CEN/TS 17455:2020
(Main)Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of mycotoxins
This document specifies performance criteria for the selection of single-laboratory validated or collaborative study validated methods of analysis of mycotoxins in feed. The terms and definition of the relevant parameters for method validation are included. The performance requirements and characteristics are provided. This document could serve as a guide:
- to assess the quality of new European Standard methods under validation;
- to review the quality of previous collaborative trials;
- to confirm the extension of the scope of an already published European Standard applied to other analyte concentrations or matrices; or
- to evaluate the fitness-for-purpose of single-validated methods.
The performance criteria can apply to methods dedicated to the determination of mycotoxins.
Futtermittel - Probenahme- und Untersuchungsverfahren - Leistungskriterien für laborintern validierte und im Ringversuch validierte Analysemethoden zur Bestimmung von Mykotoxinen
Dieses Dokument legt Leistungskriterien für die Auswahl von in Einzellaboratorien validierten oder in Laborvergleichsuntersuchungen validierten Analyseverfahren für Mykotoxine in Futtermitteln fest. Enthalten sind die Begriffe der relevanten Parameter für die Verfahrensvalidierung. Die Leistungsanforderungen und merkmale werden zur Verfügung gestellt. Dieses Dokument könnte als Orientierung dienen für:
- die Beurteilung der Qualität neuer Europäischer Normverfahren während ihrer Validierung;
- die Überprüfung der Qualität vorangegangener Laborvergleichsuntersuchungen;
- die Bestätigung der Erweiterung des Anwendungsbereichs einer bereits veröffentlichten Europäischen Norm, die für andere Analytkonzentrationen oder Matrices angewendet wurde; oder
- die Evaluierung der Gebrauchseignung einfach validierter Verfahren.
Die Leistungskriterien können auf Verfahren zur Bestimmung von Mykotoxinen anwendbar sein.
Aliments des animaux - Méthodes d'échantillonnage et d'analyse - Critères de performance des méthodes d'analyse des mycotoxines validées dans un seul laboratoire ou suite à un essai interlaboratoires
Le présent document spécifie les critères de performance pour la sélection de méthodes d’analyse des mycotoxines dans les aliments pour animaux validées dans un seul laboratoire ou suite à une étude collaborative. Il inclut les termes et définitions des paramètres pertinents pour la validation de la méthode. Il fournit également les exigences et caractéristiques de performance. Le présent document pourrait servir de guide :
- pour évaluer la qualité des nouvelles méthodes de Normes européennes en cours de validation ;
- pour examiner la qualité d’essais interlaboratoires antérieurs ;
- pour confirmer l’extension du domaine d’application d’une Norme européenne déjà publiée, appliquée à d’autres concentrations d’analyte ou matrices ; ou
- pour évaluer l’adéquation à l’objectif de méthodes validées individuellement.
Les critères de performance peuvent s’appliquer aux méthodes dédiées à la détermination des mycotoxines.
Krma - Metode vzorčenja in analize - Izvedbena merila za validacijo metod v posameznem laboratoriju in v primerjalnem preskusu analiz za določanje mikotoksinov
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2020
Krma - Metode vzorčenja in analize - Izvedbena merila za validacijo metod v
posameznem laboratoriju in v primerjalnem preskusu analiz za določanje
mikotoksinov
Animal feeding stuffs - Methods of sampling and analysis - Performance criteria for
single laboratory validated and ring-trial validated methods of analysis for the
determination of mycotoxins
Futtermittel - Probenahme und Untersuchungsverfahren - Leistungskriterien für
laborintern validierte und im Ringversuch validierte Analysemethoden zur Bestimmung
von Mykotoxinen
Aliments des animaux - Méthodes d'échantillonnage et d'analyse - Critères de
performance des méthodes d'analyse des mycotoxines validées dans un seul laboratoire
ou suite à un essai interlaboratoires
Ta slovenski standard je istoveten z: CEN/TS 17455:2020
ICS:
65.120 Krmila Animal feeding stuffs
71.040.50 Fizikalnokemijske analitske Physicochemical methods of
metode analysis
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TS 17455
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
April 2020
TECHNISCHE SPEZIFIKATION
ICS 65.120; 71.040; 71.040.50
English Version
Animal feeding stuffs - Methods of sampling and analysis -
Performance criteria for single laboratory validated and
ring-trial validated methods of analysis for the
determination of mycotoxins
Aliments des animaux - Méthodes d'échantillonnage et Futtermittel - Probenahme und
d'analyse - Critères de performance des méthodes Untersuchungsverfahren - Leistungskriterien für
d'analyse des mycotoxines validées dans un seul laborintern validierte und im Ringversuch validierte
laboratoire ou suite à un essai interlaboratoires Analysemethoden zur Bestimmung von Mykotoxinen
This Technical Specification (CEN/TS) was approved by CEN on 27 January 2020 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17455:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Relation to other technical document definitions or concepts . 14
4.1 Reporting of sum parameters . 14
4.2 Requirements for multi-mycotoxin methods . 14
4.3 Identification criteria . 14
4.4 Limit of quantification (determination) and limit of detection . 14
5 Performance criteria for analytical methods for mycotoxins . 15
5.1 General criteria for methods of analysis for mycotoxins . 15
5.1.1 Overall concepts . 15
5.1.2 Screening methods for mycotoxins . 15
5.1.3 Confirmatory methods for mycotoxins . 15
5.2 Performance characteristics . 16
5.2.1 General . 16
5.2.2 Recovery . 16
5.2.3 RSD . 17
R
5.2.4 RSD . 19
r
5.2.5 RSD . 20
Ri
5.2.6 Limit of quantification . 20
5.2.7 Minimum applicability range . 21
Bibliography . 22
European foreword
This document (CEN/TS 17455:2020) has been prepared by Technical Committee CEN/TC 327
“Animal feeding stuffs - Methods of sampling and analysis”, the secretariat of which is held by NEN.
