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This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6443/full.

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 analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between cotton MON 88701 and its conventional counterpart. Since complete compositional results were reported for only three sites, the EFSA Panel on Genetically Modified Organisms (GMO Panel) is not in the position to complete the assessment of the compositional analysis. Moreover, as no 28‐day toxicity study in rodents on the MON 88701 DMO protein was provided, the GMO Panel is not in the position to complete the safety assessment of this protein in cotton MON 88701. Consequently, the GMO Panel cannot complete the toxicological, allergenicity and nutritional assessment of food/feed derived from cotton MON 88701. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the PAT protein newly expressed in cotton MON 88701. Considering the routes of exposure and limited exposure levels, the GMO Panel concludes that cotton MON 88701 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88701. In conclusion, in the absence of an appropriate comparative assessment and an appropriate assessment of the MON 88701 DMO protein, the GMO Panel is not in a position to complete its food/feed risk assessment of cotton MON 88701. The GMO Panel concludes that the cotton MON 88701 is unlikely to have any adverse effect on the environment in the context of the scope of the application.

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 authorisation application of the insect-resistant and herbicide-tolerant genetically modified (GM) maize 1507. The data package received in the frame of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, an updated bioinformatics analysis and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed this data package for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the frame of the original application. Under the assumption that the DNA sequence of the event in maize 1507 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that no new hazards or modified exposure and no new scientific uncertainties were identified for the application for renewal that would change the conclusions of the original risk assessment on maize 1507 (EFSA, 2005b, 2009).

EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1296/full

In this opinion, the GMO Panel assessed the three-event stack oilseed rape (OSR) MON 88302 x MS8 x 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 original conclusions was identified. The combination of the single OSR events and of the newly expressed proteins in the three-event stack OSR does not give rise to food and feed safety and nutrition issues -based on the molecular, agronomic/phenotypic and compositional characteristics. In the case of accidental release of viable OSR MON 88302 x MS8 x RF3 seeds into the environment, the three-event stack OSR would not raise environmental safety concerns. The GMO Panel therefore concluded that the three-event stack OSR is as safe and as nutritious as its conventional counterpart and the tested non-GM reference varieties in the context of the scope of this application. Since no new safety concerns were identified for the previously assessed two-event stack OSR MS8 x RF3, the GMO Panel considered that its previous conclusions on this subcombination remain valid. For the two subcombinations MON 88302 x MS8 and MON 88302 x RF3 for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their different combinations would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed OSR MS8 x RF3, and OSR MON 88302 x MS8 x RF3. Since the post-market environmental monitoring plan for the three-event stack OSR does not include any provisions for two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Crop diversification represents a key lever to support the development of sustainable agri-food systems. Knowledge on trade-offs and carry over effects from different crop diversification strategies is essential to inform agricultural stakeholders of potential costs and benefits. This knowledge is limited by existing data and performance measures predominantly focused on single crops, rather than complete rotations. Moreover, sustainability performance indicators are often used for assessment purposes, rather than supporting stakeholder learning and actions. A new set of 32 indicators was developed to address these needs, and used to evaluate the environmental, economic and social sustainability of the diversified agricultural systems highlighted in the case studies, which are often characterized by data availability constraints. This approach was tested in France, Germany and Italy to determine a critical ex-post diagnosis of the existing systems, and for the assessment of ex-ante innovative scenarios. The results will be used to support these case studies in the identification and design of more sustainable agricultural systems. Although the framework is based on feasible and proxy indicators, the assessment outcomes have allowed local actors to reflect on the effects generated by the implemented crop diversification strategies. Key issues include trade-offs occurring between optimizing economic and environmental performance.

Monitoring pesticide use is essential for assessing farming practices and the risks associated with the use of pesticides. Currently, there are neither consolidated, public data available on glyphosate use in Europe, nor a standardized categorization of its major uses. In this study, data on glyphosate sales and use in Europe were collected from multiple sources and compiled into a dataset of the agricultural use of glyphosate from 2013 to 2017. The survey shows that glyphosate represented 33% of the herbicide volume sold in Europe in 2017. One third of the acreage of annual cropping systems and half of the acreage of perennial tree crops received glyphosate annually. Glyphosate is widely used for at least eight agronomic purposes, including weed control, crop desiccation, terminating cover crops, terminating temporary grassland and renewing permanent grassland. Glyphosate use can be classified into occasional uses&mdash, i.e., exceptional applications, triggered by meteorological conditions or specific farm constraints&mdash, and recurrent uses, which are widespread practices that are embedded in farming systems and for which other agronomic solutions may exist but are not frequently used. This article proposes a framework for the precise monitoring of glyphosate use, based on the identification of the cropping systems in which glyphosate is used, the agronomic purposes for which it is employed, the dose used and the rationale behind the different uses.

