Foodstuffs - Detection of food allergens by liquid chromatography - mass spectrometry (LC-MS) methods - General considerations

This document establishes an overall framework covering qualitative and quantitative methods for the determination of food allergens and allergenic ingredients using mass spectrometry-based methods for the determination of specific peptides/proteins. This document provides general guidelines and performance criteria applicable to this methodology. Guidelines, minimum requirements and performance criteria laid down in this document are intended to ensure that comparable and reproducible results are obtained by different analysts, instrumentation and laboratories.

Lebensmittel - Nachweis von Lebensmittelallergenen mit flüssigkeitschromatographisch-massenspektrometrischen (LC-MS) Verfahren - Allgemeine Betrachtungen

Dieses Dokument stellt einen Gesamtrahmen für die qualitativen und quantitativen Verfahren zur Bestimmung von Lebensmittelallergenen und allergenen Inhaltsstoffen unter Anwendung von auf der Massenspektrometrie basierenden Verfahren für die Bestimmung spezifischer Peptide/Proteine auf. Dieses Dokument bietet allgemeine Leitlinien und Leistungskriterien, die auf diese Verfahren anwendbar sind. Die in diesem Dokument angeführten Leitlinien, Mindestanforderungen und Leistungskriterien sind dafür vorgesehen sicherzustellen, dass von verschiedenen Analytikern, Geräten und Laboren vergleichbare und reproduzierbare Ergebnisse erhalten werden.

Produits alimentaires - Détection des allergènes alimentaires par des méthodes de chromatographie en phase liquide couplée à la spectrométrie de masse (CL-SM) - Considérations générales

Le présent document établit un cadre général couvrant les méthodes qualitatives et quantitatives pour la détermination des allergènes alimentaires et ingrédients allergisants par des méthodes de spectrométrie de masse pour la détermination de peptides/protéines spécifiques. Le présent document fournit les lignes directrices générales et les critères de performance applicables à cette méthode. Les lignes directrices, les exigences minimales et les critères de performance exposés dans le présent document ont pour but d’assurer l'obtention de résultats comparables et reproductibles, par différents analystes, instruments et laboratoires.

Živila - Odkrivanje prisotnosti alergenov v živilih s tekočinsko kromatografijo masno spektrometrijo (LC-MS) - Splošne ugotovitve

Ta dokument podaja splošen okvir kvalitativnih in kvantitativnih metod za določanje alergenov in alergenih sestavin z uporabo metod na osnovi masne spektrometrije za določitev specifičnih peptidov/proteinov. Ta dokument podaja splošne smernice in merila učinkovitosti za to metodologijo. Smernice, minimalne zahteve in merila učinkovitosti iz tega dokumenta so namenjeni zagotavljanju, da se pridobijo primerljivi ter ponovljivi rezultati s strani različnih analitikov, z različnimi instrumenti in v različnih laboratorijih.

General Information

Status
Published
Publication Date
05-Jul-2022
Withdrawal Date
30-Jan-2023
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
06-Jul-2022
Due Date
20-Jul-2022
Completion Date
06-Jul-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 17644:2022
01-september-2022
Živila - Odkrivanje prisotnosti alergenov v živilih s tekočinsko kromatografijo
masno spektrometrijo (LC-MS) - Splošne ugotovitve
Foodstuffs - Detection of food allergens by liquid chromatography - mass spectrometry
(LC-MS) methods - General considerations
Lebensmittel - Nachweis von Lebensmittelallergenen mit flüssigkeitschromatographisch-
massenspektrometrischen (LC-MS) Verfahren - Allgemeine Betrachtungen
Produits alimentaires - Détection des allergènes alimentaires par des méthodes de
chromatographie en phase liquide couplée à la spectrométrie de masse (CL-SM) -
Considérations générales
Ta slovenski standard je istoveten z: EN 17644:2022
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST EN 17644:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 17644:2022

---------------------- Page: 2 ----------------------
SIST EN 17644:2022


EN 17644
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2022
EUROPÄISCHE NORM
ICS 67.050
English Version

Foodstuffs - Detection of food allergens by liquid
chromatography - mass spectrometry (LC-MS) methods -
General considerations
Produits alimentaires - Détection des allergènes Lebensmittel - Nachweis von Lebensmittelallergenen
alimentaires par des méthodes de chromatographie en mit flüssigkeitschromatographisch-
phase liquide couplée à la spectrométrie de masse (CL- massenspektrometrischen (LC-MS) Verfahren -
SM) - Considérations générales Allgemeine Betrachtungen
This European Standard was approved by CEN on 22 May 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC 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
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17644:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN 17644:2022
EN 17644:2022 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General laboratory requirements . 8
4.1 Principle . 8
4.2 Apparatus and equipment . 8
4.3 Material and reagents . 9
5 Method development . 9
5.1 General .
...

SLOVENSKI STANDARD
oSIST prEN 17644:2021
01-april-2021
Živila - Odkrivanje prisotnosti alergenov v živilih z metodo tekočinske
kromatografije z masno spektrometrijsko detekcijo (LC-MS) - Splošne ugotovitve
Foodstuffs - Detection of food allergens by liquid chromatography - mass spectrometry
(LC-MS) methods - General considerations
Lebensmittel - Nachweis von Lebensmittelallergenen mit flüssigkeitschromatographisch-
massenspektrometrischen (LC-MS) Verfahren - Allgemeine Betrachtungen
Produits alimentaires - Détection des allergènes alimentaires par des méthodes de
chromatographie en phase liquide couplée à la spectrométrie de masse (CL-SM) -
Considérations générales
Ta slovenski standard je istoveten z: prEN 17644
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
oSIST prEN 17644:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 17644:2021

---------------------- Page: 2 ----------------------
oSIST prEN 17644:2021


DRAFT
EUROPEAN STANDARD
prEN 17644
NORME EUROPÉENNE

EUROPÄISCHE NORM

February 2021
ICS 67.050
English Version

Foodstuffs - Detection of food allergens by liquid
chromatography - mass spectrometry (LC-MS) methods -
General considerations
Produits alimentaires - Détection des allergènes Lebensmittel - Nachweis von Lebensmittelallergenen
alimentaires par des méthodes de chromatographie en mit flüssigkeitschromatographisch-
phase liquide couplée à la spectrométrie de masse (CL- massenspektrometrischen (LC-MS) Verfahren -
SM) - Considérations générales Allgemeine Betrachtungen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 275.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17644:2021 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 17644:2021
prEN 17644:2021 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General laboratory requirements . 8
4.1 Principle . 8
4.2 Apparatus and equipment .
...

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