SIST EN 15842:2019
(Main)Foodstuffs - Detection of food allergens - General considerations and validation of methods
Foodstuffs - Detection of food allergens - General considerations and validation of methods
This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Verfahrensvalidierung
Diese Europäische Norm legt fest, wie die Normen zu Immunoassays, auf Nukleinsäuren basierenden und chromatographischen Verfahren anzuwenden sind, und deren Beziehung bei der Analyse von Lebensmittel¬allergenen; sie enthält die allgemeinen Definitionen, Anforderungen an und Leitlinien für die Gestaltung von Laboratorien, Anforderungen an die Verfahrensvalidierung, Beschreibung der Verfahren und Untersu¬chungsberichte.
Das vorliegende Dokument legt außerdem die allgemeinen Leitlinien für die Anforderungen und die Ver-wendung von Referenzmaterialien zur Bestimmung von allergenen Stoffen in Lebensmittelerzeugnissen fest. Der Begriff Referenzmaterial umfasst in diesem Dokument sowohl zertifizierte Referenzmaterialien als auch Qualitätskontrollmaterialien. Derzeit steht nur eine begrenzte Anzahl von Referenzmaterialien für die Bestimmung von Lebensmittelallergenen zur Verfügung. Wenn neue Materialien anerkannt und validiert worden sind, können sie als Anhang zu diesem Dokument hinzugefügt werden.
Das vorliegende Dokument beschäftigt sich nicht mit den Fragen der Probenahme. Es befasst sich lediglich im Einzelnen mit den vom Empfang der Laborprobe bis zum Endergebnis erforderlichen Prozessen.
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes
Le présent document explique comment utiliser les étalons des méthodes basées sur les immunoessais, des méthodes chromatographiques et des méthodes basées sur l’acide nucléique, ainsi que leur relation dans l’analyse des allergènes alimentaires. Il contient également les définitions générales, les exigences et les lignes directrices relatives aux éléments suivants : l’installation du laboratoire, les exigences en matière de validation de la méthode, la description des méthodes et les rapports d’essai.
Le présent document spécifie également des lignes directrices générales relatives aux exigences et à l’utilisation des matériaux de référence pour doser les produits allergènes dans les produits alimentaires. Le terme « matériaux de référence » tel qu’il est utilisé ici englobe les matériaux de référence certifiés ainsi que les matériaux de contrôle de qualité. À ce jour il n’existe qu’un nombre limité de matériaux de référence pour doser les allergènes alimentaires. Dès que de nouveaux matériaux sont acceptés et validés, ils peuvent être ajoutés sous forme d’annexes au présent document.
Le présent document ne traite pas des questions d’échantillonnage. Il détaille simplement les processus en jeu, de la réception de l’échantillon pour laboratoire au résultat final.
Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija metod
Ta dokument določa, kako uporabiti standarde za imunološke teste, nukleinske in kromatografske metode ter njihovo razmerje pri analizi prehranskih alergenov; vsebuje splošne opredelitve, zahteve in smernice za laboratorijsko pripravo, zahteve za validacijo metod, opis metod ter poročila o preskusih.
Ta dokument določa tudi splošne smernice za zahteve in uporabo referenčnih sestavin za določanje alergenih proizvodov v živilih. Izraz »referenčne sestavine« v tem dokumentu vključuje certificirane referenčne sestavine in sestavine za nadzor kakovosti. Trenutno je na voljo le omejeno število referenčnih sestavin za določanje alergenov v živilih. Ko bodo sprejete in potrjene nove sestavine, jih bo mogoče priložiti kot dodatek k temu dokumentu.
Ta dokument ne obravnava vprašanj vzorčenja. Opisuje zgolj postopke od prejema laboratorijskega vzorca do končnega rezultata.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 15842:2019
01-december-2019
Nadomešča:
SIST EN 15842:2010
Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija
metod
Foodstuffs - Detection of food allergens - General considerations and validation of
methods
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und
Verfahrensvalidierung
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales
et validation des méthodes
Ta slovenski standard je istoveten z: EN 15842:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST EN 15842:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 15842:2019
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SIST EN 15842:2019
EN 15842
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 67.050 Supersedes EN 15842:2010
English Version
Foodstuffs - Detection of food allergens - General
considerations and validation of methods
Produits alimentaires - Détection des allergènes Lebensmittel - Nachweis von Lebensmittelallergenen -
alimentaires - Considérations générales et validation Allgemeine Betrachtungen und Verfahrensvalidierung
des méthodes
This European Standard was approved by CEN on 12 August 2019.
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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15842:2019 E
worldwide for CEN national Members.
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EN 15842:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General aspects for methods and reference materials in food allergen analysis . 13
5 Guidance to the user for selection of methods . 14
6 Laboratory organization . 15
7 Procedure. 15
8 Interpretation and expression of the results . 16
9 Test report . 17
Bibliography . 18
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SIST EN 15842:2019
EN 15842:2019 (E)
European foreword
This document (EN 15842:2019) has been prepared by Technical Committee CEN/TC 275 “Food
Analysis - Horizontal Methods”, the secretariat of which is held by DIN.