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 has been prepared under a mandate given to CEN by the European Commission and
the European Free Trade Association.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to announce this Technical Specification: 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.
Introduction
The European Committee for Standardization (CEN) selects and elaborates methods of analysis for
organic contaminants that are to become European Standards. These standards can be used for those
contaminants that are subject to regulation. When used for this purpose, the main functions of a
standard are to enable feed manufacturers to determine with reasonable certainty whether a
consignment may be put on the market and to enable regulatory authorities to determine equitably
whether feedstuffs on the market comply with legal or recommended limits.
CEN/TC 327/working group (WG) 5 decided to establish a criteria guide in order to allow
benchmarking of methods of analysis for their fitness for purpose [1]. The performance criteria laid
down therein are based on published data, collected from official reports on inter-laboratory studies
[2] to [12].
Where performance characteristics are absent or limited in availability, the criteria were estimated
based on the experiences and opinions of the experts of the CEN working group. The selection criteria
could need updating in future revisions of this document, if newer or more accurate data on method
performance characteristics become available. This document lists relevant performance parameters
and gives information on their definition. It further describes how they can be practically obtained; it
indicates guidance values demonstrating fitness for purpose. As a result, these guidance values serve
as a benchmark for experienced analytical laboratories.
This document may contain useful information for CEN members, the European Commission, the
EFTA secretariat, other governmental agencies or outside bodies. The criteria in this CEN report are
used as guidance in the CEN/TC 327/WG 5. In general, method performance criteria are generated
for collaborative trials or for single laboratory validation (SLV) studies. The first case describes how a
method performs when used by several laboratories, giving greater confidence that the method is
applicable and can be implemented with the obtained method performance. The second case only
demonstrates how a method performs in a particular laboratory. As a result, SLV should be
conducted with care to avoid misinterpretation. This is important as reproducibility (between
laboratory variance) can only be derived from collaborative trials. Furthermore, performance
parameters such as limit of detection (LOD) and limit of quantification (LOQ) are laboratory specific
as the quantitative measurement capability strongly depends on the instrumental conditions used by
each laboratory.
This document relates to current EU legislation concerning performance requirements of analytical
methods for mycotoxins in food and feed chain, such as Regulation (EC) No 2017/625 on official
controls performed to ensure the verification of compliance with feed and food law, animal health
and animal welfare rules [13] as well as Regulation (EC) No 401/2006 laying down the methods of
sampling and analysis for the official control of the levels of mycotoxins in foodstuffs [14]. The latter
is specific for food, however as recent legislation on some mycotoxins does not specify the intended
final use, either food or feed, rather the raw commodity (Commission Recommendation
2013/165/EU on the presence of T-2 and HT-2 toxin in cereals and cereal products) performance
requirements for analytical methods are in the future anticipated to be equivalent independent of the
commodities' destination purpose.
Further this criteria approach document also relates to pre-existing documents such as the ISO 5725-
series, CR 13505 [15] and CEN/TR 16059 [16].
1 Scope
This document specifies performance criteria for the selection of single-laboratory validated or
collaborative study validated methods of analysis of mycotoxins in feed. The terms and definition of
the relevant parameters for method validation are included. The performance requirements and
characteristics are provided. This document could serve as a guide:
— to assess the quality of new European Standard methods under validation;
— to review the quality of previous collaborative trials;
— to confirm the extension of the scope of an already published European Standard applied to
other analyte concentrations or matrices; or
— to evaluate the fitness-for-purpose of single-validated methods.
The performance criteria can apply to methods dedicated to the determination of mycotoxins.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp/ui
3.1
accuracy
closeness of agreement between a test result and the accepted reference value
Note 1 to entry: The term accuracy, when applied to a set of test results, involves a combination of random
components and a common systematic error or bias component.
Note 2 to entry: It is assessed by determining trueness and precision.
[SOURCE: ISO 5725-1:1994, 3.6, see [17], modified; 2002/657/EEC, see [18], modified]
3.2
applicability
scope of the analytical method; description of the analytes, matrices, and concentration ranges (mass
fractions) for which a method of analysis can be used satisfactorily to determine compliance with a
given standard (i.e. CEN, ISO, CODEX)
Note 1 to entry: In addition to a statement of the range of capability of satisfactory performance for each
factor, the statement of applicability (scope) also includes warnings as to known interference by other analytes,
or inapplicability to certain matrices and situations.
3.3
bias
difference between the expectation of the test results (x) and an accepted reference value (x )
ref
Note 1 to entry: The bias can be expressed in absolute or relative terms (b or b(%)
...
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