EN ISO 14501:2021

Milk and milk powder - Determination of aflatoxin M1 content - Clean-up by immunoaffinity chromatography and determination by high-performance liquid chromatography (ISO 14501:2021)

This document specifies a method for the determination of aflatoxin M1 content in milk and milk powder. The lowest level of validation is 0,08 µg/kg for whole milk powder, i.e. 0,008 µg/l for reconstituted liquid milk. The limit of detection (LOD) is 0,05 μg/kg for milk powder and 0,005 μg/kg for liquid milk. The limit of quantification (LOQ) is 0,1 μg/kg for milk powder and 0,01 μg/kg for liquid milk.
The method is also applicable to low-fat milk, skimmed milk, low-fat milk powder and skimmed milk powder.

Milch und Milchpulver - Bestimmung des Gehalts an Aflatoxin M1 - Reinigung durch Immunaffinitäts-Chromatographie und Bestimmung mit Hochleistungs-Flüssigchromatographie (ISO 14501:2021)

Dieses Dokument legt ein Verfahren zur Bestimmung des Aflatoxin-M1-Gehalts von Milch und Milchpulver fest. Der kleinste Validierungswert beträgt 0,08 μg/kg für Vollmilchpulver, d. h. 0,008 μg/l für rekonstituierte flüssige Milch. Die Nachweisgrenze (LOD, en: limit of detection) beträgt 0,05 μg/kg für Milchpulver sowie 0,005 μg/kg für flüssige Milch. Die Bestimmungsgrenze (LOQ, en: limit of quantification) beträgt 0,1 μg/kg für Milchpulver sowie 0,01 μg/kg für flüssige Milch.
Das Verfahren ist auch auf fettarme Milch, Magermilch, fettarmes Milchpulver und Magermilchpulver anwendbar.

Lait et lait en poudre - Détermination de la teneur en aflatoxine M1 - Purification par chromatographie d'immunoaffinité et détermination par chromatographie en phase liquide à haute performance (ISO 14501:2021)

Le présent document spécifie une méthode pour le dosage de l’aflatoxine M1 dans le lait et le lait en poudre. Le niveau de validation le plus bas est de 0,08 µg/kg de poudre de lait entier, ce qui correspond à 0,008 µg/l de lait liquide reconstitué. La limite de détection (LOD) est de 0,05 μg/kg pour le lait en poudre et de 0,005 μg/kg pour le lait liquide. La limite de quantification (LOQ) est de 0,1 μg/kg pour le lait en poudre et de 0,01 μg/kg pour le lait liquide.
La méthode est également applicable au lait à faible teneur en matière grasse, au lait écrémé et au lait en poudre à faible teneur en matière grasse ou écrémé.

Mleko in mleko v prahu - Določevanje vsebnosti aflatoksina M1 - Čiščenje z imunoafinitetno kromatografijo in določevanje s tekočinsko kromatografijo visoke ločljivosti (ISO 14501:2021)

General Information

• Status: Published
• Publication Date: 25-May-2021
• Withdrawal Date: 29-Nov-2021
• ICS: 67.100.10 - Milk and processed milk products
• Technical Committee: CEN/TC 302 - Milk and milk products - Methods of sampling and analysis
• Drafting Committee: CEN/TC 302 - Milk and milk products - Methods of sampling and analysis
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-May-2021
• Completion Date: 26-May-2021
• Ref Project: SIST EN ISO 14501:2021 - Milk and milk powder - Determination of aflatoxin M1 content - Clean-up by immunoaffinity chromatography and determination by high-performance liquid chromatography (ISO 14501:2021)

