FSA FS101206 Development of Quality Control Materials for Food Allergen Analysis - The Review of, sourcing and characterisation of allergenic food ingredients for use in reference materials

Internal description

Research Project Agreement [RPA]

Description

Food hypersensitivity is an increasing problem for many stakeholders with much effort focused on assessment and management of the risks including risk assessment toolkits (e.g. VITAL® and the iFAAM consortium). The toolkits use action levels, a combination of the estimated eliciting dose, amount of allergenic food, (mg of total protein per kg of food), provoking a reaction in a given population fraction, and the food serving size. The eliciting dose is extrapolated from oral food clinical trial dose-distribution relationships. Precautionary advisory labelling, well recognized as sub-optimal, could also be improved via an action level approach. Implementation and regulation depends on the ability to measure allergens properly; yet all current analytical approaches exhibit severe deficiencies many of which can be addressed by the proper use of appropriate allergen reference materials.

The UK Food STandards Agency has funded a joint project between LGC (MIchael Walker and Gill Holcomb) and the UNiversity of Manchester (Professor Clare Mills and Dr Chiara Nitride) to address some of these gaps by:

1)Systematically review allergen analytical targets used in ELISA, PCR and MS to allow the creation of a repository of reliable markers and open access verified allergen sequence sets for the studied allergens;
2)Facilitate a guided stakeholder workshop to achieve consensus on priority allergens, physical format of RMs, incurred concentrations and impact of processing;
3)Prepare a RM kit containing (a) a food matrix shown to be devoid of the target allergens, (b) the food matrix incurred with 5 allergens and (c) the raw material allergens;
4)Disseminate to encourage RM use to achieve tangible improvements in allergen analysis, establish a template of best practice for the future and make recommendations for follow up work to complete a set of RMs for the legislated and priority allergens.

The RM matrix will be based on that used for clinical dose-distribution studies and the raw allergen materials will be characterised by proteomics. The matrix and incurred allergens will be industrially relevant to processed foods and the allergen concentrations will be clinically relevant in the light of eliciting dose studies. The RM will be prepared following a well-established process that includes prescribed homogeneity and stability studies and a formal sign-off procedure of the statement of measurement, in accordance with ISO Guide 34.

The consortium is world leading in (a) the preparation, curation and distribution of RMs in an accredited environment (ISO Guide 34) and (b) the characterisation of allergen proteins. Synergy with other work currently in progress and contemplated (e.g. by iFAAM, EFSA, ILSI, MONIQA, JRC, and AOAC) will ensure value for money. It iwll also work in close collaboration with the EFSA-funded ThRAll project maximise synergies.
Short titleR:KAC Materials for Food
Effective start/end date12/02/1810/08/19

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