Foodstuffs - Minimum performance requirements for determination of gluten by ELISA

This document specifies minimum method performance requirements for enzyme-linked immunosorbent assays that quantify non-fragmented or fragmented gluten from wheat (e.g. Triticum aestivum), rye, and barley in raw and processed foodstuffs.
This document is intended to be used in addition to EN 15842.

Lebensmittel - Mindestleistungsanforderungen für die Glutenbestimmung mit ELISA

In diesem Dokument werden Mindestanforderungen an die Verfahrensleistung für Enzym-gekoppelte Immunosorbent-Tests festgelegt, die nicht-fragmentiertes oder fragmentiertes Gluten aus Weizen (z. B. Triticum aestivum), Roggen und Gerste in rohen und verarbeiteten Lebensmitteln quantifizieren.
Dieses Dokument ist für die Verwendung in Ergänzung zu EN 15842 vorgesehen.

Produits alimentaires - Exigences de performances minimales pour la détermination du gluten par une méthode ELISA

Le présent document spécifie les exigences de performances minimales pour les méthodes ELISA permettant de quantifier le gluten de blé (par exemple, Triticum aestivum), de seigle et d’orge non fragmenté ou fragmenté, dans des produits alimentaires crus et transformés.
Le présent document est destiné à être utilisé conjointement avec l’EN 15842.

Živila - Minimalne zahteve za ugotavljanje glutena z metodo ELISA

V tem dokumentu so opredeljene minimalne zahteve glede učinkovitosti encimskih imunosorbentnih testov, ki količinsko opredeljujejo nefragmentiran ali fragmentiran gluten v pšenici (npr. Triticum aestivum), rži in ječmenu v surovih in predelanih živilih.

General Information

Status
Published
Publication Date
01-Oct-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
02-Oct-2019
Completion Date
02-Oct-2019

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SLOVENSKI STANDARD
SIST EN 17254:2019
01-december-2019
Živila - Minimalne zahteve za ugotavljanje glutena z metodo ELISA

Foodstuffs - Minimum performance requirements for determination of gluten by ELISA

Lebensmittel - Minimale Leistungsanforderungen für die Glutenbestimmung mit ELISA

Produits alimentaires - Exigences de performances minimales pour la détermination du

gluten par une méthode ELISA
Ta slovenski standard je istoveten z: EN 17254:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST EN 17254:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 17254:2019
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SIST EN 17254:2019
EN 17254
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 67.050
English Version
Foodstuffs - Minimum performance requirements for
determination of gluten by ELISA

Produits alimentaires - Exigences de performances Lebensmittel - Minimale Leistungsanforderungen für

minimales pour la détermination du gluten par une die Glutenbestimmung mit ELISA
méthode ELISA
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 17254:2019 E

worldwide for CEN national Members.
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SIST EN 17254:2019
EN 17254:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 3

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 General information on the test system.................................................................................................. 7

5 Performance requirements ......................................................................................................................... 7

5.1 General ................................................................................................................................................................ 7

5.2 Applicability range ......................................................................................................................................... 7

5.3 Limit of Detection (LOD) ............................................................................................................................... 7

5.4 Limit of Quantification (LOQ) ..................................................................................................................... 7

5.5 Recovery ............................................................................................................................................................. 8

5.6 Precision ............................................................................................................................................................. 8

5.7 Specificity ........................................................................................................................................................... 8

5.8 Cross-Reactivity ............................................................................................................................................... 8

5.9 Robustness......................................................................................................................................................... 8

5.10 Overview on minimum performance requirements .......................................................................... 8

Bibliography ................................................................................................................................................................. 10

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SIST EN 17254:2019
EN 17254:2019 (E)
European foreword

This document (EN 17254:2019) 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.

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 17254:2019
EN 17254:2019 (E)
Introduction
0.1 Coeliac Disease

Coeliac disease (CD) is an autoimmune disease of the small intestine, primarily affecting genetically

susceptible individuals. Its prevalence has been estimated to be 1 % of the population worldwide. CD

becomes manifest in a chronic enteropathy, caused by an irreversible intolerance for gluten. Upon

ingestion of gluten, the incomplete gastrointestinal digestion of these proteins leads to the appearance

of gluten-derived peptides. It contains overlapping T-cell epitopes, and its deamidated form is a potent

T-cell stimulator. Toxic gluten peptides cause the stimulation of the innate and the adaptive immune

system. This leads to histological changes in the small intestine mucosa of coeliac patients, resulting in

severe symptoms including chronic diarrhoea, abdominal distension, and malabsorption of nutrients.

Coeliac disease, if untreated, is associated with increased morbidity and the only accepted treatment is

a strict and lifelong adherence to a gluten free diet, which interrupts the immune response triggered by

gluten [1].
0.2 Gluten

The definition of gluten slightly differs depending on the context in which it is used. In this document,

the gluten definition (see 3.1) according to the Osborne fractionation is used, similar to the definition

stated in the Codex Alimentarius.

Gluten in starch industry refers to the protein rich fraction that is separated from starch during the

starch production process. The term is therefore applied to different cereals, mainly wheat and corn,

which are predominantly used for starch production. In the baking industry, gluten refers to a protein

rich ingredient, which leads to an increase in volume and “fluffiness” of baking products such as bread.

In this context, only wheat contains gluten since only the protein rich fraction from this cereal leads to

an improvement of the physicochemical properties of baking products. The definition of gluten in the

context of coeliac disease refers to the protein fraction, which is toxic for CD patients. This definition is

based on the Osbourne fractionation of cereal proteins (e.g. from wheat and its crossbred varieties),

precisely the proteins insoluble in water and 0,5 mol/l sodium chloride solution.

Due to thermal processing and enzymatic hydrolysis during food production, gluten in food is often not

present in its native form. The above-mentioned processing can lead to the denaturation and/or to the

fragmentation of gluten proteins into peptides. Gluten peptides have partly different properties in

regards to solubility and detectability by immuno-analytical techniques, but are still able to trigger

immune reactions in coeliac disease patients [2].

Commission Implementing Regulation 828/2014 [3] states that oats contained in foodstuffs for people

intolerant to gluten shall have been specially produced, prepared and/or processed in a way to avoid

contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats

may not exceed 20 mg/kg.
0.3 Regulatory limits

Commission Implementing Regulation (EU) No 828/2014 of the European Union states that there are

two different threshold levels for gluten in foodstuffs.

The term “gluten-free” may be used for food products if the gluten content does not exceed

20 mg gluten/kg. On the other hand, if the gluten content does not exceed 100 mg gluten/kg products

may bear the term “very low gluten”.

Oats can be tolerated by most but not all people who are intolerant to gluten. Therefore, the allowance

of oats that are not contaminated with wheat, rye or barley in foods covered by this standard can be

determined at the national level [4], [5].
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SIST EN 17254:2019
EN 17254:2019 (E)
0.4 Measurement of the gluten content
The gluten concen
...

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