EN ISO 21569:2005
(Main)Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Qualitative nucleic acid based methods (ISO 21569:2005)
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Qualitative nucleic acid based methods (ISO 21569:2005)
ISO 21569:2005 describes the procedure to qualitatively detect genetically modified organisms (GMOs) and derived products by analysing the nucleic acids extracted from the sample under study. The main focus is on polymerase chain reaction (PCR) based amplification methods.
It gives general requirements for the specific detection and identification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified DNA sequence.
Guidelines, minimum requirements and performance criteria laid down in ISO 21569:2005 are intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories.
ISO 21569:2005 has been established for food matrices, but could also be applied to other matrices (e.g. feed and plant samples from the environment).
Specific examples of methods are provided in Annexes A to D.
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Qualitative auf Nukleinsäuren basierende Verfahren (ISO 21569:2005)
Diese Internationale Norm beschreibt das Verfahren zum qualitativen Nachweis gentechnisch modifizierter Organismen (GMOs) und ihrer Produkte durch Analyse der aus der zu untersuchenden Probe extrahierten Nukleinsäuren. Der Schwerpunkt dieser Norm sind Amplifikationsverfahren auf der Grundlage der Polymerase-Kettenreaktion (PCR).
Sie gibt allgemeine Anforderungen an den spezifischen Nachweis und die Identifizierung von Target-Nukleinsäuresequenzen (DNA) und an die Bestätigung der Identität der amplifizierten DNA-Sequenz.
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, könnte jedoch auch auf andere Matrices angewendet werden (z. B. Futtermittel und aus der Umwelt entnommene Pflanzenproben).
Typische Beispiele der Verfahren sind in den Anhängen A bis D angegeben.
Produits alimentaires - Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés - Méthodes qualitatives basées sur l'utilisation des acides nucléiques (ISO 21569:2005)
L'ISO 21569:2005 décrit le mode opératoire pour la détection qualitative des organismes génétiquement modifiés (OGM) et produits dérivés par analyse des acides nucléiques extraits de l'échantillon à l'étude. Elle couvre principalement les méthodes d'amplification fondées sur la réaction de polymérisation en chaîne (PCR). Elle concerne les exigences générales relatives à la détection et l'identification spécifiques de séquences d'acides nucléiques cibles (ADN) et à la confirmation de l'identité de la séquence d'ADN amplifiée.
Les lignes directrices, les exigences minimales et les critères de performance exposés dans l'ISO 21569:2005 ont pour but de garantir l'obtention de résultats comparables et reproductibles dans différents laboratoires.
L'ISO 21569:2005 a été élaborée pour les matrices alimentaires mais pourrait également être appliquée pour d'autres matrices (par exemple des aliments pour animaux et des échantillons de plantes issus de l'environnement).
Des exemples spécifiques de méthodes sont fournis dans les Annexes A à D.
Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov - Kvalitativne metode na osnovi nukleinske kisline (ISO 21569:2005
Ta standard opisuje zahteve za zagotavljanje kakovosti, ki naj bi jih laboratorij upošteval, da se zagotovita kakovost in celovitost podatkov ter kompetentnost laboratorija, ki ugotavlja prisotnost gensko spremenjenih organizmov (GMO) v živilih s polimerazno verižno reakcijo (PCR). Nanaša se na splošne zahteve za posebno povečanje ciljnih sekvenc nukleinske kisline (DNK) in za potrditev identitete povečane sekvence nukleinske kisline.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2005
Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in
njihovih produktov - Kvalitativne metode na osnovi nukleinske kisline (ISO
21569:2005
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and
derived products - Qualitative nucleic acid based methods (ISO 21569:2005)
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und
ihren Produkten - Qualitative auf Nukleinsäuren basierende Verfahren (ISO 21569:2005)
Produits alimentaires - Méthodes d'analyse pour la détection des organismes
génétiquement modifiés et des produits dérivés - Méthodes qualitatives basées sur
l'utilisation des acides nucléiques (ISO 21569:2005)
Ta slovenski standard je istoveten z: EN ISO 21569:2005
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 21569
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2005
ICS 67.050
English version
Foodstuffs - Methods of analysis for the detection of genetically
modified organisms and derived products - Qualitative nucleic
acid based methods (ISO 21569:2005)
Produits alimentaires - Méthodes d'analyse pour la Lebensmittel - Verfahren zum Nachweis von gentechnisch
détection des organismes génétiquement modifiés et des modifizierten Organismen und irhen Produkten - Qualitative
produits dérivés - Méthodes qualitatives basées sur auf Nukleinsäuren basierende Verfahren (ISO 21569:2005)
l'utilisation des acides nucléiques (ISO 21569:2005)
This European Standard was approved by CEN on 6 June 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 21569:2005: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 21569:2005) 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 December 2005, and conflicting national standards shall be
withdrawn at the latest by December 2005.