Currently, European farmers do not have access to sufficient numbers and diversity of crop species/varieties. This prevents them from designing cropping systems more resilient to abiotic and biotic stresses. Crop diversification is a key lever to reduce pest (pathogens, animal pests and weeds) pressures at all spatial levels from fields to landscapes. In this context, plant breeding should consist of: (1) increased efforts in the development of new or minor crop varieties to foster diversity in cropping systems, and (2) focus on more resilient varieties showing local adaptation. This new breeding paradigm, called here 'breeding for integrated pest management (IPM)', may boost IPM through the development of cultivars with tolerance or resistance to key pests, with the goal of reducing reliance on conventional pesticides. At the same time, this paradigm has legal and practical implications for future breeding programs, including those targeting sustainable agricultural systems. By putting these issues into the context, this article presents the key outcomes of a questionnaire survey and experts' views expressed during an EU workshop entitled 'Breeding for IPM in sustainable agricultural systems'. © 2017 Society of Chemical Industry.

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 MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM soybean reference varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

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 that require further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the AtHB17113 protein, as expressed in maize MON 87403. The nutritional value of food and feed derived from maize MON 87403 is not expected to differ from that of food and feed derived from non-genetically modified (GM) maize varieties. Based on the outcome of the studies considered in the comparative analysis and molecular characterisation, the GMO Panel concludes that maize MON 87403 is as safe and nutritious as the conventional counterpart and the non-GM maize reference varieties tested. In the case of accidental release of viable maize MON 87403 grains into the environment, maize MON 87403 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87403. In conclusion, the GMO Panel considers that maize MON 87403, as described in this application, is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to potential effects on human and animal health and the environment. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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 LLCotton25 x MON 15985 are expected to have the same nutritional impact as those derived from the non-GM comparator. In the case of accidental release of viable GHB614 x LLCotton25 x MON 15985 cottonseeds into the environment, this three-event stack cotton would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 x LLCotton25 x MON 15985. In conclusion, the GMO Panel considers that cotton GHB614 x LLCotton25 x MON 15985, as described in this application, is as safe as the non-GM comparator with respect to potential effects on human and animal health and the environment. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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 x MIR162 x 1507 x GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non-GM maize varieties. In the case of accidental release of viable grains of maize Btll x MIR162 x 1507 x GA21 into the environment, this would not raise environmental safety concerns. The GMO Panel concludes that maize Btll x MIR162 x 1507 x GA21 is nutritionally equivalent to and as safe as its non-GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Btll x MIR162 x 1507 x GA21 and its subcombinations. A minority opinion expressed by a GMO Panel member is appended to this opinion. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411-derived food and feed is expected to be the same as those derived from the conventional counterpart and non-GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non-GM maize reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87411 grains into the environment, maize MON 87411 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87411. The GMO Panel concludes that maize MON 87411, as described in this application, is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to potential effects on human and animal health and the environment. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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 no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non‐GM maize varieties and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non‐GM comparator(s) and non‐GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

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 Panel considers that the three-event stack cotton GHB614 x T304-40 x GHB119 has the same nutritional impact as its comparator and the non-GM reference varieties tested. The GMO Panel concludes that the three-event stack cotton GHB614 x T304-40 x GHB119, as described in this application, is nutritionally equivalent to and as safe as its comparator and the non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable GHB614 x T304-40 x GHB119 cottonseeds into the environment, this three-event stack would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 x T304-40 x GHB119 seeds. The GMO Panel concludes that cotton GHB614 x T304-40 x GHB119, as described in this application, is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

We developed a simulation model for quantifying the spatio-temporal distribution of contaminants (e.g., xenobiotics) and assessing the risk of exposed populations at the landscape level. The model is a spatio-temporal exposure-hazard model based on (i) tools of stochastic geometry (marked polygon and point processes) for structuring the landscape and describing the exposed individuals, (ii) a dispersal kernel describing the dissemination of contaminants from polygon sources, and (iii) an (eco)toxicological equation describing the toxicokinetics and dynamics of contaminants in affected individuals. The model was implemented in the briskaR package (biological risk assessment with R) of the R software. This article presents the model background, the use of the package in an illustrative example, namely, the effect of genetically modified maize pollen on nontarget Lepidoptera, and typical comparisons of landscape configurations that can be carried out with our model (different configurations lead to different mortality rates in the treated example). In real case studies, parameters and parametric functions encountered in the model will have to be precisely specified to obtain realistic measures of risk and impact and accurate comparisons of landscape configurations. Our modeling framework could be applied to study other risks related to agriculture, for instance, pathogen spread in crops or livestock, and could be adapted to cope with other hazards such as toxic emissions from industrial areas having health effects on surrounding populations. Moreover, the R package has the potential to help risk managers in running quantitative risk assessments and testing management strategies.

