prCEN ISO/TS 21569-10

SLOVENSKI STANDARD
01-september-2025
Horizontalne metode za analizo molekularnih biomarkerjev - Analitske metode za
odkrivanje gensko spremenjenih organizmov in njihovih proizvodov - 10. del:
Konstruktno- in dogodkovno-specifične metode za odkrivanje gensko
spremenjenega lososa, ki izraža rastni hormon CS-GHc2 (ISO/DTS 21569-10:2025)
Horizontal methods for molecular biomarker analysis - Methods of analysis for the
detection of genetically modified organisms and derived products - Part 10: Construct-
and event-specific detection methods for genetically modified salmon expressing CS-
GHc2 growth hormone (ISO/DTS 21569-10:2025)
Untersuchung auf molekulare Biomarker - Verfahren zum Nachweis von gentechnisch
modifizierten Organismen und ihren Produkten - Teil 10: Konstrukt- und
ereignisspezifische Nachweisverfahren für gentechnisch veränderte AquAdvantage-
Lachse
Titre manque — Partie 10: Titre manque
Ta slovenski standard je istoveten z: prCEN ISO/TS 21569-10
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
67.120.30 Ribe in ribji proizvodi Fish and fishery products
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
Technical
Specification
ISO/DTS 21569-10
ISO/TC 34/SC 16
Horizontal methods for molecular
Secretariat: ANSI
biomarker analysis — Methods
Voting begins on:
of analysis for the detection of
2025-07-11
genetically modified organisms and
Voting terminates on:
derived products —
2025-10-03
Part 10:
Construct- and event-specific
detection methods for genetically
modified salmon expressing CS-
GHc2 growth hormone
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 21569-10:2025(en) © ISO 2025

FINAL DRAFT
ISO/DTS 21569-10:2025(en)
Technical
Specification
ISO/DTS 21569-10
ISO/TC 34/SC 16
Horizontal methods for molecular
Secretariat: ANSI
biomarker analysis — Methods
Voting begins on:
of analysis for the detection of
genetically modified organisms and
Voting terminates on:
derived products —
Part 10:
Construct- and event-specific
detection methods for genetically
modified salmon expressing CS-
GHc2 growth hormone
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ISO/DTS 21569-10:2025(en) © ISO 2025

ii
ISO/DTS 21569-10:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Reagents and materials . 2
6 Apparatus . 3
7 Procedure . 3
7.1 Preparation of test samples .3
7.2 DNA extraction .3
7.3 PCR setup.3
7.4 Temperature-time programme.4
8 Accept/reject criteria . 4
8.1 General .4
8.2 Detection .4
9 Validation status and performance criteria . 5
9.1 Sensitivity .5
9.2 Specificity .5
9.3 Robustness of the two methods .6
9.4 Interlaboratory trial for the construct-specific detection method .6
9.4.1 General .6
9.4.2 PCR efficiency and limit of detection (LOD ) .8
95 %
9.4.3 False-positive and false-negative rates for DNA samples (blind samples) .9
9.5 Interlaboratory trial for the event-specific detection method .9
9.5.1 General .9
9.5.2 Validation results (blind samples) . .10
9.6 Summary evaluation .10
10 Test report .11
Bibliography .12

iii
ISO/DTS 21569-10:2025(en)
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,
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
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Any trade name used in this document is information given for the convenience of users and does not
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 16,
Horizontal methods for molecular biomarker analysis, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 275, Food analysis - Horizontal methods, in accordance
with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 21569 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
FINAL DRAFT Technical Specification ISO/DTS 21569-10:2025(en)
Horizontal methods for molecular biomarker analysis —
Methods of analysis for the detection of genetically modified
organisms and derived products —
Part 10:
Construct- and event-specific detection methods for genetically
modified salmon expressing CS-GHc2 growth hormone
1 Scope
This document specifies procedures for the detection of a DNA sequence of a construct used to (genetically)
enhance the growth of fish commonly found in aquaculture. The genetically modified AquAdvantage
Atlantic salmon (Salmo salar) carries this construct and can be detected based on a real-time polymerase
chain reaction (PCR) targeting either the border between the growth hormone coding sequence (CS-GHc2)
of Oncorhynchus tshawytscha (Chinook salmon) and the antifreeze terminator (T-AFP) of (Macro-) Zoarces
americanus (ocean pout), i.e. with the construct-specific method, or the border between the Atlantic salmon
genomic DNA and the antifreeze promoter (P-AFP) of ocean pout, i.e. with the event-specific method. These
methods can be applied to identify the genetically modified (GM) fish or for screening purposes.
This document is applicable for the analysis of DNA extracted from foodstuffs. It can also be suitable for the
analysis of DNA extracted from other products such as feedstuffs. The application of these methods requires
the extraction of an adequate am
...