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European Network Of Gmo Laboratories
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Book Synopsis European Network of GMO Laboratories by : European Communities
Download or read book European Network of GMO Laboratories written by European Communities and published by . This book was released on 2004 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The activity report of the European Network of GMO Laboratories describes the progress made and the work carried out from the official inauguration of the Network held in Brussels, Belgium, on 4th December 2002 to nowadays. It provides a general overview of the scientific activities, accomplishments and resources related to this expert group (in 2004 more than 70 European laboratories are included in the Network under the chairmanship of the JRC-Biotechnology & GMOs Unit) that has been set up to create a forum for EU and EEA to collaborate on detection and quantification of GMOs, on sampling and on the development of suitable reference materials. An overview is given of the mission and its implementation, the relations with the outside world and a particular emphasis is given to the personal experience of participating experts.
Book Synopsis How to Reliably Test for GMOs by : Jana Žel
Download or read book How to Reliably Test for GMOs written by Jana Žel and published by Springer Science & Business Media. This book was released on 2011-10-26 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: The detection of genetically modified organisms (GMOs) is becoming very complex, with new GMOs, approved and unapproved, constantly entering world markets. Traceability and labelling of GMOs is defined in regulations worldwide, demanding accurate and reliable testing to support the requirements of legislation. This Brief provides the current state-of-the-art on all key topics involved in GMO testing and is a source of detailed practical information for laboratories. Special focus is given to qualitative and quantitative real-time PCR analysis relevant to all areas where detection and identification rely on nucleic acid-based methods. The following topics, important for testing laboratories, are also discussed: organization of the laboratory, focusing on aspects of the quality system and methods for testing, validation and verification of methods, and measurement uncertainty. The Brief also discusses the new challenges of GMOs and novel modified organisms, using new technologies, and the possible solutions for GMO detection, including bioinformatics tools. Finally, legislation on GMOs and sources of information on GMOs are provided, which are relevant not only to testing laboratories, but to anyone interested in GMOs. The authors of this Brief have many years of experience in GMO testing, development of real-time PCR methods, implementation of quality system requirements, validations and verification of methods, and measurement uncertainty. The National Institute of Biology is a highly qualified research laboratory and a National Reference Laboratory, which also performs routine analyses of food, feed and seed. The Institute for Health and Consumer Protection of the European Union Joint Research Centre has extensive knowledge and experience of GMO detection. It hosts the European Union Reference Laboratory for GM Food and Feed in addition to chairing the European Network of GMO Laboratories.
Book Synopsis Overview on the Detection, Interpretation and Reporting on the Presence of Unauthorised Genetically Modified Materials by : Arne Holst-Jensen
Download or read book Overview on the Detection, Interpretation and Reporting on the Presence of Unauthorised Genetically Modified Materials written by Arne Holst-Jensen and published by . This book was released on 2011 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unauthorised GMOs (UGM) and derived materials are not uncommon in products found on the European market. At present there is zero tolerance for UGM in the EU. In most documented cases, the UGM concentration relative to the product in which the UGM material is found, was low. Low level presence will always represent a challenge to analytically based detection, in particular if the UGM is obscured by other GM material. Analytical ad hoc implementation of the zero tolerance for particular UGMs in feed is described in Regulation (EU) No 619/2011. In Europe, GM detection is predominantly achieved with polymerase chain reaction (PCR) derived methods targeting the transgenic construct and insertion site DNA sequences.^The increase in number and divergence of GMOs developed and commercialised has gradually forced the GM detection laboratories to rationalise their analytical work, and most laboratories now apply initial PCR based screenings followed by (when appropriate) more specific PCR based identification and quantification. The detection of any GM is dependent on availability of suitable detection method(s) and control materials to verify the performance of the method(s). Other information, e.g. describing the novel trait, introduced genetic elements, etc. may also facilitate detection, verification and identification of the GM. For UGM, this is a major challenge, and the GMOs are therefore classified into four knowledge groups in the present document. This classification may facilitate stakeholder communication and decision making in analytical laboratories. A decision tree is presented, summarising the recommended principles of GM and UGM detection.^Notably, the state-of-the-art of GMO analysis is not static, and it is expected that the guidelines and recommendations presented in this document will have to be modified on a regular basis. Finally, the document highlights a number of R&D priorities and points out the need for reinforced information sharing at the global level.
