Search

Abstract Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA‐GMO‐NL‐2015‐126). The applicant conducted a 90‐day feeding study on GM soybean MON 87705 and provided a proposal for post‐market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90‐day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment‐related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA‐GMO‐NL‐2015‐126 and in the supplementary toxicity study, is as safe as its non‐GM comparator and the non‐GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application.

In 2003, the European Commission established the principle of coexistence which refers to “the ability of farmers to make a practical choice between conventional, organic and GM-crop production, in compliance with the legal obligations for labelling and/or purity standards” and laid down guidelines defining the context of this coexistence1. In order to determine what is needed for the sustainable introduction of GM crops in Europe, the cross-disciplinary SIGMEA Research Project was set up to create a science-based framework to inform decision-makers. SIGMEA has (i) collated and analysed European data on gene flow and the environmental impacts of the major crop species which are likely to be transgenic in the future (maize, rapeseed, sugar beet, rice, and wheat), (ii) designed predictive models of gene flow at the landscape level, (iii) analysed the technical feasibility and economic impacts of coexistence in the principal farming regions of Europe, (iv) developed novel GMO detection methods, (v) addressed legal issues related to coexistence, and (vi) proposed public and farm scale decisionmaking tools, as well as guidelines regarding management and governance. This publishable version of the final activity report of the FP6 SIGMEA research project, covers the fourteen major issues under investigation.

Oilseed rape seed loss during harvest can cause subsequent unwanted gene flow and thus give raise to management difficulties in order to keep segmented different productions. Furthermore, seed loss reduces benefits of producers. This loss was evaluated in different conditions and trials carried out in three French regions from 2002 to 2004. Seed loss was divided into three categories : before harvest, under the cutter bar and behind the combine harvester. Total loss represented on average 8,2 % of the harvest for grain water content under 12 %. But this figure does not take an important variability into account. Indeed, an advanced cutter bar could reduce loss by 80 % and grain humidity at harvest plays an important part in the total loss level and its distribution. Before harvest low grain water content could make seed loss more sensitive to climatic events. Under the cutter bar, seed loss is inversely proportional to grain water content. On the contrary, it increases with grain water content behind the combine, due to loss in green siliquae. These studies can help improving advice to producers and contribute to improve gene flow models.

The Biomolecular Engineering Commission considers that the knowledge acquired in the last three years has provided significant information in reply to the points raised in its review dated 16 February 2001. The Commission has studied the potential environmental impacts associated with large-scale herbicidetolerantGMoilseed rape crops, making a distinction between direct and indirect impacts. Direct impacts stem from the intrinsic properties of herbicide-tolerant GM oilseed rape crops whereas indirect impacts result from practices associated with the farming of these crops. The Commission considers that, in the absence of the use of the herbicide in question in and outside of farmed land, there is no direct environmental risk (development of invasive crops per se) associated with the presence of a herbicide-tolerance gene in oilseed rape (or related species). Nevertheless, since the interest of these tolerant crops lies in the use of the herbicide in question, indirect effects, to varying extents, have been identified and must be taken into account: the use of the herbicide in question, applied to agricultural fields containing the herbicide-tolerant crop could lead to an increase in oilseed rape volunteer populations in crop rotations; the selective pressure exerted by non-specific herbicides (to which the crops have been rendered tolerant) may be very high in cases of continuous and uncontrolled use of these herbicides, and may result in the persistence of rare events such as the reproduction of fertile interspecies hybrids; the change to the range of herbicides used should be conveyed by more effective weed control and, like any change in farming practices, induce indirect effects on the agri-ecosystem, particularly in terms of changes to weeds and the associated animal life. Accordingly, the Biomolecular Engineering Commission recommends a global approach in terms of the large-scale farming of herbicide-tolerant crops that: accounts for the characteristics of the herbicide and its current and future use; accounts for herbicide-tolerant varieties belonging to other species, liable to be farmed in French agriculture in the short term; targets, if applicable, the selection of crop/herbicide combinations according to the constraints associated with French agriculture; coordinates the evaluations conducted on herbicide-tolerant crops and those conducted on herbicides; implements a biovigilance system and its associated resources whenever herbicide-tolerant crop farming is envisaged. Our report highlights the need for the management of any herbicide-tolerant GM oilseed rape crops. Such a management plan must account for the diverse cropping situations, including crop rotations and farming practices. Management should be based on the prior evaluation of situations encountered, the development of measures commensurate with the risks, and a validation of their efficacy through biovigilance. The Biomolecular Engineering Commission considers that the indirect environmental and agronomic impacts associated with current management practices employed for herbicide-tolerant oilseed rape crops can only be determined, in addition to the knowledge acquired, by continuing ongoing experimental studies initiated. Mathematical and computer models – by formalizing complex scenarios that incorporate the functioning of different oilseed rape populations (farmed, spontaneous, volunteer plants) under specific farming practices – enables the simulation of potential impacts and the identification of suitable management measures. Nevertheless, at the present time, the introduction of more extensive farming than that currently practised, or managed progressive introduction, would make it possible to progress in the study of impacts and develop and validate management procedures enabling the limitation of adverse impacts. In the specific case of imports, the Biomolecular Engineering Commission considers that herbicidetolerant GM oilseed rape seed imports for processing and animal feed does not represent additional risks for the environment compared to other oilseed rape varieties on the market. Due to the very low likelihood of the dispersal of tolerant oilseed rape crops from imported seed, the impact of the herbicides used on communication routes is considered to be negligible in the current context. However, in order to supplement the information available on environmental impacts and avert any changes to the current situation, the Commission recommends that a general monitoring plan be implemented in parallel to the introduction of seeds onto the market. Finally, the Biomolecular Engineering Commission considers that biovigilance systems adapted to the various risks should be in place before any farming of commercial herbicide-tolerant varieties is undertaken. The Biomolecular Engineering Commission considers its analysis to be valid for non-selective herbicidetolerant varieties of oilseed rape obtained both by transgenesis and by means of a technique other than transgenesis.

