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The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 × MON 89788 (EFSA-GMO-NL-2010-85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two-event stack soybean (RBD GM-oil). The assessment was mainly based on a replacement scenario with a list of target foods where RBD GM-oil is intended to be added. Intake estimations for several fatty acids present in the RBD GM-oil, in particular γ-linolenic acid (GLA), stearidonic acid (SDA) and linoleic acid (LA) were based on the consumption of the corresponding foods that are likely to be displaced. The assessment of LA considered the established adequate intake of 4% of total energy intake (E%) and that LA deficiency has not been observed with intakes > 1 E%. The assessment of GLA and SDA was conducted using maximum doses without adverse effects from intervention human studies as reference (4.2 grams/day for SDA and 2.8 grams/day for GLA) since no tolerable upper intake levels are set for these fatty acids. The decrease observed in the levels of LA in RBD GM-oil as compared to oil from conventional soybean does not represent a nutritional concern as intakes were in all cases above 1 E%. For GLA, all intake estimations were below the reference dose indicating no safety concern. SDA intake estimations do not pose any safety concerns based on the overly conservative nature of the estimates, the absence of toxicological hazards and the rapid metabolism of SDA in humans. The GMO Panel concluded that the consumption of soybean MON 87769 × MON 89788 and their derived products, in particular its RBD oil, does not represent a nutritional concern in humans. A post-market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre-market risk assessment., European Commission: EFSA-Q-2019-00329

© 2020 European Food Safety Authority., The scope of application EFSA‐GMO‐DE‐2012‐111 is for food and feed uses, import and processing of genetically modified (GM) soybean SYHT0H2 in the European Union. Soybean SYHT0H2 was developed to confer tolerance to the herbicidal active substances mesotrione and other p‐hydroxyphenylpyruvate dioxygenase (HPPD)‐inhibiting herbicides and glufosinate ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues except for sequence similarity of AvHPPD‐03 to bacterial haemolysins that was considered in food/feed safety assessment. The outcome of the comparative analysis (agronomic/phenotypic and compositional characteristics) did not need further assessment except for the changes in seed levels of α‐tocopherol and γ‐tocopherol that were assessed for food and feed relevance. The GMO Panel does not identify toxicological and allergenicity concerns for the AvHPPD‐03 and PAT proteins expressed in soybean SYHT0H2 and finds no evidence that the genetic modification would change the overall allergenicity of soybean SYHT0H2. The nutritional impact of food/feed from soybean SYHT0H2 is expected to be the same as that of food/feed from the conventional counterpart and commercial non‐GM soybean reference varieties. The GMO Panel concludes that soybean SYHT0H2 is as safe as and nutritionally equivalent to the conventional counterpart and the tested non‐GM soybean reference varieties, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean SYHT0H2 grains into the environment, soybean SYHT0H2 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean SYHT0H2. In conclusion, the GMO Panel considers that soybean SYHT0H2, 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.

UMR BFP - Equipe Métabolisme; International audience; Introduction In addition to classical targeted biochemical analyses, metabolomic analyses seem pertinent to reveal expected as well as unexpected compositional differences between plant genetically modified organisms (GMO) and non-GMO samples. Data previously published in the existing literature led to divergent conclusions on the effect of maize transgenes on grain compositional changes and feeding effects. Therefore, a new study examining field-grown harvested products and feeds derived from them remains useful. Objectives Our aim was to use a metabolomics approach to characterize grain and grain-based diet compositional changes for two GMO events, one involving Bacillus thuringiensis toxin to provide insect resistance and the other one conferring herbicide tolerance by detoxification of glyphosate. We also investigated the potential compositional modifications induced by the use of a glyphosate-based herbicide on the transgenic line conferring glyphosate tolerance. Results The majority of statistically significant differences in grain composition, evidenced by the use of 1H-NMR profiling of polar extracts and LC-ESI-QTOF-MS profiling of semi-polar extracts, could be attributed to the combined effect of genotype and environment. In comparison, transgene and glyphosate effects remained limited in grain for the compound families studied. Some but not all compositional changes observed in grain were also detected in grain-based diets formulated for rats. Conclusion Only part of the data previously published in the existing literature on maize grains of plants with the same GMO events could be reproduced in our experiment. All spectra have been deposited in a repository freely accessible to the public. Our grain and diet characterization opened the way for an in depth study of the effects of these diets on rat health.

