Criticità

The difficulty encountered globally in determining exactly a minimum concentration of allergen such that no sensitive individual will cause an allergic reaction has not yet allowed for the adoption of shared risk management criteria, and currently the criteria for defining threshold values are based on the assignment of method performance limit values and on scientific evaluation models that refer mainly to the Allergeen Bureau's assessment through the Vital® 3.0 program  
The possibility of defining threshold values to protect allergic consumers also through the implementation of data collection on contamination levels of food products highlights the need for suitable analytical methods for the detection of such substances.
Data on consumption of potentially allergenic products by vulnerable segments of the population and the availability of harmonized presence data still appear to be deficient in terms of numerosity, distribution and homogeneity and do not allow for adequate risk assessment at the level of the population of allergic consumers to date. Such deficiency consequently result in the difficulty of setting tolerance limits at the regulatory level.
The identification and quantification of an allergen, moreover, can be carried out through different analytical models that are based on direct analytical techniques, which allow, that is, the direct identification of the allergenic protein, or on indirect analytical techniques, where the DNA sequence of the allergen is determined. The most frequently used methods are immuno-chemical or molecular biology-based methods. More recently, methods have been developed for direct identification of allergens or their fragments by mass spectrometry-based analysis.
There are, however, several critical aspects that at present have not made it possible to have harmonized analytical methodologies that can be simply disseminated in the different contexts of interest.
Indeed, it has not yet been possible to standardize in all analytical fields the methods of operation (proprietary information on kits and reference materials), of expression of the result (units of measurement, decimal digits, measurement uncertainty) and of evaluation of possible analytical matrix interference and cross-reactivity on the interpretation of the result (possibility of false positives and false negatives).  At the same time, the effects due to food processing still need to be thoroughly investigated and evaluated with approaches that in most situations will have to proceed on a case-by-case basis.
Total elimination of the risk of reactions from incidental exposure to allergens (zero risk) is not a realistic or achievable option at present, and steps will have to be taken continuously to define a tolerable level of risk with the aim of improving safety by preventing severe reactions and minimizing the risk of other types of reactions.