EN ISO 22753:2022

Molecular biomarker analysis - Method for the statistical evaluation of analytical results obtained in testing sub-sampled groups of genetically modified seeds and grains - General requirements (ISO 22753:2021, Corrected version 2022-11)

This document describes general requirements, procedures and performance criteria for evaluating the content of genetically modified (GM) seeds/grains in a lot by a group testing strategy that includes qualitative analysis of sub-sampled groups followed by statistical evaluation of the results.
This document is applicable to group testing strategy estimating the GM content on a percentage seed/grain basis for purity estimation, testing towards a given reject/accept criterion and for cases where seed/grain lots are carrying stacked events.
This document is not applicable to processed products.
NOTE       Description of the use of group testing strategy are available in References [1], [7], [8], [18], [19] and [20].

Untersuchung auf molekulare Biomarker - Verfahren zur statistischen Auswertung von Analyseergebnissen aus der Untersuchung von Untergruppen von gentechnisch verändertem Saatgut und Getreide - Allgemeine Anforderungen (ISO 22753:2021, Korrigierte Fassung 2022-11)

Dieses Dokument beschreibt allgemeine Anforderungen, Verfahren und Leistungskriterien für die Bewertung des Gehalts an gentechnisch verändertem (GV )Saatgut/Getreide in einer Partie mittels einer Gruppenunter¬suchungsstrategie, die die qualitative Analyse von Untergruppen und die anschließende statistische Auswertung der Ergebnisse umfasst.
Dieses Dokument ist anwendbar auf Strategien zur Gruppenuntersuchung, bei denen der GVO-Gehalt auf Grundlage der Saatgut /Getreideprozentanteile zur Einschätzung der Reinheit geschätzt wird, auf Strategien, bei denen mit dem Ziel eines Ablehn /Annahmekriteriums untersucht wird, und in Fällen von Saatgut /Getreidepartien, die kombinierte Ereignisse enthalten.
Dieses Dokument ist nicht anwendbar auf verarbeitete Erzeugnisse.
ANMERKUNG   Beschreibungen der Anwendung von Gruppenuntersuchungsstrategien finden sich in den Literaturhinweisen [1] [7] [8] [18] [19] und [20].

Analyse moléculaire de biomarqueurs - Méthode pour l'évaluation statistique des résultats d'analyse obtenus lors des essais de sous-échantillons multiples de semences et de graines génétiquement modifiées - Exigences générales (ISO 22753:2021, Version corrigée 2022-11)

Le présent document décrit les exigences générales, les modes opératoires et les critères de performance applicables à l’évaluation de la teneur en semences/graines génétiquement modifiées (GM) dans un lot par une stratégie d’analyse de groupe qui comprend l’analyse qualitative de sous-échantillons multiples puis l’évaluation statistique des résultats.
Le présent document est applicable à la stratégie d’analyse de groupe permettant d’estimer la teneur en OGM sur un pourcentage de semences/graines afin d’en estimer la pureté, d'évaluer si un critère de rejet/d'acceptation défini est respecté et de déterminer les cas où des lots de semences/graines contiennent un empilement d’événements.
Le présent document n’est pas applicable aux produits transformés.
NOTE          Une description de l’utilisation de la stratégie d’analyse de groupe est donnée dans les Références [1], [7], [8], [18], [19] et [20].

Analiza molekularnih biomarkerjev - Metoda za statistično vrednotenje rezultatov analiz, pridobljenih pri preskušanju podvzorcev skupin gensko spremenjenih semen in zrn - Splošne zahteve (ISO 22753:2021, popravljena verzija 2022-11)

Ta dokument opisuje splošne zahteve, postopke in merila za ocenjevanje vsebnosti gensko spremenjenih (GS) semen/zrn v seriji s strategijo skupinskega preskušanja, ki vključuje kvalitativno analizo podvzorcev skupin, ki ji sledi statistična ocena rezultatov.
Dokument se uporablja za strategijo skupinskega preskušanja, pri katerem se vsebnost GS ocenjuje na podlagi odstotka semena/zrna za oceno čistosti, preskušanja v skladu z danim merilom za zavrnitev/sprejem in za primere, ko serije semena/zrna vsebujejo naložene dogodke.
Ta dokument se ne uporablja za predelane proizvode.
OPOMBA: Opis uporabe strategije preskušanja skupin je na voljo v referencah [1], [7], [8], [18], [19] in [20].