The general purpose of the primary and secondary data available in this article is to support an integrated assessment of scenarios of crop-livestock integration at the territorial level i.e. of exchanges between arable and livestock farms. The data is a result of a research collaboration between the scientist from INRAE, agricultural advisers from Chamber of Agriculture of Pays de la Loire (CRAPL) and a collective of five arable and two livestock farmers located in the district of Pays de Pouzauges (Vendee department, western France). All participants formed part of the DiverIMPACTS project ( https://www.diverimpacts.net/ ) that aims to achieve the full potential of diversification of cropping systems for improved productivity, delivery of ecosystem services and resource-efficient and sustainable value chains in Europe. The first dataset corresponds to the inputs of MAELIA ( http://maelia-platform.inra.fr/ ), a spatial agent-based simulation platform that was used to support an iterative design and assessment of scenarios to redesign cropping systems. The second dataset corresponds to the outputs of MAELIA simulations and the associated indicators at the farm, group and territory level. The data comprise multiple shape and csv files characterizing the edaphic-climatic heterogeneity of the territory and cropping systems, farmers’ crop management rules (IF-THEN rules) and general information about the farms (e.g. crops, agricultural equipment, average crop yields). Data is reported for the baseline situation and three exchange scenarios containing different innovative cropping systems co-designed by scientists, agricultural advisers and the farmers. The data presented here can be found in the Portail Data INRA repository ( https://doi.org/10.15454/3ZTCF5 ) and were used in the research article “Fostering local crop-livestock integration via legume exchanges using an innovative integrated assessment and modelling approach: MAELIA” [1] .

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 nutritional issues. The GMO Panelconcludes that the four-event stack maize is as safe and as nutritious as its non-GM comparator. In the case of accidental release of viable grains of maize 1507 x 59122 x MON810 x NK603 into the environment, this would not raise environmental safety concerns. For four of the subcombinations not previously assessed, protein expression data were provided and did not indicate an interaction affecting the levels of the newly expressed proteins in these subcombinations. The five subcombinations not previously assessed are expected to be as safe as the single maize events, the previously assessed subcombinations and the four-event stack maize. The GMO Panelconsiders that post-market monitoring of maize 1507 x 59122 x MON810 x NK603 and its subcombinations is not necessary. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 1507 x 59122 x MON810 x NK603 and its subcombinations. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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 evaluation of literature, updated bioinformatics analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize GA21 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-005 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize GA21.

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., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1329/full

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 compositional characteristics – regarding food and feed safety and nutrition. Considering the scope of this application, the known biological function of the newly expressed proteins and the data available for the five‐event stack maize and its previously assessed maize subcombinations, the GMO Panel considered that different combinations of the single events would not raise environmental concerns. The GMO Panel concludes that the five‐event stack maize is as safe and as nutritious as the non‐genetically modified (GM) comparator and the tested non‐GM reference varieties in the context of its scope. For the 14 maize subcombinations for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and maize MON 87427 ×MON 89034 × 1507 × MON 88017 × 59122. Since the post‐market environmental monitoring plan for the five‐event stack maize does not include any provisions for the 14 maize subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

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 evaluation of literature, updated bioinformatics analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape MS8, RF3 and MS89RF3 considered for renewed authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the context of this renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS89RF3.

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 appropriate., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1259/full

EU agriculture is currently in transition from conventional crop protection to integrated pest management (IPM). Because biocontrol is a key component of IPM, many European countries recently have intensified their national efforts on biocontrol research and innovation (R&I), although such initiatives are often fragmented. The operational outputs of national efforts would benefit from closer collaboration among stakeholders via transnationally coordinated approaches, as most economically important pests are similar across Europe. This paper proposes a common European framework on biocontrol R&I. It identifies generic R&I bottlenecks and needs as well as priorities for three crop types (arable, vegetable and perennial crops). The existing gap between the market offers of biocontrol solutions and the demand of growers, the lengthy and expensive registration process for biocontrol solutions and their varying effectiveness due to variable climatic conditions and site-specific factors across Europe are key obstacles hindering the development and adoption of biocontrol solutions in Europe. Considering arable, vegetable and perennial crops, a dozen common target pests are identified for each type of crop and ranked by order of importance at European level. Such a ranked list indicates numerous topics on which future joint transnational efforts would be justified. © 2016 Society of Chemical Industry

International audience; Conventionally bred (CHT) and genetically modified herbicide-tolerant (GMHT) crops have changed weed management practices and made an important contribution to the global production of some commodity crops. However, a concern is that farm management practices associated with the cultivation of herbicide-tolerant (HT) crops further deplete farmland biodiversity and accelerate the evolution of herbicide-resistant (HR) weeds. Diversification in crop systems and weed management practices can enhance farmland biodiversity, and reduce the risk of weeds evolving herbicide resistance. Therefore, HT crops are most effective and sustainable as a component of an integrated weed management (IWM) system. IWM advocates the use of multiple effective strategies or tactics to manage weed populations in a manner that is economically and environmentally sound. In practice, however, the potential benefits of IWM with HT crops are seldom realized because a wide range of technical and socio-economic factors hamper the transition to IWM. Here, we discuss the major factors that limit the integration of HT crops and their associated farm management practices in IWM systems. Based on the experience gained in countries where CHT or GMHT crops are widely grown and the increased familiarity with their management, we propose five actions to facilitate the integration of HT crops in IWM systems within the European Union

