EN ISO 21570:2005

Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570:2005)

ISO 21570:2005 provides the overall framework of quantitative methods for the detection of genetically modified organisms (GMO) in foodstuffs, using the polymerase chain reaction (PCR).
It defines general requirements for the specific amplification of DNA target sequences in order to quantify the relative GMO-derived DNA content and to confirm the identity of the amplified DNA sequence.
Guidelines, minimum requirements and performance criteria laid down in ISO 21570:2005 are intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories.
ISO 21570:2005 has been established for food matrices, but is also applicable to other matrices, e.g. feed and plant samples from the environment.

Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Quantitative auf Nukleinsäuren basierende Verfahren (ISO 21570:2005)

Diese Internationale Norm liefert den Gesamtrahmen für die quantitativen Verfahren zum Nachweis von gentechnisch veränderten Organismen (GVO) in Lebensmitteln mit der Polymerase-Kettenreaktion (PCR).
Sie legt allgemeine Anforderungen an die spezifische Amplifikation von DNA Zielsequenzen zur Quantifizierung des relativen DNA-Gehaltes an GVO und zur Bestätigung der Identität der amplifizierten DNA Sequenz fest.
In dieser internationalen Norm angeführte Anleitungen, Mindestanforderungen und Leistungskriterien sind dafür vorgesehen sicherzustellen, dass in verschiedenen Laboratorien vergleichbare, genaue und reproduzierbare Ergebnisse erhalten werden.
Diese Internationale Norm wurde für Lebensmittelmatrices erarbeitet, ist jedoch auch auf andere Matrices anwendbar, z. B. Futtermittel und aus der Umwelt entnommene Pflanzenproben.
In den Anhängen A bis D sind spezifische Beispiele von Verfahren angegeben.

Produits alimentaires - Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés - Méthodes quantitatives basées sur l'utilisation des acides nucléiques (ISO 21570:2005)

L'ISO 21570:2005 fournit un cadre général auquel doit satisfaire toute méthode quantitative de détection des organismes génétiquement modifiés (OGM) dans les produits alimentaires utilisant la PCR (réaction de polymérisation en chaîne).
Elle définit les exigences générales relatives à l'amplification spécifique de séquences cibles d'ADN, afin de quantifier la teneur relative en ADN dérivé d'OGM et de confirmer l'identité de la séquence d'ADN amplifiée.
Les lignes directrices, les exigences minimales et les critères de performance exposés dans l'ISO 21570:2005 ont pour but de garantir l'obtention de résultats comparables, exacts et reproductibles, dans différents laboratoires.
L'ISO 21570:2005 a été élaborée pour les matrices de produits alimentaires, mais elle est aussi applicable à d'autres matrices, par exemple des aliments pour animaux et des échantillons de plantes issus de l'environnement.

Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov – Kvantitativne metode na osnovi nukleinske kisline (ISO 21570:2005)

Ta mednarodni standard določa splošni okvir kvantitativnih metod za odkrivanje gensko spremenjenih organizmov (GMO) v živilih s polimerazno verižno reakcijo (PCR). Določa splošne zahteve za posebno povečanje ciljnih sekvenc DNK, da bi se količinsko opredelila relativna vsebnost DNK iz gensko spremenjenih organizmov in potrdila identiteta povečane sekvence DNK. Smernice, minimalne zahteve in merila učinkovitosti iz tega mednarodnega standarda so namenjeni zagotavljanju, da se v različnih laboratorijih pridobijo primerljivi, točni in ponovljivi rezultati. Ta mednarodni standard je bil pripravljen za živilske matrice, a se uporablja tudi za druge matrice, npr. za vzorce krme in rastlin iz okolja. Posebni primeri metod so opisani v dodatkih od A do D.

General Information

• Status: Published
• Publication Date: 31-Oct-2005
• Withdrawal Date: 30-May-2006
• 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: 01-Nov-2005
• Completion Date: 01-Nov-2005
• Ref Project: SIST EN ISO 21570:2006 - Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570:2005)

Relations

• Amended By: EN ISO 21570:2005/A1:2013 - Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570:2005/Amd 1:2013)
• Effective Date: 21-Jan-2009
• Corrected By: EN ISO 21570:2005/AC:2007 - Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570:2005/Cor.1:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2006
Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in
njihovih produktov – Kvantitativne metode na osnovi nukleinske kisline (ISO
21570:2005)
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and
derived products - Quantitative nucleic acid based methods (ISO 21570:2005)
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und
ihren Produkten - Quantitative auf Nukleinsäuren basierende Verfahren (ISO
21570:2005)
Produits alimentaires - Méthodes d'analyse pour la détection des organismes
génétiquement modifiés et des produits dérivés - Méthodes quantitatives basées sur
l'utilisation des acides nucléiques (ISO 21570:2005)
Ta slovenski standard je istoveten z: EN ISO 21570:2005
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.

