EN ISO 21570-2005 en Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (Incorporat.pdf

1、BRITISH STANDARDBS EN ISO 21570:2005Incorporating corrigendum no. 1Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Quantitative nucleic acid based methodsThe European Standard EN ISO 21570:2005 has the status of a BritishStandardICS 67.050 BS E

2、N ISO +A1:2013Incorporating corrigendum no. 1BS EN ISO 21570:2005+A1:2013ISBN 978 0 580 76308 3Amendments/corrigenda issued since publicationAmd. No. Date Comments17383 Corrigendum No. 131 October 2007 See national foreword30 June 2013 Implementation of ISO amendment 1:2013 with CEN endorsement A1:2

3、013This British Standard was published under the authority of the Standards Policy and Strategy Committee on 23 January 2006 The British Standards Institution 2013. Published by BSI Standards Limited 2013National forewordThis British Standard is the UK implementation of EN ISO 21570:2005+A1:2013, in

4、corporating corrigendum February 2007. It is identical to ISO 21570:2005, incorporating amendment 1 and corrigendum December 2006. It supersedes BS EN ISO 21570:2005, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating

5、changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by .The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by ISO corrigendum December 2006 is indicated in the text by .The

6、UK participation in its preparation was entrusted to Technical Committee AW/275, Food analysis Horizontal methods.A list of organizations represented on this committee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract.

7、Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21570November 2005ICS 67.050English VersionFoodstuffs - Methods of analysis for the detection of geneticallymodifie

8、d organisms and derived products - Quantitative nucleicacid based methods (ISO 21570:2005)Produits alimentaires - Mthodes danalyse pour ladtection des organismes gntiquement modifis et desproduits drivs - Mthodes quantitatives bases surlutilisation des acides nucliques (ISO 21570:2005)Lebensmittel -

9、 Verfahren zum Nachweis von gentechnischmodifizierten Organismen und ihren Produkten -Quantitative auf Nukleinsuren basierende Verfahren (ISO21570:2005)This European Standard was approved by CEN on 26 October 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

10、ate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists

11、 in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies o

12、f Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDA

13、RDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21570:2005: EIncorporating corrigendum February 2007

14、EN ISO 21570:2005+A1April 2013Foreword This document (EN ISO 21570:2005) has been prepared by TechnicalCommittee CEN/TC 275 “Foodanalysis- Horizontal methods“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 34 “Agricultural food products“.This European Stan

15、dard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by May 2006, and conflicting national standardsshall be withdrawn atthe latest by May 2006.Accordingto theCEN/CENELEC Internal Regulations,the national standardsorganizat

16、ionsofthe following countries are bound to implement this European Standard: Austria,Belgium, Cyprus, Czech Republic,Denmark, Estonia, Finland,France,Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,Luxembourg, Malta, Netherlands,Norway, Poland, Portugal, Slovakia, Slovenia, Spain

17、, Sweden, Switzerlandand United Kingdom.EN ISO 21570:2005Foreword This document (EN ISO 21570:2005) has been prepared by TechnicalCommittee CEN/TC 275 “Foodanalysis- Horizontal methods“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 34 “Agricultural food p

18、roducts“.This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by May 2006, and conflicting national standardsshall be withdrawn atthe latest by May 2006.Accordingto theCEN/CENELEC Internal Regulations,the

19、national standardsorganizationsofthe following countries are bound to implement this European Standard: Austria,Belgium, Cyprus, Czech Republic,Denmark, Estonia, Finland,France,Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,Luxembourg, Malta, Netherlands,Norway, Poland, Portugal

20、, Slovakia, Slovenia, Spain, Sweden, Switzerlandand United Kingdom.EN ISO 21570:2005BS EN ISO 21570:2005+A1:2013EN ISO 21570:2005+A1:2013EN ISO 21570:2005/A1:2013 (E) 3 Foreword This document (EN ISO 21570:2005/A1:2013) has been prepared by Technical Committee ISO/TC 34 “Food products“ in collaborat

21、ion with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 21570:2005 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the lates

22、t by October 2013, and conflicting national standards shall be withdrawn at the latest by October 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all su

23、ch patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Mace

24、donia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21570:2005/Amd 1:2013 has been app

25、roved by CEN as EN ISO 21570:2005/A1:2013 without any modification. Foreword to amendment 1iiiContents PageForeword. vIntroduction. vi1Scope . 12Normative references. 13Terms and definitions. 14Principle. 24.1 General. 24.2 Amplification, detection and confirmation of PCR products. 24.3 Quantitation

26、 of PCR products. 25Reagents26Apparatus and equipment. 27Guidelines concerning the procedure 37.1 General. 37.2 Target sequence stability. 37.3 Calibration of the analysis. 37.4 Quantitation considerations 37.5 Quality assurance requirements. 38Interpretation. 49Expression of results. 410 Test repor

27、t.5Annex A (informative) Target taxon-specific methods. 6A.1Target taxon-specific method for the absolute quantitation of the adh1 gene DNA of maize using real-time PCR. 6Annex B (informative) Screening methods 12B.1 Screening method for the relative quantitation of the 35S-promoterDNA of soya bean

28、lineGTS 40-3-2 using real-time PCR12Annex C (informative) Construct-specific methods . 20C.1 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA usingreal-time PCR (Method 1). 20C.2 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA usingreal-

