A recent article authored by a group of experts from the International Life Sciences Institute Europe (ILSI Europe) identifies challenges associated with the allergenicity assessment of novel proteins and proposes a potential framework for prioritizing proteins for allergenicity assessment.
According to the paper, currently, no current test or combination of tests can provide sufficiently robust allergenicity information for novel foods containing multiple proteins. Moreover, the criteria for regulatory decisions on allergenic novel proteins remain diverse and not clear enough. The authors call for a “level playing field” with clearly defined safety requirements regarding allergenicity to support innovation and contribute to a more sustainable food supply. To achieve this, the authors propose an approach initially developed by the European Cooperation in Science and Technology (COST) Action ImpARAS, which starts with the targeted health protection goal and works backwards to the safety assurance of food allergens.
The four-year Action ImpARAS was launched in 2020, led by the Netherlands Organisation for Applied Scientific Research and involving more than 300 experts and stakeholders. COST Action ImpARAS addressed the current situation and future needs in the fields of protein chemistry and structure, in vitro and in vivo methods for predicting sensitisation and allergy, and risk analysis. Experts arrived at an approach in which the selection of an allergenicity assessment method is based on the specific risk management problem under investigation. However, developing such a strategy and the methods required for implementation requires consensus and harmonization on risk management decision-making criteria and assessment parameters, which currently do not exist.
Furthermore, reflecting the conclusions of Action ImpARAS, allergenicity assessment of novel or modified proteins is currently only partially possible, because while there is already sufficient scientific support for the allergy risk assessment of novel and modified food proteins that share similarities with known allergenic proteins, there is a significant lack of strategies and methods to assess the potential of novel and modified food proteins to cause novel food allergies (i.e., de novo sensitization and allergenicity).
The authors suggest using allergological threshold of concern (TAC) criteria and bioinformatics tools to establish allergenicity in the context of sensitization. However, rational strategies to predict allergic reactions after sensitization (provocation) are lacking, and scientific developments are needed.
