Migration Testing for Plastic Food Contact Materials

Blogpost

Ensuring the safety and compliance of plastic food contact materials is a critical task for quality management professionals, particularly those working within the plastic recycling industry. Migration testing plays a pivotal role in this process by assessing the extent to which substances can transfer from the material to the food. This blog post provides an in-depth look at migration testing, its importance, the regulatory framework in Europe, and practical considerations for implementing these tests.

What is Migration Testing?

Migration testing evaluates the transfer of substances from food contact materials into food or food simulants. This testing is essential to ensure that any potential contaminants remain within safe limits and that the materials comply with relevant safety regulations.

Why is Migration Testing of Food Contact Materials Important?

Migration testing is crucial because it helps prevent harmful substances from leaching into food, ensuring consumer safety. It also ensures that products meet stringent regulatory standards, fostering consumer trust and compliance with the law.

Regulatory Framework in Europe

The European Union has established comprehensive regulations to safeguard the safety of food contact materials. Specifically, migration testing requirements are detailed in regulations such as EU 10/2011, which set out specific limits and test methods for evaluating the safety of these materials.

What is the Difference Between Overall Migration and Specific Migration?

Overall migration tests measure the total amount of non-volatile substances that migrate from the material into a food simulant. In contrast, specific migration tests focus on individual, potentially harmful substances that may transfer from the material to the food.

How Do I Determine Which Test Methods to Apply?

Choosing the appropriate test method depends on the material type, its intended use, and the specific regulatory requirements. Consider the following tips:

  • Material Type: Different materials may require different simulants and conditions.
  • Intended Use: Contact conditions (e.g., temperature, duration) affect migration rates.
  • Regulatory Requirements: Ensure compliance with local and international regulations.

Overall Migration Testing

Overall migration testing assesses the total quantity of substances that can migrate from the material into food. The following table outlines the different simulants used in overall migration testing:

Simulant
Simulant A Ethanol 10%
Simulant B Acetic Acid 3%
Simulant C Ethanol 20%
Simulant D1 Ethanol 50%
Simulant D2 Vegetable Oil
Substitute 1 for D2 95% Ethanol
Substitute 2 for D2 iso-Octane
Simulant E Tenax 60-80 mesh, pore size 200nm

Specific Migration Testing

Specific migration testing focuses on measuring individual substances that may pose health risks. The table below lists the simulants used in specific migration testing:

Simulant
Simulant A Ethanol 10%
Simulant B Acetic Acid 3%
Simulant C Ethanol 20%
Simulant D1 Ethanol 50%
Simulant D2 Vegetable Oil
Substitute 1 for D2 95% Ethanol
Substitute 2 for D2 iso-Octane
Simulant E Tenax 60-80 mesh, pore size 200nm

Analysis After Specific Migration

After conducting specific migration tests, various analytical methods are used to identify and quantify the substances. The table below outlines these methods and their corresponding analytes:

Method Analyte
Screening after specific migration VOC-, semi-VOC, non-VOC NIAS (semi-quantitative)
Targeted NIAS quantitative VOC-, semi-VOC, non-VOC NIAS (quantitative)
EN 13130-2 Quantitative determination of terephthalic acid iso-phthalic acid in food simulants
EN 13130-7 Quantitative determination of monoethylene glycol and diethylene glycol in food simulants
EN 13130-1 Quantitative determination of primary aromatic Amines
EN 13130-1 Elements (Ba, Co, Mn, Zn, Cu, Fe, Li, Al, Ni, Hg, Cr, As, Pb, Cd, Sb)

How Many Samples Should I Prepare?

The number of samples required for migration testing depends on several factors, including the type of material, the number of different food simulants used, and the specific regulatory requirements. Generally, multiple samples are needed to ensure reliable and reproducible results. A typical approach includes:

  • Replication: At least three replicates per test condition.
  • Different Conditions: Samples for each different food simulant and contact conditions (temperature, time, etc.).
  • Controls: Negative controls to validate the testing process.

On our Labs platform customers can send in orders that include both an input and output sample, and specify the type of material, like flake or pellet for the input or sheet, tray, tube etc. for the output. We always ensure that according to the EU regulation the laboratory keeps a remainder of the samples for 6 months, in suitable conditions for enabling backtracking.

During the order process we provide detailed packaging guidelines for our customers to ensure that the samples won’t get contaminated during the workflow.

When ordering migration tests in in Labs we aim to provide a smooth and user friendly workflow, ensuring that we ask for the right amount of information regarding the samples, which is sufficient for a chemical lab to conduct the tests on the sample, and provide detailed and valuable result data back to our customers.

How Much Time Does Migration Testing Take?

Migration testing duration varies based on the test type and regulatory requirements. Overall migration tests usually take longer because they assess total substance migration over extended periods to simulate long-term storage conditions. Typical timelines include:

  • Preparation Time: 1-2 weeks for sample preparation and pre-testing setup.
  • Testing Time: 10 days to several weeks, depending on the specific migration conditions and regulatory guidelines.
  • Analysis Time: 1-2 weeks for analytical testing and data interpretation.

In total, migration testing can take anywhere from 3-8 weeks, depending on the complexity and scope of the testing program.

Compliance with the EU 10/2011 requires continuous testing within defined testing cycles with hard deadlines. To make sure companies won’t go out of compliance, we strongly recommend testing of each active production site, and production line on a quarterly basis, and reporting to the European Commission and your corresponding local regulatory authorities.

Since testing itself can take time according to the parameters above, we encourage ordering as early as possible into a quarter. Turn around time of the laboratory may vary, and there is also the process of logistics, and other administrative details.

Our Labs system aims to provide accurate info about the expected turn around time of each of our laboratory partners, so that it's easy for customers to set expectation regarding the timing. During each step of the process, detailed statuses are provided by the chemical labs, so customers can follow the testing of the samples, and get back the results instantly when a test is done - when ordering multiple or interdependent tests, we continuously provide results through the platform whenever some part of the testing is completed.

How Much Does Migration Testing Cost?

The cost of migration testing can vary widely based on several factors:

  • Number of Tests: More tests and replicates increase the overall cost.
  • Type of Analysis: Specific migration testing for particular substances is generally more expensive than overall migration testing.
  • Complexity of Analysis: Advanced analytical techniques and methods, such as GC-MS or LC-MS for NIAS screening, add to the cost.
  • Laboratory Fees: Different laboratories have varying fee structures based on their equipment, expertise, and location.

On average, costs can range from a few hundred to several thousand euros per material, depending on the above factors. For precise budgeting try KÖR's Labs to get a detailed quote for free.

How Will I Get the Results of a Migration Test?

The only useful test is that with a valuable result for the requester. In Labs, no matter which vendor you work with, every laboratory partner of us will provide results in a standardized format. When the result is uploaded it goes through an automatic validation process, to make sure it has all the required data for a given test result, in the right format. After validation the customer is notified that the result is ready, and they can check it and accept it.

We keep test results for an indefinite period for our customers, to ensure they are always accessible, ready for reporting purposes, and future traceability.

Conclusion

Migration testing is a fundamental aspect of ensuring the safety and regulatory compliance of plastic food contact materials. Understanding the differences between overall and specific migration tests and knowing how to choose the appropriate methods is crucial. Additionally, being aware of practical considerations such as sample preparation, timeframes, and costs helps quality management professionals in the plastic recycling industry effectively manage and optimize their testing processes. KÖR's Labs offers a comprehensive suite of NIAS testing services to support manufacturers in achieving the highest safety standards and regulatory compliance.