1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58modified organisms and derived products Information to be supplied and procedure for the addition o
2、f methods to ISO 21569, ISO 21570 or ISO 21571 ICS 67.050Foodstuffs Nucleic acid based methods of analysis of genetically DRAFT FOR DEVELOPMENTDD ISO/TS 21098:2005DD ISO/TS 21098:2005This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 4 Janu
3、ary 2006 BSI 4 January 2006ISBN 0 580 47306 6National forewordThis Draft for Development reproduces verbatim ISO/TS 21098:2005.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publications and is of a provisional nature because th
4、e new edition of the international document has been issued as a Technical Specification and is open to further development. It should be applied on a provisional basis, so that information and experience of its practical application may be obtained.Comments arising from the use of this Draft for De
5、velopment are requested so that UK experience can be reported to the international organization responsible for the Technnical Specification. A review of this publication will be initiated not later than 3 years after its publication by the international organization so that a decision can be taken
6、on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the
7、 conversion into an international standard, to extend the life of the Technical Specification for another 3 years or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee AW/-/3, Food analysis Horizontal methods, at British Standards House, 389 Chiswick High
8、Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text.A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement internationa
9、l publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all t
10、he necessary provisions of a contract. Users are responsible for its correct application.Summary of pagesThis document comprises a front cover, an inside front cover, the ISO/TS title page, pages ii to v, a blank page, pages 1 to 18, an inside back cover and a back cover.The BSI copyright notice dis
11、played in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsReference numberISO/TS 21098:2005(E)TECHNICAL SPECIFICATION ISO/TS21098First edition2005-09-15Foodstuffs Nucleic acid based methods of analysis of genetically modified organis
12、ms and derived products Information to be supplied and procedure for the addition of methods to ISO 21569, ISO 21570 or ISO 21571 Produits alimentaires Mthodes bases sur les acides nucliques pour lanalyse des organismes gntiquement modifis et des produits drivs Informations fournir et procdure pour
13、laddition de mthodes lISO 21569, lISO 21570 ou lISO 21571 DD ISO/TS 21098:2005ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 DNA-based analysis . 1 3 Multi-laboratory studies . 1 4 Description of information to be supplied about a method submitted to be annexed to ISO 21569, ISO 21570
14、and ISO 21571 2 5 Validation of methods 3 5.1 General. 3 5.2 Validation of quantitative methods. 3 5.3 Validation of qualitative methods . 4 6 Process for adding, amending and retaining methods (as annexes) 5 6.1 Expert group for consideration of the methods 5 6.2 Addition of methods to the standard
15、s 5 6.3 Amending of methods in the standards. 5 6.4 Retention of methods in the standards 6 Annex A (normative) Template for supplying the required information about a method to be annexed to ISO 21569. 7 Annex B (normative) Template for supplying the required information about a method to be annexe
16、d to ISO 21570. 11 Annex C (normative) Template for supplying the required information about a method to be annexed to ISO 21571. 15 Bibliography . 18 DD ISO/TS 21098:2005iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
17、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 established has the right to be represented on that committee. International organizations, govern
18、mental 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 standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Di
19、rectives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member b
20、odies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts
21、 in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is ap
22、proved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed
23、 again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. 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
24、or all such patent rights. ISO/TS 21098 was prepared by Technical Committee ISO/TC 34, Food products. The reasons why this document is published as a Technical Specification are given in the Introduction. DD ISO/TS 21098:2005vIntroduction ISO has an obligation to ensure that the international standa
25、rds it develops, adopts and publishes are globally relevant. Among the criteria detailed in Annex 4, paragraph 10, of the Second Triennial review of the operation and implementation of the Barriers to Trade Agreement, dated 13 November 2000, it is stated that a globally relevant standard should be p
26、erformance based as opposed to design prescriptive. Thus any method submitted for inclusion in an International Standard should contain sufficient information for its performance to be judged. Although ISO 24276 states “The criteria for the selection of methods are listed in the standards on the det
27、ection of genetically modified organisms and derived products, ISO 21568, ISO 21569, ISO 21570 and ISO 21571. Acceptable levels of performance for methods included in the annexes are those which have preferably been collaboratively trialed/single laboratory validated. Methods selected for inclusion
28、in the annexes have either been validated according to ISO 5725, or the Harmonized Protocol (Horwitz 1995) or according to Thompson et al. (2002)”, there is insufficient guidance in these documents to allow the analyst to test whether a method is specifically suitable for inclusion in the annexes. I
29、t is important that an International Standard or Technical Specification should be performance based. For a standard to be performance based, a clear definition of performance characteristics must be available. It was noted at the 5th meeting of ISO/TC 34/WG 7, held 18th to 20th February 2004 in Seo
