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Guidelines for the single-laboratory validation of qualitative real-time PCR methods (Publication Date: Nov 2016)

The present guidelines for single-laboratory validation of qualitative real-time PCR methods were developed by the international working group "Development of methods for the identification of food produced by genetic engineering", established pursuant to § 64 of the German Food and Feed Code. It aims to ensure that qualitative real-time PCR methods developed by this group are able to meet the performance criteria defined at the European (ENGL, CEN) and international (ISO, Codex) level. The guid ...

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bch-vlr-scbd-293575-2
Article, Manual, Methodologies, Technical guide
25 Mar 2026

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Guidelines for the validation of qualitative real-time PCR methods by means of a collaborative study (Publication Date: Mar 2016)

The present guidelines for conducting a collaborative validation study of qualitative real-time PCR methods were developed by the international working group "Development of methods for the identification of food produced by genetic engineering" established pursuant to § 64 of the German Food and Feed Code. It aims to ensure that respective methods can meet the performance criteria defined at the European (ENGL, CEN) and international (ISO, Codex) level. The main criterion for validation a quali ...

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bch-vlr-scbd-293576-1
Article, Manual, Methodologies, Technical guide
25 Mar 2026

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Detection of food and feed plant products obtained by targeted mutagenesis and cisgenesis (Publication Date: Jun 2023)

Author's Abstract. The current EU legislation on GMOs and food and feed containing GMOs requires analytical testing to support traceability of these products on the market. Here the European Network of GMO Laboratories has reviewed the implications of the analytical requirements when they are applied to plant products developed by new genomic techniques, i.e. targeted mutagenesis and cisgenesis. This review concluded that analytical testing to support traceability is not considered feasible for ...

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bch-vlr-scbd-281905-1
Report
15 Jan 2026

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Considerations for the Successful Detection and Quantification of Genetically Modified Events in Grain and Food Samples Using Multiplex Digital PCR (Publication Date: Dec 2024)

Author's Abstract. The number of genetically modified (GMO) events for canola, corn, and soybean is steadily increasing. Some countries, including those in the EU, have regulatory requirements for the approval and use of plant ingredients containing GMOs. Multiplex digital PCR (dPCR) has been used for the simultaneous detection and quantification of various GMO events. This review covers the various factors to consider for multiplex digital PCR detection and the quantification of GMO events. DN ...

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bch-vlr-scbd-281904-1
Article
15 Jan 2026

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ddPCR strategy to detect a gene-edited plant carrying a single variation point: Technical feasibility and interpretation issues (Publication Date: Mar 2022)

Author's Abstract. Gene-edited organisms and derived food and feed products commercialized on the European market falls within the scope of the Directive, 2001/18/EC. Therefore, the possibility to specifically detect and quantify them has become a priority. To this end, PCR-based approaches, such as real-time PCR and digital droplet PCR, targeting a single variation point carried by a gene-edited organism are expected to be suitable, even if potentially challenging at the technical level. Howev ...

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bch-vlr-scbd-281901-2
Article
15 Jan 2026

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A Novel Quantification Method for Gene-Edited Animal Detection Based on ddPCR (Publication Date: Feb 2025)

Author's Abstract. As gene-editing technologies continue to evolve, gene-edited products are making significant strides. These products have already been commercialized in the United States and Japan, prompting global attention to their safety and regulatory oversight. However, the detection of gene editing still relies on qPCR, and there is a lack of quantitative detection methods to quantify gene-editing components in products. To ensure consumer safety and transparency, we developed a novel ...

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bch-vlr-scbd-281899-1
Article
15 Jan 2026

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Detection method for CRISPR-Cas9 edited tomato with single nucleotide deletion using multiplex probe-based real-time PCR and confirmation of non-transgenicity: A case study (Publication Date: Oct 2025)

Author's Abstract. The adoption of gene-edited (GE) food crops has increased due to applicability of technology without drastically affecting the genetic information. However, the discussion on regulatory regime pertaining to GE plants throughout the globe is overwhelming. In the countries where GE products are regulated, or for the verification of gene-editing as claimed by the developers, detection of GE plants (referred to as GE detection here) plays an imperative role. Precisely detecting s ...

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bch-vlr-scbd-281897-1
Article
15 Jan 2026

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Future perspectives of GMO detection in agriculture: strategies for electrochemical nucleic acid detection (Publication Date: Jun 2025)

Author's Abstract. The uncontrolled distribution of genetically modified organisms (GMO)-based food and feed is an increasing global concern, primarily due to limited information about their potential harmful effects. The growing diversity and complexity of GMOs present significant challenges for their detection, traceability, and safety monitoring. Traditionally, GMOs are detected using molecular methods, among which PCR methods are the most explored and are considered the gold standard. Howev ...