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 April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
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 15842:2010.
Significant technical changes between this standard and EN 15842:2010 are as follows:
a) documents under normative references removed (2);
b) updated terms and definitions (3);
c) general considerations for methods and reference materials added (4.1);
d) requirements regarding the production and storage of reference materials deleted (4.3);
e) clause on "Quality assurance requirements" deleted;
f) the test report should comply with EN ISO/IEC 17025;
g) updated bibliography.
According to the CEN-CENELEC Internal Regulations, the national standards organisations 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.
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SIST EN 15842:2019
EN 15842:2019 (E)
Introduction
The main focus of this document is on immunoassays, chromatographic and nucleic acid based methods
for the determination of food allergens. However, because of the rapid developments in this area, other
technologies can be considered.
The analysis of food allergens is performed by means of the following successive (or simultaneous)
steps. After sample collection, proteins, nucleic acids or other markers are extracted from the test
portion. Extracted analytes can be further purified, simultaneously or after the extraction process.
Afterwards, they are diluted (if necessary) and subjected to analytical procedures such as
immunoassays (e.g. ELISA), nucleic acid based assays (e.g. PCR) or chromatographic (e.g. LC-MS).
These steps are detailed in this document and in the following documents:
EN 15633-1, Foodstuffs — Detection of food allergens by immunological methods — Part 1: General
considerations
EN 15634-1, Foodstuffs — Detection of food allergens by molecular biological methods — Part 1: General
considerations
For the use of this document the term:
— ‘shall’ indicates a requirement;
— ‘should’ indicates a recommendation;
— ‘may’ indicates a permission; and
— ‘can’ indicates a possibility and/or a capability.
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EN 15842:2019 (E)
1 Scope
This document specifies how to use the standards for immunoassays, nucleic based and
chromatographic methods and their relationship in the analysis of food allergens; and contains general
definitions, requirements and guidelines for laboratory set-up, method validation requirements,
description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for
the determination of allergenic commodities in food products. The term “reference materials” in this
document includes certified reference materials as well as quality control materials. Currently only a
limited number of reference materials for food allergen determination are available. As new materials
become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of
the laboratory sample to the end result.
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
3.1 Method performance characteristics
3.1.1
fitness for purpose
degree to which data produced by a measurement process enables a user to make technically and
administratively correct decisions for a stated purpose
Note 1 to entry: The measurement process can be based on a screening method, a confirmatory method or a
reference method.
Note 2 to entry: For further information refer to [10].
3.1.2
screening method
method that will rapidly and reliably eliminate (screen) a large number of negative (or positive) test
samples and restrict the number of test samples requiring the application of a rigorous method
Note 1 to entry: See [11].
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3.1.3
practicability
ease of operations, in terms of sample throughput and costs, to achieve the required performance
criteria and thereby meet the specified purpose
[SOURCE: EN ISO 24276:2006+A1:2013, 3.1.22]
3.1.4
selectivity
extent to which a method can determine particular analyte(s) in mixtures or matrices without
interferences from other components
Note 1 to entry: See [12].
3.1.5
sensitivity
change in the response divided by the corresponding change in the concentration of a standard
(calibration) curve
Note 1 to entry: See [12].
3.1.6
specificity
property of a method to respond exclusively to the characteristic or analyte under investigation
Note 1 to entry: See [12].
3.1.7
linearity
ability to elicit test results that are directly, or by means of well defined, mathematical transformations,
proportional to the concentration of analyte in samples within a given range
Note 1 to entry: For further information refer to [12].
3.1.8
applicability range
interval of quantity values within which the analytical procedure has been demonstrated by
collaborative trial or other appropriate validation to have a suitable level of precision and accuracy
3.1.9
limit of detection
LOD
minimum amount or concentration of the analyte in test sample which can be detected reliably but not
necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation
3.1.10
limit of quantitation
limit of determination
LOQ
lowest concentration or amount of the analyte in a test sample which can be quantitatively determined
with an acceptable level of precision and accuracy, as demonstrated by collaborative trial or other
appropriate validation
Note 1 to entry: For further information refer to [13].
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3.1.11
precision
closeness of agreement between independent test/measurement results obtained under stipulated
conditions
Note 1 to entry: Precision depends only on the distribution of random errors and does not relate to the true
value or the specified value.
Note 2 to entry: The measure of precision is usually expressed in terms of imprecision and computed as
standard deviation of the test results or measurements results. Less precision is reflected by a larger standard
deviation.
Note 3 to entry: Quantitative measures of precision depend critically on the stipulated conditions. Repeatability
conditions and reproducibility conditions are particular sets of extreme stipulated conditions.
[SOURCE: ISO 3534-2:2006, 3.3.4]
3.1.12 Repeatability related terms
3.1.12.1
repeatability
precision under repeatability conditions
Note 1 to entry: Repeatability can be expressed quantitatively in terms of the dispersion characteristics of the
results.