EUROPEAN STANDARD
EN ISO 21570
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2005
ICS 67.050
English Version
Foodstuffs - Methods of analysis for the detection of genetically
modified organisms and derived products - Quantitative nucleic
acid based methods (ISO 21570:2005)
Produits alimentaires - Méthodes d'analyse pour la Lebensmittel - Verfahren zum Nachweis von gentechnisch
détection des organismes génétiquement modifiés et des modifizierten Organismen und ihren Produkten -
produits dérivés - Méthodes quantitatives basées sur Quantitative auf Nukleinsäuren basierende Verfahren (ISO
l'utilisation des acides nucléiques (ISO 21570:2005) 21570:2005)
This European Standard was approved by CEN on 26 October 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21570:2005: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 21570:2005) has been prepared by Technical Committee CEN/TC 275 "Food
analysis - Horizontal methods", the secretariat of which is held by DIN, in collaboration with Technical
Committee ISO/TC 34 "Agricultural food products".

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 2006, and conflicting national standards shall be withdrawn at
the latest by May 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
INTERNATIONAL ISO
STANDARD 21570
First edition
2005-11-01
Foodstuffs — Methods of analysis for the
detection of genetically modified
organisms and derived products —
Quantitative nucleic acid based methods
Produits alimentaires — Méthodes d'analyse pour la détection des
organismes génétiquement modifiés et des produits dérivés —
Méthodes quantitatives basées sur l'utilisation des acides nucléiques

Reference number
ISO 21570:2005(E)
©
ISO 2005
ISO 21570:2005(E)
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ii © ISO 2005 – All rights reserved

ISO 21570:2005(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Principle. 2
4.1 General. 2
4.2 Amplification, detection and confirmation of PCR products . 2
4.3 Quantitation of PCR products . 2
5 Reagents. 2
6 Apparatus and equipment . 2
7 Guidelines concerning the procedure. 3
7.1 General. 3
7.2 Target sequence stability. 3
7.3 Calibration of the analysis . 3
7.4 Quantitation considerations . 3
7.5 Quality assurance requirements . 3
8 Interpretation. 4
9 Expression of results . 4
10 Test report . 5
Annex A (informative) Target taxon-specific methods. 6
A.1 Target taxon-specific method for the absolute quantitation of the adh1 gene DNA of
maize using real-time PCR. 6
Annex B (informative) Screening methods. 12
B.1 Screening method for the relative quantitation of the 35S-promoter DNA of soya bean line
GTS 40-3-2 using real-time PCR. 12
Annex C (informative) Construct-specific methods . 20
C.1 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA using
real-time PCR (Method 1) . 20
C.2 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA using
real-time PCR (Method 2) . 27
C.3 Construct-specific method for the quantitation of Event176 maize DNA using real-time
PCR. 34
C.4 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA using
real-time PCR . 41
C.5 Construct-specific method for the quantitation of maize line MON 810 DNA using
real-time PCR . 49
C.6 Construct-specific method for the quantitation of maize line Event176 DNA using
real-time PCR . 56
C.7 Construct-specific method for the quantitation of maize line Bt11 DNA using real-time
PCR. 63
ISO 21570:2005(E)
C.8 Construct-specific method for the quantitation of maize line GA21 DNA using real-time
PCR. 71
C.9 Construct-specific method for the quantitation of maize line T25 DNA using real-time PCR . 78
Annex D (informative) Event-specific methods . 87
D.1 Event-specific method for the absolute and relative quantitation of maize line Bt11 DNA
based on real-time PCR. 87
D.2 Event-specific method for the relative quantitation of maize line MON 810 DNA using
real-time PCR. 93
Bibliography . 100

iv © ISO 2005 – All rights reserved

ISO 21570:2005(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 21570 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 275, Food Analysis — Horizo
...