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Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing

Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing
Author:
Publisher:
Total Pages: 0
Release: 2023
Genre:
ISBN: 9789268017456

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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.


Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing

Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing
Author:
Publisher:
Total Pages: 8
Release: 2008
Genre:
ISBN: 9789279111532

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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.


How to Reliably Test for GMOs

How to Reliably Test for GMOs
Author: Jana Žel
Publisher: Springer Science & Business Media
Total Pages: 110
Release: 2011-10-26
Genre: Technology & Engineering
ISBN: 1461413907

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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.


Testing and Analysis of GMO-containing Foods and Feed

Testing and Analysis of GMO-containing Foods and Feed
Author: Salah E. O. Mahgoub
Publisher: CRC Press
Total Pages: 288
Release: 2019-01-15
Genre: Health & Fitness
ISBN: 135171385X

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An increasing number of genetically modified organisms (GMOs) continues to be produced every day. In response to the concerns raised by the development of GMOs and their incorporation in foods and feed, guidelines and regulations to govern and control the use of GMOs and their products have been enacted. These regulations necessitated the design of methods to detect and analyse the presence of GMOs or their products in agriculture produce, food and feed production chains. Design of techniques and instruments that would detect, identify, and quantify GM ingredients in food and feed will help inspection authorities to relay reliable information to consumers who might be concerned about the presence of GM ingredients. Information generated by detection of GMOs in food and feed would be helpful for setting regulations that govern the use of GM components as well as for labeling purposes. Qualitative detection methods of GM-DNA sequences in foods and feeds have evolved fast during the past few years. There is continuous need for the development of more advanced multi-detection systems and for periodic updates of the databases related to these systems. Testing and Analysis of GMO-containing Foods and Feed presents updates and comprehensive views on the various methods and techniques in use today for the detection, identification and quantification of GMOs in foods and feed. The eleven book chapters cover recent developments on sample preparation techniques, immunoassays methods and the PCR technique used in GMO analysis, the use of biosensors in relation to GMO analysis, the application of nucleic acid microarrays for the detection of GMOs, validation and standardization methods for GMO testing, in addition to the type of reference material and reference methods used in GMO testing and analysis. Some of the ISO standards designed for identifying and detecting the presence of GM material in foods are also presented in the book.


Application of Sampling and Detection Methods in Agricultural Plant Biotechnology

Application of Sampling and Detection Methods in Agricultural Plant Biotechnology
Author: Ray Shillito
Publisher: Elsevier
Total Pages: 322
Release: 2022-07-30
Genre: Business & Economics
ISBN: 0323992943

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Application of Sampling and Detection Methods in Agricultural Plant Biotechnology describes detection methods for seed, plants and grain derived from biotechnology. This international handbook, based on a series of workshops carried out for governments in collaboration with ILSI and Co-published in partnership with the Cereals & Grains Association, provides the technical and practical information needed to develop, validate and use detection methods. This useful resource provides readers with the tools necessary to carry out reliable sampling, detection and interpretation of data. Presents a review of the technologies and approaches used for sampling and detecting biotechnology products in seed, plants, grain, food and feed Serves as a GM detection manual for international regulators and government agencies, testing laboratories, and academic and industrial professionals Contains case studies, applications, literature reviews and coverage of recent developments


Control of GMO Content in Seed and Feed

Control of GMO Content in Seed and Feed
Author: Nordic Council of Ministers
Publisher: Nordic Council of Ministers
Total Pages: 77
Release: 2004
Genre: Crops
ISBN: 9289310340

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Great efforts are made to develop and validate methods of analysis of Genetically Modified Organism (GMO) contents in seed, food and feed in order to be able to comply with the new EU regulations on genetically modified food and feed and on traceability and labeling of genetically modified organisms. This report describes some of the current possibilities and limitations regarding analysis of genetically modified contents in seed and feed. This final part of this report contains an overview of the current GMO analysis situation regarding seed and feed in the individual Nordic countries.


