EN 17855:2024
(Main)Foodstuffs - Minimum performance requirements for quantitative measurement of the food allergens milk, egg, peanut, hazelnut, almond, walnut, cashew, pecan nut, brazil nut, pistachio nut, macadamia nut, wheat, lupine, sesame, mustard, soy, celery, fish, molluscs and crustaceans
Foodstuffs - Minimum performance requirements for quantitative measurement of the food allergens milk, egg, peanut, hazelnut, almond, walnut, cashew, pecan nut, brazil nut, pistachio nut, macadamia nut, wheat, lupine, sesame, mustard, soy, celery, fish, molluscs and crustaceans
This document specifies minimum performance requirements for methods that quantify the food allergens milk, egg, peanut, hazelnut, almond, brazil nut, macadamia nut, cashew, pistachio nut, walnut, pecan nut, lupine, sesame, mustard, soy, celery, fish, molluscs, crustaceans, and wheat in raw and processed foodstuffs. Within the scope of this document, minimum requirements for an LOQ (Limit of Quantification) will be derived from threshold data of allergic consumers. For quantitative antibody-based methods, a normative annex will describe what specific information the method developer needs to deliver and how performance characteristics shall be validated. Regarding PCR and LC-MS/MS, information on performance characteristics are in parts covered by EN 15634-1 and EN 17644. This document does not apply to fragmented or hydrolysed food allergens, such as casein hydrolysates or soy sauce. It also does not apply to methods that deliver qualitative results only. Methods that cover gluten-containing cereals (wheat, rye, and barley) with regard to coeliac disease are covered by EN 17254.
Lebensmittel – Mindestleistungsanforderungen für die quantitative Bestimmung der Lebensmittelallergene Milch, Ei, Erdnuss, Haselnuss, Mandel, Walnuss, Cashew, Pekannuss, Paranuss, Pistazie, Macadamianuss, Weizen, Lupine, Sesam, Senf, Soja, Sellerie, Fisch, Mollusken und Krustentiere
Dieses Dokument legt Mindestleistungsanforderungen für Verfahren zur Quantifizierung der Lebensmittelallergene Milch, Ei, Erdnuss, Haselnuss, Mandel, Paranuss, Macadamianuss, Cashew, Pistazie, Walnuss, Pekannuss, Lupine, Sesam, Senf, Soja, Sellerie, Fisch, Weichtiere, Krustentiere und Weizen in rohen und verarbeiteten Lebensmitteln fest. Im Rahmen dieses Dokuments werden die Mindestanforderungen für die Bestimmungsgrenze (LOQ, en: limit of quantification) aus den Schwellenwerten allergischer Verbraucher abgeleitet. Bei quantitativen antikörperbasierten Verfahren wird in einem normativen Anhang beschrieben, welche spezifischen Informationen der Verfahrensentwickler liefern muss und wie die Leistungsmerkmale validiert werden müssen. Für PCR und LC MS/MS sind die Informationen zu den Leistungsmerkmalen zum Teil in EN 15634-1 und EN 17644 enthalten. Dieses Dokument ist nicht anzuwenden für fragmentierte oder hydrolysierte Lebensmittelallergene, wie z. B. Kaseinhydrolysate oder Sojasauce. Es ist auch nicht anzuwenden für Verfahren, die nur qualitative Ergebnisse liefern. Verfahren, die glutenhaltiges Getreide (Weizen, Roggen und Gerste) im Hinblick auf Zöliakie abdecken, werden von EN 17254 abgedeckt.
Produits alimentaires - Performances minimales requises pour la mesure quantitative des allergènes alimentaires du lait, de l’œuf, de l’arachide, de la noisette, de l’amande, de la noix, de la noix de cajou, de la noix de pécan, de la noix du Brésil, de la pistache, de la noix de macadamia, du blé, du lupin, du sésame, de la moutarde, du soja, du céleri, du poisson, des mollusques et des crustacés
Le présent document définit les performances minimales requises pour les méthodes de quantification des allergènes lait, oeuf, arachide, noisette, amande, noix du Brésil, noix de macadamia, noix de cajou, pistache, noix, noix de pécan, lupin, sésame, moutarde, soja, céleri, poisson, mollusques, crustacés et blé dans les denrées alimentaires brutes et transformées. Dans le domaine d’application du présent document, les exigences minimales concernant une LOQ (limite de quantification) sont dérivées des données de seuil des consommateurs allergiques. Pour les méthodes quantitatives basées sur les anticorps, une annexe normative précise les informations spécifiques que le développeur de la méthode doit fournir et la façon dont les caractéristiques de performances doivent être validées. En ce qui concerne les méthodes PCR et CL-SM/SM, les informations relatives aux caractéristiques de performances sont, en partie, couvertes par l’EN 15634-1 et l’EN 17644 . Le présent document ne s’applique pas aux allergènes alimentaires fragmentés ou hydrolysés, tels que les hydrolysats de caséine ou la sauce soja. Il ne s’applique pas non plus aux méthodes qui fournissent uniquement des résultats qualitatifs. Les méthodes destinées aux céréales contenant du gluten (blé, seigle et orge) en ce qui concerne la maladie coeliaque sont couvertes par l’EN 17254.
