Periodic Reporting for period 1 - ALLPreT (Allergenicity Prediction Toolbox for novel foods)
Reporting period: 2022-09-01 to 2024-08-31
The introduction of novel foods, such as insect-based products, presents a significant opportunity to enhance the security and sustainability of the European food supply. However, ensuring the safety of these foods is paramount, as mandated by EU regulation 2015/2283 and aligned with the FOOD 2030 Policy Framework (FITFOOD2030). One critical safety concern is food allergy, which affects approximately 20 million Europeans and places an estimated €55 billion annual burden on the healthcare system.
When introducing novel food proteins, it is essential to ensure they do not exacerbate this public health challenge. A robust allergenicity assessment is a key requirement for food safety evaluations. Unfortunately, existing methods for assessing the potential allergenicity of novel proteins are inadequate; they lack predictive accuracy and have not been validated. This gap creates challenges for food producers and regulatory bodies, delaying the approval and integration of innovative food products into the market.
Scientific and Societal Need
To enable the safe introduction of novel and sustainable food sources, while mitigating food allergy risks, an interdisciplinary approach is required. Such an approach should:
Deepen understanding of the factors that determine allergenic potency in proteins.
Develop and validate predictive testing methodologies.
Establish harmonized criteria for decision-making and risk assessment.
Provide a clear system for ranking allergenicity relative to existing allergenic proteins.
These advancements will support industry and regulatory bodies in evaluating novel foods with greater confidence and efficiency. Addressing these needs has become increasingly urgent, as the European Food Safety Authority (EFSA) faces a growing number of novel food dossiers that cannot be adequately assessed due to the lack of reliable tools. This issue has been highlighted in recent reports by EFSA, the EU COST Action ImpARAS (Improved Allergenicity Risk Assessment Strategy for new food proteins), and the European Technology Platform (ETP) Food for Life.
ALLPreT: A Transformative Solution
The ALLPreT project aims to revolutionize allergenicity assessment by addressing knowledge gaps and developing a comprehensive toolbox of scientifically validated methodologies. These tools will include in vitro, in vivo, and in silico approaches, providing accessible and reliable resources for both industry stakeholders and regulatory authorities.
Pathway to Impact
ALLPreT's key objectives are:
Interdisciplinary Toolbox Development: To create a suite of scientifically validated allergenicity prediction tools for novel foods that are user-friendly and reliable for both industry and regulatory applications.
Threshold of Sensitisation (TAS): To explore the hypothesis of a threshold below which proteins in novel foods pose no allergenic risk, simplifying risk assessment.
Protein Properties: To identify the intrinsic factors distinguishing allergenic from non-allergenic proteins.
Matrix and Digestion Effects: To examine how food matrices and digestion influence allergenicity.
Immune Response Modulation: To investigate the differential effects of allergenic and non-allergenic proteins on the immune system.
Routes of Sensitisation: To determine the pathways through which proteins induce sensitisation, providing crucial insights for risk mitigation.
By achieving these objectives, ALLPreT will facilitate the safe, efficient, and sustainable introduction of novel foods into the European market. Its outcomes are expected to reduce the burden of food allergies, promote innovation, and strengthen consumer trust in emerging food technologies.
When introducing novel food proteins, it is essential to ensure they do not exacerbate this public health challenge. A robust allergenicity assessment is a key requirement for food safety evaluations. Unfortunately, existing methods for assessing the potential allergenicity of novel proteins are inadequate; they lack predictive accuracy and have not been validated. This gap creates challenges for food producers and regulatory bodies, delaying the approval and integration of innovative food products into the market.
Scientific and Societal Need
To enable the safe introduction of novel and sustainable food sources, while mitigating food allergy risks, an interdisciplinary approach is required. Such an approach should:
Deepen understanding of the factors that determine allergenic potency in proteins.
Develop and validate predictive testing methodologies.
Establish harmonized criteria for decision-making and risk assessment.