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bch-vlr-scbd-281895-1
Article
15 Jan 2026

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Detection of commercialized plant products derived from new genomic techniques (NGT) - Practical examples and current perspectives (Publication Date: Oct 2023)

Author's Abstract. New genomic techniques (NGT) are increasingly applied in plant research and development in many countries due to their simplicity in introducing genetic modifications that alter specific traits. First NGT products are on the market in several countries where no specific regulatory approval is required. In the European Union (EU), however, all NGT derived products are subject to the existing genetically modified organism (GMO) authorization regulations. This nourishes the disc ...

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bch-vlr-scbd-281887-1
Article
14 Jan 2026

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Development and in-house validation of two real-time PCR methods for the detection of genome-editing events in soybean FAD2 gene variants (Publication Date: Jan 2025)

Author's Abstract. Since the commercialization of the first genetically modified (GM) crops, their relevance in agricultural applications has increased. Soybean (Glycine max) ranks as the most widely cultivated GM crop globally. With the advancements in site-specific genome-editing tools, the development of GM organisms (GMO) using new genomic techniques has accelerated, particularly in agriculture. In the US, a genome-edited soybean variety, Calyno, was developed with altered fatty acid composi ...

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bch-vlr-scbd-281851-3
Article, Methodologies
14 Jan 2026

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Development and collaborative validation of an event-specific quantitative real-time PCR method for detection of genetically modified CC-2 maize (Publication Date: Sep 2024)

Author Summary: As one of the developed genetically modified (GM) maize varieties in China, CC-2 has demonstrated promising commercial prospects during demonstration planting. The establishment of detection methods is a technical prerequisite for effective supervision and regulation of CC-2 maize. In this study, we have developed an event-specific quantification method that targets the junction region between the exogenous gene and the 5’ flanking genomic DNA (gDNA) of CC-2. The accuracy and pre ...

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bch-vlr-scbd-281850-1
Article, Methodologies
12 Jan 2026

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Detection of Soybean GMO Events Using Two Multiplex Droplet Digital PCR Assays (Publication Date: Oct 2024)

Author Abstract: Background. Detection methods for GMO events are required because of regulatory compliance requirements. Efficient detection and quantification of GMO events saves time and resources. Multiplex digital PCR (dPCR) allows detection and quantification of more than one GMO event at the same time. Objective. The study used two tetraplex droplet digital PCR (ddPCR) assays for the detection of 19 soybean GMO events. Methods. Two multiplex dPCR assays were developed and optimized for t ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281778-2
Article
12 Jan 2026

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In-House Validation of Four Duplex Droplet Digital PCR Assays to Quantify GM Soybean Events (Publication Date: Dec 2024)

Author Abstract: Due to the increasing number of authorized events in the European Union, it is crucial for the official laboratories to enforce market control to detect and quantify genetically modified organisms. In this study, an in-house validation of quantitative duplex ddPCR methods was performed involving MON87701, MON87769, MON89788 and CV-127-9 assays with respect to the lectin reference gene. Since the ddPCR methods provide accurate quantification, show less sensitivity to PCR inhibito ...

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bch-vlr-scbd-281849-1
Article
12 Jan 2026

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New Breeding Techniques and Their Possible Regulation (Jan 2018)

Author abstract: New breeding techniques (NBTs) are gaining greater uptake in plant breeding programs around the world, due to their greater precision and potential to reduce varietal development times. As the first products of research begin to enter the commercial domain, some of their technical and conceptual overlaps with GM biotechnology have become the focus of international discussions concerning their regulatory status. This review provides an insight into the mechanisms of NBTs, how the ...

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bch-vlr-scbd-278735-1
Article
09 May 2025

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A Curriculum-Based Approach to Teaching Biosafety Through eLearning (Apr 2018)

Author abstract: Anyone working in biosafety capacity enhancement faces the challenge of ensuring that the impact of a capacity enhancing activity continues and becomes sustainable beyond the depletion of funding. Many training efforts face the limitation of one-off events: they only reach those people present at the time. It becomes incumbent upon the trainees to pass on the training to colleagues as best they can, whilst the demand for the training never appears to diminish. However, beyond th ...

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bch-vlr-scbd-278732-1
Article
08 May 2025

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Biosafety and Risk Assessment in Niger: Challenges and Solutions (Apr 2025)

Summary: To strengthen biosafety governance, Niger must invest in advanced monitoring technologies and community-driven biodiversity surveillance. Local communities play a pivotal role in early detection of biosafety risks, but addressing these challenges also requires enhanced coordination with security forces to curb illegal activities and strengthen biosafety oversight. Strengthening scientific infrastructure, implementing policy reforms, and fostering regional biosafety cooperation will be e ...

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bch-vlr-scbd-278445-2
Assessments, Policy briefs
24 Apr 2025

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Detection and identification of authorized and unauthorized GMOs using high-throughput sequencing with the support of a sequence-based GMO database (Mar 2022)

The increasing number and diversity of genetically modified organisms (GMOs) for the food and feed market calls for the development of advanced methods for their detection and identification. This issue can be addressed by next generation sequencing (NGS). However, the efficiency of NGS-based strategies depends on the availability of bioinformatic methods to find sequences of the transgenic insert and junction regions, which is a challenging topic. To facilitate this task, we have developed Nexp ...

