Companies developing new food contact materials cannot place these materials on the market when the starting substances involved are not already authorised. In such cases, regulatory approval requires a food contact material petition demonstrating that the intended use of the substance in the material is considered safe for consumers. In the European Union, for plastic FCM this typically involves a safety evaluation by the European Food Safety Authority (EFSA), followed by amending the relevant regulation by the European Commission (EC).
For other FCM materials, this might be regulated by national law or recommendations (Dutch “Warenwet” or German BfR recommendations). In the United States, comparable authorisations are obtained through Food Contact Notifications (FCN) submitted to the Food and Drug Administration (FDA).
Preparing a food contact substance petition requires more than analytical testing. Authorities evaluate whether the available scientific evidence demonstrates that substances migrating from the material into food under foreseeable conditions of use do not pose a risk to human health. Triskelion supports companies by compiling their dossiers, providing consultancy, and generating the analytical data and scientific interpretation required to build a defensible regulatory petition for food contact materials.
Developing innovative food contact materials often requires demonstrating safety through analytical data and scientifically supported interpretation. Triskelion helps companies identify migrating substances, generate defensible analytical data, and structure the scientific evidence required for regulatory evaluation.
Contact our expert Sander Aalders at sander.aalders@triskelion.nl to discuss the analytical strategy required for your EU (i.e., EFSA, BfR) or FDA food contact material petition.
A food contact material petition is a scientific dossier requesting approval for the use of a new substance or material in food contact applications. Such petitions become necessary when companies introduce substances, materials, or processes that fall outside existing regulatory authorisations.
Examples include:
Regulatory authorities evaluate whether substances migrating from the material into food could pose a risk to human health. A successful petition therefore demonstrates:
Building this scientific case requires analytical data, exposure assessment, and regulatory interpretation.
Food contact materials placed on the European market must comply with Regulation (EC) No 1935/2004, which requires that materials do not transfer substances to food in quantities that could endanger human health. For plastics, additional requirements are defined in Regulation (EU) No 10/2011, which lists authorised substances and establishes migration limits. For other materials (i.e., paper and board), lists of authorised substances and established migration limits from national regulations or recommendations might apply.
When a substance is not included in existing authorisation lists, companies may need to submit a food contact material petition to EFSA (or national authorities) requesting scientific evaluation. Such dossiers typically include information on:
In the United States, comparable evaluations take place through Food Contact Notifications submitted to the FDA, which include a safety narrative and an environmental assessment. In each regulatory system, authorities evaluate whether the available scientific evidence supports the safe use of the material.
The principle is consistent across product types: the efficacy package must reflect intended function, target organisms and realistic conditions of use.
This is where most challenges originate. The same biocidal product can need fundamentally different efficacy data depending on three decisions made before testing begins.
The first is the choice of product type. A surface disinfectant marketed for hospital use (PT2) requires a different test panel than a sold for food contact surfaces (PT4) or a veterinary environment (PT3). Expanding the PT scope changes required organisms, contact times, soiling conditions and acceptance criteria.
The second is the claim. Bactericidal, fungicidal, yeasticidal, virucidal, mycobactericidal, sporicidal: each opens a separate test pathway. A virucidal claim alone has three levels: activity against enveloped viruses only, limited spectrum virucidal activity, and full virucidal activity.
The third is the use conditions. Dirty versus clean conditions, contact times of 30 seconds versus 5 minutes, spray versus wipe, hard water versus distilled. These are not just laboratory details. They are the regulatory conditions under which authorisation is granted and changing them later requires new data.
By prioritizing efficacy testing early as a strategic investment rather than a routine procurement task, companies ensure their testing align better with their intended claims. This proactive approach secures a smooth, more predictable dossier process, and gives more control over the market claims, and saves valuable time and resources.
Regulatory petitions rely on analytical data demonstrating which substances may migrate from food contact materials into food and at what levels. These analytical studies form the scientific basis used by regulatory authorities such as EFSA and FDA when evaluating the safety of new food contact materials. Typical analytical studies include migration testing and identification of intentionally added substances (IAS) and non-intentionally added substances (NIAS), two key elements in food contact material safety evaluation.
Specific migration testing determines the amount of a substance that transfers from packaging into food or food simulants under defined conditions. These studies help estimate consumer exposure and evaluate compliance with migration limits.
Food contact materials may contain non-intentionally added substances such as impurities, reaction products, or degradation products. Identifying these substances is an essential step in evaluating potential risks. Advanced screening techniques such as UPLC-HRMS and GC-MS are commonly used to identify and characterise unknown migrants.
Manufacturing processes may generate impurities or transformation products that require evaluation as NIAS. Analytical profiling helps determine whether these substances may migrate into food and whether additional toxicological assessment is required.
Reliable analytical methods are required to quantify substances at the levels relevant for regulatory evaluation. Validated methods ensure that analytical results are scientifically robust and suitable for inclusion in regulatory dossiers.
Triskelion supports companies during all stages of preparing regulatory petitions for food contact materials, including consultancy on migration test protocols, manufacturing of test samples by our scientific experts, performing migration tests and chemical analysis by our dedicated technicians, and risk assessment by our toxicological experts. Our laboratories in the Netherlands combine ISO 17025 accredited analytical capabilities with regulatory expertise in food contact materials, migration testing, and NIAS evaluation. Our work focuses on generating analytical data that supports the scientific safety argument required by regulatory authorities.
We help identify substances that may migrate from materials into food, including:
Understanding the chemical composition of the material provides the foundation for regulatory assessment.
Our ISO 17025 accredited laboratories perform analytical testing relevant for regulatory evaluation.
Analytical results must be interpreted within the context of exposure and toxicological relevance. Our experts translate laboratory data into conclusions that address the regulatory safety question. This includes:
Where required, Triskelion supports the preparation of scientific data packages suitable for submission to regulatory authorities. By aligning analytical data with regulatory expectations, we help ensure that the scientific case supporting the petition is clear and defensible.
the product claim is aligned with data.
An EFSA petition is a scientific dossier submitted to the European Food Safety Authority requesting authorisation for the use of a new substance in food contact materials. The dossier must demonstrate that the intended use of the substance does not pose a risk to human health.
A Food Contact Notification must be submitted to the FDA when a substance used in food contact materials is not already authorised for the intended application.
NIAS stands for non-intentionally added substances. These include impurities, reaction products, or degradation products that may be present in food contact materials and may migrate into food.
Typical analytical studies include migration testing, substance identification, impurity profiling, and NIAS analysis. These studies help determine potential consumer exposure.
Early analytical screening helps identify potential regulatory questions before preparing a petition. This can reduce delays and prevent additional testing later in the approval process.
The EFSA evaluation process can take at least 6 months to more than several years depending on the complexity of the dossier and the completeness of the submitted data. Authorities may request additional information during the evaluation process.
Migration testing determines whether substances present in packaging materials can transfer into food under realistic conditions of use. These studies help estimate consumer exposure and are an important component of EFSA and FDA safety evaluations.
Developing innovative food contact materials often requires demonstrating safety through analytical data and scientifically supported interpretation. Triskelion helps companies identify migrating substances, generate defensible analytical data, and structure the scientific evidence required for regulatory evaluation.
Contact our expert Sander Aalders at sander.aalders@triskelion.nl to discuss the analytical strategy required for your EU (i.e., EFSA, BfR) or FDA food contact material petition.