[SOURCE: ISO 3534-2:2006, 3.3.5]
3.1.12.2
repeatability conditions
observation conditions where independent test/measurement results are obtained with the same
method on identical test/measurement items in the same test or measuring facility by the same
operator using the same equipment within short intervals of time
Note 1 to entry: Repeatability conditions include:
— the same measurement procedure or test procedure;
— the same operator;
— the same measuring or test equipment used under the same conditions;
— the same location;
— repetition over a short period of time.
[SOURCE: ISO 3534-2:2006, 3.3.6]
3.1.12.3
repeatability limit
r
repeatability critical difference for a specified probability of 95 %
[SOURCE: ISO 3534-2:2006, 3.3.9]
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3.1.12.4
repeatability standard deviation
standard deviation of test results or measurement results obtained under repeatability conditions
Note 1 to entry: It is a measure of the dispersion of the distribution of test or measurement results under
repeatability conditions.
Note 2 to entry: Similarly “repeatability variance” and “repeatability coefficient of variation” can be defined and
used as measures of the dispersion of test or measurement results under repeatability conditions.
[SOURCE: ISO 3534-2:2006, 3.3.7]
3.1.13
collaborative study
interlaboratory study in which each laboratory uses a defined method of analysis to analyse identical
portions of homogenous material to assess the performance characteristics obtained for the method of
analysis
Note 1 to entry: Guidelines for performing collaborative trials are elaborated in ISO 5725-1 [3] and in IUPAC
harmonized protocol 1995 [14].
3.1.14 Reproducibility related terms
3.1.14.1
reproducibility
precision under reproducibility conditions
Note 1 to entry: Reproducibility can be expressed quantitatively in terms of the dispersion characteristics of the
results.
Note 2 to entry: Results are usually understood to be corrected results.
[SOURCE: ISO 3534-2:2006, 3.3.10]
3.1.14.2
reproducibility conditions
observation conditions where independent test/measurement results are obtained with the same
method on identical test/measurement items in different test or measurement facilities by different
operators using different equipment
[SOURCE: ISO 3534-2:2006, 3.3.11]
3.1.14.3
reproducibility limit
R
reproducibility critical difference for a specified probability of 95 %
[SOURCE: ISO 3534-2:2006, 3.3.14]
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3.1.14.4
reproducibility standard deviation
standard deviation of test results or measurement results obtained under reproducibility conditions
Note 1 to entry: It is a measure of the dispersion of the distribution of test or measurement results under
reproducibility conditions.
Note 2 to entry: Similarly, “reproducibility variance” and “reproducibility coefficient of variation” can be
defined and used as measures of the dispersion of test or measurement results under reproducibility conditions.
[SOURCE: ISO 3534-2:2006, 3.3.12]
3.1.15
recovery
proportion of the amount of analyte, present in or added to the analytical portion of the test material,
which is extracted and determined for measurement
Note 1 to entry: See [15].
3.1.16
metrological traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty
[SOURCE: JCGM 200:2012, 2.41, modified — notes were removed]
3.1.17
trueness
closeness of agreement between the expectation of a test result or a measurement result and a true
value
Note 1 to entry: The measurement of trueness is usually expressed in terms of bias.
Note 2 to entry: Trueness is sometimes referred to as “accuracy of the mean”. This usage is not recommended.
Note 3 to entry: In practice, the accepted reference value is substituted for the true value.
[SOURCE: ISO 3534-2:2006, 3.3.3]
3.1.18
accuracy
closeness of agreement between a test result or measurement result and the true value
Note 1 to entry: In practice, the accepted reference value is substituted for the true value.
Note 2 to entry: The term “accuracy”, when applied to a set of test or measurement results, involves a
combination of random components and a common systematic error or a bias component.
Note 3 to entry: Accuracy refers to a combination of trueness and precision.
[SOURCE: ISO 3534-2:2006, 3.3.1]
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3.1.19
bias
difference between the expectation of a test result or measurement result and a true value
Note 1 to entry: Bias is the total systematic error as contrasted to random error. There could be one or more
systematic error components contributing to the bias. A larger systematic difference from the true value is
reflected by a larger bias value.
Note 2 to entry: The bias of a measuring instrument is normally estimated by averaging the error of indication
over an appropriate number of repeated measurements. The error of indication is the: “indication of a measuring
instrument minus a true value of the corresponding input quantity”.
[SOURCE: ISO 3534-2:2006, 3.3.2, modified — note 3 was removed]
3.1.20
robustness
ruggedness
measure of the capacity of an analytical procedure to remain unaffected by small variations in method
parameters and provides an indication of the method’s reliability during normal usage
[SOURCE: ISO 16577:2016, 3.184]
3.2 Sample and material related terms
3.2.1
matrix
components of the sample other than the analyte of interest
Note 1 to entry: Each matrix has generally a common name that permits classification.
3.2.2
laboratory sample
sample as prepared for sending to the laboratory and intended for inspection or testing
[SOURCE: ISO 78-2:1999, 3.1]
3.2.3
test sample
sample prepared from the laboratory sample and from which test portions will be taken
[SOURCE: ISO 78-2:1999, 3.2]
3.2.4
test portion
the quantity of material drawn from the test sample (or from the laboratory sample if both are the
same) and on which the test or observation is actually carried out
[SOURCE: ISO 78-2:1999, 3.3]
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