Provide a clear system for ranking allergenicity relative to existing allergenic proteins.
These advancements will support industry and regulatory bodies in evaluating novel foods with greater confidence and efficiency. Addressing these needs has become increasingly urgent, as the European Food Safety Authority (EFSA) faces a growing number of novel food dossiers that cannot be adequately assessed due to the lack of reliable tools. This issue has been highlighted in recent reports by EFSA, the EU COST Action ImpARAS (Improved Allergenicity Risk Assessment Strategy for new food proteins), and the European Technology Platform (ETP) Food for Life.
ALLPreT: A Transformative Solution
The ALLPreT project aims to revolutionize allergenicity assessment by addressing knowledge gaps and developing a comprehensive toolbox of scientifically validated methodologies. These tools will include in vitro, in vivo, and in silico approaches, providing accessible and reliable resources for both industry stakeholders and regulatory authorities.
Pathway to Impact
ALLPreT's key objectives are:
Interdisciplinary Toolbox Development: To create a suite of scientifically validated allergenicity prediction tools for novel foods that are user-friendly and reliable for both industry and regulatory applications.
Threshold of Sensitisation (TAS): To explore the hypothesis of a threshold below which proteins in novel foods pose no allergenic risk, simplifying risk assessment.
Protein Properties: To identify the intrinsic factors distinguishing allergenic from non-allergenic proteins.
Matrix and Digestion Effects: To examine how food matrices and digestion influence allergenicity.
Immune Response Modulation: To investigate the differential effects of allergenic and non-allergenic proteins on the immune system.
Routes of Sensitisation: To determine the pathways through which proteins induce sensitisation, providing crucial insights for risk mitigation.
By achieving these objectives, ALLPreT will facilitate the safe, efficient, and sustainable introduction of novel foods into the European market. Its outcomes are expected to reduce the burden of food allergies, promote innovation, and strengthen consumer trust in emerging food technologies.
The ALLPreT project is advancing the development of a comprehensive toolbox for assessing the allergenicity of novel foods. This toolbox integrates in vitro, in vivo, and in silico methods, enabling food safety authorities and industry stakeholders to predict allergenicity with scientific accuracy and reliability. Below is an overview of the main technical and scientific activities and achievements across the project's objectives.
Objective 1: Development of an Interdisciplinary Toolbox for Allergenicity Assessment
Progress: 30%
Ten doctoral candidates (DCs) are conducting research on novel approaches for allergenicity prediction. Key developments include:
In Silico Models: DC1 is constructing a model simulating gastrointestinal digestion and protein degradation. Collaboration with DC5 is translating findings from in vitro digestion into in silico models.
Protein Extracts: DC3 has prepared and tested extracts from various legumes, such as peanuts, soybeans, and chickpeas, which will serve as a reference set for other DCs.
Objective 2: Testing the Threshold of Sensitisation (TAS)
Progress: 50%
DC2 has made significant progress in investigating whether a sensitisation threshold exists, below which risk assessment may not be required. Key activities include:
Developing and optimizing LC-MS methods to quantify allergenic and non-allergenic proteins.
Analyzing the dietary consumption of allergenic foods (e.g. peanuts, hazelnuts, fish) in Dutch and Danish populations.
Objective 3: Identification of Allergenic and Non-Allergenic Protein Properties
Progress: 30%
Protein extracts prepared by DC3 are now available for use across various experimental setups. These extracts will support testing in digestion models, skin models, and immune response assays.
Objective 4: Effects of Food Matrix and Digestion on Allergenicity
Progress: 30%
This objective explores how food structure and digestion influence allergenicity:
DC4 has integrated brush border enzymes into digestion protocols and tested methods with milk proteins.
DC5 developed a peptide-based assay for protease activity and optimized endolysosomal degradation assays. LC-MS analyses are being used to measure digestion products.
