Systematic review protocol to identify clinically relevant allergens

In silico methods are an integral part of the allergenicity risk assessment process, both for novel foods and newly expressed proteins in Genetically Modified Organisms (GMOs) for food use. They help to identify novel proteins that have the potential to cause cross-reactive food allergies in the existing allergic population. Many of the tools developed rely on databases of curated allergen sequences but the curation process does not necessarily consider whether an allergen is clinically relevant and plays a role in triggering an IgE-mediated reaction. In order to fill this gap in our knowledge, a systematic review of allergens identified in a range of foods is planned. The foods include those for which food allergen labelling is mandated in the European Union and the UK, other foods such as fruit, which are known to cause IgE-mediated food allergies in at least 0.5% of the European population and foods of low allergenicity such as rice. The approach taken includes a Population-Outcome (PO) approach in order to address the primary research question “What scientific knowledge (evidence) is there that clinical manifestation(s) of IgE-mediated allergic reaction(s) are caused by ingestion of a food?”. A modified Population-Exposure-Comparator-Outcome (PECO) approach will be taken to address the secondary research question “Which food protein molecules are recognised by serum-IgE from individuals allergic to foods (identified by addressing the primary question) and are responsible for causing an IgE-mediated adverse reaction to those foods?” A protocol for executing the systematic review has been developed together with grading criteria and risk of bias analysis. The research process will be fully documented to allow the search to be assessed and reproduced as per PRISMA guidelines.OC/EFSA/GMO/2021/04 Novel strategies for predicting allergenicity: development of a ranking method and screening tools to assess the allergy risk of innovative proteins; new version includes lupin (previously omitted in error) BE; EN; PDF; sa@eurofir.or