Book Synopsis Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing by :
Download or read book Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing written by and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The document "Definition of Minimum Performance Requirements for analytical methods of GMO testing" (ENGL 2015) is a guidance developed by the ENGL and the EU Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF). It supports the development and validation of methods for GMO analysis submitted in the frame of applications for EU market authorisation of GMO products, as well as those to be used in the official control of food and feed. The guidance document provides definitions and requirements to assess the performance of the methods developed for the detection and quantification of GMOs based on real-time PCR. More recently, technologies like digital PCR were successfully applied in various fields for the quantification of nucleic acid molecules, including GMOs. Moreover, GM animals and products developed by means of so-called new genomic techniques (Broothaerts et al. 2021) are being released on the market and present additional challenges from the analytical viewpoint. Therefore, ENGL experts have extended the original method performance parameters for guiding users in the development and validation of digital PCR methods for GMO analysis. While the developments in the fields of GM animals and new genomic techniques are still evolving, in addition to the Minimum Performance Requirements guidelines also specific recommendations for methods for the detection and quantification of organisms with short genomic alterations and of GM animals are provided. Given that developments in the fields of GM animals and new genomic techniques are ongoing, these recommendations may be further elaborated in the future.
Book Synopsis European Network of GMO Laboratories by : European Commission. Joint Research Centre
Download or read book European Network of GMO Laboratories written by European Commission. Joint Research Centre and published by . This book was released on 2004 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis European Network of GMO Laboratories Working Group "Seed Testing" (WG-ST) Working Group Report by :
Download or read book European Network of GMO Laboratories Working Group "Seed Testing" (WG-ST) Working Group Report written by and published by . This book was released on 2015 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: Testing seed lots for the unintended presence of genetically modified (GM) seeds is carried out in European Union Member States (MS). The aim of the testing of seeds for genetically modified organisms (GMOs) is to test whether GMOs are present in non-GM seed lots. Splitting samples of seeds taken from lots into subsamples, testing for the presence of GM seeds in each subsample, and counting the number of positive subsamples is a suitable method for estimating the proportion of GM seeds impurities with a specified probability. The detection of lower proportions of GM seeds in lots requires the analysis of larger seed samples and larger amounts of DNA. This entails more effort and cost to detect lower quantities of GM seed. A decision to form a Working Group (WG) for "seed testing" (WGST) was taken during the 26th ENGL Steering Committee meeting. The WGST was formed to study the relation between the impurity of GM seed that could be detected and the cost of the analyses required to detect the unintended presence of GM seed in conventional seed lots. The WGST was tasked with producing a report on the issue for the approval of the ENGL Steering Committee. The report would then form the basis of ENGL/EURL advice to the Commission on testing seed samples for the unintended presence of GM seeds for the most important crops. The WG elaborated a statistical model to describe the relation between the impurity level of GMO seeds in seed lots that will, with a high probability, be reliably detected by test plans (the limit of detection) and the cost of the test plans needed to achieve this and effort devoted to the plan.
Book Synopsis European Network of GMO Laboratories by :
Download or read book European Network of GMO Laboratories written by and published by . This book was released on 2014 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report represents an overview of the current state of the art as discussed during the ENGL Steering Committee meeting of March 2014. The Working Group was asked to remain active and to monitor developments and advances in the field. The European Commission, however, would appreciate a more active role and invites the ENGL to continue its reflection and discussions and to provide regular updates on the progress made in this field. The current report will be reviewed and updated accordingly.
Book Synopsis Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods by : Institute for Health and Consumer Protection
Download or read book Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods written by Institute for Health and Consumer Protection and published by . This book was released on 2011 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification. Despite the fact that several guidelines on method verification have been published, no specific guidelines are available for GMO detection. The aim of this guidance document is to harmonise the in-house verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs, including element-, construct-, and event-specific methods. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfill legal requirements, then this document will be amended accordingly.
