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)

2012-10-24 EMA: Draft for // vote received in ISO/CS (see notification of 2012-10-24 in dataservice).
2011-07-14 ANP: Text received in ISO/CS (see notification from 2011-07-14 in dataservice).

Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Allgemeine Anforderungen und Definitionen (ISO 24276:2006/Amd 1:2013)

Der erste Abschnitt wird durch den folgenden ersetzt:
Diese Internationale Norm legt fest, wie die Normen für Nukleinsäureextraktion (ISO 21571), qualitative Nukleinsäureanalyse (ISO 21569), quantitative Nukleinsäureanalyse (ISO 21570) und Proteinverfahren (ISO 21572) anzuwenden sind und erläutert deren Zusammenhang bei der Untersuchung auf gentechnisch veränderte Organismen in Lebensmitteln.
Seite 5, 3.1
Die Definitionen in 3.1.2 bis 3.1.26 werden durch die folgenden ersetzt:

Produits alimentaires - Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés - Exigences générales et définitions (ISO 24276:2006/Amd 1:2013)

Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov - Splošne zahteve in definicije - Dopolnilo A1 (ISO 24276:2006/Amd 1:2013)

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: 28-May-2013
• Withdrawal Date: 29-Nov-2013
• 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: 29-May-2013
• Completion Date: 29-May-2013
• Ref Project: SIST 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)

Relations

• Amends: 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)
• Effective Date: 18-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2013
Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in
njihovih produktov - Splošne zahteve in definicije - Dopolnilo A1 (ISO
24276:2006/Amd 1:2013)
Foodstuffs - Methods of analysis for the detection of genetically modified organisms and
derived products - General requirements and definitions (ISO 24276:2006/Amd 1:2013)
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und
ihren Produkten - Allgemeine Anforderungen und Definitionen (ISO 24276:2006/Amd
1:2013)
Produits alimentaires - Méthodes d'analyse pour la détection des organismes
génétiquement modifiés et des produits dérivés - Exigences générales et définitions (ISO
24276:2006/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 24276:2006/A1:2013
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 24276:2006/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2013
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/Amd 1:2013)
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/Amd 1:2013) 24276:2006/Amd 1:2013)
This amendment A1 modifies the European Standard EN ISO 24276:2006; it was approved by CEN on 11 April 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24276:2006/A1:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 24276:2006/A1:2013) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the
secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 24276:2006 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by November 2013, and
conflicting national standards shall be withdrawn at the latest by November 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 24276:2006/Amd 1:2013 has been approved by CEN as EN ISO 24276:2006/A1:2013 without
any modification.
INTERNATIONAL ISO
STANDARD 24276
First edition
2006-02-01
AMENDMENT 1
2013-04-15
Foodstuffs — Methods of analysis for
the detection of genetically modified
organisms and derived products —
General requirements and definitions
AMENDMENT 1
Produits alimentaires — Méthodes d’analyse pour la détection
des organismes génétiquement modifiés et des produits dérivés —
Exigences générales et définitions
AMENDEMENT 1
Reference number
ISO 24276:2006/Amd.1:2013(E)
©
ISO 2013
ISO 24276:2006/Amd.1:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO 24276:2006/Amd.1:2013(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.
Amendment 1 to ISO 24276:2006 was prepared by Technical Committee ISO/TC 34, Food products,
Subcommittee SC 16, Horizontal methods for molecular biomarker analysis.
ISO 24276:2006/Amd.1:2013(E)
Foodstuffs — Methods of analysis for the detection of
genetically modified organisms and derived products —
General requirements and definitions
AMENDMENT 1
Page v, Introduction
Replace the existing text with the following.
The purpose of an analysis for the detection of genetically modified organisms and derived products
is to identify and optionally quantify genetic elements or proteins common to genetically modified
organisms (GMOs) and their derived products in a given matrix.
These steps are detailed in this International Standard and in the following documents:
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.
Page 1, Scope
Replace the existing first paragraph with the following.
This International Standard specifies how to use the standards for nucleic acid extraction (ISO 21571),
qualitative nucleic acid analysis (ISO 21569), quantitative nucleic acid analysis (ISO 21570) and
protein-based methods (ISO 21572), and explains their relationship in the analysis of genetically
modified organisms in foodstuffs.
Page 1, 3.1
Replace 3.1.2 to 3.1.26 with the following.
3.1.2
laboratory sample
sample received by the laboratory and intended for inspection or testing
[9]
NOTE Adapted from ISO 7002:1986, A.19.
ISO 24276:2006/Amd.1:2013(E)
3.1.3
test sample
representative fraction of the laboratory sample to be ground
3.1.4
test portion
portion of the test sample as prepared for testing or analysis, the whole quantity being used for analyte
extraction at one time
[5]
NOTE Adapted from ISO 6887-2:2003, 3.2.
3.1.5
specificity
property of a method to respond exclusively to the characteristic or analyte under investigation
3.1.6
sensitivity
change in the response divided by the corresponding change in the concentration of a standard
(calibration) curve
NOTE This is the slope of the analytical calibration curve.
3.1.7
limit of detection
LOD
minimum amount or concentration of the analyte in a test sample which can be detected reliably but not
necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation
NOTE See Reference [2] for collaborative trial and Reference [3] for validation.
3.1.8
limit of quantification
LOQ
lowest concentration or amount of the analyte in a test sample which can be quantitatively determined
with an acceptable level of precision and accuracy, as demonstrated by a collaborative trial or other
appropriate validation
NOTE See Reference [2] for collaborative trial and Reference [3] for validation.
3.1.9
accuracy
closeness of agreement between a test result and the accepted reference value
[ISO 5725-1:1994, 3.6].
3.1.10
trueness
closeness of agreement between the average value obtained from a large series of test results and an
accepted reference value
NOTE 1 The measure of trueness is usually expressed in terms of bias. Trueness has been referred to as
“accuracy of the mean”.
NOTE 2 Adapted from ISO 5725-1:1994, 3.7.
3.1.11
precision
closeness of agreement between independent test results obtained under stipulated conditions
NOTE 1 Precision depends only on the distribution of random errors and does not relate to the true value or to
the specified value.
2 © ISO 2013 – All rights reserved