Živila - Minimalne zahteve za kvantitativno določanje alergenov v živilih: mleko, jajca, arašidi, lešniki, mandlji, orehi, indijski oreščki, pekan orehi, brazilski oreščki, pistacije, makadamijei, pšenica, volčji bob, sezam, gorčica, soja, zelena, ribe, mehkužci in raki
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Živila - Minimalne zahteve za kvantitativno določanje alergenov v živilih: mleko,
jajca, arašidi, lešniki, mandlji, orehi, indijski oreščki, pekan orehi, brazilski oreščki,
pistacije, makadamijei, pšenica, volčji bob, sezam, gorčica, soja, zelena, ribe,
mehkužci in raki
Foodstuffs - Minimum performance requirements for quantitative measurement of the
food allergens milk, egg, peanut, hazelnut, almond, walnut, cashew, pecan nut, brazil
nut, pistachio nut, macadamia nut, wheat, lupine, sesame, mustard, soy, celery, fish,
molluscs and crustaceans
Lebensmittel - Minimal-Leistungsanforderungen für die Bestimmung der
Lebensmittelallergene Milch, Ei, Erdnuss, Haselnuss, Mandel, Walnuss, Cashew,
Pekannuss, Paranuss, Pistazie, Macadamia, Weizen, Lupine, Sesam, Senf, Soja,
Sellerie, Fisch, Weichtiere und Schalentiere
Produits alimentaires - Performances minimales requises pour la mesure quantitative
des allergènes alimentaires lait, oeuf, arachide, noisette, amande, noix, noix de cajou,
noix de pécan, noix du Brésil, pistache, noix de macadamia, blé, lupin, sésame,
moutarde, soja, céleri, poisson, mollusques et crustacés
Ta slovenski standard je istoveten z: EN 17855:2024
ICS:
07.100.30 Mikrobiologija živil Food microbiology
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17855
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 07.100.30; 67.050
English Version
Foodstuffs - Minimum performance requirements for
quantitative measurement of the food allergens milk, egg,
peanut, hazelnut, almond, walnut, cashew, pecan nut,
brazil nut, pistachio nut, macadamia nut, wheat, lupine,
sesame, mustard, soy, celery, fish, molluscs and
crustaceans
Produits alimentaires - Performances minimales Lebensmittel - Mindestleistungsanforderungen für die
requises pour la mesure quantitative des allergènes quantitative Bestimmung der Lebensmittelallergene
alimentaires du lait, de l'œuf, de l'arachide, de la Milch, Ei, Erdnuss, Haselnuss, Mandel, Walnuss,
noisette, de l'amande, de la noix, de la noix de cajou, de Cashew, Pekannuss, Paranuss, Pistazie,
la noix de pécan, de la noix du Brésil, de la pistache, de Macadamianuss, Weizen, Lupine, Sesam, Senf, Soja,
la noix de macadamia, du blé, du lupin, du sésame, de la Sellerie, Fisch, Mollusken und Krustentiere
moutarde, du soja, du céleri, du poisson, des
mollusques et des crustacés
This European Standard was approved by CEN on 8 April 2024.
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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17855:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Deduction of LOQ requirements . 11
5 Minimum performance requirements for allergenic food commodities . 13
Annex A (informative) Quantitative antibody-based methods: Validation of performance
characteristics by method developers . 14
A.1 General information on the test system . 14
A.2 Method validation . 14
A.2.1 General. 14
A.2.2 Incurred samples . 14
A.2.3 Limit of Detection (LOD) . 15
A.2.4 Limit of Quantification (LOQ) . 15
A.2.5 Trueness . 15
A.2.6 Recovery . 15
A.2.7 Precision: RSD , RSD . 16
r R
A.2.8 Specificity . 16
A.2.9 Cross reactivity . 16
A.2.10 Interference . 16
A.2.11 Dilutability of sample extracts . 17
A.2.12 Robustness . 17
A.2.13 Stability . 17
A.2.14 Measurement uncertainty . 17
Bibliography . 18
European foreword
This document (EN 17855:2024) 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 November 2024, and conflicting national standards shall
be withdrawn at the latest by November 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the United
Kingdom.