Ascorbic acid is considered to be one of the most important antioxidants in plants and plays a vital role in the adaptation of plants to unfavorable conditions. In the present study, an ascorbate oxidase gene (Solyc04g054690) was over-expressed in cherry tomato cv. West Virginia 106 lines and compared with previously studied RNAi silenced ascorbate oxidase lines. Two lines with lower ascorbate oxidase activity (AO&minus, 15 and AO&minus, 42), two lines with elevated activity (AO+14 and AO+16), and the non-transgenic line (WVa106) were grown and irrigated with 75 mM and 150 mM NaCl in 2015 and 2016. Growth, yield, and chemical composition of the lines under salinity stress were evaluated. Lines with lower ascorbate oxidase activity resulted in higher plant growth parameters (plant height, leaf number, flower, and cluster number in 2015 and stem diameter and flower number in 2016), and improved fruit quality (firmness in 2016 and soluble solid content in 2015) and total yield per plant under salinity stress over both years. In addition, we show that ascorbic acid, lycopene, and carotene contents of fruits were higher in lines with lower ascorbate oxidase activity compared to lines with elevated activity and the non-transgenic line under conditions of moderate and high salinity in both years.

Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six–event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 34 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

International audience; 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 (GM) maize 3272 (EFSA-GMO-UK-2006-34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to non-GM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alpha-amylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from non-GM maize.

Since the commercial releases of GMOs in the 90s, new genetic modification tools known as New breeding techniques have been developed for e.g. gene silencing or more precise genomic modifications such as Crispr-endonuclease based systems. As for GMOs several consumers view may prevail about the societal interest in agricultural production and food of such genetic modification. Ensuring the freedom of choice to consumers needs to develop detection tools which could infer the NBT nature of the modification technique used. This article reviews all the elements which could allow the identification and detection of such techniques and products.

International audience; Maize MON 89034 9 1507 9 NK603 9 DAS-40278-9 (four-event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS-40278-9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the four-event stack maize does not give rise to food/feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable grains of the four-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations for which no experimental data were provided, and concludes that these are expected to be as safe as and nutritionally equivalent to 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 the four-event stack maize. No post-market monitoring for food/feed is necessary. The GMO Panel concludes that the four-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

International audience; Maize MON 87427 9MON 87460 9 MON 89034 9 MIR162 9 NK603 (five-event stack maize) was produced by conventional crossing to combine five single events: MON 87427, MON 87460, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the five single maize events and eleven of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 11 subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the five-event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable grains of the five-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 14 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the five-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the five-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

Safety concerns arising from the consumption of foods derived from genetically modified (GM) crops remains a highly debated and controversial subject. We report here a faecal microbiota compositional analysis in Wistar rats from the GMO90+ study, which fed glyphosate-tolerant NK603 (+/− Roundup application during cultivation) and Bt toxin MON810 GM maize for 6 months (at 11 and 33% composition of the feed) in comparison to their closest non-GM isogenic lines. We first integrated the faecal microbiota compositional data with results from plasma metabolomics to establish a baseline allowing us to understand which bacterial species can influence host metabolism.CoriobacteriaceaeandAcetatifactorsignificantly predicted plasma metabolic profile in males, whileBifidobacteriumandRuminococcuswere able to predict female plasma metabolites. We then investigated the differences in fecal microbiota composition between group of rats fed MON810 or NK603 GM maize varieties in comparison to their respective isogenic lines. Bacterial community richness was not altered by the test diets. There were no statistically significant differences in taxa abundance in the rat faecal microbiota that we could attribute to the consumption of either MON810 or NK603 GM maize varieties. In conclusion, we show that the consumption of the widely cultivated GM maize varieties NK603 and MON810 even up to 33% of the total diet had no effect on the status of the faecal microbiota compared to non-GM near isogenic lines.

International audience; We investigated how teachers' attitudes on GMO in 30 countries relate to two Major Environmental values of Preservation and Utilization. Participating teachers (N = 10651) filled in a questionnaire including items on Preservation-and Utilization-related values (Major Environmental Values, 2-MEV model), and on attitudes to GMO. We analyzed the responses using Exploratory Factor Analysis, and investigated the structure of attitudes based on the multivariate structure. The study confirmed the bi-dimensional nature of the 2-MEV model. The GMO items formed an independent third dimension, although several Pro-GMO attitudes were related to Utilization values. We also found variation of attitudes among countries, plausibly reflecting the influence of different socioeconomic and cultural contexts. The results indicate that attitudes and reasoning on sensitive socio-scientific issues such as GMO relate partly to the basic Environmental values of Preservation and Utilization, and partly to pro or anti-GMO attitudes. 2

Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, 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 for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. In addition, the applicant provided sequence data on the LLCotton25 event using the material from a commercial variety that, according to the applicant, may be imported into the EU at the time of this renewal application. 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. The GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on LLCotton25.