Book Synopsis Guidance Document on Measurement Uncertainty for GMO Testing Laboratories by :
Download or read book Guidance Document on Measurement Uncertainty for GMO Testing Laboratories written by and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides guidance on how to estimate measurement uncertainty (MU) and supports the enforcement of EU food and feed labelling legislation in the GMO sector. Measurement uncertainty is a parameter which is always associated with the result of a measurement, and characterises the dispersion of values attributed to that result. This measurement uncertainty needs to be estimated when compliance is investigated. The first version of this guidance document was written on request of the European Network of GMO Laboratories (ENGL) as a follow-up to a workshop on MU in the GMO sector organised by the European Commission, Joint Research Centre and was published in 2007. It was updated in 2009. The current version takes into account current EU legislation, availability of certified reference materials (CRMs) and validated quantification methods and the need for control laboratories which carry out measurements for the enforcement of EU legislation to be accredited according to ISO/IEC 17025. This guidance document contributes towards a harmonised approach for how EU Member States check compliance of food and feed samples with EU legislation. Other documents, e.g. the flexible scope accreditation document refer to this document concerning aspects related to MU.
Book Synopsis Detection of Food and Feed Plant Products Obtained by Targeted Mutagenesis and Cisgenesis by :
Download or read book Detection of Food and Feed Plant Products Obtained by Targeted Mutagenesis and Cisgenesis written by and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The current EU legislation on GMOs and GM food and feed requires analytical testing to support traceability of these products on the market. The European Network of GMO Laboratories has reviewed the implications of the analytical requirements when they are applied to plant products developed with the use of new genomic techniques, i.e. targeted mutagenesis and cisgenesis. This review concluded that analytical testing to support traceability is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis, both due to technical restrictions and because of implementation issues.
Book Synopsis Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods by :
Download or read book Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods written by and published by . This book was released on 2017 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfil legal requirements, then this document will be amended accordingly.
Book Synopsis Impact Analysis of the Joint Research Centre's Activities for the Regulation of GMOs in the European Union by : European Commission. Joint Research Centre
Download or read book Impact Analysis of the Joint Research Centre's Activities for the Regulation of GMOs in the European Union written by European Commission. Joint Research Centre and published by . This book was released on 2013 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents an analysis of impacts and results from the JRC's scientific and technical support for the implementation of the EU regulations for genetically modified organisms (GMO). The report is complementary to the mandatory evaluations of the EU Research Framework Programmes. A Steering Group of independent external experts accompanied the preparation of the report and helped to carry out the analysis in an objective way. Over the last 20 years the JRC has built up a specialised laboratory infrastructure to validate procedures for detecting and measuring the concentration of GMOs in food and feed, to harmonise the tests and verification methods, and to produce the necessary reference materials for the various methods. Since 2003 it operates the designated EU Reference Laboratory (EURL) for GMOs, implementing the necessary verification tasks through the European Network of GMO Laboratories (ENGL). The report puts well in evidence the JRC's experience to establish a network of European laboratories to support EU food and- feed regulations using sophisticated DNA-based test methods. The report presents as most important impacts: The existence of a technical infrastructure in the EU that allows harmonised implementation of GMO legislation and regulations, including the availability of certified reference materials ; EU-wide agreed coexistence measures in national legislation to avoid the unintended presence of GMOs in conventional and organic crops based on objective data concerning the socio-economic aspects of GMOs ; the technical clarification of the EU zero-tolerance policy; an impact of which the history is elaborated in the case study in the report -- EU Bookshop.
