DIN EN 15842:2010-06

This standard specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens and contains general definitions, requirements and guidelines for: laboratory set-up, method validation requirements, description of methods and test reports. This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. In this document the term reference material includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination is available. As new materials have been accepted and validated, they may be added as an annex to this standard. This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result. The main focus of this European Standard is on immunoassays, chromatographic and nucleic acid based methods for the determination of food allergens. However, because of the rapid technological developments in this area, other technologies may be also considered. The search for food allergens is performed by means of the following successive (or simultaneous) steps. After sample collection, proteins, nucleic acids or other markers are extracted from the test portion. Extracted analytes can be further purified, simultaneously or after the extraction process. Afterwards, they are diluted (if necessary) and subjected to analytic procedures such as immunoassays (for instance ELISA), nucleic acid based assays (for instance PCR) or chromatographic (for instance LC-MS). These steps are detailed in EN 15842 and in the following documents: - EN 15633-1:2009, "Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations" - EN 15634-1:2009, "Foodstuffs - Detection of food allergens by molecular biological methods - Part 1: General considerations"