EN ISO 21570:2005/A1:2013
(Amendment)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)
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)
2012-10-30 GVN: Draft for // vote available in ISO/CS (see notification in dataservice from 2012-10-30)
2010-03-03 EMA: WI updated as ISO decided to proceed with an amendment instead of a revision (former ID 53576).
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Quantitative auf Nukleinsäuren basierende Verfahren (ISO 21570:2005/Amd 1:2013)
No scope available.
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/Amd 1:2013)
Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov - Kvantitativne metode na osnovi nukleinske kisline - Dopolnilo A1 (ISO 21570:2005/Amd 1:2013)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2013
Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in
njihovih produktov - Kvantitativne metode na osnovi nukleinske kisline - Dopolnilo
A1 (ISO 21570:2005/Amd 1:2013)
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)
Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und
ihren Produkten - Quantitative auf Nukleinsäuren basierende Verfahren (ISO
21570:2005/Amd 1:2013)
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/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 21570:2005/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 21570:2005/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2013
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/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 - Méthodes quantitatives basées sur Quantitative auf Nukleinsäuren basierende Verfahren (ISO
l'utilisation des acides nucléiques (ISO 21570:2005/Amd 21570:2005/Amd 1:2013)
1:2013)
This amendment A1 modifies the European Standard EN ISO 21570:2005; 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 21570:2005/A1:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 21570:2005/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 21570:2005 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2013, and
conflicting national standards shall be withdrawn at the latest by October 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 21570:2005/Amd 1:2013 has been approved by CEN as EN ISO 21570:2005/A1:2013 without
any modification.
INTERNATIONAL ISO
STANDARD 21570
First edition
2005-11-01
AMENDMENT 1
2013-04-15
Foodstuffs — Methods of analysis for
the detection of genetically modified
organisms and derived products —
Quantitative nucleic acid based
methods
AMENDMENT 1
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
AMENDEMENT 1
Reference number
ISO 21570:2005/Amd.1:2013(E)
©
ISO 2013
ISO 21570:2005/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
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ii © ISO 2013 – All rights reserved
ISO 21570:2005/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 21570:2005 was prepared by Technical Committee ISO/TC 34, Food products,
Subcommittee SC 16, Horizontal methods for molecular biomarker analysis.
ISO 21570:2005/Amd.1:2013(E)
Foodstuffs — Methods of analysis for the detection of
genetically modified organisms and derived products —
Quantitative nucleic acid based methods
AMENDMENT 1
No attempt has been made in this amendment to update the footnote numbering to fit in with the scheme
adopted in ISO 21570:2005. The footnote numbers given are for use solely within this amendment.
Page 1, Clause 2
Update entries 1 to 3 as follows and delete footnote 1).
ISO 21569:2005 + AM1:2013, Foodstuffs — Methods of analysis for the detection of genetically modified
organisms and derived products — Qualitative nucleic acid based methods
ISO 21571:2005 + AM1:2013, Foodstuffs — Methods of analysis for the detection of genetically modified
organisms and derived products — Nucleic acid extraction
ISO 24276:2006 + AM1:2013, Foodstuffs — Methods of analysis for the detection of genetically modified
organisms and derived products — General requirements and definitions
Page 2, 7.1, last paragraph; Page 8, A.1.5.1; Page 15, B.1.5.1; Page 23, C.1.5.1; Page 31, C.2.5.1; Page 38,
C.3.5.1; Page 45, C.4.5.1; Page 53, C.5.5.1; Page 60, C.6.5.1; Page 68, C.7.5.1; Page 75, C.8.5.1; Page 83,
C.9.5.1; Page 90, D.1.5.1; Page 96, D.2.5.1
Delete “ISO 24276:—”, insert “ISO 24276:2006”.
Page 4, Clauses 8–10
Replace the existing text with the following.
