The European Food Safety Authority (EFSA) has recently published a document providing supplementary guidance for the allergenicity assessment of genetically modified (GM) plants addressing non-IgE-mediated adverse immune reactions to food and endogenous allergenicity. In particular, a risk assessment strategy for the assessment of (novel) proteins with regard to celiac disease, a non-IgE-mediated adverse reaction to foods, is provided for the first time. For this assessment, a stepwise approach is proposed where knowledge of the (novel) protein under assessment is used as starting point to calibrate the subsequent risk assessment strategy which is undertaken on a case-by-case basis. Depending on the outcome of the information retrieved, searches for sequence identity can be used. If concerns from this analysis are identified, in a second step, HLADQ peptide modelling can be applied. In a third step, in vitro tests such as HLA-DQ-peptide binding assays and/or testing with T-cell clones derived from patients with celiac disease can be carried out to determine the safety profile of the (novel) protein. In relation to endogenous allergenicity, the measurement of relevant endogenous allergens is mandatory with the EU Implementing Regulation 503/2013. The new EFSA document provides detailed guidance on how to address this requirement. Specifically, the guidance elaborates on the following topics: i) relevant crops for analysis, considering their regulatory status and/or their public health importance as the starting point in the assessment; ii) relevant allergens for quantification, being international recognition and/or clinical relevance the main aspects to consider for the selection of allergens; iii) methodology for quantification, where ELISA and mass spectrometry are appropriate methods for the quantification of individual allergens; and iv) data interpretation and risk assessment, providing additional considerations taking into account the number and magnitude of the changes identified as well as the clinical relevance of the specific allergen involved. In this guidance document, EFSA also describes a refined in vitro protein digestion test for the safety assessment that will undergo an interim phase before any additional recommendations in the form of guidance for applicants can be provided. This is considered a major step forward with a great potential for the safety assessment of (novel) proteins and is the subject of an additional abstract in this conference.

Resumen del trabajo presentado a la 3rd International ImpARAS Conference, celebrada en Helsingør (Dinamarca) del 10 al 12 de octubre de 2017.

Peer reviewed