Gene flow in rapeseed is a process taking place both in space and over the years and cannot be studied exclusively by field trials. Consequently, the GENESYS model was developed to quantify the effects of cropping systems on transgene escape from rapeseed crops to rapeseed volunteers in neighbour plots and in the subsequent crops. In the present work, this model was used to evaluate the risk of rape harvest contamination by extraneous genes in various farming systems in case of co-existing GM, conventional and organic crops. When 50 % of the rape varieties in the region were transgenic, the rate of GM seeds in non-GM crop harvests on farms with large fields was lower than the 0.9 % purity threshold proposed by the EC for rape crop production (food and feed) harvests, but on farms with smaller fields, the threshold was exceeded. Harvest impurity increased in organic farms, mainly because of their small field size. The model was then used to evaluate the consequences of changes in farming practices and to identify those changes reducing harvest contamination. The effects of these changes depended on the field pattern and farming system. The most efficient practices in limiting harvest impurity comprised improved set-aside management by sowing a cover crop in spring on all set-aside fields in the region, permanently banning rape crops and set-aside around seed production fields and (for non-GM farmers) clustering farm fields to reduce gene inflow from neighbour fields.

The objective of foresight (future studies) is to enlighten decision-makers, by exploring collectively the sphere of possible “futures” and bringing out different scenarios for the future. CETIOM has carried out such an approach in order to assess oilseed (rapeseed and sunflower) competitiveness in France and Europe, taking into account the European and worldwide context by 2010-2015. The competition between domestic oilseeds and other sources of fats takes place at all levels of production, transformation and consumption processes. Thus, this future study has involved about 150 people from several scientific fields, economic bodies and institutions. The overall methodology used has been designed by INRA and is based on a systemic view of the various issues addressed and requires graphic representation models. Seven strategic topics have been set up at the end of this work: agricultures and their relationships with the economic environment \; the role of information on fat consumption \; the consideration of nutritional recommendations made by the transformation industries \; the evolution of animal feeding models \; the place of oilseeds within production systems \; oilseeds and the environmental challenge \; the impact of non-food uses as a driven force for oilseed development. For each of these seven topics, various scenarios were drawn up as well as their consequences on oilseed competitiveness and on the future of the economic and social sectors concerned.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north‐eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether ‘very highly’ and ‘extremely’ sensitive non‐target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non‐target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.