General Information

• Status: Published
• Publication Date: 29-Nov-2022
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: CEN/TC 275 - Food analysis - Horizontal methods
• Drafting Committee: CEN/TC 275/WG 11 - Genetically modified foodstuffs
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 30-Nov-2022
• Due Date: 23-Aug-2024
• Completion Date: 30-Nov-2022
• Ref Project: SIST EN ISO 22753:2023 - Molecular biomarker analysis - Method for the statistical evaluation of analytical results obtained in testing sub-sampled groups of genetically modified seeds and grains - General requirements (ISO 22753:2021, Corrected version 2022-11)

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2023
Analiza molekularnih biomarkerjev - Metoda za statistično vrednotenje rezultatov
analiz, pridobljenih pri preskušanju podvzorcev skupin gensko spremenjenih
semen in zrn - Splošne zahteve (ISO 22753:2021, popravljena verzija 2022-11)
Molecular biomarker analysis - Method for the statistical evaluation of analytical results
obtained in testing sub-sampled groups of genetically modified seeds and grains -
General requirements (ISO 22753:2021, Corrected version 2022-11)
Untersuchung auf molekulare Biomarker - Verfahren zur statistischen Auswertung von
Analyseergebnissen aus der Untersuchung von Untergruppen von gentechnisch
verändertem Saatgut und Getreide - Allgemeine Anforderungen (ISO 22753:2021,
Korrigierte Fassung 2022-11)
Analyse moléculaire de biomarqueurs - Méthode pour l'évaluation statistique des
résultats d'analyse obtenus lors des essais de sous-échantillons multiples de semences
et de graines génétiquement modifiées - Exigences générales (ISO 22753:2021, Version
corrigée 2022-11)
Ta slovenski standard je istoveten z: EN ISO 22753:2022
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 22753
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2022
EUROPÄISCHE NORM
ICS 67.050
English Version
Molecular biomarker analysis - Method for the statistical
evaluation of analytical results obtained in testing sub-
sampled groups of genetically modified seeds and grains -
General requirements (ISO 22753:2021, Corrected version
2022-11)
Analyse moléculaire de biomarqueurs - Méthode pour Untersuchung auf molekulare Biomarker - Verfahren
l'évaluation statistique des résultats d'analyse obtenus zur statistischen Auswertung von Analyseergebnissen
lors des essais de sous-échantillons multiples de aus der Untersuchung von Untergruppen von
semences et de graines génétiquement modifiées - gentechnisch verändertem Saatgut und Getreide -
Exigences générales (ISO 22753:2021, Version corrigée Allgemeine Anforderungen (ISO 22753:2021,
2022-11) Korrigierte Fassung 2022-11)
This European Standard was approved by CEN on 14 November 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, Türkiye 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 ISO 22753:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Endorsement notice . 3

European foreword
The text of ISO 22753:2021, Corrected version 2022-11 has been prepared by Technical Committee
ISO/TC 34 "Food products” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO 22753:2022 by Technical Committee CEN/TC 275 “Food analysis - Horizontal
methods” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2023, and conflicting national standards shall be
withdrawn at the latest by May 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 22753:2021, Corrected version 2022-11 has been approved by CEN as
INTERNATIONAL ISO
STANDARD 22753
First edition
2021-08
Corrected version
2022-11
Molecular biomarker analysis —
Method for the statistical evaluation of
analytical results obtained in testing
sub-sampled groups of genetically
modified seeds and grains — General
requirements
Analyse moléculaire de biomarqueurs — Méthode pour l'évaluation
statistique des résultats d'analyse obtenus lors des essais de sous-
échantillons multiples de semences et de graines génétiquement
modifiées — Exigences générales
Reference number
ISO 22753:2021(E)
ISO 22753:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 22753:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
4.1 General . 4
4.2 Preparation of seed/grain groups . 4
4.3 Detection methods for the qualitative analysis of GM seed/grain in seed/grain
groups . 5
4.4 Statistical evaluation . 5
5 Reagents . 6
6 Apparatus and equipment . 6
7 Design of testing plan . 6
7.1 General . 6
7.2 Single-stage testing plan . 6
7.3 Double-stage testing plan . 7
8 Selection of qualitative methods . 8
8.1 General . 8
8.2 Performance criteria . 8
9 Interpretation .8
10 Expression of results .10
10.1 Classification of a seed/grain lot into “accept” or “reject” category . 10
10.2 Estimation of the level of molecular biomarker in the seed/grain lot . 10
11 Test report .10
Annex A (informative) Terms and definitions comparison table .12
Annex B (informative) Implementation of the method to evaluate GMO content in seeds/
grains example .14
Annex C (informative) Estimation of the limit of detection for a testing plan to detect GM
seeds/grains in seed lots .21
Annex D (informative) Experimental determination of maximum group size .24
Bibliography .25
iii
ISO 22753:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
ed
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