International audience; Integrated pest management (IPM) is facing both external and internal challenges. External challenges include increasing needs to manage pests (pathogens, animal pests and weeds) due to climate change, evolution of pesticide resistance as well as virulence matching host resistance. The complexity of designing effective pest management strategies, which rely less heavily on the use of conventional pesticides, is another external challenge. Internal challenges include organizational aspects such as decreasing trend in budget allocated to IPM research, increasing scarcity of human expertise, lack of knowledge transfer into practice and the communication gap both at country level and between countries, and lack of multi-, inter- and transdisciplinary IPM research. There is an increasing awareness that trans-national networking is one means to overcome such challenges and to address common priorities in agriculture. A large number of stakeholders (researchers, policy makers, growers and industries) are involved in the sector of crop protection, which needs to be coordinated through effective communications and dynamic collaboration to make any IPM strategy successful. Here we discuss a decade-long IPM networking experiences in Europe emphasizing how IPM research, implementation and adoption in Europe may benefit from a broader level networking.

International audience; Crop diversification is considered as a major lever to increase the sustainability of arable farming systems, allowing reduced inputs (irrigation water, pesticides, fertilizers), increasing the heterogeneity of habitat mosaics, or reducing yield gap associated with too frequent returns of the same species. To free up paths of collective action, this article highlights obstacles to crop diversification, existing at various levels of the value chains. We used a threefold approach: (i) a cross-cutting analysis of impediments to the development of 11 diversifying crops (5 species of grain legumes, alfalfa, flax, hemp, linseed, mustard, sorghum), based on published documents and on 30 interviews of stakeholders in French value chains; (ii) a detailed study (55 semi-structured surveys, including 39 farmers) of three value chains: pea and linseed for animal feed, hemp for insulation and biomaterials; and (iii) a bibliometric analysis of the technical journals and websites (180 articles) to characterize the nature of information diffused to farmers. We highlight that the development of minor crops is hindered by a socio-technical lock-in in favor of the dominant species (wheat, rapeseed, maize, etc.). We show for the first time that this lock-in is characterized by strongly interconnected impediments, occurring at every link of the value chains, such as lack of availability of improved varieties and methods of plant protection, scarcity of quantified references on crop successions, complexity of the knowledge to be acquired by farmers, logistical constraints to harvest collection, and difficulties of coordination within the emerging value chains. On the basis of this lock-in analysis, that could concern other European countries, the article proposes levers aimed at encouraging actors to incorporate a greater diversity of crops into their productive systems: adaptation of standards and labelling, better coordination between stakeholders to fairly share added value within value chains, and combination of genetic, agronomic, technological, and organizational innovations.

Following a request from the European Commission, EFSA assessed the annual post‐market environmental monitoring (PMEM) report for the 2016 growing season of the Cry1Ab‐expressing maize event MON 810 provided by Monsanto Europe S.A. Partial compliance with refuge requirements was reported in Spain, as observed in previous years. EFSA reiterates the need to achieve full compliance in areas of high maize MON 810 adoption to delay resistance evolution, and therefore advocates increasing the level of compliance in such areas. Resistance monitoring data do not indicate a decrease in susceptibility to the Cry1Ab protein in the field corn borer populations tested in the 2016 season. However, EFSA identified some methodological and reporting limitations pertaining to resistance monitoring that need improvement in future PMEM reports. No complaints related to corn borer infestation of maize MON 810 were received via the farmer alert system during the 2016 cultivation season. EFSA encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. EFSA reiterates its recommendations on the methodology and analysis of farmer questionnaires, and considers that future literature searches on maize MON 810 performed in the context of annual PMEM reports should follow the guidelines given in the 2017 EFSA explanatory note on literature searching. Moreover, EFSA encourages relevant stakeholders to implement a methodological framework that enables the use of existing networks in the broader context of environmental monitoring. EFSA concludes that no new evidence has been reported in the 2016 PMEM report that would invalidate previous EFSA evaluations on the safety of maize MON 810.

International audience; The cultivation of Genetically Modified (GM) crops may have substantial impacts on populations of nontarget organisms (NTOs) in agroecosystems. These impacts should be assessed at larger spatial scales than the cultivated field, and, as landscape-scale experiments are difficult, if not impossible, modelling approaches are needed to address landscape risk management.& para;& para;We present an original stochastic and spatially explicit modelling framework for assessing the risk at the landscape level. We use techniques from spatial statistics for simulating simplified landscapes made up of (aggregated or non-aggregated) GM fields, neutral fields and NTO's habitat areas. The dispersal of toxic pollen grains is obtained by convolving the emission of GM plants and validated dispersal kernel functions while the locations of exposed individuals are drawn from a point process. By taking into account the adherence of the ambient pollen on plants, the loss of pollen due to climatic events, and, an experimentally-validated mortality-dose function we predict risk maps and provide a distribution giving how the risk varies within exposed individuals in the landscape.& para;& para;Then, we consider the impact of the Bt maize on Inachis io in worst-case scenarii where exposed individuals are located in the vicinity of GM fields and pollen shedding overlaps with larval emergence. We perform a Global Sensitivity Analysis (GSA) to explore numerically how our input parameters influence the risk. Our results confirm the important effects of pollen emission and loss. Most interestingly they highlight that the optimal spatial distribution of GM fields that mitigates the risk depends on our knowledge of the habitats of NTOs, and finally, moderate the influence of the dispersal kernel function.