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 21569
First edition
2005-06-15
Foodstuffs — Methods of analysis for the
detection of genetically modified
organisms and derived products —
Qualitative nucleic acid based methods
Produits alimentaires — Méthodes d'analyse pour la détection des
organismes génétiquement modifiés et des produits dérivés —
Méthodes qualitatives basées sur l'utilisation des acides nucléiques
Reference number
ISO 21569:2005(E)
©
ISO 2005
ISO 21569:2005(E)
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ii © ISO 2005 – All rights reserved
ISO 21569:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Principle of the method. 2
5 Reagents. 2
6 Apparatus and equipment. 3
7 Procedure. 3
8 Interpretation. 6
9 Expression of results and quality assurance . 6
10 Test report. 7
Annex A (informative) Target-taxon-specific methods. 8
Annex B (informative) Screening methods. 24
Annex C (informative) Construct-specific methods . 40
Annex D (informative) Event-specific methods. 62
Bibliography . 67
ISO 21569:2005(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.
ISO 21569 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 275, Food analysis — Horizontal methods, in collaboration with Technical Committee ISO/TC 34,
Food products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
iv © ISO 2005 – All rights reserved
ISO 21569:2005(E)
Introduction
The search for a genetically modified origin of ingredients is performed by means of the following successive
(or simultaneous) steps. After sample collection, nucleic acids are extracted from the test portion. Extracted
nucleic acids can be further purified, simultaneously or after the extraction process. Afterwards, they are
quantified (if necessary), diluted (if necessary) and subjected to analytical procedures (such as PCR). These
steps are detailed in this International Standard and in the following series of International Standards with the
general title Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived
products:
Sampling (ISO 21568);
Quantitative nucleic acid based methods (ISO 21570);
Nucleic acid extraction (ISO 21571).
Further information about general requirements and definitions involving the steps cited above are collected in
ISO 24276.
The qualitative detection of DNA target sequences is performed in order to obtain a yes or no answer to the
question whether a certain target sequence is detected or not relative to appropriate controls and within the
detection limits of the analytical method used and test portion analysed.
The specificity of the methods, as described in Annexes A to D, ranges from screening methods to detect
common DNA sequences characteristic of GMOs, to specific identification of a genetic construct or a specific
transformation event.
The International Organization for Standardization (ISO) draws attention to the fact that it is claimed that
compliance with this document may involve the use of a patent concerning the PCR technology.
ISO takes no position concerning the evidence, validity and scope of this patent right.
ISO has been informed that Applied Biosystems, Roche Molecular Systems, Inc. and F. Hoffman La Roche
Ltd. hold patent rights concerning the PCR technology. The companies have assured the ISO that they are
willing to negotiate licences under reasonable and non-discriminatory terms and conditions with applicants
throughout the world. In this respect, the statements of the holders of these patent rights are registered with
ISO. Information may be obtained from:
Licensing Department
Applied Biosystems
850 Lincoln Centre Drive
Foster City, CA 94404
USA
and
Roche Molecular Systems, Inc.
Licensing Department
1145 Atlantic Avenue
Alameda, CA 94501
USA
ISO 21569:2005(E)
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights other than those identified above. ISO shall not be held responsible for identifying any or all such patent
rights.
vi © ISO 2005 – All rights reserved
INTERNATIONAL STANDARD ISO 21569:2005(E)
Foodstuffs — Methods of analysis for the detection of
genetically modified organisms and derived products —
Qualitative nucleic acid based methods
1 Scope
This International Standard describes the procedure to qualitatively detect genetically modified organisms
(GMOs) and derived products by analysing the nucleic acids extracted from the sample under study. The main
focus is on polymerase chain reaction (PCR) based amplification methods.
It gives general requirements for the specific detection and identification of target nucleic acid sequences
(DNA) and for the confirmation of the identity of the amplified DNA sequence.
Guidelines, minimum requirements and performance criteria laid down in this International Standard are
intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories.
This International Standard has been established for food matrices, but could also be applied to other
matrices (e.g. feed and plant samples from the environment).
Specific examples of methods are provided in Annexes A to D.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited a
...
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