oSIST prEN ISO 21569-1:2025

SLOVENSKI STANDARD
01-december-2025
Horizontalne metode za analizo molekularnih biomarkerjev - Analitske metode za
določanje gensko spremenjenih organizmov in njihovih proizvodov - 1. del:
Kvalitativne metode na osnovi nukleinskih kislin (ISO/DIS 21569-1:2025)
Horizontal methods for molecular biomarker analysis - Methods of analysis for the
detection of genetically modified organisms and derived products - Part 1: Qualitative
nucleic acid based methods (ISO/DIS 21569-1:2025)
Untersuchung auf molekulare Biomarker - Verfahren zum Nachweis von gentechnisch
modifizierten Organismen und ihren Produkten - Qualitative auf Nukleinsäuren
basierende Verfahren (ISO/DIS 21569-1:2025)
Méthodes horizontales d’analyse de biomarqueurs moléculaires - Méthodes d’analyse
pour la détection des organismes génétiquement modifiés et des produits dérivés -
Partie 1: Méthodes qualitatives basées sur l’utilisation des acides nucléiques (ISO/DIS
21569-1:2025)
Ta slovenski standard je istoveten z: prEN ISO 21569-1
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.

DRAFT
International
Standard
ISO/DIS 21569-1
ISO/TC 34/SC 16
Horizontal methods for molecular
Secretariat: ANSI
biomarker analysis — Methods
Voting begins on:
of analysis for the detection of
2025-10-15
genetically modified organisms and
Voting terminates on:
derived products —
2026-01-07
Part 1:
Qualitative nucleic acid based
methods
ICS: 67.050
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 21569-1:2025(en)
DRAFT
ISO/DIS 21569-1:2025(en)
International
Standard
ISO/DIS 21569-1
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 1:
Qualitative nucleic acid based
methods
ICS: 67.050
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 21569-1:2025(en)
ii
ISO/DIS 21569-1:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
4.1 General .2
4.2 PCR amplification .2
4.3 Detection and confirmation of PCR products .2
5 Reagents . 2
6 Apparatus and equipment . 3
7 Procedure . 3
7.1 Quality, integrity and amplifiability of nucleic acid extracts .3
7.2 Performance criteria .3
7.3 Aspects of PCR design .4
7.3.1 General .4
7.3.2 Size of PCR products .4
7.3.3 Primers.4
7.4 PCR target descriptions .5
7.5 Controls .5
7.6 PCR set-up, detection and confirmation of PCR products .5
8 Interpretation . 6
8.1 General .6
8.2 Verification . .6
9 Expression of results and quality assurance . 6
9.1 General .6
9.2 Expression of a negative result .6
9.3 Expression of a positive result .7
9.4 Quality assurance requirements .7
10 Test report . 7
Bibliography . 8

iii
ISO/DIS 21569-1:2025(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,
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.
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 documents 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).
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. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following URL: 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.
This second edition cancels and replaces the first edition (ISO 21569:2005), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— inclusion of the amendment from 2013;
— publication of all annexed methods in ISO/TS 21569-11
— editorial revison.
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 atwww.iso.org/members.html.

iv
ISO/DIS 21569-1:2025(en)
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:
— Quantitative nucleic acid based m
...