International audience; Minor crops include mostly vegetables, fruits, nursery stock and ornamentals. These crops account for an EU production value of over (sic) 60 billion per year, representing more than 20% of the value of EU's total agricultural production. The sustainable production of such crops, from an economic point of view, is vital for both human health and European economies. For minor crops, this sustainability can only be realized by the continued availability of crop protection solutions for pest control. The number of minor crops in Europe without viable solutions for plant protection has increased in recent years. This is mainly due to the lack of pesticides in certain crops, as a number of previously authorized pesticides has not been re-authorized due to a stricter regulation. Also the introduction of tropical or sub-tropical crops and their pests into Europe has contributed to the problem of minor crops without any crop protection solutions as pesticides used elsewhere to protect these crops are not allowed in Europe. The limited range of pesticides available to farmers has increased the risk of resistance development since, in absence of a sufficient number of pesticides with various modes of action, farmers apply repetitively only a narrow spectrum of molecules. The direct economic impact due to the absence of viable plant protection solutions for minor crops has been estimated over a billion Euros per year, impacting 9 million hectares throughout Europe. In light of this, here we discuss the current state of the art of minor crops in Europe and elucidate ongoing efforts to address such problems through Integrated Pest Management (IPM). The information reported is expected to provide relevance of minor crops in Europe and encourage the development and implementation of effective IPM solutions.

International audience; The introduction of genetically-modified (GM) crops is often accompanied by other changes in cultural practices. The objective of the present study was to evaluate these changes with the simulation model FLORSYS which quantifies the effects of cropping systems and pedoclimate on weed dynamics as well as indicators of weed-related biodiversity (species richness and equitability, trophic resources for birds, insects and pollinators) and crop production loss (yield loss, harvest contamination, harvesting problems, field infestation). The study focused on two GM maize variety types, i.e. expressing Bacillus thuringiensis toxins against insects (Bt) and tolerating the non-selective herbicide glyphosate (HT). Two contrasting maize-growing sites were studied: Aquitaine, a region in South-Western France, and Catalonia in North-Eastern Spain. Typical regional cropping systems containing maize were identified for each site from expert knowledge and the Biovigilance database recording French agricultural practices. GM scenarios were based on expert knowledge, literature and current Spanish practices. A total of 11 most probable scenarios (1 conventional, 3 Bt and 8 HT) were simulated over 28 years for each region, and repeated with 10 different regional random weather series. An additional series of 5-7 scenarios per region was run to decorrelate factors, and make it easier to identify the cultural practices responsible for changes in weed flora, biodiversity and production. The simulations showed that the changes accompanying the introduction of GM maize varieties affected weed flora as well as weed-related biodiversity and crop production loss, but that the consequences depended on local conditions. Most of these consequences were caused by simplifications in the cropping systems made possible by the GM varieties, rather than by the glyphosate associated to GM varieties. Simplified tillage or no-till increased weed harmfulness, particularly in Aquitaine where the weed flora was poorer and dominated by larger and more persistent species. Conversely, no-till cancelled part or all of the nefarious effects on biodiversity of simplified rotations (maize/wheat and maize monoculture), particularly by improving trophic resources offered by weeds to birds, insects and pollinators. Overall, biodiversity was less affected by simplified rotations in Catalonia where the initial weed flora was richer and more equitable. Delayed maize sowing reduced weed harmfulness and biodiversity, except food offer for insects and pollinators whose pertinent feeding period covered spring and summer (vs. winter for birds). Based on the two most affected weed-based biodiversity indicators, ex post monitoring after GM introduction should focus on birds in Aquitaine and on pollinators in Catalonia. (C) 2015 Elsevier Ltd. All rights reserved.

International audience; Agriculture in the twenty-first century faces the challenge of meeting food demands while satisfying sustainability goals. The challenge is further complicated by climate change which affects the distribution of crop pests (intended as insects, plants, and pathogenic agents injurious to crops) and the severity of their outbreaks. Increasing concerns over health and the environment as well as new legislation on pesticide use, particularly in the European Union, urge us to find sustainable alternatives to pesticide-based pest management. Here, we review the effect of climate change on crop protection and propose strategies to reduce the impact of future invasive as well as rapidly evolving resident populations. The major points are the following: (1) the main consequence of climate change and globalization is a heightened level of unpredictability of spatial and temporal interactions between weather, cropping systems, and pests; (2) the unpredictable adaptation of pests to a changing environment primarily creates uncertainty and projected changes do not automatically translate into doom and gloom scenarios; (3) faced with uncertainty, policy, research, and extension should prepare for worst-case scenarios following a “no regrets” approach that promotes resilience vis-à-vis pests which, at the biophysical level, entails uncovering what currently makes cropping systems resilient, while at the organizational level, the capacity to adapt needs to be recognized and strengthened; (4) more collective approaches involving extension and other stakeholders will help meet the challenge of developing more robust cropping systems; (5) farmers can take advantage of Web 2.0 and other new technologies to make the exchange of updated information quicker and easier; (6) cooperation between historically compartmentalized experts in plant health and crop protection could help develop anticipation strategies; and (7) the current decline in skilled crop protection specialists in Europe should be reversed, and shortcomings in local human and financial resources can be overcome by pooling resources across borders.

