EN ISO 19343-2017 en Microbiology of the food chain - Detection and quantification of histamine in fish and fishery products - HPLC method.pdf

1、Microbiology of the food chain - Detection and quantification of histamine in fish and fishery products - HPLC methodBS EN ISO 19343:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19343 July 2017 ICS 07.10

2、0.30 English Version Microbiology of the food chain - Detection and quantification of histamine in fish and fishery products - HPLC method (ISO 19343:2017) Microbiologie de la chane alimentaire - Dtection et quantification de lhistamine dans le poisson et les produits de la pche - Mthode par CLHP (I

3、SO 19343:2017) Mikrobiologie der Lebensmittelkette - Nachweis und Bestimmung von Histamin in Fisch und Fischereierzeugnissen - HPLC-Methode (ISO 19343:2017) This European Standard was approved by CEN on 8 June 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stip

4、ulate 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

5、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

6、 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania

7、, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form a

8、nd by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19343:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 19343:2017.The UK participation in its preparation was entrusted to Technical Committee AW/9, Microbiology.A list of organizations repres

9、ented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580

10、 85197 1ICS 07.100.30Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STAND

11、ARDBS EN ISO 19343:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19343 July 2017 ICS 07.100.30 English Version Microbiology of the food chain - Detection and quantification of histamine in fish and fishery products - HPLC method (ISO 19343:2017) Microbiologie de la chane alimentaire -

12、 Dtection et quantification de lhistamine dans le poisson et les produits de la pche - Mthode par CLHP (ISO 19343:2017) Mikrobiologie der Lebensmittelkette - Nachweis und Bestimmung von Histamin in Fisch und Fischereierzeugnissen - HPLC-Methode (ISO 19343:2017) This European Standard was approved by

13、 CEN on 8 June 2017. 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

14、 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 notifi

15、ed 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icel

16、and, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENEL

17、EC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19343:2017 EBS EN ISO 19343:2017EN ISO 19343:2017 (E) 2 European foreword This document (EN ISO 19343:2017) has been p

18、repared by Technical Committee ISO/TC 34 “Food products” in collaboration with 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 t

19、ext or by endorsement, at the latest by January 2018 and conflicting national standards shall be withdrawn at the latest by January 2018. 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 identi

20、fying 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 organizations of the following countries are bound to implem

21、ent this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

22、Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19343:2017 has been approved by CEN as EN ISO 19343:2017 without any modification. ISO 19343:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and defini

23、tions . 14 Principle 15 Reagents and materials . 16 Apparatus . 27 Procedure. 37.1 Sample preparation 37.2 Extraction 37.3 Derivatization . 37.4 Purification . 37.5 LC condition . 47.6 Range of standard sample . 48 Calculation 48.1 Calibration line (curve) 48.2 Histamine quantification 59 Precision

24、. 59.1 Interlaboratory study 59.2 Repeatability limit 59.3 Reproducibility limit 5Annex A (informative) Recommendations for HPLC separation . 7Annex B (informative) Performance characteristics of the method 9Bibliography .14 ISO 2017 All rights reserved iiiContents PageBS EN ISO 19343:2017ISO 19343:

25、2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 15 Reagents and materials . 16 Apparatus . 27 Procedure. 37.1 Sample preparation 37.2 Extraction 37.3 Derivatization . 37.4 Purification . 37.5 LC condition . 47.6 Range of standard sample . 48

26、Calculation 48.1 Calibration line (curve) 48.2 Histamine quantification 59 Precision . 59.1 Interlaboratory study 59.2 Repeatability limit 59.3 Reproducibility limit 5Annex A (informative) Recommendations for HPLC separation . 7Annex B (informative) Performance characteristics of the method 9Bibliog

27、raphy .14 ISO 2017 All rights reserved iiiContents PageBS EN ISO 19343:2017ISO 19343:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried o

28、ut through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO c

29、ollaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different ap

30、proval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be

31、the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents

32、).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about I

33、SOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food analysis Horizontal me

34、thods, in collaboration with ISO Technical Committee TC 34, Food products, Subcommittee SC 9, Microbiology, in accordance with the agreement on technical cooperation between ISO and CEN (Vienna Agreement).iv ISO 2017 All rights reservedBS EN ISO 19343:2017ISO 19343:2017(E)ForewordISO (the Internatio

35、nal Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been

36、established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standar

37、dization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordanc

38、e with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details

39、of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an end

40、orsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the followi

41、ng URL: www .iso .org/ iso/ foreword .html.This document was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food analysis Horizontal methods, in collaboration with ISO Technical Committee TC 34, Food products, Subcommittee SC 9, Microbiology, in accordan

42、ce with the agreement on technical cooperation between ISO and CEN (Vienna Agreement).iv ISO 2017 All rights reserved ISO 19343:2017(E)IntroductionHistamine is a causative agent of scombroid poisoning or histamine fish poisoning. Histamine can be present mainly in Scombridae (tuna, mackerel) and Clu

43、peidae (herring, sardine), species which contain a high level of free histidine. Histamine is formed through the decarboxylation of histidine by microbiological histidine decarboxylase.Histamine 2-(1H-imidazol-5-yl)ethanamine is defined as a biologically active low molecular weight basic nitrogenous

44、 molecule. The consumption of food containing significant concentration of histamine can cause symptoms similar to those associated to food allergies.This document was developed in response to the need to standardize a method for histamine detection and quantification in fish and fishery products, i

45、n particular for European Regulation 2073/20051on microbiological criteria for foodstuffs. ISO 2017 All rights reserved vBS EN ISO 19343:2017BS EN ISO 19343:2017Microbiology of the food chain Detection and quantification of histamine in fish and fishery products HPLC methodWARNING Persons using this

46、 document should be familiar with normal laboratory practice. This document does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices.1 ScopeThis document specifies a high perform

47、ance liquid chromatography (HPLC) method to analyse histamine in fish and fishery products (fish sauces, fish maturated by enzyme in brine, etc.) intended for human consumption.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content c

48、onstitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3696, Water for analytical laboratory use Specification and test methods3 Terms and definitions

49、No terms and definitions are listed in this document.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp4 PrincipleThis method enables the separation of histamine among biogenic amines in fish and fishery products. The sample is extracted by mixing with perchloric acid. Precolumn derivatization is performed using dansyl chloride. The biogeni