29、time PCR (Method 2). 27C.3 Construct-specific method for the quantitation of Event176 maize DNA using real-timePCR. 34C.4Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA usingreal-time PCR 41C.5Construct-specific method for the quantitation of maize line MON 810 DNA us

30、ingreal-time PCR 49C.6Construct-specific method for the quantitation of maize line Event176 DNA using real-time PCR 56C.7Construct-specific method for the quantitation of maize line Bt11 DNA using real-timePCR. 63EN ISO 21570:2005iiiContents PageForeword. vIntroduction. vi1Scope . 12Normative refere

31、nces. 13Terms and definitions. 14Principle. 24.1 General. 24.2 Amplification, detection and confirmation of PCR products. 24.3 Quantitation of PCR products. 25Reagents26Apparatus and equipment. 27Guidelines concerning the procedure 37.1 General. 37.2 Target sequence stability. 37.3 Calibration of th

32、e analysis. 37.4 Quantitation considerations 37.5 Quality assurance requirements. 38Interpretation. 49Expression of results. 410 Test report.5Annex A (informative) Target taxon-specific methods. 6A.1Target taxon-specific method for the absolute quantitation of the adh1 gene DNA of maize using real-t

33、ime PCR. 6nnex B (infor ative) Screening methods 12B.1 Screening method for the relative quantitation of the 35S-promoterDNA of soya bean lineGTS 40-3-2 using real-time PCR12nnex C (infor ative) Construct-specific methods . 20C.1 Construct-specific method for the quantitation of soya bean line GTS 4

34、0-3-2 DNA usingreal-time PCR (Method 1). 20C.2 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA usingreal-time PCR (Method 2). 27C.3 Construct-specific method for the quantitation of Event176 maize DNA using real-timePCR. 34C.4Construct-specific method for the quantita

35、tion of soya bean line GTS 40-3-2 DNA usingreal-time PCR 41C.5Construct-specific method for the quantitation of maize line MON 810 DNA usingreal-time PCR 49C.6Construct-specific method for the quantitation of maize line Event176 DNA using real-time PCR 56C.7Construct-specific method for the quantita

36、tion of maize line Bt11 DNA using real-timePCR. 63EN ISO 21570:2005BS EN ISO 21570:2005+A1:2013ISO 21570:2005+A1:2013iA.2 Target-taxon-specific method for the detection of DNA derived from rice .A.3 Target-taxon-specific method for the detection of components derived from tomato (Lycopersicon excule

37、ntum 191iiiiv2122626343441485563iv C.8 Construct-specific method for the quantitation of maize line GA21DNA using real-timePCR.71C.9Construct-specific method for the quantitation of maize line T25 DNA using real-time PCR78Annex D (informative) Event-specific methods.87D.1 Event-specific method for t

38、he absolute and relative quantitation of maize line Bt11 DNAbased on real-time PCR87D.2Event-specific method for the relative quantitation of maize line MON 810 DNAusing real-time PCR.93Bibliography.100EN ISO 21570:2005iiiContents PageForeword. vIntroduction. vi1Scope . 12Normative references. 13Ter

39、ms and definitions. 14Principle. 24.1 General. 24.2 Amplification, detection and confirmation of PCR products. 24.3 Quantitation of PCR products. 25Reagents26Apparatus and equipment. 27Guidelines concerning the procedure 37.1 General. 37.2 Target sequence stability. 37.3 Calibration of the analysis.

40、 37.4 Quantitation considerations 37.5 Quality assurance requirements. 38Interpretation. 49Expression of results. 410 Test report.5Annex A (informative) Target taxon-specific methods. 6A.1Target taxon-specific method for the absolute quantitation of the adh1 gene DNA of maize using real-time PCR. 6A

41、nnex B (informative) Screening methods 12B.1 Screening method for the relative quantitation of the 35S-promoterDNA of soya bean lineGTS 40-3-2 using real-time PCR12Annex C (informative) Construct-specific methods . 20C.1 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA

42、 usingreal-time PCR (Method 1). 20C.2 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA usingreal-time PCR (Method 2). 27C.3 Construct-specific method for the quantitation of Event176 maize DNA using real-timePCR. 34C.4Construct-specific method for the quantitation of s

43、oya bean line GTS 40-3-2 DNA usingreal-time PCR 41C.5Construct-specific method for the quantitation of maize line MON 810 DNA usingreal-time PCR 49C.6Construct-specific method for the quantitation of maize line Event176 DNA using real-time PCR 56C.7Construct-specific method for the quantitation of m

44、aize line Bt11 DNA using real-timePCR. 63EN ISO 21570:2005BS EN ISO 21570:2005+A1:2013ISO 21570:2005+A1:2013ii70778592114107101101vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inter

45、national Standards is normally carried out through ISO technical committees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with

46、ISO, also take part in the work. ISO collaborates closelywith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical co

47、mmittees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval byat least 75 % of the member bodies casting a vote. Attention is drawn to the p

48、ossibility 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. ISO21570 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food Analysis Horizont

49、al methods, in collaboration with Technical Committee ISO/TC34, Food products, in accordance with the Agreement on technical cooperation between ISO and CEN (ViennaAgreement).EN ISO 21570:2005BS EN ISO 21570:2005+A1:2013ISO 21570:2005+A1:2013iii vi Introduction The search for ingredients of genetically modified origin is performed by means of th