A recent article authored by an expert group of the International Life Sciences Institute, Europe (ILSI Europe) identifies the challenges associated with allergenicity assessments of novel proteins and proposes a potential framework to prioritize proteins for allergenicity assessment.  

According to the paper, at present, no current test or combination of tests is able to provide sufficiently certain allergenicity information about novel foods containing multiple proteins. Additionally, the criteria on which regulatory decisions are made regarding allergenic novel proteins remain diverse and insufficiently clear. The authors call for a "level playing field" with well-defined safety requirements regarding allergenicity to support innovation and contribute to a more sustainable food supply. To do this, the authors propose an approach first developed by the European Cooperation in Science and Technology (COST) Action ImpARAS, which involves starting with target health protection goals and working backwards to food allergen safety assurance.

The four-year Action ImpARAS began in 2020, initiated by the Netherlands Organization for Applied Scientific Research and comprising more than 300 experts and stakeholders. COST Action ImpARAS addressed the current status of and future needs in the fields of protein chemistry and structure, in vitro and in vivo methods to predict sensitization and allergy, and risk analysis. The experts landed on an approach in which the allergenicity assessment method is chosen based on the specific risk management questions being investigated. However, developing such a strategy and the methods required for implementation needs to be based on consensus and harmonization—which currently does not exist—regarding the criteria for risk management decision-making and assessment parameters.

Additionally, reflecting the conclusions of Action ImpARAS, the allergenicity assessment of new or modified proteins is currently only partly possible because, although there is already sufficient scientific support for allergen risk assessment of novel and modified food proteins that share similarities to known allergenic proteins, strategies and methods to assess the potential of novel and modified food proteins to induce new food allergies, (i.e., de novo sensitization and allergenicity), are largely lacking.

The authors suggest using the threshold of allergological concern (TAC) criterion and bioinformatics tools to for establishing allergenicity in the context of sensitization. However, scientific developments are required to address a lack of reasonable strategies for predicting allergic response after sensitization (elicitation).