Adinda De Schrijver

Sciensano

CRISPR-Cas-based genome editing allows for precise and targeted genetic modification of plants. Nevertheless, unintended off-target edits can arise that might confer risks when present in gene-edited food crops. Through an extensive literature review we gathered information on CRISPR-Cas off-target edits in plants. Most observed off-target changes...

Synthetic Biology (SynBio) is an interdisciplinary field at the interface of engineering and biology aiming to develop new biological systems and impart new functions to living cells. EFSA has been asked by the European Commission to evaluate SynBio developments in agri‐food with the aim of identifying the adequacy of existing guidelines for risk a...

Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment f...

As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No?503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, ), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has...

In this opinion, the GMO Panel assessed the four-event stack maize Bt11 × MIR162 × 1507 × GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations l...

Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of autho...

The three-event stack cotton GHB614 x T304-40 x GHB119 was produced by conventional crossing to combine three single events, GHB614, T304-40 and GHB119. The genetically modified organisms (GMO) Panel previously assessed the three single cotton events and did not identify safety concerns. No new data on the single cotton events that could lead to mo...

Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate-containing herbicides by the expression of a CP4 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) gene. T...

Maize 4114 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate-ammonium by expression of the PAT pr...

The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28-day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28-day toxicity study in mice on the eCry3.1Ab pr...

The three-event stack cotton GHB614 × LLCotton25 × MON 15985 was produced by conventional crossing to combine three single cotton events, GHB614, LLCotton25 and MON 15985. The EFSA GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events that could lead to modification of the origi...

Maize MON 87403 was developed to increase ear biomass at early reproductive phase through the expression of a modified AtHB17 gene from Arabidopsis thaliana, encoding a plant transcription factor of the HD-Zip II family. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed saf...

Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-to...

Abstract The GMO Panel has previously assessed the single events Bt11, 59122, MIR604, 1507 and GA21 as well as different stacked events corresponding to combinations of these events and no safety concerns were identified. In its assessment of the five‐event maize stack Bt11 × 59122 × MIR604 × 1507 × GA21 (application EFSA‐GMO‐DE‐2011‐99), the GMO P...

Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 from KWS SAAT SE and Monsanto Company, the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation applicat...

This document provides guidance for the risk assessment under Regulation (EC) No1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum...

Following the submission of application EFSA-GMO-RX-004 under Regulation (EC) No 1829/2003 from Bayer CropScience, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in thecontext of the renewal of authorisation application of the gene...

In this opinion, the GMO Panelassessed the four-event stack maize 1507 x 59122 x MON810 x NK603 and its ten subcombinations, independently of their origin. The GMO Panelpreviously assessed the four single events combined in this four-event stack maize and five of their combinations and did not identify safety concerns. No new data on the single eve...

Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No1829/2003 from Syngenta Crop Protection NV/SA, the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMOPanel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application...

In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 × MON 89034 × NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three-event stack maize and did not identify safety conc...

In this opinion, the GMO Panel assessed the five-event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five-event stack maize and 11 subcombinations of these events and did not identify safety...

This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non-IgE-mediated adverse immune reactions t...

Following the submission of application EFSA-GMO-RX-003 under Regulation (EC) No 1829/2003 from Pioneer Overseas Corporation and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of...

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2015 growing season of the Cry1Ab-expressing maize event MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that...

In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO) assesses the two-event stack soybean FG72 × A5547-127 for food and feed uses, import and processing. The EFSA GMO Panel previously assessed the two single events combined to produce the two-event stack soybean FG72 × A5547-127 and did not identify safety concerns. No new data o...

In this opinion, the GMO Panel assessed the three-event stack oilseed rape (OSR) MON 88302 × MS8 × RF3 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the single events combined to produce this three-event stack OSR and did not identify safety concerns; no new information that would modify the ori...

Soybean DAS-68416-4 was developed by Agrobacterium tumefaciens-mediated transformation to express the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the phosphinothricin acetyltransferase (PAT) protein, conferring tolerance to glufosinate amm...

