Scientific opinion on an application by Dow AgroSciences LLC (EFSA-GMO-NL-2012-106) for the placing on the market of genetically modified herbicide-tolerant soybean DAS-44406-6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
Abstract 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 glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/feed safety. The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS‐44406‐6 and its conventional counterpart, except for pod count, seed cou…
Arabidopsis mutant dnd2 exhibits increased auxin and abscisic acid content and reduced stomatal conductance
Arabidopsis thaliana cyclic nucleotide-gated ion channel gene 4 (AtCNGC4) loss-of-function mutant dnd2 exhibits elevated accumulation of salicylic acid (SA), dwarfed morphology, reduced hypersensitive response (HR), altered disease resistance and spontaneous lesions on plant leaves. An orthologous barley mutant, nec1, has been reported to over-accumulate indole-3-acetic acid (IAA) and to exhibit changes in stomatal regulation in response to exogenous auxin. Here we show that the Arabidopsis dnd2 over-accumulates both IAA and abscisic acid (ABA) and displays related phenotypic and physiological changes, such as, reduced stomatal size, higher stomatal density and stomatal index. dnd2 showed i…
Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)
Abstract 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 protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non‐genetically modified (GM) comparator(s) required further assessment. There were …
Potent SARS-CoV-2 mRNA Cap Methyltransferase Inhibitors by Bioisosteric Replacement of Methionine in SAM Cosubstrate
Viral mRNA cap methyltransferases (MTases) are emerging targets for the development of broad-spectrum antiviral agents. In this work, we designed potential SARS-CoV-2 MTase Nsp14 and Nsp16 inhibitors by using bioisosteric substitution of the sulfonium and amino acid substructures of the cosubstrate S-adenosylmethionine (SAM), which serves as the methyl donor in the enzymatic reaction. The synthetically accessible target structures were prioritized using molecular docking. Testing of the inhibitory activity of the synthesized compounds showed nanomolar to submicromolar IC50 values for five compounds. To evaluate selectivity, enzymatic inhibition of the human glycine N-methyltransferase invol…
Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)
The three-event stack cotton GHB614 x LLCotton25 x 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 original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events and of the newly expressed proteins in the three-event stack cotton did not give rise to food and feed safety or nutritional issues. Food and feed derived from cotton GHB614 x LLCott…
Implications of the EFSA Scientific Opinion on Site Directed Nucleases 1 and 2 for Risk Assessment of Genome-Edited Plants in the EU
Genome editing is a set of techniques for introducing targeted changes in genomes. It may be achieved by enzymes collectively called site-directed nucleases (SDN). Site-specificity of SDNs is provided either by the DNA binding domain of the protein molecule itself or by RNA molecule(s) that direct SDN to a specific site in the genome. In contrast to transgenesis resulting in the insertion of exogenous DNA, genome editing only affects specific endogenous sequences. Therefore, multiple jurisdictions around the world have exempted certain types of genome-edited organisms from national biosafety regulations completely, or on a case-by-case basis. In the EU, however, the ruling of the Court of J…
Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)
In this opinion, the GMO Panel assessed the four-event stack maize Btll x MIR162 x 1507 x 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 leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Btll …
Impact of Green Manure and Vermicompost on Soil Suppressiveness, Soil Microbial Populations, and Plant Growth in Conditions of Organic Agriculture of Northern Temperate Climate
The impact of organic amendments on the soil microorganisms and plant growth and health in conditions of organic agriculture of Northern temperate climate was analyzed. Some case studies dealing with green manure or vermicompost amendments are discussed giving deeper analyses of the vermicompost impact on plant growth. The first case study is about the impact of green manure on soil microbial populations and soil suppressiveness against such pathogens as late blight, potato scab, and black scurf of potato in organic agriculture. The second case study is about the use of vermicompost in organic starch potato cultivation. Significantly higher numbers of all groups of analyzed cultivable micro…
Phenotypic Evaluation of Spring Barley RIL Mapping Populations for Pre-harvest Sprouting, Fusarium Head Blight and β-Glucans