La spécialisation, à l’œuvre dans les exploitations françaises depuis plusieurs décennies, a remodelé le paysage agricole de l’Hexagone : la céréaliculture est aujourd’hui largement dominante dans le centre du Bassin Parisien, en Alsace ou en Aquitaine, tandis que l’Ouest de la France, qui se consacre à l’élevage intensif, donne une large place dans ses assolements, au maïs ensilage et aux prairies monospécifiques de courte durée. Cette spécialisation régionale s’accompagne d’une réduction du nombre d’espèces cultivées, et d’un raccourcissement des rotations, qui engendre des difficultés à maîtriser les populations d’adventices ou les parasites et de nombreux problèmes écologiques (perte de biodiversité; faible recyclage des éléments minéraux N, P, K...).

La diversification des cultures est souvent présentée comme un levier d’action pour accroître la durabilité des systèmes de production agricoles. Bien raisonnée, elle favorise en effet une réduction de l’usage d’intrants extérieurs à l’exploitation – pesticides, engrais, eau – et des nuisances environnementales associées à leur utilisation excessive. À l’inverse, la simplification des systèmes de culture engagée depuis plus de 40 ans s’est accompagnée d’un recours croissant aux intrants. Cependant, malgré son intérêt pour les systèmes de production en termes de durabilité écologique mais aussi économique (répartition des risques), et son inscription dans divers plans et dispositifs incitatifs, la diversification des cultures progresse peu. Les ministères en charge de l’agriculture et de l’environnement ont donc commandé à l’INRA une étude visant à identifier les freins à la diversification des cultures en France et les leviers mobilisables, par les pouvoirs publics notamment, pour la favoriser. L’hypothèse de travail est que ces freins relèvent du fonctionnement global du système agro-industriel, et de la capacité de développement de filières valorisant les cultures de diversification. L’étude a examiné un certain nombre de cas représentatifs de la diversité des filières et notamment de leurs modes d’organisation, qui déterminent la coordination et l’engagement des acteurs économiques impliqués dans le développement d’une culture de diversification.

Le processus d’intensification des élevages, entamé dans les années 1970, s’est accompagné d’un développement croissant du recours aux aliments dits « composés », fabriqués à partir de différentes matières premières pour la plupart d’origine végétale. Les pratiques de la formulation des fabricants d’aliments composés, fondées sur une très forte substituabilité des matières premières, génèrent une concurrence très forte entre ces commodités. Dans un tel contexte de marché, la valorisation de certaines espèces repose sur des mécanismes permettant de contourner ou de s’affranchir de cette concurrence, mais dont l’efficacité reste fortement dépendante de l’organisation des acteurs au sein des filières. À partir de la comparaison des filières pois et lin, nous montrons ainsi qu’au-delà de la reconnaissance de propriétés nutritionnelles spécifiques pouvant valoriser différemment certaines espèces, la coordination des acteurs le long d’une filière est déterminante dans la diffusion des incitations économiques et informationnelles nécessaires à une orientation des agriculteurs en faveur d’espèces de diversification d’intérêt agro-écologique.

All innovation in agriculture constitutes a significant and complex ecological disturbance, even if limited to a single and simple action. Indeed, whatever the nature and objective of the action, a large number of ecological processes are affected and numerous discontinuities may occur within the agro-ecosystem, in both time and space. As the GMO example illustrates, it is not sufficient to focus on direct effect of innovation, it is necessary to forecast mid- and long-term impacts of innovation with respect to the environment. Modelling phenomena appear then to be a key element to achieve this goal.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2021 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Evidence provided in the PMEM report shows that farmers growing maize MON 810 in Spain complied partially with refuge requirements, while full compliance was achieved in Portugal. Cry1Ab susceptibility tests performed on European and Mediterranean corn borer populations collected from north‐eastern Spain in 2021 indicated no symptoms of resistance evolution to maize MON 810. However, unexpected damage to maize MON 810 plants was observed in a field trial in the province of Girona (north‐eastern Spain), which may point to the presence of resistance alleles in this region. Information retrieved through farmer questionnaires and the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2021 PMEM report does not invalidate its previous conclusions on the safety of maize MON 810. The possible presence of Cry1Ab resistance alleles at frequencies leading to damage to maize MON 810 plants in Girona requires twofold actions: (1) increase monitoring efforts in this area; and (2) implement remedial measures to limit the suspected evolution and spread of resistance. As in previous years, EFSA identified shortcomings on resistance monitoring that need revision. In particular, full refuge compliance must be achieved in Spain. Moreover, the sensitivity of the monitoring plan must be increased, which can be achieved by replacing the current susceptibility assays by periodic F2 screens. EFSA also recommends the consent holder to revise the farmer questionnaires to account for the emergence of teosinte as a noxious agricultural weed in maize MON 810‐growing areas in Spain.