ISO 24276:2006/Amd.1:2013(E)
NOTE 2 The measure of precision usually is expressed in terms of imprecision and computed as a standard
deviation of the test results. Lower precision is reflected by a larger standard deviation.
NOTE 3 “Independent test results” means results obtained in a manner not influenced by any previous result on
the same or similar test object. Quantitative measures of precision depend critically on the stipulated conditions.
Repeatability and reproducibility conditions are particular sets of extreme conditions.
[ISO 5725-1:1994, 3.12]
3.1.12
repeatability
precision under repeatability conditions
[ISO 5725-1:1994, 3.13]
3.1.13
reproducibility
precision under reproducibility conditions
[ISO 5725-1:1994, 3.17]
3.1.14
repeatability conditions
conditions where independent test results are obtained with the same method on identical test items
in the same laboratory by the same operator using the same equipment within short intervals of time
[ISO 5725-1:1994, 3.14]
3.1.15
reproducibility conditions
conditions where test results are obtained with the same method on identical test items in different
laboratories with different operators using different equipment
[ISO 5725-1:1994, 3.18]
NOTE When different methods give test results that do not differ significantly, or when different methods
are permitted by the design of the experiment (as in a proficiency study or a material certification study for the
establishment of a consensus value of a reference material), the term “reproducibility” may be applied to the
resulting parameters. The conditions should be explicitly stated.
3.1.16
repeatability standard deviation
standard deviation of test results obtained under repeatability conditions
[ISO 5725-1:1994, 3.15]
NOTE Repeatability standard deviation is a measure of the dispersion of the distribution of test results under
repeatability conditions. Similarly “repeatability variance” and “repeatability coefficient of variation” could be
defined and used as measures of the dispersion of test results under repeatability conditions.
3.1.17
reproducibility standard deviation
standard deviation of test results obtained under reproducibility conditions
[ISO 5725-1:1994, 3.19]
NOTE Reproducibility standard deviation is a measure of the dispersion of the distribution of test results
under reproducibility conditions. Similarly “reproducibil
...