The overall objective of the research is to develop molecular markers which can be used in spring barley breeding. The aim of this study was to summarise phenotyping data from recombinant inbred line (RIL) populations for mapping the QTLs for resistance to pre-harvest sprouting and Fusarium head blight (FHB) as well as content of β-glucans. The field and laboratory experiments were performed at the State Priekuli Plant Breeding Institute and at the State Stende Cereal Breeding Institute for two seasons (2010–2011). The mapping populations for pre-harvest sprouting consist of 93 (RILs produced from a cross between hulless barley (HB) breeding line ‘PR 3642’ (susceptible) and HB variety ‘CDC …
Assessment of genetic diversity and relatedness in the Latvian potato genetic resources collection by DArT genotyping
Potato (Solanum tuberosumL.) has been cultivated in Latvia since the 17th century, and formal breeding programmes have been established since the start of the 20th century. The Latvian potato genetic resource collection consists of 83 accessions of Latvian origin, including landraces, old cultivars released starting from the 1930's, modern cultivars and breeding material. These are maintained in field andin vitrocollections. Pedigree information about the potato cultivars is often limited, and the use of hybrids of local cultivars as parents is common in the Latvian potato breeding programme. Ninety-four Latvian potato varieties and breeding lines and some commonly used foreign accessions w…
Development and implementation of high-throughput SNP genotyping in barley
Abstract Background High density genetic maps of plants have, nearly without exception, made use of marker datasets containing missing or questionable genotype calls derived from a variety of genic and non-genic or anonymous markers, and been presented as a single linear order of genetic loci for each linkage group. The consequences of missing or erroneous data include falsely separated markers, expansion of cM distances and incorrect marker order. These imperfections are amplified in consensus maps and problematic when fine resolution is critical including comparative genome analyses and map-based cloning. Here we provide a new paradigm, a high-density consensus genetic map of barley based…
Differential disease resistance response in the barley necrotic mutant nec1
Abstract Background Although ion fluxes are considered to be an integral part of signal transduction during responses to pathogens, only a few ion channels are known to participate in the plant response to infection. CNGC4 is a disease resistance-related cyclic nucleotide-gated ion channel. Arabidopsis thaliana CNGC4 mutants hlm1 and dnd2 display an impaired hypersensitive response (HR), retarded growth, a constitutively active salicylic acid (SA)-mediated pathogenesis-related response and elevated resistance against bacterial pathogens. Barley CNGC4 shares 67% aa identity with AtCNGC4. The barley mutant nec1 comprising of a frame-shift mutation of CNGC4 displays a necrotic phenotype and co…
Reiterative transcription initiation from galP2 promoter of Escherichia coli
The expression of gal operon in Escherichia coli is driven by two promoters, P1 and P2 separated by 5 bp. The transcription initiated from the P2 generates a large amount of abortive transcripts to produce a comparable amount of full-length transcript as P1 in vitro. In this study, we investigated the source of the abortive transcripts by employing a quantitative potassium permanganate footprinting method that determines the extent of open promoter complex formation. The extents of open promoter complex formation at the two gal promoters were about the same during the given reaction time while the amount of transcription initiation determined by in vitro transcription assay showed a conside…
Revised annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2013 from Monsanto Europe S.A
Question number: EFSA-Q-2015-00432On request from: European Commission; Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the results of the general surveillance activities contained in the revised annual post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The supplied data do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 cultivation in 2013. Similar methodological shortcomings to those observed in previous annual PME…
Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
Abstract 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, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and r…
The stem rust resistance gene Rpg5 encodes a protein with nucleotide-binding-site, leucine-rich, and protein kinase domains
We isolated the barley stem rust resistance genes Rpg5 and rpg4 by map-based cloning. These genes are colocalized on a 70-kb genomic region that was delimited by recombination. The Rpg5 gene consists of an unusual structure encoding three typical plant disease resistance protein domains: nucleotide-binding site, leucine-rich repeat, and serine threonine protein kinase. The predicted RPG5 protein has two putative transmembrane sites possibly involved in membrane binding. The gene is expressed at low but detectable levels. Posttranscriptional gene silencing using VIGS resulted in a compatible reaction with a normally incompatible stem rust pathogen. Allele sequencing also validated the candi…
Wild
Graphical abstract
Development of retrotransposon-based SSAP molecular marker system for study of genetic diversity in sea holly (Eryngium maritimum L.)
