kSIST FprEN 17855:2024

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 - 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

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 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

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 (ameriški) orehi, brazilski orehi, pistacije, makadamij, pšenica, volčji bob, sezam, gorčica, soja, zelena, ribe, mehkužci in raki

General Information

• Status: Not Published
• Public Enquiry End Date: 08-Sep-2022
• ICS: 07.100.30 - Food microbiology
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 24-Jan-2024
• Due Date: 13-Mar-2024
• Ref Project: FprEN 17855 - 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

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 17855:2022
01-september-2022
Živila - Minimalne zahteve za kvantitativno merjenje alergenov v živilih: mleko,
jajca, arašidi, lešniki, mandlji, orehi, indijski oreščki, pekan (ameriški) orehi,
brazilski orehi, pistacije, makadamij, 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: prEN 17855
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
oSIST prEN 17855:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17855:2022


DRAFT
EUROPEAN STANDARD
prEN 17855
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2022
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 - Minimal Leistungsanforderungen für
requises pour la mesure quantitative des allergènes die Bestimmung der Lebensmittelallergene Milch, Ei,
alimentaires du lait, ¿uf, arachide, noisette, amande, Erdnuss, Haselnuss, Mandel, Walnuss, Cashew,
noix, noix de cajou, noix de pécan, noix du Brésil, Pekannuss, Paranuss, Pistazie, Macadamia, Weizen,
pistache, noix de macadamia, blé, lupin, sésame Lupine, Sesam, Senf, Soja, Sellerie, Fisch, Weichtiere
und Schalentiere
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 275.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17855:2022 E
worldwide for CEN national Members.

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oSIST prEN 17855:2022
prEN 17855:2022 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope .
...