Objective 5: Immune Response to Allergenic and Non-Allergenic Proteins
Progress: 30%
DC8 has established methods to study immune responses, including:
Collecting and culturing peripheral blood mononuclear cells (PBMCs) from allergic patients and healthy individuals.
Developing a multicolor flow cytometry panel to analyze immune cell populations and their response to allergenic and non-allergenic stimuli.
Objective 6: Routes of Sensitisation
Progress: 30%
Research focuses on the mechanisms through which allergenic and non-allergenic proteins induce sensitisation:
DC6 is refining intestinal cell models and preparing peanut protein digests.
DC7 is establishing skin models (2D and 3D) and using PCR to analyze activation markers.
DC9 is studying sensitisation pathways in mice, examining both oral and respiratory exposure, and exploring cross-reactivity between food allergens and inhalant allergens.
DC10 has developed two Brown Norway rat models to assess allergenicity through different exposure routes and doses.
Conclusion
ALLPreT is progressing steadily toward its objectives. The project’s interdisciplinary and collaborative approach ensures that challenges are addressed effectively. The insights gained from this research will significantly enhance allergenicity assessment capabilities, supporting the safe introduction of novel foods and reducing allergy-related health risks.
Objective 1: Development of an Interdisciplinary Toolbox for Allergenicity Assessment
Progress: 30%
Ten doctoral candidates (DCs) are conducting research on novel approaches for allergenicity prediction. Key developments include:
In Silico Models: DC1 is constructing a model simulating gastrointestinal digestion and protein degradation. Collaboration with DC5 is translating findings from in vitro digestion into in silico models.
Protein Extracts: DC3 has prepared and tested extracts from various legumes, such as peanuts, soybeans, and chickpeas, which will serve as a reference set for other DCs.
Objective 2: Testing the Threshold of Sensitisation (TAS)
Progress: 50%
DC2 has made significant progress in investigating whether a sensitisation threshold exists, below which risk assessment may not be required. Key activities include:
Developing and optimizing LC-MS methods to quantify allergenic and non-allergenic proteins.
Analyzing the dietary consumption of allergenic foods (e.g. peanuts, hazelnuts, fish) in Dutch and Danish populations.
Objective 3: Identification of Allergenic and Non-Allergenic Protein Properties
Progress: 30%
Protein extracts prepared by DC3 are now available for use across various experimental setups. These extracts will support testing in digestion models, skin models, and immune response assays.
Objective 4: Effects of Food Matrix and Digestion on Allergenicity
Progress: 30%
This objective explores how food structure and digestion influence allergenicity:
DC4 has integrated brush border enzymes into digestion protocols and tested methods with milk proteins.
DC5 developed a peptide-based assay for protease activity and optimized endolysosomal degradation assays. LC-MS analyses are being used to measure digestion products.
Objective 5: Immune Response to Allergenic and Non-Allergenic Proteins
Progress: 30%
DC8 has established methods to study immune responses, including:
Collecting and culturing peripheral blood mononuclear cells (PBMCs) from allergic patients and healthy individuals.
Developing a multicolor flow cytometry panel to analyze immune cell populations and their response to allergenic and non-allergenic stimuli.
Objective 6: Routes of Sensitisation
Progress: 30%
Research focuses on the mechanisms through which allergenic and non-allergenic proteins induce sensitisation:
DC6 is refining intestinal cell models and preparing peanut protein digests.
DC7 is establishing skin models (2D and 3D) and using PCR to analyze activation markers.
DC9 is studying sensitisation pathways in mice, examining both oral and respiratory exposure, and exploring cross-reactivity between food allergens and inhalant allergens.
DC10 has developed two Brown Norway rat models to assess allergenicity through different exposure routes and doses.
Conclusion
ALLPreT is progressing steadily toward its objectives. The project’s interdisciplinary and collaborative approach ensures that challenges are addressed effectively. The insights gained from this research will significantly enhance allergenicity assessment capabilities, supporting the safe introduction of novel foods and reducing allergy-related health risks.