30、ul, Korea, that there is no formal process for submitting methods for inclusion in the standards. Although a number of specific methods have been proposed as part of the proposed standards (ISO 21569, ISO 21570 and ISO 21571) and associated general document (ISO 24276), there is not sufficient clari
31、ty for submitters to be able to judge whether a method meets the standard, and no mechanism is in place to govern acceptability and/or adoption of such method or for retaining methods in the standards. Therefore, this Technical Specification was developed in order to provide guidance and to define t
32、he performance characteristics that should be supplied for each method in order to ensure the global relevance of these standards, and to delineate the process for adding, amending and retaining methods annexed to the standards. DD ISO/TS 21098:2005blank1Foodstuffs Nucleic acid based methods of anal
33、ysis of genetically modified organisms and derived products Information to be supplied and procedure for the addition of methods to ISO 21569, ISO 21570 or ISO 21571 1 Scope This Technical Specification defines the principles and specifies the nature of the information to be supplied for acceptance
34、of a method as an annex to ISO 21569, ISO 21570 or ISO 21571. It also specifies the process for adding, amending and retaining methods annexed to these standards. This Technical Specification is necessary in order to attain consistency in methods that are to be employed as part of the standards. It
35、does not cover the specifics of the development of a method or laboratory set-up. The operation of laboratories is covered in ISO/IEC 17025. Method validation is instrumental in assessing the reliability of a test method. Its central role is to establish numerical values for the performance criteria
36、 that are to be established. ISO 24276 includes details on method validation, taking into consideration specific technical issues related to the detection of genetically modified organisms and derived products. Given the attention to, and widespread use of deoxyribonucleic acid-based tests or protei
37、n-based tests, and the implications to trade of any discrepancies in test results, a single-laboratory validation is most likely not warranted in this case and a multi-centre method validation could be performed according to the international guidelines. 2 Deoxyribonucleic acid (DNA)-based analysis
38、DNA-based analysis is commonly performed using polymerase chain reaction (PCR), although ISO 21569, ISO 21570 and ISO 21571 also allow for other methods. DNA is a high-molecular weight polymer that may be degraded during food processing by, for example, heat, enzymes and mechanical shearing. In addi
39、tion, the DNA may be chemically altered by the formation of adducts, or by loss of the bases. Any degradation of the DNA shall be considered when assessing method validation and applying performance criteria. Degradation of DNA will affect the limit of detection and the limit of quantitation of the
40、tests. It is important that the performance criteria for a method consider this effect. Additionally, it is important to point out the restrictions that method(s) may have in certain food matrices. The annexes in ISO 21569, ISO 21570 and ISO 21571 should contain information on performance criteria f
41、rom which methods fit for ISO purposes may be selected. It is possible that two different methods for the same event/sequence, both fulfilling the performance criteria, once established, will be included in the annexes. It should be noted that, due to the limitations of the instruments and other fac
42、tors, quantitative PCR methods in general do not follow a Gaussian distribution for blank values around the zero. Thus, the determination of the limit of detection and limit of quantitation cannot be carried out assuming such a distribution, and will not follow the procedures outlined, for example,
43、in ISO 11843-1 Thus detection limits for quantitative PCR methods cannot be determined using the mean and standard deviation of the blank samples, and shall be determined experimentally, or methods shall be performed at levels which are significantly above the detection limit. 3 Multi-laboratory stu
44、dies Under certain circumstances (i.e. when the conduct of a formal collaborative trial is not practicable), methods may be validated via single laboratory validation (see Reference 11). The methods used for determination of the presence of material originating from biotechnology-derived crops and f
45、ood are able to be, and are intended to be, performed at multiple laboratories and shall therefore be validated by multi-laboratory DD ISO/TS 21098:20052 collaborative studies. The results of such studies may be incorporated by reference to the relevant scientific publication(s), in which case copie
46、s of the publications shall be submitted to the expert group when submitting the method. At the time that ISO 21569, ISO 21570 and ISO 21571 are being prepared, few methods have completed a full multi-laboratory validation on a multi-regional basis. Therefore, as an interim measure, methods may be a
47、ppended as informative annexes to the standards, after a properly conducted single-laboratory validation, or after validation in a small number of laboratories, providing that all the other criteria have been met. Methods which have been validated on a limited basis but are lacking full interlaborat
48、ory validation data, may be temporarily endorsed for a period not exceeding 3 years. Such methods will be reviewed within 3 years, at which time they should have been properly validated in a full interlaboratory collaborative study. 4 Description of information to be supplied about a method submitte
49、d to be annexed to ISO 21569, ISO 21570 and ISO 21571 The proposed informative annex should contain information about the performance characteristics of a method. This includes specific information on the multi- or single-laboratory trial, including relevant information obtained during prevalidation of the method (e.g. variation of parameters, reagents). The method should be in a format that conforms to the template and be validated according to internationally accepted norms (see Reference 12). Templates are
