PET monomer, polyester resins |
| 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 carried out according to the following systematic workflow:
Identification of suitable simulants and test conditions: Suitable simulants and test conditions in accordance with Annex III and V of Regulation (EU) No. 10/2011 are selected according to the customer's use scenario and food type.
Migration test: The packaging sample is subjected to contact using the selected simulan in standardized contact cells or by means of immersion at the specified temperature and over the specified period of time.
Analysis of the Simulan Extract: The Simulan extract obtained after contact is analyzed using an analysis method validated for the target substance. The main instrument platforms used in Nano-Test for this purpose include:
LC-MS/MS: For the determination of bisphenols, phthalates, primary aromatic amines and other polar/semi-polar organic substances in the ultra-trace range.
GC-MS/GC-MS/MS: For the determination of volatile and semi-volatile organic substances, phthalates and nias compounds.
HPLC-DAD / UV-VIS: For determining specific additives and substances with known chromophore groups.
Comparison of the results with the SML and reporting: The quantitative results obtained are compared with the legal SML value of the respective substance and evaluated for conformity or non-conformity. The results are presented to the customer in the form of a GLP-compliant analysis report.
The integrated service approach of nano-test for migration tests
As a Nano-Test Labor Services, we do not offer migration tests as isolated analyzes, but as an integral part of the process for compliance with PPWR and food contact regulations. Our range of services includes the following phases:
| Service phase | Scope |
|---|---|
| Regulatory consulting | Determining the correct simula- tion, test conditions and analytical parameters according to the conditions of use of your product and the type of food it comes into contact with |
| Analytical Test | Carrying out overall and/or specific migration tests with GLP-compliant, validated methods |
| Conformity assessment | Preparation of a declaration of conformity or non-conformity by comparing the results with the legal limit values (OML, SML) |
| Technical Reporting | Assistance with the preparation of a comprehensive analysis report and a declaration of conformity (DOC) for official applications |
| Consulting in Case of Non-Conformity | Determination of the cause if the limit values are exceeded and suggestions for corrective measures |
To ensure the full compliance of your food contact packaging exported to the European market with PPWR and the relevant EU regulations and to carry out your overall and specific migration tests with a reliable partner, you can contact our expert team to obtain detailed information about Nano-Test's accredited laboratory services and technical consulting.