Introduction
Allergic reaction to food components and legislation
While eating is necessary to sustain life and to enhance the quality of life for most individuals,
some individuals experience adverse, Immunoglobulin E (IgE)-mediated (allergic) reactions to
certain food commodities. The reactions can range from mild symptoms up to life-threatening
anaphylactic shock. As Coeliac disease is not an allergy, there is a separate document for minimum
performance requirements for determination of gluten by ELISA (see EN 17254 [1]).
Allergic consumers react mostly to the proteins found in a food commodity, which always consist of a
mixture of different proteins; for example, milk proteins are composed of α/β/γ/κ-caseins, β-
lactoglobulin, α-lactalbumin and several minor proteins. Allergic consumers react differently to various
proteins from a given commodity. Furthermore, allergenic reactions to food commodities vary among
consumers from different parts of the world, as shown by the corresponding regional food allergen
legislations in Europe, Canada, Australia/New Zealand, the USA or Japan. These legislations are essential
due to the established global food trade, as they ensure the protection of the consumers across the various
regions against exposure to allergenic commodities, regardless of the food’s origin.
While no regulatory limits for allergens in food are established yet, the VITAL (Voluntary Incidental Trace
Allergen Labelling) values act as a common base of understanding and a way to handle results [2]. These
values are absolute amounts of protein from the allergenic commodity below which more than 95 % or
99 % of the susceptible consumers will not react in an adverse way. Since this amount of protein could
occur in any amount of food that will be ingested, the linkage to an analytical result (reported as mass of
−1
total protein of the allergenic food ingredient per mass of food, expressed as mg kg ) is quite challenging.
Measurement of food allergens
It is often advisable to measure one or more major marker proteins that represent a significant part of
the protein content of the food commodity. When the allergenic food commodity is fractionated into more
than one commodity, such as casein and whey in milk, test kit manufacturers often develop systems to
measure the main protein of each fraction.
The amount of an allergenic food commodity in food samples can be quantified by different methods.
While mass spectrometry and nucleic acid-based methods (e.g. PCR, Polymerase chain reaction) can be
applied, the enzyme-linked immunosorbent assay (ELISA) and lateral flow devices (LFD) are the most
commonly used techniques.
The ELISA and LFD use specific monoclonal or polyclonal antibodies targeting epitopes that are specific
for the allergenic food commodity. Currently, sandwich ELISA is generally used to quantify the protein
level by comparing the colour reactions of sample solutions to calibrators. Some ELISA systems require
conversion factors to be applied. These factors are either (i) included in the calibration (when the results
are expressed as “total protein content”) or (ii) require the use of a calibration factor (when the results
refer to the content of specific protein(s), such as caseins in milk). Most LFDs provide qualitative results
in food allergen analysis.
The PCR method aims to detect a specific DNA sequence that codes for a protein in the investigated
commodity. At present, quantifying the numbers of DNA copies from an extracted sample is challenging.
The complexity further increases when estimating the corresponding protein concentrations from
estimated DNA copy numbers due to the lack of certified reference materials. For example, PCR is not
suitable for the detection of DNA in milk and egg due to the extremely low level of specific DNA to be
detected.
In LC-MS (Liquid chromatography mass spectrometry) analysis, proteins are extracted from a sample
and enzymatically digested into peptides. The peptides, including specific marker peptides, undergo
separation by chromatography, followed by fragmentation and quantification by LC-MS. Isotopically
labelled peptides are used as internal standards, while synthetic natural peptides (with well
characterized purity) are used for calibration. The concentration of a single marker peptide is re-
calculated to single proteins applying conversion factors and finally to the total allergenic protein content
for a given allergen. Recently, an LC-MS method for quantification of milk proteins was published that
does not require any conversion factor [3].
While reliable analytical methods are required for compliance with national and international
regulations worldwide, there are no harmonized guidelines available regarding specific requirements on
performance of quantitative methods for food allergenic commodity and regarding specific information
to be provided by the test kit manufacturers. Some guidance is provided by an AOAC publication [4].
...
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