Soybean DAS-44406-6 expresses 5-enolpyruvyl-shikimate-3-phosphate synthase (2mEPSPS), conferring tolerance to glyphosate-based herbicides, aryloxyalkanoate dioxygenase (AAD-12), conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase (PAT), conferring tolerance to...

The EFSA Panel on Genetically Modified Organisms (GMO) has previously assessed the single events Bt11, MIR162, MIR604 and GA21 as well as different stacked events corresponding to combinations of these events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential e...

Cotton MON 88701 was developed through Agrobacterium tumefaciens-mediated transformation to express the dicamba mono-oxygenase (DMO) protein, conferring tolerance to dicamba, and the phosphinothricin N-acetyltransferase PAT protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics...

Following the submission of application EFSA-GMO-RX-001 under Regulation (EC) No 1829/2003 from Pioneer Overseas Corporation and Dow Agrosciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the frame of a renewal of auth...

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scie...

Maize DAS-40278-9 was developed by direct Whiskers-mediated transformation to express the aryloxyalkanoate dioxygenase-1 (AAD-1) protein, conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) herbicides. The molecular characterisation of maize DAS-40278-9 did not raise safety issues. The agronomic, pheno...

The EFSA Panel on Genetically Modified Organisms (GMO Panel) has previously assessed genetically modified (GM) maize DAS-59122-7 as a single event as well as part of several stacked events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and...

Soybean DAS-81419-2 was developed by Agrobacterium tumefaciens-mediated transformation. It expresses the Cry1F and Cry1Ac proteins to confer resistance to certain lepidopteran species and the PAT protein that confers tolerance to glufosinate ammonium-based herbicides and that was used as a selectable marker gene. The molecular characterisation of s...

The potential risks that genetically modified plants may pose to non-target organisms and the ecosystem services they contribute to are assessed as part of pre-market risk assessments. This paper reviews the early tier studies testing the hypothesis whether exposure to plant-produced Cry34/35Ab1 proteins as a result of cultivation of maize 59122 is...

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the relevance of the Hofmann et al. (2016) publication for the environmental risk assessment and risk management of the Bt-maize events MON810, Bt11 and 1507 for cultivation. Hofmann et al. (2016) reported data on pollen deposition on maize and weed...

In this opinion, the EFSA GMO Panel assesses the five-event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five-event stack maize Bt11 × 59122 × MIR604 × 1507 × GA21 and did not identify safety concerns. No new data on the s...

The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the two single events combined to produce soybean 305423 × 40-3-2 and did not identify safety concerns. No new data on the single events affecting the original conclusions were identified. Based on the molecular, agronomic, phenotypic a...

The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed the three single events that are combined to produce the three-event stack oilseed rape (OSR) MS8 3 RF3 3 GT73. In this Scientific Opinion, the GMO Panel assessed the three-event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 3 GT73 and RF3...

Following a request from the European Commission, the European Food Safety Authority (EFSA) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of genetically modified oilseed rape Ms8, Rf3 and Ms8×Rf3 for food and feed uses in Austria. EFSA assessed wheth...

Following a request from the European Commission, the European Food Safety Authority (EFSA) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of genetically modified oilseed rape GT73 for food and feed uses in Austria. EFSA assessed whether the submitted...

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2014 growing season of maize MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monito...

The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation FLO-40685-2 cut flowers to be imported into the EU for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the newly intro...

The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the three single events combined to produce a three-event stack cotton 281-24-236 9 3006-210-23 9 MON 88913 and did not identify safety concerns. In this opinion, the GMO Panel assesses only the three-event stack cotton. No new data on...

Cotton GHB119 was developed by Agrobacterium tumefaciens-mediated transformation. It expresses the Cry2Ae and phosphinothricin acetyltransferase (PAT) proteins which, respectively, confer resistance to certain lepidopteran species and tolerance to glufosinate ammonium-based herbicides. The molecular characterisation of cotton GHB119 did not give ri...