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA‐GMO‐NL‐2015‐126). The applicant conducted a 90‐day feeding study on GM soybean MON 87705 and provided a proposal for post‐market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90‐day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment‐related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA‐GMO‐NL‐2015‐126 and in the supplementary toxicity study, is as safe as its non‐GM comparator and the non‐GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north‐eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether 'very highly' and 'extremely' sensitive non‐target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non‐target lepidoptera to maize MON 810 pollen is reduced to levels of no concern. [ABSTRACT FROM AUTHOR]

Abstract Teosinte, wild maize relatives originating from Mexico and Central America, emerged as a noxious agricultural weed in France and Spain. In 2016, the European Food Safety Authority (EFSA) issued a technical report that assessed the available scientific information on teosinte for its relevance for the environmental risk assessment (ERA) and risk management (RM) of genetically modified (GM) maize MON810, Bt11, 1507 and GA21 for cultivation. It was concluded that the impact of insect resistance and/or herbicide tolerance in GM teosinte hybrid progeny (potentially acquired through hybridisation between GM maize and teosinte) on target and non‐target organisms, the abiotic environment and biogeochemical cycles would be very low under EU conditions. Following a request of the European Commission, EFSA evaluated whether the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, or require revision in light of new scientific evidence on teosinte that has become available since the publication of EFSA (2016). A protocol was developed to clarify the interpretation of the terms of reference of the mandate and make them operational. The assessment relied on evidence retrieved via an extensive literature search and from reports of the Competent Authorities of France and Spain, and on hearing expert testimonies. A limited collection of 18 publications of varying relevance and quality was retrieved and assessed. Based on this evidence, it is concluded that the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, except those pertaining to the use of glyphosate‐based herbicides on maize GA21 which should be considered under Regulation (EC) No 1107/2009. In infested agricultural areas (especially in regions where maize MON810 is widely grown), weed management measures implemented to monitor, control and/or eradicate teosinte must remain in place, as they will contribute to further reduce the low vertical gene flow potential between GM maize and EU teosinte.

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2021 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Evidence provided in the PMEM report shows that farmers growing maize MON 810 in Spain complied partially with refuge requirements, while full compliance was achieved in Portugal. Cry1Ab susceptibility tests performed on European and Mediterranean corn borer populations collected from north‐eastern Spain in 2021 indicated no symptoms of resistance evolution to maize MON 810. However, unexpected damage to maize MON 810 plants was observed in a field trial in the province of Girona (north‐eastern Spain), which may point to the presence of resistance alleles in this region. Information retrieved through farmer questionnaires and the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2021 PMEM report does not invalidate its previous conclusions on the safety of maize MON 810. The possible presence of Cry1Ab resistance alleles at frequencies leading to damage to maize MON 810 plants in Girona requires twofold actions: (1) increase monitoring efforts in this area; and (2) implement remedial measures to limit the suspected evolution and spread of resistance. As in previous years, EFSA identified shortcomings on resistance monitoring that need revision. In particular, full refuge compliance must be achieved in Spain. Moreover, the sensitivity of the monitoring plan must be increased, which can be achieved by replacing the current susceptibility assays by periodic F2 screens. EFSA also recommends the consent holder to revise the farmer questionnaires to account for the emergence of teosinte as a noxious agricultural weed in maize MON 810‐growing areas in Spain. [ABSTRACT FROM AUTHOR]