Requestor: European CommissionQuestion number: EFSA-Q-2013-01032; 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 on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean FG72 × A5547-127 did not give rise to safety concerns and no reason to expect interactions between the single events impacting on the food and feed safety of the two-event stack soybean was identified. Although the EFSA GMO Panel cannot conclude on forage composition, soybean forage is not expected to be imported in a significant amount for use as feed. Considering the routes of exposure and limited exposure levels, the EFSA GMO Panel concludes that soybean FG72 × A5547-127 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean FG72 × A5547-127. The EFSA GMO Panel concludes that soybean FG72 × A5547-127 is as safe as the non-genetically modified (GM) comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

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 × MIR162 × MIR604 × GA21, the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the two‐stack maize event Bt11 × MIR162 (application EFSA‐GMO‐DE‐2009‐66). On 8 November 2016, the European Commission received from Syngenta information on the subcombination Bt11 × MIR162. On 14 December 2016, the European Commission tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the four‐event stack Bt11 × MIR162 × MIR604 × GA21 and its subcombinations. The GMO Panel used the appropriate principles described in its guidelines for the risk assessment of genetically modified (GM) plants to analyse the provided data. The levels of the newly expressed proteins Cry1Ab, PAT, Vip3Aa20 and PMI are similar between the two‐event stack Bt11 × MIR162 and the corresponding single events Bt11 and MIR162. Based on this analysis, there is no indication of an interaction between the events combined in maize Bt11 × MIR162 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel considers that the new information for maize Bt11 × MIR162 does not alter the conclusions of the scientific opinion on application EFSA‐GMO‐DE‐2009‐66.

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 count and yield. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 31%) in lectin activity in soybean DAS-44406-6. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition of soybean DAS-44406-6 as compared to its conventional counterpart and non-GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the three newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-44406-6. Soybean DAS-44406-6 is as nutritious as its conventional counterpart and the non-GM soybean reference varieties tested. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-44406-6 plants, unless exposed to the intended herbicides. The likelihood of environmental effects from the accidental release of viable seeds from soybean DAS-44406-6 into the environment is therefore very low. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-44406-6. In conclusion, the GMO Panel considers that the information available for soybean DAS-44406-6 addresses the scientific comments raised by Member States and that soybean DAS-44406-6, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

All three dimensions of sustainability —economic, social and environmental— must be integrated into a holistic assessment framework in the development of sustainable cropping systems (CS). Numerous sustainability assessment methods meet this requirement, but most of them handle only one type of production system (arable crops, fruit or vegetables). We propose here a common framework for sustainability assessment applicable to various types of crop production. The DEXiPM model, which was designed for the ex ante assessment of innovative arable CS was adapted to other production systems. Three groups of experts analyzed and modified this model, to develop suitable methods for assessing the sustainability of pomefruit orchards, field vegetable systems, and grapevine systems. We used the resulting models to formalize a sustainability assessment framework, in which a fixed core of hierarchically organized generic agricultural sustainability issues can be weighted according to stakeholder priorities, and a set of basic attributes can be estimated in a flexible manner, depending on the situation to be assessed and the data available. This common framework for sustainability assessment has several advantages. It can facilitate communication between stakeholders involved in the development of innovative production systems. It can also help researchers to identify gaps in knowledge and the means of bridging them. Its results can provide recommendations for policy makers, concerning actions likely to incite the adoption of innovative systems, for example. We also consider the general applicability and limitations of this framework.

In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Docuinent introduces the rationale that GMPs, as well as their newly produced metabolites, represent the potential stressor to be evaluated during ERA. As a consequence, during several phases of ERA for cultivation purposes, it is considered necessary to use whole plants or plant parts in experimental protocols. The importance of in planta studies as a strategy to address impacts of GMPs tin non-target organislns is demonstrated, to evaluate both effects due to the intended modification in plant phenotype (e.g. expression of Cry proteins) and effects due to unintended modifications in plant phenotype resultihg from the transformation process (e.g. due to somaclonal variations or pleiotropic effects). In planta tests are also necessary for GMPs in which newly expressed metabolites cannot easily be studied in vitro. This paper reviews the scientific literature supporting the choice of in planta studies as a fundamental tool in ERA of GMPs in cultivation dossiers; the evidence indicates they can realistically mimic the ecological relationships occurring in their receiving environments and provide important insights into the biology and sustainable management of GMPs.

Question Number: EFSA-Q-2016-00690 on request from the European Commission; 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 the insect resistance monitoring data submitted to EFSA do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein during the 2015 season. However, since the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations on resistance monitoring to provide sufficient detection sensitivity. Although the farmer alert system to report complaints about product performance could complement the information obtained from the laboratory bioassays, the GMO Panel is currently not in a position to appraise its usefulness, and therefore encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance (GS) do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The GMO Panel reiterates its previous recommendations on the analysis of farmer questionnaires, and advises the consent holder to provide more detailed information on the conducting and reporting of the literature search in future annual PMEM reports. Moreover, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring. The GMO Panel concludes that the case-specific monitoring (CSM) and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maize MON 810.