The EFSA GMO Panel previously assessed the four single events combined to produce a four-event stack maize Bt11 × MIR162 × MIR604 × GA21 and did not identify safety concerns. In this opinion, the EFSA GMO Panel assesses the four-event stack maize and all its subcombinations independently of their origin. No new data on the single events, leading to...

In 2007, 2010 and 2011, the European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO Panel) concluded the assessment of genetically modified (GM) maize GA21, MIR604 x GA21 and MIR604 x GA21 x Bt11. These were xfound to be as safe as their conventional counterparts and other appropriate comparators with respect to potential...

The EFSA GMO Panel previously assessed the two single events that are combined to produce soybean MON 87769 × MON 89788 and did not identify safety concerns. No new data on these single events, leading to a modification of the original conclusions on safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean MON...

Background Legislations and international organizations provide a framework to ensure proper risk assessment of Genetically Modified Organisms (GMO). With regard to the deliberate release of GMO as food or feed, applications for Genetically Modified Plants (GMP) typically contain data for the molecular characterisation at the nucleic acid level bas...

In recent years, different Bacillus thuringiensis (Bt) toxin-encoding genes have been combined or 'stacked' in genetically modified (GM) crops. Synergism between Bt proteins may occur and thereby increase the impact of the stacked GM event on nontarget invertebrates compared to plants expressing a single Bt gene. On the basis of bioassay data avail...

The principles for the safety assessment of genetically modified (GM) organisms (GMOs) are harmonised worldwide to a large extent. There are, however, still differences between the European GMO regulations and the GMO regulations as they have been formulated in other parts of the world. One of these differences relates to the so-called 'stacked GM...

Genes expressing Bacillus thuringiensis (Bt) toxins have been incorporated into genetically modified (GM) plants to render these resistant to certain insect pests. Of particular interest have been the genes encoding Cry (Crystal) proteins, but also the gene encoding the vegetative insecticidal protein Vip3Aa has been incorporated into crop plants....

Most regulatory authorities require that developers of genetically engineered insect-resistant (GEIR) crops evaluate the potential for these crops to have adverse impacts on valued non-target organisms (NTOs), i.e., organisms not intended to be controlled by the trait. In many cases, impacts to NTOs are assessed using surrogate species, and it is c...

Environmental risk assessments (ERA) support regulatory decisions for the commercial cultivation of genetically modified (GM) crops. The ERA for terrestrial agroecosystems is well-developed, whereas guidance for ERA of GM crops in aquatic ecosystems is not as well-defined. The purpose of this document is to demonstrate how comprehensive problem for...

Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms: Conference Proceedings Most regulatory authorities require that developers of genetically engineered insect-resistant crops evaluate the potential for these crops to have adverse impacts on organisms not intend...

This review paper explores whether the cultivation of the genetically modified Bt-maize transformation event MON 88017, expressing the insecticidal Cry3Bb1 protein against corn rootworms (Coleoptera: Chrysomelidae), causes adverse effects to non-target organisms (NTOs) and the ecological and anthropocentric functions they provide. Available data do...

The use of genetically modified plants for large-scale production of recombinant compounds for pharmaceutical or industrial use, known as plant molecular farming, holds several promises. However, any development in this field must be counterbalanced by a thorough evaluation of risks to human health and the environment. The possible impact of accide...

This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussio...

According to European Union (EU) legislation, genetically modified (GM) crops released for commercial cultivation have to be monitored. Here we summarise the discussion of a working group that convened during the 4th International Workshop on Post Market Environmental Monitoring (PMEM) of Genetically Modified Plants in Quedlinburg from 3–4 May 2010...

According to European Union (EU) legislation, genetically modified (GM) crops released for commercial cultivation have to be monitored. Here we summarise the discussion of a working group that convened during the 4th International Workshop on Post Market Environmental Monitoring (PMEM) of Genetically Modified Plants in Quedlinburg from 3-4 May 2010...

Biosafety relates to the evaluation of the potential risks to human health and the environment associated with the use of genetically modified organisms (GMOs) or pathogenic organisms. The first European Directives on biosafety were adopted in 1990. Since then, biosafety has evolved considerably at Belgian, European and international level. The Sc...