Eryngium maritimum L. is a wild plant species threatened or endangered in most of Northern Europe, where species is on the northern margin of its distribution range. Recent studies have found reduction of size and even extinction of many populations. Assessment of genetic diversity in natural populations of endangered wild plant species can reflect condition and fitness of particular population and inform decisions on appropriate conservation measures. Application of inter simple sequence repeat markers and chloroplast DNA sequencing could not resolve genetic relationship between E. maritimum populations in Northern Europe. Therefore, the more sensitive retrotransposon-sequence-specific amp…
Impact of barley (Hordeum vulgare L.) transgenic line H228.2A on substrate and rhizosphere microorganisms and the possibility of horizontal gene transfer
Numerous investigations have been carried out to determine the impact of genetically modified plants, such as potato, maize, alfalfa and tobacco, on soil microorganisms and the results are contradictory. We applied classical microbiology methods to study quantitative changes of bacterial and fungal abundance in substrate and rhizosphere from barley (Hordeum vulgare L.) transgenic line H228.2A containing Rpg1 and bar genes, and its parent nontransgenic variety ‘Golden Promise’. In addition, molecular biology methods were used to determine, if horizontal gene transfer from barley transgenic line to soil bacteria has occurred under experimental conditions by screening bacterial genomes for the…
Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐DE‐2011‐95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG taking into consideration an additional toxicological study
Abstract 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 protein (1,000 mg/kg body weight (bw) per day) to complement its scientific opinion on application EFSA‐GMO‐DE‐2011‐95 for the placing on the market of the maize 5307 for food and feed uses, import and processing. The supplementary 28‐day toxicity study did not show adverse effects. Taking into account the previous assessment and the new in…
Development and Validation of a Reversed-Phase Liquid Chromatography Method for the Simultaneous Determination of Indole-3-Acetic Acid, Indole-3-Pyruvic Acid, and Abscisic Acid in Barley (Hordeum vulgare L.)
A simple, sensitive, precise, and specific reverse HPLC method was developed and validated for the determination of plant hormones in barley (Hordeum vulgareL.). The method includes extraction in aqueous organic solvent followed by solid-phase extraction, sample evaporation, and reversed-phase HPLC analysis in a general purpose UV-visible (abscisic acid (ABA)) and fluorescence detection (indole-3-acetic acid (IAA) and indole-3-pyruvic acid (IPA)), high-performance liquid chromatography system. The separation was carried out on Zorbax Eclipse XDB C8 column (150 × 4.6 mm I.D) with a mobile phase composed of methanol and 1% acetic acid (60 : 40 v/v) in isocratic mode at a flow rate of 1 ml min…
Efficient Control of raf Gene Expression by CAP and Two Raf Repressors that Bend DNA in Opposite Directions
The plasmid-borne raf operon of Escherichia coli encodes proteins involved in the uptake and utilisation of the trisaccharide raffinose. The operon is subject to dual regulation; to negative control by the binding of RafR repressor to twin operators, O1 and O2, and to positive control by the cAMP-binding protein, CAP. We have identified the CAP binding site (CBS) as a 22 bp palindromic sequence with incomplete dyad symmetry by deletion analysis, DNasel footprinting and electrophoretic mobility shift assays (EMSA) of CAP-DNA complexes. The CBS is centred 60.5 bp upstream of the transcription start point and partially overlaps O1. In vivo, CAP increases rafA (alpha-galactosidase) gene express…
Analysis of Specific Protein-DNA Interactions
The central issue in the regulation of genome functions is the mechanism of sequence-specific protein-nucleic acid interactions. Gene expression, replication, recombination and DNA condensation in chromatin are steered by binding of regulatory protein ligands to specific sites in DNA. Numerous methods have been developed to study protein-DNA interactions. In this chapter we discuss two widely used and straightforward approaches to address this problem.