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bch-vlr-scbd-259918-2
Article
16 Apr 2025

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Nexplorer (Jan 2022)

Nexplorer is a database containing authorised GMO events and links to their respective annotated DNA sequences, which are stored in a structured, searchable and extractable format. It is made available as a web-application offering a user-friendly interface that allows non-IT experts to manage the database and the sequences. This application gives the GMO lab a secure way to store the data by the use of functionalities such as change tracking and confidentiality management.

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bch-vlr-scbd-259917-3
Online database
16 Apr 2025

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Africa and zero hunger agenda: genome editing policy landscape, challenges and opportunities. (Mar 2025)

Abstract: Africa has historically struggled to adopt innovative agricultural technologies, which has significantly hindered efforts to ensure food security and improve livelihoods over the past century. A major obstacle in this regard has been the persistent skepticism surrounding the potential benefits of agricultural biotechnology. The challenges contributing to this skepticism include a notable knowledge gap among stakeholders, widespread technophobia, or fear of technology, as well as incons ...

Biosafety Virtual Library Resources
bch-vlr-scbd-277880-1
Article
27 Mar 2025

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What’s in (y)our food? Occurrence of GM-containing foods on the Nigerian market and compliance with national regulations (Mar 2025)

Author summary: The regulation of genetically modified (GM) food products in several jurisdictions considers appropriate labelling to be a key requirement for food safety and to ensure the protection of consumer choices. In Nigeria, such regulations are enforced by relevant government agencies. There is, however, little information on compliance levels with appropriate labeling regimes of GM products in Nigeria. This study was conducted to ascertain compliance with existing labeling guidelines a ...

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bch-vlr-scbd-277879-1
Article
27 Mar 2025

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Current status and trends in the analysis of GMO and new genomic techniques (Jan 2025)

Author summary: The detection of genetically modified organisms (GMO) is crucial for regulatory compliance and market control. Therefore, detection methods are constantly being developed and improved. New genomic techniques (NGT) present unique challenges for detection due to the minimal genetic changes they introduce. The ‘International Conference on GMO Analysis and New Genomic Techniques’ held in March 2023 in Berlin, explored advances in detection methods, such as Next-Generation Sequencing ...

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bch-vlr-scbd-276740-1
Journal
28 Jan 2025

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Quantification of Cry1Ac Protein in Bt Eggplant Fruits (Sep 2017)

Abstract: The cultivation of genetically engineered crops has been expanded rapidly in worldwide in a very short span of time. Bt eggplant is a transgenic eggplant created by inserting a crystal protein gene Cry1Ac from the soil bacterium Bacillus thuringiensis. Four Bt eggplant varieties - BARI Bt Begun-1, BARI Bt Begun-2, BARI Bt Begun-3 and BARI Bt Begun-4 are started to cultivate in Bangladesh in 2014 as first genetically engineered crop in the country. In the present study, ELISA technique ...

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bch-vlr-scbd-276424-1
Journal
16 Dec 2024

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Bioinformatics evaluation of GMO reference genes and their amplification systems (Jun 2024)

Abstract: The present report summarises the bioinformatics analyses performed by the European Union Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF) on the reference genes commonly used for detecting GM events in maize, soybean, cotton and rapeseed. The analysis had two objectives: first, to estimate the copy number of these genes in the available genomes of these species to ensure their low and constant copy number in the varieties possibly present on the market; second, ...

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bch-vlr-scbd-270623-1
Report
26 Jul 2024

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Guideline for the verification of digital PCR methods in analytical GMO testing (Jun 2024)

Author abstract: The international working group “Development of methods for identification of foodstuffs produced by means of genetic engineering techniques” was established pursuant to § 64 of the German Food and Feed Code (LFGB). It has developed a guideline for implementing and verifying digital PCR methods previously validated as real-time PCR techniques. While event-specific methods in testing of genetically modified organisms (GMO) have traditionally relied on real-time PCR, new digital P ...

Biosafety Virtual Library Resources
bch-vlr-scbd-270622-1
Article
26 Jul 2024

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Guidelines for Importation, Exportation, Handling, Labelling and Storage of Genetically Modified Mosquitoes (Apr 2022)

The emergence of gene drive technologies holds prospects for future deployment to significantly improve control and accelerate efforts towards the elimination of malaria. Current approaches can be used to either suppress malaria vector populations or to alter them such that they no longer transmit malaria. Due to the biased inheritance of traits, gene drive modified mosquitoes spread faster than the limits imposed by Mendelian inheritance. There are, however, still many unknowns regarding the sa ...

Biosafety Virtual Library Resources
bch-vlr-scbd-266927-2
Technical guide
27 May 2024

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