DIN EN ISO 21570-2013 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570.pdf

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1、August 2013 Translation by DIN-Sprachendienst.English price group 33No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS

2、 67.050!%($Q“2050146www.din.deDDIN EN ISO 21570Foodstuffs Methods of analysis for the detection of genetically modified organismsand derived products Quantitative nucleic acid based methods(ISO 21570:2005 + Cor 1:2006 + Amd 1:2013);English version EN ISO 21570:2005 + AC:2007 + A1:2013,English transl

3、ation of DIN EN ISO 21570:2013-08Lebensmittel Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihrenProdukten Quantitative auf Nukleinsuren basierende Verfahren(ISO 21570:2005 + Cor 1:2006 + Amd 1:2013);Englische Fassung EN ISO 21570:2005 + AC:2007 + A1:2013,Englische bersetzung

4、von DIN EN ISO 21570:2013-08Produits alimentaires Mthodes danalyse pour la dtection des organismes gntiquement modifis et desproduits drivs Mthodes quantitatives bases sur lutilisation des acides nucliques(ISO 21570:2005 + Cor 1:2006 + Amd 1:2013);Version anglaise EN ISO 21570:2005 + AC:2007 + A1:20

5、13,Traduction anglaise de DIN EN ISO 21570:2013-08SupersedesDIN EN ISO 21570:2006-02 andDIN EN ISO 21570 www.beuth.deDocument comprises 127 pages In case of doubt, the German-language original shall be considered authoritative.Corrigendum 1:2007-0608.13 DIN EN ISO 21570:2013-08 2 A comma is used as

6、the decimal marker. National foreword This document (EN ISO 21570:2005 + A1:2013) has been prepared by Technical Committee ISO/TC 34 “Food products”, Subcommittee SC 16 “Horizontal methods for molecular biomarker analysis” in collaboration with Technical Committee CEN/TC 275 “Food analysis Horizonta

7、l methods” (Secretariat: DIN, Germany), Working Group WG 11 “Genetically modified foodstuffs”, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). The responsible German body involved in its preparation was the Normenausschuss Lebensmittel und landwirtsc

8、haftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-01-04 AA Gentechnisch modifizierte Lebensmittel. This standard includes Amendment A1 approved by CEN on 2013-04-11. The start and finish of text introduced or altered by amendment is indicated in the te

9、xt by tags !“. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 21569 DIN EN ISO 21569 ISO 21571 DIN EN ISO 21571 ISO 24276 DIN EN ISO 24276 Amendments This standard differs from DIN EN ISO 21570:2006-02 and DIN EN ISO 21570

10、Corrigendum 1:2007-06 as follows: a) the reference to ISO 24276:2006 has been updated; b) Clause 8 “Interpretation” has been reformulated (in particular the interpretation of ambiguous results); c) Clause 9 “Expression of results” has been reformulated; d) Clause 10 “Test report” has been reformulat

11、ed; e) two new methods, A.2 and A.3, have been included in the informative Annex A “Target taxon-specific methods”; f) the document has been editorially revised (footnotes); g) the Bibliography has been supplemented. Previous editions DIN EN ISO 21570: 2006-02 DIN EN ISO 21570 Corrigendum 1: 2007-06

12、 DIN EN ISO 21570:2013-08 3 National Annex NA (informative) Bibliography DIN EN ISO 21569, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Qualitative nucleic acid based methods DIN EN ISO 21571, Foodstuffs Methods of analysis for the detection

13、 of genetically modified organisms and derived products Nucleic acid extraction DIN EN ISO 24276, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions DIN EN ISO 21570:2013-08 4 This page is intentionally blank E

14、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21570 November 2005 +AC +A1 February 2007 April 2013 ICS 67.050 English Version Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Quantitative nucleic acid based methods (ISO 21570:2005

15、+ Cor 1:2006 + Amd 1:2013) Produits alimentaires - Mthodes danalyse pour la dtection des organismes gntiquement modifis et des produits drivs - Mthodes quantitatives bases sur lutilisation des acides nucliques (ISO 21570:2005 + Cor 1:2006 + Amd 1:2013) Lebensmittel - Verfahren zum Nachweis von gente

16、chnisch modifizierten Organismen und ihren Produkten - Quantitative auf Nukleinsuren basierende Verfahren (ISO 21570:2005 + Cor 1:2006 + Amd 1:2013) EN ISO 21570:2005 was approved by CEN on 2005-10-16, Corrigendum AC:2007 on 2007-02-14 and Amendment A1:2013 on 2013-04-11. CEN members are bound to co

17、mply 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-CENEL

18、EC 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

19、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembou

20、rg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All

21、 rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21570:2005 + AC:2007 + A1:2013 EContents Page Foreword to EN ISO 21570:2005 3 !Foreword to EN ISO 21570:2005/A1:2013 .3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and def

22、initions .5 4 Principle 6 5 Reagents .6 6 Apparatus and equipment 6 7 Guidelines concerning the procedure .7 8 !Interpretation 8 9 Expression of results 9 10 Test report 9 Annex A (informative) Target taxon-specific methods 11 A.1 Target taxon-specific method for the absolute quantitation of the adh