Variability of Spring Barley Traits Essential for Organic Farming in Association Mapping Population
Association mapping population consisting of 154 Latvian and foreign spring barley genotypes contrasting for traits that are important for organic agriculture was established with the aim to develop molecular markers useful in breeding for organic farming. The mapping population was genotyped at 3072 single-nucleotide polymorphism loci using Illumina GoldenGate platform to provide marker data for association mapping. Field trials in two organically and two conventionally managed locations are being carried out during three seasons. The following traits essential for organic farming were phenotyped: plant morphological traits ensuring competitive ability against weeds, grain yield in organic…
Assessment of genetically modified oilseed rape MS8, RF3 and MS8×RF3 for renewal of authorisation under regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐004)
Efsa Panel On Genetically Modified Organisms (gmo)Opinion scientificRequestor: European CommissionQuestion number: EFSA-Q-2016-00569; 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 the context of the renewal of authorisation application of the genetically modified (GM) herbicide-tolerant oilseed rape MS8, RF3 and MS89RF3. The data received in the context of this renewal application contain post-market environmental monitoring reports, systematic searches and…
Guidance on allergenicity assessment of genetically modified plants
Abstract 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 to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where …
Assessment of genetically modified maize MON 87403 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐BE‐2015‐125)
GMO; maize (Zea mays); MON 87403; ear biomass; Regulation (EC) No 1829/2003; International audience; aize 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 safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87403 and its conventional counterpart were identified. The compositional analysis of maize MON 87403 did not identify differences…
Assessment of genetically modified sugar beet H7‐1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐006)
Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor: European Commission (DG SANTE)Question number: EFSA-Q-2017-00026; Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 fromKWS SAAT SE and Monsanto Company, the Panel on Genetically Modified Organisms of the EuropeanFood Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the datasubmitted in the context of the renewal of authorisation application for the herbicide-tolerantgenetically modified sugar beet H7-1. The data received in the context of this renewal applicationcontained a systematic search and evaluation of literature, updated bioinforma…
Assessment of genetically modified cotton GHB614 × T304‐40 × GHB119 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐122)
International audience; 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 modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single cotton events and of the newly expressed proteins in the three-event stack cotton did not give rise to food and feed safety concern. The GMO P…
Increased Auxin Content and Altered Auxin Response in Barley Necrotic Mutant nec1
The role of hormone crosstalk in plant immunity is lately emerging as significant topic of plant physiology. Although crosstalk between salicylic acid and auxin affects plant disease resistance, molecular mechanisms of this process have not yet been uncovered in details. Mutations disrupting cyclic nucleotide-gated ion channel 4 (CNGC4) affect SA-mediated disease resistance in barley Hordeum vulgare and in A. thaliana. Significantly, decreased stomatal apertures of barley CNGC4 mutant nec1 and dwarfed stature of A. thaliana CNGC4 mutant dnd2 suggest that nonfunctional CNGC4 might be affecting also auxin signaling. Excised coleoptile elongation, stomatal conductance, and cell size measuremen…
Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)
Abstract 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 for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MO…
Genetic Diversity in Latvian Spring Barley Association Mapping Population
Certified organic crop area is continuously increasing in European Union and in Latvia (Eurostat data), despite somewhat lower yield and higher potential for disease damage in organic farming. It is increasingly recognized that breeding varieties for organic farming requires focus on specific traits that may be less important under conventional agriculture. Molecular markers are becoming essential tools for plant breeding allowing reducing time and cost of development of new varieties by early selection of progeny with desired traits. However, there is lack of information on molecular markers for traits that may be important for organic farming, such as plant morphological traits ensuring c…
Part C notification (reference C/NL/13/01) from Suntory Holdings Limited for the import, distribution and retailing of carnation SHD-27531-4 cut flowers with modified petal colour for ornamental use
Requestor: European CommissionQuestion number: EFSA-Q-2015-00126; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the po…
Genetic Diversity and Structure of Northern Populations of the Declining Coastal Plant Eryngium maritimum
Abstract Genetic diversity among 13 northern populations of the declining coastal plant Eryngium maritimum L. at the northernmost extent of the species distribution range was studied using retro-transposon-based SSAP molecular markers. Diversity indices varied extensively among populations; some showing extremely low diversity whereas other populations exhibited moderate amounts of genetic variation. Differentiation among populations was highly variable as well. Interestingly, differentiation among northern populations was not influenced strongly by geographic distance. Closely situated populations were often more divergent than more distant populations suggesting other factors may be respo…
Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company
Scientific opinionRequestor: Competent Authority of BelgiumQuestion number: EFSA-Q-2013-00765; In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 9 MON 89034 9 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 concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and …
Suppression of Phyllospheric Microbiota Alters Content of Pharmacologically Relevant Compounds of <i>S. nigra</i> Flowers
Accumulating scientific evidence suggests that medicinal plant-associated microbiota has a significant role in biosynthesis of pharmacologically relevant compounds. Suppression of S. nigra microbiota by an antibiotic treatment leads to a decreased emission of volatile terpenoids from S. nigra flowers and an altered metabolome of a host plant. However, it is not known if suppression of microbiota also affects an abundance of health promoting compounds and pharmacologically relevant properties of S. nigra. The present study reveals, that suppression of phyllospheric microbiota by an antibiotic treatment affects total phenolic content (TPC), anti-radical activity (ARA) and total flavonol conte…
Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)
Efsa Panel On Genetically Modified Organisms (gmo) Requestor: European Commission (DG SANTE)Question number: EFSA-Q-2016-00714Correspondence; Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, 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-tolerant genetically modified maize GA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and eval…
Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003
Abstract This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 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 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.
Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)
Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor:European Commission (DG SANTE)Question number:EFSA-Q-2017-00028; 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-tolerant and insect-resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic searc…
Comparison of soil microorganism abundance and diversity in stands of European aspen (Populus tremulaL.) and hybrid aspen (Populus tremuloidesMichx. ×P. tremulaL.)
The use of short rotation forest tree species is increasing worldwide. The hybrid aspen (Populus tremuloides Michx. × P. tremula L.) is one of the suitable tree species under the climatic conditions of the Baltic region. The cultivation of these trees on former agricultural soils differs from agricultural practices with reduced soil tillage and is characterized by increased demand of nutrients, which in long term can cause changes in the soil microbial populations. The aim of our investigation was to compare soil microbial populations in hybrid aspen and European aspen (P. tremula L.) stands in four sampling plots with aspen age ranging from 10 to 46 years. The abundance and diversity of so…
Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)
International audience; 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 authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 x NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioin…
Assessment of genetically modified maize 1507 × 59122 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐92)
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 events or their previously assessed combinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the four-event stack maize did not give rise to food and feed safety or…
Potential risk evaluation for unintended entry of genetically modified plant Propagating material in Europe through import of seeds and animal feed – the experience of Latvia
Significant attention has been drawn to the adventitious and technically unavoidable presence of genetically modified (GM) organisms in the food and feed imported into the European Union (EU), while the potential presence of GM seeds in material for cultivation is less studied. Here we report a study from an EU member state, Latvia, during years 2017–2018 regarding monitoring for the presence of GM seeds in certified seed and animal feed material. Eighty-two and 28 samples of seeds intended for cultivation were analyzed in 2017 and 2018, respectively. One soybean sample contained MON40-3-2 soybean seeds (0.09 ± 0.01%) and one maize sample contained MON810 maize seeds (0.08 ± 0.01%). In addi…
Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company
Abstract 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 concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or c…
Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
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. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411…
Risk assessment of information on the subcombination Bt11 × 1507 × GA21, related to the application of Syngenta (EFSA‐GMO‐DE‐2011‐99) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21
Efsa Panel On Genetically Modified Organisms (gmo)StatementRequestor: European CommissionQuestion number: EFSA-Q-2016-00730; 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 effects on human and animal health and the environment. In its assessment of the four-event maize stack Bt11 9 MIR162 9 MIR604 9 GA21, the GMO Panel also assessed all the subcombinations of these events not previously assesse…
Genetically modified seeds and plant propagating material in Europe: potential routes of entrance and current status
Genetically modified organisms (GMO), mainly crop plants, are increasingly grown worldwide leading to large trade volumes of living seeds and other plant material both for cultivation and for food and animal feed. Even though all the traded GMOs have been assessed for their safety with regards to human and animal health and the environment, there still are some concerns regarding the potential uncontrolled release in the environment of authorized or unauthorized GM plants. In this review, we identify the possible entrance routes of GM seeds and other propagating plant material in the EU which could be linked to unauthorized release of GMOs in the environment. In addition, we discuss the sit…
Annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.
Requestor: European CommissionQuestion number: EFSA-Q-2015-00650; 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 monitoring data do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein over the 2014 season. However, as the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates …
Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2009-66) for placing on the market of herbicide tolerant and insect resistant maize Bt11 × MIR162 × MIR604 × GA21 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003
Question number: EFSA-Q-2009-00444 on request from Competent Authority of Germany; 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 modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the four-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the singl…