Review of allergen analytical testing methodologies: Executive summary and Introduction

The Food Information Regulation (FIR) states that accurate and understandable allergen information needs to be supplied to consumers for the 14 priority allergens. Food allergies affects between 1-2% of the UK population, with some allergens responsible for hospital admissions with anaphylaxis. Food businesses have a legal responsibility to provide food that is safe, which means declaring allergens present as ingredients and warning consumers about their potential unintended presence due to cross-contact. A system needs to be implemented for testing allergens in foods, responding to incidents, and manage risks to protect consumers. This review was prepared to inform FSA on the current state of the art of allergen testing methodologies and the remaining challenges. This project combined a critical literature review of testing methods with assessments of allergen proficiency testing data, consultation with stakeholders from the food industry, and consultation with industry experts regarding multiplex methodologies and the harmonisation of methods in an unbiased review of the current status of testing capabilities for the 14 EU-retained regulated food allergens. Gaps in testing capabilities were highlighted in order to inform future direction, including a lack of transparent public data for the performance and applicability of commercial test kits. Cross-reactivities of kits were also highlighted along with the need for development of fast and accurate point-of-use tests to support food production. A review of allergen proficiency testing data revealed gaps in testing capabilities and variations between the outputs of different test kits when testing for the same allergen. This review critically compares current testing methods to progress towards a suitable harmonised testing protocol that facilitates allergen risk management, and to mitigate limitations and evidence gaps. Suitable workflows outlining recommended testing protocols are presented for priority allergens to provide a resource for compliant testing and incident management. Estimations of the cost of setting up new testing laboratories to support allergen workflows are also included in addition to detailing the cost of testing by established laboratories.