EN 15633-1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Živila - Odkrivanje prisotnosti alergenov v živilih z imunološkimi metodami - 1. del: Splošne ugotovitveLebensmittel - Nachweis von Lebensmittelallergenen mit immunologischen Verfahren - Teil 1: Allgemeine BetrachtungenProduits alimentaires - Détection des allergènes alimentaires par des méthodes d'analyse immunologiques - Partie 1: Considérations généralesFoodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations67.050Splošne preskusne in analizne metode za živilske proizvodeGeneral methods of tests and analysis for food productsICS:Ta slovenski standard je istoveten z:EN 15633-1:2009SIST EN 15633-1:2009en,fr,de01-maj-2009SIST EN 15633-1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15633-1January 2009ICS 67.050 English VersionFoodstuffs - Detection of food allergens by immunologicalmethods - Part 1: General considerationsProduits alimentaires - Détection des allergènesalimentaires par des méthodes d'analyse immunologiques -Partie 1: Considérations généralesLebensmittel - Nachweis von Lebensmittelallergenen mitimmunologischen Verfahren - Teil 1: AllgemeineBetrachtungenThis European Standard was approved by CEN on 1 December 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15633-1:2009: ESIST EN 15633-1:2009

1 Scope This European Standard provides the overall framework of qualitative and quantitative methods for the determination of allergens and allergenic ingredients in foodstuffs using antibody-based methods. This European Standard specifies general guidelines and performance criteria for antibody-based methods for the detection and quantification of proteins that serve as a marker for the presence of allergy provoking foods or food ingredients. Other methods than those described may also detect and identify the proteins. Guidelines, minimum requirements and performance criteria laid down in the European Standard are intended to ensure that comparable and reproducible results are obtained in different laboratories. This European Standard has been established for food matrices. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
prEN 15842:2008, Foodstuffs – Detection of food allergens – General considerations and validation of methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in prEN 15842:2008 and the following apply.
3.1 General terms 3.1.1 denaturation of proteins treatment (thermal or chemical), which destroys or modifies the secondary and/or tertiary structure of a protein NOTE The denaturation may modify functional, enzymatic or antigenic properties of the protein. 3.2 Terms relative to antibodies 3.2.1 antibody protein (immunoglobulin) produced and secreted by B lymphocytes in response to a molecule recognised as foreign (antigen) [adapted from EN ISO 21572:2004] [1] NOTE 1 The antibody is capable of binding to that specific antigen. NOTE 2 Antibodies recognise specific areas in the antigen called epitopes. 3.2.2 antigen substance that is recognised as foreign by the immune system and elicits an immune response SIST EN 15633-1:2009

NOTE 2 The antigen elicits an immune response to that antigen. 3.2.3 allergen antigen with special properties to induce an allergic reaction 3.2.4 clone population of identical cells derived from a single cell line [EN ISO 21572:2004] [1] 3.2.5 cross-reactivity binding of the antibody to substances other than the analyte of primary interest [EN ISO 21572:2004] [1] NOTE 1 The ability of antibodies to bind to similar epitopes present on different antigens. NOTE 2 The reaction of an antibody with another antigen than those used for immunisation. 3.2.6 monoclonal antibody antibody produced from a single hybridoma clone and directed to a single antigen determinant [EN ISO 21572:2004] [1] NOTE Antibodies produced from a B-cell clone with identical physical, biochemical and immunological properties. 3.2.7 polyclonal antibodies antibodies produced by several clones of lymphocytes [EN ISO 21572:2004] [1] NOTE Antibodies produced by several B-cells that recognise different epitopes in the same antigen. 3.2.8 specificity of an antibody ability of an antibody to specifically bind to an antigen determinant and not to other similar structures on that or other antigens [EN ISO 21572:2004] [1] NOTE The ability of antibodies to recognise and distinguish between related structures. 3.2.9 epitope molecular structure of an antigen specifically recognised by antibodies or receptors on cells SIST EN 15633-1:2009
...