Genetically Modified and non-Genetically Modified Food Supply Chains

Genetically Modified and non-Genetically Modified Food Supply Chains
Author: Yves Bertheau
Publisher: John Wiley & Sons
Total Pages: 967
Release: 2012-09-10
Genre: Technology & Engineering
ISBN: 1118373804

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In the European Union nations, and other countries including Japan, Australia and Malaysia, it is a legal requirement that food products containing genetically modified organism (GMO) materials are labelled as such in order that customers may make informed purchasing decisions. For manufacturers and consumers to be confident about these assertions, systems must be in place along the entire food chain which support the co-existence of GM and non GM materials whilst maintaining a strict segregation between the two. This book is an output of a European Union-funded project entitled "Co-Extra: GM and non-GM food and feed supply chains: their Co-Existence and Traceability". The objective of this four year project is to provide practical tools and methods for implementing co-existence that will: enable the co-existence of genetically modified (GM) and non-GM crops enable the segregation and tracing of genetically modified organism (GMO) materials and derived products along the food and feed chains anticipate the future expansion of the use of GMOs The project is designed to foster a robustly science-based debate amongst all of the stakeholders involved in the food and feed chains, and the tools will be assessed not only from a technical point of view but with regard to the economic and legal aspects. It also surveys the GMO-related legal regimes and practices that exist in and beyond the EU. This book examines the practical tools and methods available to implement the co-existence and traceability of GM and non-GM food materials along the entire food and feed chains, as demanded by consumers and by legislation in force in the EU and elsewhere. GM and Non-GM Supply Foods is a source of valuable information for food manufacturers, food research institutions and regulatory bodies internationally.


Regulation of Genome Editing in Plant Biotechnology

Regulation of Genome Editing in Plant Biotechnology
Author: Hans-Georg Dederer
Publisher: Springer
Total Pages: 372
Release: 2019-08-16
Genre: Law
ISBN: 3030171191

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This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.


Genetically Modified Organisms in Food

Genetically Modified Organisms in Food
Author: Ronald Ross Watson
Publisher: Academic Press
Total Pages: 517
Release: 2015-08-20
Genre: Technology & Engineering
ISBN: 0128025301

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Genetically Modified Organisms in Food focuses on scientific evaluation of published research relating to GMO food products to assert their safety as well as potential health risks. This book is a solid reference for researchers and professionals needing information on the safety of GMO and non-GMO food production, the economic benefits of both GMO and non-GMO foods, and includes in-depth coverage of the surrounding issues of genetic engineering in foods. This is a timely publication written by a team of scientific experts in the field who present research results to help further more evidence based research to educate scientists, academics, government professionals about the safety of the global food supply. Provides the latest on research and development in the field of GMOs and non-GMO safety issues and possible risk factors incorporating evidence based reviews for a better understanding of these issues Covers various aspects of GMO production, analysis and identification to better understand GMO development and use Includes definitions, a brief overview and history of GM foods from a global perspective and concise summaries with recommendations for actions for each chapter


DNA Techniques to Verify Food Authenticity

DNA Techniques to Verify Food Authenticity
Author: Malcolm Burns
Publisher: Royal Society of Chemistry
Total Pages: 251
Release: 2019-10-14
Genre: Technology & Engineering
ISBN: 1788018974

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The food supply chain needs to reassure consumers and businesses about the safety and standards of food. Global estimates of the cost of food fraud to economies run into billions of dollars hence a huge surge in interest in food authenticity and means of detecting and preventing food fraud and food crime. Approaches targeting DNA markers have assumed a pre-eminence. This book is the most comprehensive and timely collection of material from those working at the forefront of DNA techniques applied to food authenticity. Addressing the new field of analytical molecular biology as it combines the quality assurance rigour of analytical chemistry with DNA techniques, it introduces the science behind DNA as a target analyte, its extraction, amplification, detection and quantitation as applied to the detection of food fraud and food crime. Making the link with traditional forensic DNA profiling and describing emerging and cutting-edge techniques such as next generation sequencing, this book presents real-world case studies from a wide perspective including from analytical service providers, industry, enforcement agencies and academics. It will appeal to food testing laboratories worldwide, who are just starting to use these techniques and students of molecular biology, food science and food integrity. Food policy professionals and regulatory organisations who will be using these techniques to back up legislation and regulation will find the text invaluable. Those in the food industry in regulatory and technical roles will want to have this book on their desks.