Book Synopsis Overview and Recommendations for the Application of Digital PCR by : Sven Pecoraro
Download or read book Overview and Recommendations for the Application of Digital PCR written by Sven Pecoraro and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Impact Analysis of the Joint Research Centre's Activities for the Regulation of GMOs in the European Union by : European Commission. Joint Research Centre
Download or read book Impact Analysis of the Joint Research Centre's Activities for the Regulation of GMOs in the European Union written by European Commission. Joint Research Centre and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents an analysis of impacts and results from the JRC's scientific and technical support for the implementation of the EU regulations for genetically modified organisms (GMO). The report is complementary to the mandatory evaluations of the EU Research Framework Programmes. A Steering Group of independent external experts accompanied the preparation of the report and helped to carry out the analysis in an objective way. Over the last 20 years the JRC has built up a specialised laboratory infrastructure to validate procedures for detecting and measuring the concentration of GMOs in food and feed, to harmonise the tests and verification methods, and to produce the necessary reference materials for the various methods. Since 2003 it operates the designated EU Reference Laboratory (EURL) for GMOs, implementing the necessary verification tasks through the European Network of GMO Laboratories (ENGL). The report puts well in evidence the JRC's experience to establish a network of European laboratories to support EU food and- feed regulations using sophisticated DNA-based test methods. The report presents as most important impacts: The existence of a technical infrastructure in the EU that allows harmonised implementation of GMO legislation and regulations, including the availability of certified reference materials ; EU-wide agreed coexistence measures in national legislation to avoid the unintended presence of GMOs in conventional and organic crops based on objective data concerning the socio-economic aspects of GMOs ; the technical clarification of the EU zero-tolerance policy; an impact of which the history is elaborated in the case study in the report -- EU Bookshop.
Book Synopsis Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods by : Institute for Health and Consumer Protection
Download or read book Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods written by Institute for Health and Consumer Protection and published by . This book was released on 2011 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification. Despite the fact that several guidelines on method verification have been published, no specific guidelines are available for GMO detection. The aim of this guidance document is to harmonise the in-house verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs, including element-, construct-, and event-specific methods. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfill legal requirements, then this document will be amended accordingly.
Book Synopsis Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing by :
Download or read book Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing written by and published by . This book was released on 2008 with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt: As laid down in the Annex of Commission Regulation (EC) No. 1829/2003 as amended by Commission Regulation (EC) No 1981/2006, and Annex 1 of Commission Regulation (EC) N. 641/2004, the Community Reference Laboratory for GM Food and Feed (CRL-GMFF) is responsible for the evaluation and validation of methods of analysis in the context of GMO authorisation under Commission Regulation (EC) No 1829/2003. The CRL-GMFF is assisted by the ENGL (European Network of GMO Laboratories). The ENGL recommends that the assessment, by the CRL-GMFF, of methods submitted by the applicants as part of the GMO authorisation process is undertaken in two distinct phases: Phase 1 - evaluation of the method performance data submitted by the applicant as part of the official dossier; and Phase 2 - evaluation of method performance data following a full validation study by collaborative trial. At present this document refers to polymerase chain reaction (PCR) based analytical methods for the determination and quantification of GMOs. However, if novel methods (e.g. those using technologies other than PCR) are subsequently developed that fulfil legal requirements then this document will be amended accordingly.
Book Synopsis Guidance Document on Measurement Uncertainty for GMO Testing Laboratories by :
Download or read book Guidance Document on Measurement Uncertainty for GMO Testing Laboratories written by and published by . This book was released on 2009 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt: This technical report outlines the technical issues related to the estimation of measurement uncertainty (MU) involved in the GMO sector. In particular it gives guidance to GMO testing laboratories how to estimate the analytical variability of quantitative analytical results obtained by real-time PCR. This guidance document has been written on request of the European Network of GMO Laboratories (ENGL) as a follow-up of a workshop on Measurement Uncertainty in the GMO sector organised by the Institute for Reference Materials and Measurements (IRMM), Geel, Belgium and held on 05.07.2005. It is recognised that in order to be able to judge if an analytical results exceeds a threshold; the MU must be estimated and reported together with the measurement result. Enforcement Authorities shall therefore estimate the MU associated with an analytical result and use it to decide whether an analytical result falls within the specification of food and feed control. The value obtained by subtracting the expanded uncertainty from the reported concentration is used to assess compliance. Only if this value is greater than the legal threshold, it is sure 'beyond reasonable doubt' that the sample concentration of the analyte is beyond what is permissible. Two selected approaches for the estimation of MU are presented in detail; references to alternative approaches are given. The first approach presented in detail is using data from collaborative trial in combination with in-house quality control data for the estimation of MU. Prerequisites for the use of such collaborative trial data are outlined. In case no suitable collaborative trial data are available, an alternative approach using data from within-laboratory samples for the estimation of MU is presented.
