Overview

While no regulatory limits for allergens in food are established yet, the VITAL (Voluntary Incidental Trace Allergen Labelling) values act as a common base of understanding and a way to handle results. These values are absolute amounts of protein from the allergenic commodity below which more than 95 % or 99 % of the susceptible consumers will not react in an adverse way. Since this amount of protein could occur in any amount of food that will be ingested, the linkage to an analytical result (reported as mass of total protein of the allergenic food ingredient per mass of food, expressed as mg kg) is quite challenging. While reliable analytical methods are required for compliance with national and international regulations worldwide, there are no harmonized guidelines available regarding specific requirements on performance of quantitative methods for food allergenic commodity and regarding specific information to be provided by the test kit manufacturers. This document specifies minimum performance requirements for methods that quantify the following food allergens in raw and processed foodstuffs: milk, egg, peanut, hazelnut, almond, brazil nut, macadamia nut, cashew, pistachio nut, walnut, pecan nut, lupine, sesame, mustard, soy, celery, fish, molluscs, crustaceans, and wheat. The minimum requirements for the Limit of Quantification (LOQ), presented in this document, are derived from the reference doses (RfD) and VITAL eliciting dose (ED05) published by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations. Annex A provides specific information for quantitative antibody-based methods, which should be supplied by the method developers. In addition, it provides guidance on how performance characteristics should be determined in the form of a validation study. The principles described in this document equally apply to PCR and LC-MS/MS methods. More information on performance characteristics is available in EN 15634-1 and EN 17644. Methods that describe gluten-containing cereals (wheat, rye, and barley) with regard to coeliac disease are covered by EN 17254. This document does not apply to fragmented or hydrolysed food allergens, such as casein hydrolysates or soy sauce. It also does not apply to qualitative methods. This document has been prepared by Technical Committee CEN/TC 275 "Food analysis - Horizontal methods", the secretariat of which is held by DIN. The responsible German standardization committee is Working Committee NA 057-01-05 AA "Lebensmittelallergene" ("Food allergens") at DIN Standards Committee Food and Agricultural Products (NAL).

Responsible national committee

NA 057-01-05 AA - Food allergens  

Responsible european committee

CEN/TC 275/WG 12 - Food allergens