Migration Testing in IS9835: Ensuring Safety of Food Contact Materials

Migration testing, as outlined in IS9835, is a critical process that evaluates the potential transfer of substances from food contact materials (FCMs) into food products. FCMs encompass a wide range of items, including packaging materials, containers, utensils, and processing equipment, which are specifically designed to come into contact with food. The primary aim of migration testing is to ensure that any substances migrating from these materials remain within the acceptable limits set by regulatory authorities, safeguarding consumer health and ensuring food safety. By adhering to established testing methodologies, IS9835 provides a comprehensive framework for assessing the safety of FCMs in various food contact scenarios.

Food contact materials (FCMs) are materials or articles that come into contact with food during production, processing, storage, packaging, or serving. These materials are designed and used to ensure the safety and quality of the food during its lifecycle. Food contact materials can be made from various substances, including plastic, metal, glass, paper, and ceramics.

Here are some common types of food contact materials

Food Contact Material	Examples
Plastics	Plastic bottles, food containers, films, wraps, utensils
Metals	Aluminum cans, stainless steel equipment, tin foil, trays, utensils
Glass	Glass containers, bottles, jars, beverage glasses
Paper and Cardboard	Paper boxes, bags, wrappers, labels, disposable plates, cups
Ceramics	Glazed pottery, porcelain, bone china tableware
Wood	Cutting boards, serving trays, utensils (Note: Care should be taken to choose food-safe wood)
Coatings and Films	Barrier coatings, lacquers, films applied to various materials

Some common challenges faced in determining the suitable simulants and test conditions

Simulant Selection: Selecting an appropriate food simulant that closely represents the food type and composition that the packaging material will come into contact with is essential. Simulants can be categorized into different types, such as aqueous simulants (e.g., distilled water), acidic simulants (e.g., 3% acetic acid), alcoholic simulants (e.g., 10% ethanol), or fatty simulants (e.g., vegetable oil). The selection should consider the food characteristics, pH, and solubility parameters.

Test Condition Determination: Simulated test conditions should replicate the expected storage, handling, and usage conditions of the packaging material. Factors such as temperature, contact time, and mechanical stress need to be considered. These conditions may vary based on the regulatory requirements or the intended use of the packaging material.

Regulation Compliance: Different regulations or standards may have specific requirements for migration testing, including the choice of simulants and test conditions. Companies need to be aware of the applicable regulations and standards in the target markets and ensure their testing protocols align with the specified requirements.

Material-Specific Considerations: The nature of the packaging material itself may influence the selection of simulants and test conditions. For example, the presence of specific additives or coatings on the material may require additional testing or consideration of specific simulants.

Regulations and standards

Migration testing standards and regulations play a crucial role in ensuring the safety and compliance of food contact materials (FCMs). Here are some key standards and regulations related to migration testing:

European Union (EU) Regulations

European Framework Regulation (EC) No. 1935/2004: This regulation establishes general requirements for FCMs, including migration limits and safety criteria.
European Plastic Regulation (EU) No. 10/2011: This regulation specifically addresses plastic FCMs, setting overall migration limits and specific migration limits for various substances.

Food and Drug Administration (FDA) Regulations (United States)

Title 21 CFR Part 174-186: This series of regulations covers food additives and FCMs in the United States, including requirements for migration testing.

International Organization for Standardization (ISO) Standards:

IS 9845:1998 (India): This Indian standard prescribes methods for determining the overall migration of constituents from single or multi-layered plastic films, containers and closures intended to come into contact with foodstuffs. It aligns with EU directives and FDA regulations on food contact materials

Testing methods

Testing Method	Description
Total Immersion Test	FCM sample is fully immersed in a food simulant for a specified time and temperature. Migrated substances are extracted and analyzed.
Migration Cell Test	FCM sample is placed in a migration cell with a food simulant. Migration occurs over a set time and temperature. Migrated substances are analyzed.
SML Test	Determines migration levels of specific substances with regulatory limits. FCM sample is exposed to a food simulant, and migration is analyzed against the limit.
Extraction Test	FCM sample is extracted with a suitable solvent, and the extracted solution is analyzed to determine migration levels of specific substances.
Global Migration Test	Evaluates overall migration of all substances from FCM sample into a food simulant. Sample is exposed to simulant, and overall migration is analyzed.
Gas Chromatography (GC)	Analyzes volatile and semi-volatile substances in migration testing. Separates and quantifies individual components.
Liquid Chromatography (LC)	Suitable for analyzing a wide range of non-volatile substances, including polar and non-polar compounds.
Mass Spectrometry (MS)	Coupled with GC or LC to identify and quantify migrated substances based on their mass-to-charge ratio.

Eurofins role in Migration testing

Eurofins is a global provider of testing, inspection, and certification services.
They offer migration testing services for food contact materials (FCMs).
Eurofins has expertise in regulatory compliance and stays up-to-date with relevant standards.
They conduct comprehensive migration testing for various types of FCMs.
Testing is performed under simulated conditions that mimic real-world food contact scenarios.
Eurofins operates accredited laboratories with advanced instrumentation and experienced scientists.
They provide customized testing programs to meet the unique needs of each client.
Eurofins offers consultancy and guidance on migration testing and regulatory compliance.
Their services help businesses ensure FCMs meet safety standards and comply with regulations.
Partnering with Eurofins enhances consumer trust and mitigates potential health risks.