Relations

• Replaces: EN ISO 14501:2007 - Milk and milk powder - Determination of aflatoxin M1 content - Clean-up by immunoaffinity chromatography and determination by high-performance liquid chromatography (ISO 14501:2007)
• Effective Date: 02-Jun-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2021
Nadomešča:
SIST EN ISO 14501:2007
Mleko in mleko v prahu - Določevanje vsebnosti aflatoksina M1 - Čiščenje z
imunoafinitetno kromatografijo in določevanje s tekočinsko kromatografijo visoke
ločljivosti (ISO 14501:2021)
Milk and milk powder - Determination of aflatoxin M1 content - Clean-up by
immunoaffinity chromatography and determination by high-performance liquid
chromatography (ISO 14501:2021)
Milch und Milchpulver - Bestimmung des Gehalts an Aflatoxin M1 - Reinigung durch
Immunaffinitäts-Chromatographie und Bestimmung mit Hochleistungs-
Flüssigchromatographie (ISO 14501:2021)
Lait et lait en poudre - Détermination de la teneur en aflatoxine M1 - Purification par
chromatographie d'immunoaffinité et détermination par chromatographie en phase
liquide à haute performance (ISO 14501:2021)
Ta slovenski standard je istoveten z: EN ISO 14501:2021
ICS:
67.100.10 Mleko in predelani mlečni Milk and processed milk
proizvodi products
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 14501
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2021
EUROPÄISCHE NORM
ICS 67.100.10 Supersedes EN ISO 14501:2007
English Version
Milk and milk powder - Determination of aflatoxin M1
content - Clean-up by immunoaffinity chromatography and
determination by high-performance liquid
chromatography (ISO 14501:2021)
Lait et lait en poudre - Détermination de la teneur en Milch und Milchpulver - Bestimmung des Gehalts an
aflatoxine M1 - Purification par chromatographie Aflatoxin M1 - Reinigung durch Immunaffinitäts-
d'immunoaffinité et détermination par Chromatographie und Bestimmung mit Hochleistungs-
chromatographie en phase liquide à haute Flüssigchromatographie (ISO 14501:2021)
performance (ISO 14501:2021)
This European Standard was approved by CEN on 12 April 2021.

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 CEN-CENELEC Management Centre 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14501:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14501:2021) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 302 “Milk and milk products - Methods of
sampling and analysis” the secretariat of which is held by NEN.
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 November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14501:2007.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14501:2021 has been approved by CEN as EN ISO 14501:2021 without any modification.

INTERNATIONAL ISO
STANDARD 14501
IDF 171
Third edition
2021-05
Milk and milk powder —
Determination of aflatoxin M content
— Clean-up by immunoaffinity
chromatography and determination
by high-performance liquid
chromatography
Lait et lait en poudre — Détermination de la teneur en aflatoxine
M — Purification par chromatographie d'immunoaffinité et
détermination par chromatographie en phase liquide à haute
performance
Reference numbers
ISO 14501:2021(E)
IDF 171:2021(E)
©
ISO and IDF 2021
ISO 14501:2021(E)
IDF 171:2021(E)
© ISO and IDF 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 International Dairy Federation
CP 401 • Ch. de Blandonnet 8 Silver Building • Bd Auguste Reyers 70/B
CH-1214 Vernier, Geneva B-1030 Brussels
Phone: [phone] Phone: [phone]
Fax: [phone]
Email: [e-mail] Email: [e-mail]
Website: www.iso.org Website: www.fil-idf.org
Published in Switzerland
ii © ISO and IDF 2021 – All rights reserved

ISO 14501:2021(E)
IDF 171:2021(E)
Contents Page
Forewords .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Reagents . 2
6 Apparatus . 4
7 Sampling . 5
8 Procedure. 5
8.1 General . 5
8.2 Preparation of test samples . 5
8.2.1 Milk . 5
8.2.2 Milk powder . 5
8.3 Immunoaffinity column preparation . 6
8.4 Test sample purification . 6
8.5 High performance liquid chromatography (HPLC) . 6
8.5.1 Pump setting. 6
8.5.2 Chromatographic performance . 6
8.5.3 Calibration curve of aflatoxin M . 7
8.5.4 Analysis of the purified extracts and injection scheme . 7
9 Calculation and expression of results . 7
9.1 Skimmed milk . 7
9.1.1 Calculation . 7
9.1.2 Expression of results . 7
9.2 Skimmed milk powder . 8
9.2.1 Calculation . 8
9.2.2 Expression of results . 8
10 Precision . 8
10.1 Interlaboratory test. 8
10.2 Repeatability . 8
10.3 Reproducibility . 8
11 Test report . 9
Annex A (informative) Results of an interlaboratory trial .10
Bibliography .11
ISO 14501:2021(E)
IDF 171:2021(E)
Forewords
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 docume
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