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2 Introduction Legislation in the EU regulates the placing on the market of food and feed consisting of, containing or produced from GMOs. They are referred to as 'GM food and feed' and require authorisation before being placed on the market in the EU. Food and feed products which contain, consist of or are produced from GMOs in a proportion higher than 0.9 per cent of the food and feed ingredient considered individually or food or feed consisting of a single ingredient, need to be labelled [2]. In this context, it needs to be noted that the labelling threshold is applicable for adventitious presence of GMOs, while GMOs added on purpose need to be labelled independent from a threshold. Additionally feed may contain 0.1 mass per cent of a GM event which was previously authorised in the EU or for which an authorisation process is pending [3]. During the EU authorisation process, the applicant seeking authorisation for a GM event needs to ensure that a reference material for the GM event is available and that an eventspecific quantification method has been successfully validated and is published by the EURL-GMFF. Successfully validated methods fulfil the minimum performance criteria laid down by the EURL-GMFF in [4]. As a consequence, reference materials and validated methods are publically available to GMO testing laboratories for the GM events covered by this guidance document. As the number of new GM events for which authorisation is granted, is increasing rapidly every year and as GMO testing laboratories are obliged to operate under ISO/IEC 17025 accreditation [5], the testing laboratories need to take up new GM events within their scope of accreditation in a timely manner. As a consequence, a flexible scope accreditation is requested by more and more GMO testing laboratories. The number of matrices on which the quantification method needs to be applied is also increasing. 3 Flexible scope — ISO/IEC 17025, Section 1.2 The accreditation of laboratories is based on a defined scope of accreditation which is clear and unambiguous, and provides the laboratory and other interested parties with a detailed list of the tests for which the laboratory is accredited. A precise description of the specific tests for which the laboratory is deemed competent is needed for a fixed as well as flexible scope. A fixed scope of accreditation requires an evaluation of the laboratory’s competence by the accreditation body for each new test that is added to the scope. A flexible scope allows adding a new test based on a competence evaluation carried out by the laboratory. This inclusion of a new test to the flexible scope is verified by the accreditation body a posteriori. It has become desirable to establish mechanisms which permit more laboratories to extend the range of their scope on the basis that their competence related to GMO quantification by qPCR has already been evaluated. A flexible scope for the measurement of the GM content is needed by the laboratories, allowing the quantification of GM events newly authorised in Europe without prior approval by the accreditation body. As the necessity for such flexibility is clearly established, the additional efforts to develop, implement and maintain an extended management system that a flexible scope requires can be beneficial. 8
A laboratory’s scope of accreditation is laid down in the accreditation document and refers to one or more of the following items. • Product The materials, in which the GM content is quantified, can be classified as being seed or food or feed, including their ground forms. Accredited laboratories are in some cases accredited only for one of these specific products. Note: 'Seed' has to be understood in this context as seeds suitable for agricultural purposes. Laboratories accredited for food or feed matrices do not test seeds but test food/feed products, while the food/feed can consist of grains (harvested material). Furthermore, laboratories can be explicitly accredited for GM quantification of vegetative parts from plants (e.g. potato tubers, plant leaves), while others are accredited for GM quantification in plant material in the general sense. • GM event GM event refers to the unique DNA recombination event that took place in one plant cell, which was then used to generate transgenic plants. GM event-specific methods are targeting the unique insertion region of the DNA construct (junction between transgenic and conventional DNA sequence, further referred to as the transgenespecific DNA target). The concentration of the GM event is calculated as the ratio of two small (e.g. 60 to 150 bp) DNA fragments present in DNA extracted from the material tested. The relative concentration of those two fragments amplified by qPCR is determined. One of the two fragments is chosen to be specific to a particular GM event whereas the other fragment is specific to the taxon or species (further referred to as the taxonspecific DNA target). The qPCR measurement result is expressed as ratio of those two relative DNA fragment concentrations. Note: The measurement result can be expressed in GM mass fractions or in GM DNA copy numbers. In this context the material used for the calibration has to be taken into account. • Analytical procedure The analytical procedure applied for the quantification of GMO is composed of a DNA extraction method, which can be based on different principles, and a DNA quantification method based on the measurement principle qPCR. Note: Due to the fact that the here concerned GM events are authorised in the EU, European standardised methods validated by interlaboratory comparison (ILC) organised by the EURL-GMFF and completed with the help of the ENGL are available. As the methods applied for GM labelling in the EU need to be event-specific [6], all methods concerned here are based on qPCR. 9
Page 1 and 2: European technical guidance documen
Page 3: European technical guidance documen
Page 6 and 7: 7.2.2 GM and non-GM CRMs available
Page 8 and 9: Abstract The aim of this guidance d
Page 12 and 13: • Range of measurements For some
Page 14 and 15: In each case, the laboratory would
Page 16 and 17: and the Compendium of reference met
Page 18 and 19: For the impact of the particle size
Page 20 and 21: 5.2.1.9 Limit of detection Procedur
Page 22 and 23: The absolute within-laboratory repr
Page 24 and 25: uΔ um uCRM u + 2 2 m CRM u u = Equ
Page 26 and 27: 5.2.2.4 Estimation of the uncertain
Page 28 and 29: 6.1 Calibration of qPCR measurement
Page 30 and 31: mass fractions for the calibration
Page 32 and 33: Example: Solution A is DNA extracte
Page 34 and 35: up the calibration curve and to use
Page 36 and 37: should also be checked in accordanc
Page 38 and 39: • detection and quantification of
Page 40 and 41: References [1] ISO/IEC 17025:2005 G
Page 43 and 44: ` European Commission EUR 25484 - J

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