Allergenicity assessment in new protein-containing food: study suggests comprehensive risk management approach

The growing global population necessitates the exploration of protein and innovative food products through both new and existing sources in novel ways, including insects, plant-based proteins, and ancient grains. However, these novelties raise concerns about their allergenicity. A study, recently published in Food and Chemical Toxicology Journal, discussed the challenges associated with allergenicity assessment in novel or modified protein-based foods and propose a comprehensive risk management approach to address allergenicity.  

The allergenicity assessment of new and novel protein sources poses significant challenges due to their distinct characteristics compared to genetically modified (GM) proteins. Unlike GM proteins with minimal protein introduction and well-defined origin, new and novel proteins from plants, insects, algae, and fungi are intended for substantial intake, can be presented in various forms (isolates, concentrates), and might be introduced into unfamiliar food matrices. These proteins can also be a complex mixture, making it difficult to characterize all components. Additionally, the lack of robust predictive methods for allergenicity and clear regulatory criteria for decision-making further complicates the assessment process.  

The concept of "safe" food is multifaceted and depends on context. Regulatory bodies around the world have established frameworks to ensure food safety. These frameworks consider factors like long-term and short-term health effects, allergic reactions, and the intended use of the food. While there is general agreement on how to assess allergenicity from existing allergens, there is no clear consensus on how to assess the potential for new and novel proteins to cause new allergies. In 2020, the COST Action ImpARAS brought together experts to address this challenge. They proposed a risk management-driven approach where the specific risk management questions determine the assessment strategy.  

To complement this approach, this study assessed various criteria to evaluate allergenicity, including hazard-based (e.g., sensitizing potential), exposure-based (e.g., threshold of allergological concern - TAC), and risk-based (e.g., expected allergic reactions) approaches. While acknowledging the limitations of current methods, the authors propose a combination of TAC with bioinformatics tools as a promising solution for the sensitization phase. However, identifying feasible strategies for the elicitation phase (i.e., allergic response after sensitization) remains a challenge.  

Overall, safe integration of new and novel protein foods requires navigating a complex landscape. To achieve this balance between public health, risk management, and innovation, collaborative research efforts must address critical knowledge gaps. These gaps encompass defining acceptable risk levels for allergenicity, sensitization, and elicitation, alongside overcoming technical limitations. Current methods lack the ability to comprehensively assess these risks. Furthermore, incomplete understanding of sensitization triggers, the absence of reliable allergy outcome biomarkers, and inadequate allergen databases hinder the development of robust predictive tools. By prioritizing research in these key areas and addressing these limitations, this framework paves the way for the safe introduction of new and novel protein foods, ultimately contributing to a more sustainable and healthy global food system.