EUROPE – An expert group from the International Life Sciences Institute, Europe (ILSI Europe), has published a comprehensive article addressing the challenges of allergenicity assessments for novel proteins.
The paper highlights the current limitations in testing methods and calls for a unified framework to enhance safety evaluations and foster innovation in food supply.
Currently, no single test or combination of tests can provide definitive allergenicity information for novel foods containing multiple proteins. This gap in testing capabilities leaves regulatory decisions diverse and often unclear.
The authors advocate for a “level playing field” with clearly defined safety requirements to better support innovation and ensure a sustainable food supply.
A proposed framework draws inspiration from the European Cooperation in Science and Technology (COST) Action ImpARAS initiative. This approach, which began in 2020 and spans four years, was initiated by the Netherlands Organization for Applied Scientific Research and involves over 300 experts and stakeholders.
COST Action ImpARAS focused on current and future needs in protein chemistry and structure, in vitro and in vivo methods for predicting sensitization and allergy, and risk analysis.
The experts concluded that allergenicity assessment methods should be selected based on specific risk management questions. However, developing such a strategy requires consensus and harmonization on the criteria for risk management decision-making and assessment parameters, which is currently lacking.
Reflecting the findings of Action ImpARAS, the allergenicity assessment of new or modified proteins is currently only partly feasible.
While there is scientific support for assessing allergen risks of novel and modified proteins similar to known allergens, strategies to evaluate the potential of these proteins to induce new food allergies (de novo sensitization and allergenicity) are still needed.
The authors suggest employing the threshold of allergological concern (TAC) criterion and bioinformatics tools to establish allergenicity in the context of sensitization. However, scientific advancements are necessary to develop strategies for predicting allergic responses post-sensitization (elicitation).
In addition to the proposed framework, the article emphasizes the importance of starting with target health protection goals and working backwards to ensure food allergen safety.
This backwards approach, developed by COST Action ImpARAS, aims to create a systematic and transparent process for allergenicity assessments, ultimately contributing to better regulatory decisions and consumer safety.
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