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Secretariat: MSZT. Voting begins on:. Voting terminates on:. Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Sampling.
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Annex B informative Estimation of the number of particles in mg test portions after ultracentrifugal milling. The work of preparing International Standards is normally carried out through ISO technical committees.
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Since the first draft prEN ISO has been circulated for the parallel enquiry in , new scientific approaches to sampling have been elaborated. The results of a large study on distribution of GMOs in loose material bulk agricultural commodities will be submitted for publication within the next months. Additionally, a sampling protocol based on these findings was published as a Recommendation by the European Commission in November In this study it was proved clearly, that different lots of comparable size showed a large variety of GMO distribution which is of global relevance.
This leads to the conclusion that a protocol which is based on a distribution assumption can only yield erroneous results. Therefore, it was necessary to take these new developments into account and to publish a second draft European International Standard.
Based on the new scientific evidence the chapter 6 "Sampling of loose food products" of prEN ISO was changed as follows:. A new statistical approach was introduced. While the old version suggested a sampling protocol which was based on a distribution assumption and therefore was based mainly on the size of the laboratory sample to be analysed, the new protocol is independent of the distribution of GMOs in the lot, and is therefore not affected by stratification or clustering effects within the lot.
In addition to that the new protocol allows an estimation of the sampling error, which is of great benefit for enforcement authorities as well as for trading companies. All other changes to the prEN ISO were introduced following the comments received during the first enquiry.
Correct sampling is an operation that requires the most careful attention. Emphasis should be laid on the necessity of obtaining a representative sample of the goods under investigation.
Accurate analytical work and interpretation of results are wasted if the sample does not accurately represent the lot from which it is taken. 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 which has been analysed.
It is not possible to extend the result to the rest of the lot. By applying sampling frameworks to assess the level of compliance of a given lot of products a certain number of samples has to be taken, and the result of the analysis can be extended to the whole lot. The use of sampling plans is the only effective way to make correct statements about the nature, in this case the GMO- content, of the product tested. The procedures given in this standard are recognised as good practice and it is strongly recommended that they be followed whenever practicable.
It is recognised that it is difficult to lay down fixed rules to be followed in every case, and particular circumstances may render some modification of the method desirable. This standard has been established for food products, but could also be applied to other products, e. NOTE In certain areas there are widely recognised trade associations which specify rules for the sampling plans to be used in contracts under their auspices. In no case will this standard override the rules laid down in such contracts.
This Standard 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. This draft standard incorporates, by dated or undated reference, provisions from other publications.
The normative references are cited at the appropriate places in the text, and the publications re-listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this draft standard only when incorporated in it by amendment or revision.
For undated references the latest edition of the publication referred to applies. EN ISO , Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Protein based methods. For the purposes of this document, the follo w ing terms and defini t ions apply. A quantity of some commodity delivered at one time and covered by one set of documents.
The consignment. Lot stated portion of the consignment to be tested for presence of GMO. Increments may be tested individually aiming at estimation of the variation of any characteristic throughout a. Item an actual or conventional object a defined quantity on which a set of observations may be made.
Sample one or more items or a portion of material selected in some manner from a lot. It is intended to provide information representative of the lot, and, possibly, to serve as a basis for decision on the lot. File increment sample an increment that is retained for a specific period of time for further analysis.
Bulk sample. Laboratory sample. Test portion. Lot size the number of items or quantity of material constituting the lot. Sample size the number of items or quantity of material constituting the sample. Sample division the process of selecting one or more representative subsamples from a sample by such means as riffling or mechanical dividing.
Estimation error in the estimation of a parameter, the estimation error is the difference between the calculated value of the estimator and the true value of this parameter. Sampling error part of the total estimation error due to one or several of the following parameters:. Sampling plan the 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.
Acceptance quality limit AQL quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling. This concept only applies when a sampling scheme with rules for switching and for discontinuation, such as in.
NOTE Although individual lots with quality as bad as the acceptance quality limit may be accepted with fairly high probability, the designation of an acceptance quality limit does not suggest that this is a desirable quality level. Sampling schemes found in International Standards such as this part of ISO , with their rules for switching and for discontinuation of sampling inspection, are designed to encourage suppliers to have process averages consistently better than the AQL.
Otherwise, there is a high risk that the inspection severity will be switched to tightened inspection under which the criteria for lot acceptance become more demanding. Once on tightened inspection, unless action is taken to improve the process, it is very likely that the rule requiring discontinuation of sampling inspection pending such improvement will be invoked.
Inspection level the inspection level relates the sample size to the lot size and hence to the discrimination afforded between "good" and "poor" quality. NOTE A sampling scheme involves "switching" between normal, tightened and reduced inspection sampling plans, see e. Specification limit. Non conforming item or increment. 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 which the laboratory sample is obtained by successive divisions or otherwise.
If it is necessary to determine the sampling error, file increment samples should be kept for further analysis. All sampling operations shall be carried out over a sufficiently short period of time so as to avoid any alteration.
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. Special care is necessary 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 from adventitious contamination the samples, the sampling instruments and the container in which the samples are placed.
Special attention shall be paid to avoid cross-contamination during the sampling procedure between different lots. Sampling apparatus shall be cleaned carefully, e.
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