23、1 gene DNA of maize using real-time PCR 11 A.2 !Target-taxon-specific method for the detection of DNA derived from rice 16 A.3 Target-taxon-specific method for the detection of components derived from tomato (Lycopersicon esculentum) 24 Annex B (informative) Screening methods .32 B.1 Screening metho

24、d for the relative quantitation of the 35S-promoter DNA of soya bean line GTS 40-3-2 using real-time PCR .32 Annex C (informative) Construct-specific methods 40 C.1 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA using real-time PCR (Method 1) 40 C.2 Construct-specifi

25、c method for the quantitation of soya bean line GTS 40-3-2 DNA using real-time PCR (Method 2) 47 C.3 Construct-specific method for the quantitation of Event176 maize DNA using real-time PCR .54 C.4 Construct-specific method for the quantitation of soya bean line GTS 40-3-2 DNA using real-time PCR .6

26、1 C.5 Construct-specific method for the quantitation of maize line MON 810 DNA using real-time PCR .69 C.6 Construct-specific method for the quantitation of maize line Event176 DNA using real-time PCR .76 C.7 Construct-specific method for the quantitation of maize line Bt11 DNA using real-time PCR .

27、83 C.8 Construct-specific method for the quantitation of maize line GA21 DNA using real-time PCR .91 C.9 Construct-specific method for the quantitation of maize line T25 DNA using real-time PCR .98 Annex D (informative) Event-specific methods . 107 D.1 Event-specific method for the absolute and rela

28、tive quantitation of maize line Bt11 DNA based on real-time PCR . 107 D.2 Event-specific method for the relative quantitation of maize line MON 810 DNA using real-time PCR 113 Bibliography . 120 DIN EN ISO 21570:2013-08 EN ISO 21570:2005 + AC:2007 + A1:2013 (E) 2 Foreword to EN ISO 21570:2005 This d

29、ocument (EN ISO 21570:2005) has been prepared by Technical Committee CEN/TC 275 “Food analysis Horizontal methods”, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 34 “Agricultural food products”. This European Standard shall be given the status of a nationa

30、l standard, either by publication of an identical text or by endorsement, at the latest by May 2006, and conflicting national standards shall be withdrawn at the latest by May 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are

31、 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, Sweden, Switzerland and

32、United Kingdom. !Foreword to EN ISO 21570:2005/A1:2013 This document (EN ISO 21570:2005/A1:2013) has been prepared 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 Am

33、endment 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 latest by October 2013, and conflicting national standards shall be withdrawn at the latest by October 2013. Attention is drawn to

34、 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 such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following co

35、untries are bound to implement 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,

36、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 approved by CEN as EN ISO 21570:2005/A1:2013 without any modification.“ DIN EN ISO 21570:2013-08 EN ISO 21570:2005 + AC:2007 + A

37、1:2013 (E) 3 Introduction The search for ingredients of genetically modified origin is performed by means of the following successive (or simultaneous) steps. After sample collection, nucleic acids are extracted from the test portion. Extracted nucleic acids can be further purified, simultaneously o

38、r after the extraction process. Afterwards, they are quantified (if necessary), diluted (if necessary) and subjected to analytical procedures (such as PCR). These steps are detailed in the present and in the following International Standards: ISO 21569, Foodstuffs Methods of analysis for the detecti

39、on of genetically modified organisms and derived products Qualitative nucleic acid based methods ISO 21570, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Quantitative nucleic acid based methods Further information about definitions and genera

40、l items involving the steps cited above are collected in: ISO 24276, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions. The International Organization for Standardization (ISO) draws attention to the fact that

41、 it is claimed that compliance with this document may involve the use of a patent concerning the PCR technology. ISO takes no position concerning the evidence, validity and scope of these patent rights. ISO has been informed that Applied Biosystems, Roche Molecular Systems, Inc. and Hoffman-La Roche

42、 hold patent rights concerning PCR technology. The companies have assured the ISO that they are willing to negotiate licences under reasonable and non-discriminatory terms and conditions with applicants throughout the world. In this respect, the statements of the holders of these patent rights are r

43、egistered with ISO. Information may be obtained from: Licensing Department Applied Biosystems 850 Lincoln Centre Drive Foster City, CA 94404, USA and Roche Molecular Systems, Inc. Licensing Department 1145 Atlantic Avenue Alameda, CA 94501, USA Attention is drawn to the possibility that some of the

44、elements of this document may be subject of patent rights other than those identified above. ISO shall not be held responsible for identifying any or all such patent rights. DIN EN ISO 21570:2013-08 EN ISO 21570:2005 + AC:2007 + A1:2013 (E) 4 1 Scope This International Standard provides the overall

45、framework of quantitative methods for the detection of genetically modified organisms (GMOs) in foodstuffs, using the polymerase chain reaction (PCR). It defines general requirements for the specific amplification of DNA target sequences, in order to quantify the relative GMO-derived DNA content and

46、 to confirm the identity of the amplified DNA sequence. Guidelines, minimum requirements and performance criteria laid down in this International Standard are intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories. This International Standard has

47、 been established for food matrices, but is also applicable to other matrices, e.g. feed and plant samples from the environment. Specific examples of methods are provided in Annexes A to D. 2 Normative references The following referenced documents are indispensable for the application of this docume

48、nt. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 21569:2005 + AM1:2013ISO Guide 32, Calibration in analytical chemistry and use of certified reference materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 24276 apply. ! “, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products