A major objective of the European Commission Monitoring Working Group (MWG) on Guidance Notes supplementing Annex VII of Directive 2001/18/EC was to explore the possibility of European Union (EU)-wide coordination and harmonisation of data resulting from monitoring of genetically modified (GM) crops. Firstly, we present concepts for the coordinati...

In order to estimate the introgressive hybridisation propensity (IHP) between genetically modified (GM) oilseed rape (Brassica napus) and certain of its cross-compatible wild/weedy relatives at the landscape level, a conceptual approach was developed. A gene flow index was established enclosing the successive steps to successfully achieve introgres...

To estimate the introgressive hybridisation propensity (IHP) between transgenic oilseed rape and certain of its crosscompatible wild /weedy relatives at the landscape level, a conceptual approach was developed. A questionnaire was established enclosing the successive steps to successfully achieve introgressive hybridisation. Each step was described...

The determination of the presence of genetically modified plant material by the detection of expressed genetically engineered proteins using lateral flow protein strip tests has been evaluated in different matrices. The presence of five major genetically engineered proteins (CP4-EPSPS, CryIAb, Cry9C, PAT/pat and PAT/bar protein) was detected at low...

The risk assessment of GM stacked events, which are considered as a new GMO in the EU, could be less extensive than the assessment of the parental GM events. This will be the case when the latter have been proven to be safe for the human health and the environment for the same uses as the GM stacked event. Criteria for the risk assessment of GM sta...

This article reviews several research challenges for GMO detection as some pending questions still exist and need more research efforts to be solved. The question of how to apply validation in a modular scheme is handled. It is followed by the problem of how to manage the detection of an always increasing number of new events and the fact that in s...

The ongoing discussion on the co-existence between genetically modified (GM) and non-GM crops becomes more important in the European Union (EU). With the recent inscription of 17 GM maize varieties in the common EU catalogue of varieties of agricultural plant species, the acreage of transgenic maize for market purposes is expected to increase in so...

The potential commercialization of genetically modified herbicide-tolerant (GMHT) oilseed rape in Europe raises various concerns about their potential environmental and agronomic impacts, especially those associated with the escape of transgenes. Pollen of oilseed rape can be dispersed in space, resulting in the fertilization of sympatric compatibl...

Purified thiocarbamate-inducible ThcF of Rhodococcus erythropolis NI86/21, overexpressed in Escherichia coli, displayed several characteristics of the HASH family of enzymes that groups prokaryotic proteins of the alpha/beta hydrolase superfamily possessing serine-dependent hydrolase and/or haloperoxidase activity. Kinetic analysis of bromination a...

Purified thiocarbamate-inducible ThcF of Rhodococcus erythropolis NI86/21, overexpressed in Escherichia coli, displayed several characteristics of the HASH family of enzymes that groups prokaryotic proteins of the α/β hydrolase superfamily possessing serine-dependent hydrolase and/or haloperoxidase activity. Kinetic analysis of bromination and este...

Actinomycetes have considerable potential for the biotransformation and biodegradation of pesticides. Members of this group of Gram-positive bacteria have been found to degrade pesticides with widely different chemical structures, including organochlorines, s-triazines, triazinones, carbamates, organophosphates, organophosphonates, acetanilides, an...

The complete nucleotide sequence of the 5936 bp cryptic plasmid pFAJ2600 from Rhodococcus erythropolis NI86/21 was determined. Based on the characteristics of its putative replication genes, repA and repB, pFAJ2600 was assigned to the family of pAL5000-related small replicons identified in Mycobacterium (pAL5000), Corynebacterium (pXZ10142), Brevib...

A new protocol for the isolation of RNA from Rhodococcus and other actinomycetes such as Mycobacterium and Amycolatopsis was developed. The method is based on rapid lysis of cells in a high-speed reciprocal shaker using small abrasive particles followed by spin column purification of the lysate. This quick procedure yields RNA preparations suitable...