EN ISO 24276:2006

Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requirements and definitions (ISO 24276:2006)

ISO 24276:2006 specifies how to use the standards for sampling strategies (EN/TS 21568), nucleic acid extraction (ISO 21571), qualitative nucleic acid analysis (ISO 21569) and quantitative nucleic acid analysis (ISO 21570), and their relationship in the analysis of genetically modified organisms in foodstuffs, and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods and test reports.
It has been established for food matrices, but could also be applied to other matrices (e.g. seeds, feed and plant samples from the environment).

Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Allgemeine Anforderungen und Definitionen (ISO 24276:2006)

Diese Internationale Norm legt fest, wie die Normen für Probenahmestrategien (CEN/TS 21568), Nukleinsäureextraktion (ISO 21571), qualitative Nukleinsäureanalyse (ISO 21570), quantitative Nukleinsäureanalyse (ISO 21569) und Proteinverfahren (ISO 21572) anzuwenden sind und erläutert deren Verknüpfung bei der Analyse gentechnisch veränderter Organismen in Lebensmitteln.
Sie enthält allgemeine Definitionen, Anforderungen und Leitfäden hinsichtlich: Laboreinrichtung, Anforderungen an die Validierung von Verfahren, Beschreibung von Verfahren und Untersuchungsberichte.
Diese Norm wurde für Lebensmittelmatrices erarbeitet, könnte jedoch auch auf andere Matrices angewendet werden, z. B. Saatgut, Futtermittel und pflanzliche Proben aus der Umwelt.

Produits alimentaires - Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés - Exigences générales et définitions (ISO 24276:2006)

L'ISO 24276:2006 spécifie comment utiliser les normes relatives à l'échantillonnage (EN/TS 15568), à l'extraction d'acides nucléiques (ISO 21571), à l'analyse qualitative des acides nucléiques (ISO 21569), à l'analyse quantitative des acides nucléiques (ISO 21570) et aux méthodes basées sur les protéines (ISO 21572), ainsi que leur relation dans l'analyse des organismes génétiquement modifiés présents dans les produits alimentaires. Elle contient les définitions générales, les exigences et les lignes directrices relatives à l'organisation du laboratoire, la validation des méthodes, la description des méthodes et les rapports d'essai.
Elle a été élaborée pour les matrices alimentaires mais pourrait également être appliquée pour d'autres matrices (par exemple des graines, des aliments pour animaux et des échantillons issus de l'environnement).

Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov – Splošne zahteve in definicije (ISO 24276:2006)

Ta mednarodni standard določa uporabo standardov za strategije vzorčenja (EN/TS 21568), ekstrakcijo nukleinske kisline (ISO 21571), kvalitativno analizo nukleinske kisline (ISO 21569), kvantitativno analizo nukleinske kisline (ISO 21570) in beljakovinske metode (ISO 21572) ter razlaga njihovo vlogo v analizi genetsko spremenjenih organizmov v živilih. Vsebuje splošne opredelitve, zahteve in smernice za laboratorijsko pripravo, zahteve za metodo validacije, opis metod in poročila o preskusih. Pripravljen je bil za živilske matrice, vendar se uporablja tudi za druge matrice (npr. za vzorce semen, krme in rastlin iz okolja).

General Information

• Status: Published
• Publication Date: 31-Jan-2006
• Withdrawal Date: 30-Aug-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: 9093 - Decision to confirm - Review Enquiry
• Start Date: 09-Jul-2009
• Completion Date: 09-Jul-2009
• Ref Project: SIST EN ISO 24276:2006 - Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requirements and definitions (ISO 24276:2006)

Relations

• Amended By: EN ISO 24276:2006/A1:2013 - Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requirements and definitions (ISO 24276:2006/Amd 1:2013)
• Effective Date: 18-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2006
Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in
njihovih produktov – Splošne zahteve in definicije (ISO 24276:2006)
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and
derived products - General requirements and definitions (ISO 24276:2006)
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und
ihren Produkten - Allgemeine Anforderungen und Definitionen (ISO 24276:2006)
Produits alimentaires - Méthodes d'analyse pour la détection des organismes
génétiquement modifiés et des produits dérivés - Exigences générales et définitions (ISO
24276:2006)
Ta slovenski standard je istoveten z: EN ISO 24276:2006
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 24276
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2006
ICS 67.050
English Version
Foodstuffs - Methods of analysis for the detection of genetically
modified organisms and derived products - General
requirements and definitions (ISO 24276:2006)
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 - Exigences générales et définitions (ISO Allgemeine Anforderungen und Definitionen (ISO
24276:2006) 24276:2006)
This European Standard was approved by CEN on 23 January 2006.
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, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24276:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 24276:2006) 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 August 2006, and conflicting national
standards shall be withdrawn at the latest by August 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

INTERNATIONAL ISO
STANDARD 24276
First edition
2006-02-01
Foodstuffs — Methods of analysis for
the detection of genetically modified
organisms and derived products —
General requirements and definitions
Produits alimentaires — Méthodes d'analyse pour la détection des
organismes génétiquement modifiés et des produits dérivés —
Exigences générales et définitions

Reference number
ISO 24276:2006(E)
©
ISO 2006
ISO 24276:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 24276:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
3.1 General definitions . 1
3.2 Terms relative to extraction and purification of DNA . 5
3.3 Terms referring to DNA amplification and PCR. 5
3.4 Definitions referring to DNA and PCR controls. 5
3.5 Terms relative to reference materials. 7
3.6 Terms relative to quantitation . 7
3.7 Terms relative to GMOs . 7
4 Application to the relevant International Standards . 7
4.1 General. 7
4.2 Guidance for the user on the selection of methods. 8
4.3 Performance characteristics. 9
5 General laboratory and procedural requirements. 10
5.1 General. 10
5.2 Use of controls. 10
5.3 Laboratory organization. 12
6 Interpretation and expression of results. 13
6.1 General. 13
6.2 Interpretation of controls . 13
6.3 Expression of a negative result. 14
6.4 Expression of a positive result. 14
6.5 Expression of ambiguous results . 14
6.6 Quality assurance requirements. 15
7 Test report. 15
Bibliography . 16

ISO 24276:2006(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 24276 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 2006 – All rights reserved

ISO 24276:2006(E)
Introduction
The purpose of such an analysis is to identify and quantify genetic elements or proteins common to genetically
modified organisms (GMOs) and their derived products in a given matrix.
The main focus of this International Standard is polymerase chain reaction (PCR) based methodologies.
However, because of the rapid rate of technological change in this area, other technologies may be
considered in the future.
The search for ingredients of genetically modified origin is performed by means of the following successive (or
simultaneous) steps. After sample collection, nucleic acids or proteins are extracted from the test portion.
Extracted analytes 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 or
Enzyme-Linked Immunosorbent Assay (ELISA). These steps are detailed in this International Standard and in
the following documents:
EN/TS 21568, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and
derived products — Sampling strategies
ISO 21569, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived
products — Qualitative nucleic acid based methods
ISO 21570, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived
products — Quantitative nucleic acid based methods
ISO 21571, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived
products — Nucleic acid extraction
ISO 21572, Foodstuffs — Methods for the detection of genetically modified organisms and derived
products — Protein based methods
Specific information pertaining to protein detection methods is found in ISO 21572.

INTERNATIONAL STANDARD ISO 24276:2006(E)

Foodstuffs — Methods of analysis for the detection of
genetically modified organisms and derived products —
General requirements and definitions
1 Scope
This International Standard specifies how to use the standards for sampling strategies (EN/TS 21568), nucleic
acid extraction (ISO 21571), qualitative nucleic acid analysis (ISO 21
...