1、DRAFT FOR DEVELOPMENTDD CEN/TS 15568:2006Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Sampling strategiesICS 67.050g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g
2、51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSIDD CEN/TS 15568:2006This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 31 M
3、ay 2007 BSI 2007ISBN 978 0 580 50836 3National forewordThis Draft for Development was published by BSI. It is the UK implementation of CEN/TS 15568:2006.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 pro
4、visional nature. It should be applied on this provisional basis, so that information and experience of its practical application can be obtained.Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible fo
5、r its conversion to a European standard. A review of this publication will be initiated not later than 3 years after its publication by the European organization so that a decision can be taken on its status. Notification of the start of the review period will be made in an announcement in the appro
6、priate 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 conversion into a European Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent to th
7、e Secretary of the responsible BSI Technical Committee at British Standards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to Technical Committee AW/-/3, Food analysis Horizontal methods.A list of organizations represented on this committee can be
8、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.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Un
9、controlled Copy, (c) BSITECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIONCEN/TS 15568December 2006ICS 67.050English VersionFoodstuffs - Methods of analysis for the detection of geneticallymodified organisms and derived products - Sampling strategiesProduits alimentaires - Mthodes
10、 danalyse pour ladtection des organismes gntiquement modifis et desproduits drivs - Stratgies dchantillonnageLebensmittel - Verfahren zum Nachweis von gentechnischmodifizierten Organismen und ihren Produkten -ProbenahmestrategienThis Technical Specification (CEN/TS) was approved by CEN on 7 November
11、 2006 for provisional application.The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit theircomments, particularly on the question whether the CEN/TS can be converted into a European Standard.CEN members are require
12、d to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS availablepromptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)until the final decision about the possible conversi
13、on of the CEN/TS into an EN is reached.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
14、Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwid
15、e for CEN national Members.Ref. No. CEN/TS 15568:2006: ELicensed Copy: Wang Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Principle6 5 Apparatus and equipment 7 6 Sampli
16、ng of non-packed food products7 7 Sampling of pre-packed units 9 8 Preparation of the analytical sample and the test portion 10 9 Packaging and labelling of laboratory samples .10 10 Dispatch of laboratory samples .11 11 Sampling report .11 Annex A (informative) Laboratory sample sizes of different
17、cereals and oilseeds13 Annex B (informative) Sampling scheme for consignments of more than 100 bags according to ISO 1369014 Annex C (informative) Estimation of the number of particles in 100 mg test portions after ultra-centrifugal milling15 Bibliography 16 CEN/TS 15568:2006Licensed Copy: Wang Bin,
18、 na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI3 Foreword This document (CEN/TS 15568:2006) has been prepared by Technical Committee CEN/TC 275 “Food analysis - Horizontal methods”, the secretariat of which is held by DIN. Attention is drawn to the possibility that some of the el
19、ements 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. NOTE This document has been submitted to the Enquiry under reference number prEN 21568. According to the CEN/CENELEC Internal Regulations, the
20、national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, P
21、oland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. CEN/TS 15568:2006Licensed Copy: Wang Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI4 Introduction Correct sampling is an operation that requires the most careful attention. Empha
22、sis should be laid on the necessity of obtaining a representative sample of the goods under investigation. If ad-hoc sampling of food products is undertaken without applying a sampling strategy and without considering the lot specific properties, the analytical result is only valid for the sample th
23、at has been analysed. It is not possible to extend the result to the rest of the lot. By applying sampling strategies to assess the level of compliance of a given lot of products, a certain number of samples is taken, and the result of the analysis can be extended to the whole lot. The use of sampli
24、ng strategies is the only effective way to make correct statements about the nature, in this case the GMO-content, of the product tested. This Technical Specification has been established for food products, but could also be applied to other products, e.g. animal feed and plant samples from the envi
25、ronment. NOTE In certain areas there are widely recognised trade associations which specify rules for the sampling strategies to be used in contracts under their auspices. In no case will this Technical Specification override the rules laid down in such contracts. CEN/TS 15568:2006Licensed Copy: Wan
26、g Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI5 1 Scope This Technical Specification gives guidance for setting up valid sampling strategies for food products that are to be analysed for the presence of genetically modified organisms and derived products. 2 Normative refer
27、ences The following referenced documents are indispensable for the application 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. EN ISO 21569, Foodstuffs Methods of analysi
28、s for the detection of genetically modified organisms and derived products Qualitative nucleic acid based methods (ISO 21569:2005) EN ISO 21570, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Quantitative nucleic acid based methods (ISO 21570:
29、2005) EN ISO 21571, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Nucleic acid extraction (ISO 21571:2005) EN ISO 21572, Foodstuffs Methods for the detection of genetically modified organisms and derived products Protein based methods (ISO 21
30、572:2004) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 Consignment quantity of some commodity delivered at one time and covered by one set of documents. The consignment may consist of one or more lots or part(s) of lots ISO 7002:1986 3.2 L
31、ot stated portion of the consignment to be tested for presence of GMO 3.3 Increment quantity of material taken at one time from a larger body of material NOTE Increments may be tested individually aiming at estimation of the variation of any characteristic throughout a lot (or between lots). ISO 700
32、2:1986 3.4 Item actual or conventional object (a defined quantity) on which a set of observations may be made ISO 7002:1986 3.5 Sample one or more items (or a portion of material) selected in a prescribed or systematic manner from a lot NOTE It is intended to provide information representative of th
33、e lot, and, possibly, to serve as a basis for decision on the lot. CEN/TS 15568:2006Licensed Copy: Wang Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI6 3.6 File increment sample increment that is retained for a specific period of time for further analysis 3.7 Bulk sample com
34、posite of the increments taken from a lot 3.8 Laboratory sample sample as prepared for sending to the laboratory and intended for inspection or testing ISO 7002:1986 3.9 Test portion sample, as prepared for testing or analysis, the whole quantity being used for analysis or testing at one time ISO 35
35、34-1:2006 3.10 Lot size number of items or quantity of material constituting the lot ISO 7002:1986 3.11 Sample size number of items or quantity of material constituting the sample ISO 7002:1986 3.12 Sample division process of selecting one or more representative sub-samples from a sample by such mea
36、ns as riffling or mechanical dividing 3.13 Sampling uncertainty part of the total estimation uncertainty due to one or several of the following: - the failing of a sample to accurately represent the lot; - the random nature of sampling; - the known and accepted characteristics of the sampling strate
37、gy 3.14 Sampling strategy predetermined procedure for the selection, withdrawal and preparation of samples from a lot to yield the required information so that a decision can be made regarding the acceptance of the lot ISO 7002:1986 4 Principle In this Technical Specification sampling is considered
38、to consist of the following steps: collection of a sufficient number of increments from a lot to form the bulk sample; reduction of the bulk sample to the laboratory sample; grinding the laboratory sample to the appropriate particle size and homogenisation. CEN/TS 15568:2006Licensed Copy: Wang Bin,
39、na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI7 Samples shall be representative of the lots from which they are taken. Therefore, as the composition of a lot is seldom uniform, a sufficient number of increments shall be taken and carefully mixed, thus giving a bulk sample from wh
40、ich the laboratory sample is obtained by successive divisions or otherwise. If it is necessary to determine the sampling uncertainty, file increment samples should be kept for further analysis. Appropriate measures shall be taken to avoid any alteration in the composition of the samples. 5 Apparatus
41、 and equipment Many different types of sampling instruments or equipment are available. Equipment should be chosen as appropriate for the food products to be sampled and the quantity and containers involved. Examples of sampling instruments are given in e.g. ISO 13690 and ISO 6644. Special care is n
42、ecessary to ensure that all sampling apparatus is clean to avoid contamination of the material under investigation. Sampling shall be carried out in such a manner as to protect the samples, the sampling instruments and the container in which the samples are placed, from adventitious contamination. S
43、pecial attention shall be paid to avoid cross-contamination during the sampling procedure between different lots. Material adhering to the outside of the sampling instrument shall be removed before the contents are discharged. 6 Sampling of non-packed food products 6.1 Statistical principles Lot dis
44、tribution properties affect the efficiency of sampling strategies 5. Where the variable of interest is randomly distributed within the lot under investigation, the sampling uncertainty can be estimated according to the binomial distribution 6. However, in reality, non-packed food product lots may sh
45、ow non-random distributions 7, and lot heterogeneity should be taken into account when defining sampling procedures statistically. This sampling protocol provides a way of estimating the sampling uncertainty associated with the overall GMO content of a lot without imposing any distribution assumptio
46、n. The Standard Deviation (SD) of the increment GMO content estimates may be interpreted as an indicator of the lot heterogeneity and in highly heterogeneous lots as an indication of the sampling uncertainty. Generally, the larger the standard deviation, the larger is the sampling uncertainty in hig
47、hly heterogeneous lots. 6.2 Procedure 6.2.1 General This protocol is designed to provide an estimate of the GMO content of the lot based on a bulk sample. If an estimate of the sampling uncertainty is required, 6.2.3 describes a procedure to determine it. 6.2.2 Sampling of increments Lots should be
48、sampled following the technical principles given in ISO 6644 as described in 6.3 and ISO 13690 as described in 6.4. The number of sampling points, where the increments for creating the bulk sample and the file increment samples are taken is defined according to the lot size. In case of lots from 50
49、t to 500 t, the size of the bulk sample should be 0,01 % of the total lot size. In case of lots smaller than 50 t, the size of the bulk sample should be 5 kg. In case of lots larger than 500 t, the size of the bulk sample should be 50 kg (see Table 1). CEN/TS 15568:2006Licensed Copy: Wang Bin, na, Fri Sep 14 06:00:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI8 Table 1 Number of sampling points according to the lot size Lot size t Size of the bulk sample kg Number of sampling points 50 5 10 50 to 500 0,01% of lot size 2