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 single events impacting on the food and feed safety of the four-event stack maize. Considering the routes of exposure and limited exposure levels, the Panel concludes that this four-event stack maize would not raise safety concerns in the event of accidental release of viable grains into the environment. The EFSA GMO Panel concludes that the four-event stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. Among the 10 subcombinations, four have been assessed previously and no safety concerns were identified. For the remaining six subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded they are expected to be as safe as the four-event stack maize. For some subcombinations that could be produced by conventional crossing through targeted breeding approaches, little or no specific data were submitted, giving rise to uncertainties due to data gaps. To reduce these uncertainties and to confirm assumptions made for the assessment of these subcombinations, the EFSA GMO Panel recommends that the applicant collate relevant information, if these subcombinations were to be created via targeted breeding approaches and commercialised in the future. In this case, this information should focus on expression levels of the newly expressed proteins.

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 possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

Whether modern agriculture without conventional pesticides will be possible or not is a matter of debate. The debate is meaningful within the context of rising health and environmental awareness on one hand, and the global challenge of feeding a steadily growing human population on the other. Conventional pesticide use has come under pressure in many countries, and some European Union (EU) Member States have adopted policies for risk reduction following Directive 2009/128/EC, the sustainable use of pesticides. Highly diverse crop production systems across Europe, having varied geographic and climatic conditions, increase the complexity of European crop protection. The economic competitiveness of European agriculture is challenged by the current legislation, which banned the use of many previously authorized pesticides that are still available and applied in other parts of the world. This challenge could place EU agricultural production at a disadvantage, so EU farmers are seeking help from the research community to foster and support integrated pest management (IPM). Ensuring stable crop yields and quality while reducing the reliance on pesticides is a challenge facing the farming community is today. Considering this, we focus on several diverse situations in European agriculture in general and in European crop protection in particular. We emphasize that the marked biophysical and socio-economic differences across Europe have led to a situation where a meaningful reduction in pesticide use can hardly be achieved. Nevertheless, improvements and/or adoption of the knowledge and technologies of IPM can still achieve large gains in pesticide reduction. In this overview, the current pest problems and their integrated management are discussed in the context of specific geographic regions of Europe, with a particular emphasis on reduced pesticide use. We conclude that there are opportunities for reduction in many parts of Europe without significant losses in crop yields.

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2013-00527; 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 soybean DAS-81419-2 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of soybean DAS-81419-2 tested under field conditions revealed no relevant differences between soybean DAS-81419-2 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry1Ac and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-81419-2. The nutritional value of soybean DAS-81419-2 is not expected to differ from that of non-GM soybean varieties and no post-market monitoring of food/feed is considered necessary. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-81419-2 plants, unless these plants are exposed to glufosinate ammonium-based herbicides or infested by insect pests that are susceptible to the Cry1F and Cry1Ac proteins. This will not result in different environmental impacts compared to conventional soybean. Considering the scope of this application, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean DAS-81419-2 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-81419-2. The GMO Panel concludes that the soybean DAS-81419-2 is as safe and as nutritious as its conventional counterpart and the tested non-GM reference varieties in the context of its scope.

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2010-01326; 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, phenotypic and compositional characteristics of maize DAS-40278-9 tested under field conditions revealed no differences between maize DAS-40278-9 and its non-genetically modified (GM) comparator that would give rise to food and feed or environmental safety concerns. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed protein AAD-1, and no evidence that the genetic modification might significantly change the overall allergenicity of maize DAS-40278-9. The nutritional characteristics of maize DAS-40278-9 are not expected to differ from those of non-GM maize varieties and no post-market monitoring of food/feed is considered necessary. Maize DAS-40278-9 is as nutritious as its non-GM comparator and other non-GM commercial varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral maize DAS-40278-9 plants, unless these plants are exposed to the intended herbicides. However, this will not result in different environmental impacts compared to conventional maize. Considering the scope of the application, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with the unlikely but theoretically possible horizontal gene transfer from maize DAS-40278-9 to bacteria were not identified. The post-market environmental monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for maize DAS-40278-9 addresses the scientific comments raised by the Member States and that maize DAS-40278-9, as described in this application, is as safe as the non-GM comparator and non-GM maize reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2011-00311; 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 rise to safety issues. The agronomic, phenotypic and compositional characteristics of cotton GHB119 tested under field conditions revealed no relevant differences between cotton GHB119 and its conventional counterpart that would give rise to any food and feed or environmental safety concern. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry2Ae and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of cotton GHB119. The nutritional characteristics of cotton GHB119 are not expected to differ from those of non-GM cotton varieties. There are no indications of an increased likelihood of establishment and spread of feral cotton GHB119 plants. Considering the scope of this application, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton GHB119 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for cotton GHB119 addresses the scientific comments raised by the Member States and that cotton GHB119, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

