CEN/TR 16059:2010

Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins

This Technical Report gives criteria for single laboratory validated methods of analysis for the determination of mycotoxins. The criteria and topics covered are accuracy, trueness, recovery, precision, measurement uncertainty, selectivity, applicability, linearity, limit of detection, limit of quantification, sensitivity, ruggedness, specificity. This report also contains information on terms and definitions, validation, standardization procedures and interlaboratory studies by international organizations (e.g. AOAC, CEN, ISO, IUPAC, IDF). Confirmatory methods and screening methods are described. The validation criteria specified for mycotoxins in general are given.

Untersuchung von Lebensmitteln - Leistungskriterien für Einzel-Labor-validierte Verfahren zur Bestimmung von Mykotoxinen

Dieser technische Bericht legt die Kriterien für Verfahren zur Bestimmung von Mykotoxinen fest, die in einem einzelnen Labor validiert wurden. Die Kriterien und Aspekte umfassen Genauigkeit, Richtigkeit, Wieder¬findung, Präzision, Messunsicherheit, Selektivität, Anwendbarkeit, Linearität, Nachweisgrenze, Bestimmungs¬grenze, Empfindlichkeit, Robustheit und Spezifität. Dieser Bericht enthält auch Angaben zu Begriffen, zu Validierung, zu Normungsverfahren und Laborvergleichsuntersuchungen durch internationale Organisationen (z. B. AOAC, CEN, ISO, IUPAC, IDF). Ferner sind Bestätigungsverfahren und Screening-Verfahren beschrieben. Die Validierungskriterien sind für Mykotoxine im Allgemeinen beschrieben.

Analyse des produits alimentaires - Critères de performance des méthodes validées monolaboratoires d'analyse des mycotoxines

Le présent Rapport technique établit des critères relatifs à des méthodes validées monolaboratoires d’analyse des mycotoxines. Les critères et les thèmes traités sont l’exactitude, la justesse, la récupération, la fidélité, l’incertitude de mesure, la sélectivité, le domaine d’application, la linéarité, la limite de détection, la limite de quantification, la sensibilité, la robustesse et la spécificité. Le présent rapport contient également des informations sur les termes et les définitions, la validation, les modes opératoires de normalisation et les études interlaboratoires effectuées par des organisations internationales (par exemple, AOAC, CEN, ISO, IUPAC, FIL). Les cas des méthodes de confirmation et des méthodes de dépistage sont décrits. Les critères de validation spécifiés relatifs aux mycotoxines en général sont donnés.

Analize živil - Merila za validacijo metod za določanje mikotoksinov v enem laboratoriju

To tehnično poročilo podaja merila za določanje mikotoksinov v enem laboratoriju. Merila in zajete teme so točnost, pravilnost, obnovitev, natančnost, merilna negotovost, selektivnost, uporabnost, linearnost, meje zaznave, meje določanja, občutljivost, robustnost, specifičnost. To poročilo prav tako vsebuje podatke o izrazih in definicijah, potrditvah, postopkih standardizacije in medlaboratorijskih študijah mednarodnih organizacij (npr. AOAC, CEN, ISO, IUPAC, IDF). Opisane so metode potrjevanja in metode pregledovanja. Kriteriji za validacijo, določeni za mikotoksine, so podani na splošno.

General Information

• Status: Published
• Publication Date: 12-Oct-2010
• ICS: 07.100.30 - Food microbiology
• Technical Committee: CEN/TC 275 - Food analysis - Horizontal methods
• Drafting Committee: CEN/TC 275/WG 5 - Biotoxins
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 13-Oct-2010
• Due Date: 17-Jan-2010
• Completion Date: 13-Oct-2010
• Mandate: M/383 - Mandate for standardisation addressed to CEN in the field of Methods of analysis for Mycotoxins in food
• Ref Project: SIST-TP CEN/TR 16059:2011 - Food analysis - Performance criteria for single laboratory validated methods of analysis for the determination of mycotoxins

Relations

• Revised: CR 13505:1999 - Food analysis - Biotoxins - Criteria of analytical methods of mycotoxins
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 16059:2011
01-marec-2011
$QDOL]HåLYLO0HULOD]DYDOLGDFLMRPHWRG]DGRORþDQMHPLNRWRNVLQRYYHQHP
ODERUDWRULMX
Food analysis - Performance criteria for single laboratory validated methods of analysis
for the determination of mycotoxins
Untersuchung von Lebensmitteln - Leistungskriterien für Einzel-labor validierte Verfahren
zur Bestimmung von Mykotoxinen
Analyse des produits alimentaires - Critères de performance des méthodes validées
monolaboratoires d'analyse des mycotoxines
Ta slovenski standard je istoveten z: CEN/TR 16059:2010
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST-TP CEN/TR 16059:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 16059:2011

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SIST-TP CEN/TR 16059:2011


TECHNICAL REPORT
CEN/TR 16059

RAPPORT TECHNIQUE

TECHNISCHER BERICHT
October 2010
ICS 07.100.30
English Version
Food analysis - Performance criteria for single laboratory
validated methods of analysis for the determination of
mycotoxins
Analyse des produits alimentaires - Critères de Untersuchung von Lebensmitteln - Leistungskriterien für
performance des méthodes validées monolaboratoires Einzel-labor validierte Verfahren zur Bestimmung von
d'analyse des mycotoxines Mykotoxinen


This Technical Report was approved by CEN on 19 June 2010. It has been drawn up by the Technical Committee CEN/TC 275.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16059:2010: E
worldwide for CEN national Members.

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SIST-TP CEN/TR 16059:2011
CEN/TR 16059:2010 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Terms and definitions .5
3 General criteria for analytical methods for mycotoxins . 10
4 Specific criteria for analytical methods for mycotoxins . 11
Bibliography . 14

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SIST-TP CEN/TR 16059:2011
CEN/TR 16059:2010 (E)
Foreword
This document (CEN/TR 16059:2010) has been prepared by Technical Committee CEN/TC 275 “Food
analysis - Horizontal methods”, the secretariat of which is held by DIN.
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.
3

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CEN/TR 16059:2010 (E)
Introduction
Within the European Union, regulatory and scientific interest in mycotoxins has undergone a development in
the last decade from autonomous national activity towards more EU-driven activity with a structural and
network character. Harmonized EU limits now exist for several dozens of mycotoxin-food combinations, and
this number will further grow in the coming years. The direct or indirect influence of European organizations
and programmes on the EU mycotoxin regulatory developments has become significant. For example the
position of CEN with regards to mycotoxin regulations has been strengthened as a consequence of the
European Commission’s “Mandate for standardization addressed to CEN in the field of methods of analysis
for mycotoxins in food“ [1]. The new mandate falls within the framework of regulation EC no 882/2004
...