8 Interpretation
The PCR result will be either a) or b).
a) Fit for quantification of the target sequence provided:
— the result is positive according to ISO 21569:2005, 8.1;
— the observable inhibition of the reaction is negligible;
— the analysis produces an unambiguous measurement value;
— the target sequence content is within the dynamic range of the method;
— the analysis is calibrated in an acceptable way (see 7.3).
b) Unfit for quantification of the target sequence if any of the conditions listed in a) are not fulfilled.
ISO 21570:2005/Amd.1:2013(E)
Interpretation of ambiguous results within the same test portion: in case of +/− results for the two
replicates, repeat the two PCR for the relevant test portion. If the two novel replicates are tested +/− or
−/−, the test portion is considered as negative.
Interpretation of ambiguous results between two test portions: in case of ± results for the two test
portions of a sample, the extractions and analysis of two new test portions shall be performed. If again
the results are +/−, the sample is considered as negative according to ISO 24276:2006, 6.3.
The measurement uncertainty shall be sufficiently small to enable the laboratory to draw the
relevant conclusions.
Annexes A to D describe the measurement of the target DNA quantities. These quantities can be used
to calculate the GMO content. These calculations usually take into consideration relevant biological
factors, e.g. the homo- or heterozygosity of the target sequences.
If the GM target sequence content or the taxon-specific target sequence content is below the limit of
quantification, the result shall only be expressed qualitatively.
NOTE Stating that the GMO-derived DNA content is below the practical LOQ accompanied by a specification
of that LOQ is considered to be a qualitative expression of the result.
9 Expression of results
The results shall clearly state the quantity of the GM target sequence relative to the target taxon-specific
sequence. The results should also provide values for the measurement uncertainty, such as the standard
deviation or coefficient of variation. Furthermore, the LOD and LOQ of the method and the practical
LOD and LOQ should be reported. The indication that the result refers only to GMO targets should be
reported. In the case of quantitative screening analysis on complex matrices, it is recommended to
specify that the GMO signal can come from non target taxons.
The target sequences can or cannot be detected, or the quantity of at least one of them can be below the
limit of quantification. Table 1 describes the four alternative cases and the corresponding expression of
the result to be included into the test report.
The GMO-derived DNA content can also be reported as being above or below a specific value, taking into
account the measurement uncertainty.
10 Test report
The test report shall be written in accordance with ISO 24276 and ISO 21569 and shall contain at least
the following additional information:
a) the LOQ of the method and the matrix used to establish it;
b) the practical LOQ;
c) a reference to the method which has been used for the extraction of DNA;
d) a reference to the methods used for the amplification of the DNA target sequences;
e) the reference material used;
f) the results expressed according to Clause 9;
g) the PCR target and whether considered “event specific” or “construct specific” or “screening”;
h) the definition of the measurement uncertainty used.
NOTE For g) and h), information can figure in different documents (e.g. contract review, technical data sheets).
2 © ISO 2013 – All rights reserved
ISO 21570:2005/Amd.1:2013(E)
Table 1 — Expression of results
Result Expression of the result
Target taxon-specific sequence “For species X, DNA was not detected.”
is not detected.
Target taxon-specific sequence According to ISO 21569.
is detected but GM target
“For sample X, GM target sequence Y was not detected.
sequence is not detected.
The LOD of the method is x % determined with ABC (identify the reference
material).”
If it cannot be demonstrated that the test sample size and the amount of target
DNA included in the PCR is sufficient for the LOD to be applicable, then the fol-
lowing sentence shall be added:
“However, the amount of the target DNA extracted from species X can be/was
insufficient for the LOD to be applicable for this sample. The LOD of sample is
x %.” (Specify the unit used.)
NOTE The LOD of the sample is determined by the quantity of DNA of the species
included in the analytical reaction (copy number), and the ratio relative to the absolute
LOD of the GM target (copy number), and in the case of grain and seeds, the number of
grain or seeds in the portion that is ground.
The
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