International audience; In the European Union, it has been decided that farmers and consumers should be free to choose between conventional, organic, and genetically modified (GM) crops/products. This concept of coexistence implies the necessity of developing coexistence strategies which curb the risk of mixing GM and non-GM material along agricultural supply chains. Among many things, this requires understanding and predicting the process of cross-pollination between the different varieties cultivated on a given landscape. In order to provide a prediction accurate enough to cope with legal thresholds, it is necessary to be able to rank varieties according to their pollen production. However, this parameter is rarely known, partly because it is difficult and expensive to measure. We investigated how easy-to-measure tassel morphological characteristics can be used to predict the quantity of pollen produced by hybrid maize varieties. Thirteen varieties were grown in France on experimental plots during three years with two varieties added the last year. For each variety, we measured the pollen production and variables that describe the tassel architecture. We found that the number of ramifications, the length of the tassel, the length of the emitting section, the number of spikelets and the TAI (the Tassel Area Index which aims at estimating the pollen emitting area) were correlated with pollen production. Using linear models, we identified the number of spikelets as the best architectural variable related to pollen production. In order to evaluate the ability of tassel characteristics to predict pollen production, we analysed how the relationships established in the case of any two years made it possible to predict the pollen production of the third year. The model that combined the total length of the tassel and the total number of spikelets was found to be the best predictive model of the relative pollen production between varieties.

One of the concerns surrounding the import (for food and feed uses or processing) of genetically modified herbicide tolerant (GMHT) oilseed rape is that, through seed spillage, the herbicide tolerance (HT) trait will escape into agricultural or semi-natural habitats, causing environmental or economic problems. Based on these concerns, three EU countries have invoked national safeguard clauses to ban the marketing of specific GMHT oilseed rape events on their territory. However, the scientific basis for the environmental and economic concerns posed by feral GMHT oilseed rape resulting from seed import spills is debatable. While oilseed rape has characteristics such as secondary dormancy and small seed size that enable it to persist and be redistributed in the landscape, the presence of ferals is not in itself an environmental or economic problem. Crucially, feral oilseed rape has not become invasive outside cultivated and ruderal habitats, and HT traits are not likely to result in increased invasiveness. Feral GMHT oilseed rape has the potential to introduce HT traits to volunteer weeds in agricultural fields, but would only be amplified if the herbicides to which HT volunteers are tolerant were used routinely in the field. However, this worst-case scenario is most unlikely, as seed import spills are mostly confined to port areas. Economic concerns revolve around the potential for feral GMHT oilseed rape to contribute to GM admixtures in non-GM crops. Since feral plants derived from cultivation (as distinct from import) occur at too low a frequency to affect the coexistence threshold of 0.9% in the EU, it can be concluded that feral GMHT plants resulting from seed import spills will have little relevance as a potential source of pollen or seed for GM admixture. This paper concludes that feral oilseed rape in Europe should not be routinely managed, and certainly not in semi-natural habitats, as the benefits of such action would not outweigh the negative effects of management.

Requestor: European Commission Question number: EFSA-Q-2015-00475 Correspondence: gmo@efsa.europa.eu; International audience; 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 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. On 23 July 2015, the European Commission (EC) received from Syngenta new nucleic acid sequencing data on maize event GA21 and updated bioinformatic analyses using the new sequencing data. The EC tasked EFSA to analyse these data and to indicate whether the previous conclusions of the EFSA GMO Panel on the above-listed GM maizes remain valid. The EFSA GMO Panel used the appropriate principles described in its guidelines for the risk assessment of GM plants to analyse the received data. Compared with the sequencing data originally provided, the new sequencing data indicated a one-base pair addition in a non-coding region of the insert, a three-base pair deletion in the 3’ flanking region of the insert, and a difference in the number of functional copies of the mepsps expression cassette. These differences were only recently identified, but it was confirmed that they had been present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment remain valid. The bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, the GMO Panel concludes that the original risk assessment of event GA21 as a single event, and as a part of stacked events, remains valid.

Single events NK603 and T25 were combined to produce the stack two‐event maize NK603 × T25. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single maize events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of maize NK603 × T25, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of maize NK603 × T25. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering the scope of application EFSA‐GMO‐NL‐2010‐80, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from maize NK603 × T25 to environmental bacteria does not give rise to any safety concern. The post‐market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for maize NK603 × T25 addresses the scientific comments raised by Member States and that maize NK603 × T25, as described in this application, is as safe as its non‐GM comparator and non‐GM conventional maize varieties with respect to potential effects on human and animal health and the environment in the context of its scope.

According to Articles 11(6) and 23(6) of Regulation (EC) No 1829/2003 on genetically modified food and feed, the European Food Safety Authority should publish detailed guidance to assist applicants in the preparation and presentation of their applications for the renewal of authorisations of that genetically modified food and feed. This guidance document describes the data requirements for renewal applications, which should contain a copy of the authorisation, post‐market monitoring and post‐market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period. The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid. The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan(s).