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.

International audience; Bees play an important role in the pollination of a wide range of plants and are likely to encounter genetically engineered crops (often termed "genetically modified" or "GM") during their foraging period, especially insect-resistant crops since these crops have been cultivated worldwide. Thus, it is important to assess potential impacts of these crops on the nontarget organism honey bee (Apis mellifera L.), the most important pollinator species worldwide. In the present study, we gathered all scientific data related to the effects of insect-resistant GM crops (mostly corn and cotton, and also oilseed rape, rice, soybean, and wheat) on honey bees. Assessments included feeding honey bees with purified insecticidal toxins or transgenic pollen collected from GM crops producing such toxins, namely protease inhibitors (PIs), Cry or VIP toxins from Bacillus thuringiensis. RNAi-producing and herbicide-tolerant crops were also included. A total of 64 peer-reviewed studies have been published between 1994 and 2017. We also compiled 18 studies submitted to and examined by the US EPA between 1993 and 2002. Our analyses converge to the conclusion that the studied Cry proteins, RNAi or herbicide-tolerance proteins do not negatively affect the survival of honey bees and have no potential sublethal effect in controlled laboratory conditions or in field/semifield trials. The risk of PI will mainly depend on their concentration in pollen and need to be assessed case by case.

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.

International audience; Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 x NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatic 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 x NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 x NK603 (EFSA, 2006). (C) 2018 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)Scientific opinionRequestor:European Commission (DG SANTE)Question number:EFSA-Q-2017-00028; Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic 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 events in maize NK603 x MON810 considered for renewal is identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-007 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603 x MON810.

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.

Review., According to EU regulation, genetically modified (GM) plants considered to be allergenic have to be assessed concerning their endogenous allergens before placement on the EU market, in line with the international standards described in Codex Alimentarius. Under such premises, a quantitative relevant increase in allergens might occur in GM plants as an unintended effect compared with conventionally produced crops, which could pose a risk to consumers. Currently, data showing a connection between dose and allergic sensitisation are scarce since the pathophysiological mechanisms of sensitisation are insufficiently understood. In contrast, data on population dose-distribution relationships acquired by oral food challenge are available showing a connection between quantity of allergenic protein consumed and the population of allergic individuals experiencing reactions. Soybean is currently the only recognised allergenic GM food by law for which EFSA has received applications and was therefore taken as an example for defining an assessment strategy. Identification of potential allergens, methodology for quantification as well as risk assessment considerations, are discussed. A strategy is proposed for the identification, assessment and evaluation of potential hazards/risks concerning endogenous allergenicity in food derived from plants developed by biotechnology. This approach could be expanded to other allergenic foods in the future, whenever required.

International audience; Chapters: 1. Methods for Rapid Testing of Plant and Soil Nutrients. 2. World Cultivation of Genetically Modified Crops: Opportunities and Risks. 3. Food Security in the Arab Gulf Cooperation Council States. 4. Methods to Study Agricultural Systems. 5. Comparison of Methods to Assess Agricultural Sustainability. 6. Sustainable Cultivation of Saffron in Iran. 7. Soil Fertility Management in Sub-Saharan Africa. 8. Silicon in Agriculture. 9. Long-Term Chemical Fertilization in Tanzania. 10. Interaction of Mycorrhizal Fungi and Azotobacter with Root-Knot Nematodes and Root-Chewing Insects.

Efsa Panel On Genetically Modified Organisms (gmo)StatementRequestor: European CommissionQuestion number: EFSA-Q-2016-00730; The EFSA Panel on Genetically Modified Organisms (GMO) has previously assessed the single events Bt11, MIR162, MIR604 and GA21 as well as different stacked events corresponding to combinations of these events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. In its assessment of the four-event maize stack Bt11 9 MIR162 9 MIR604 9 GA21, the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the two-stack maize event Bt11 9 MIR162 (application EFSA-GMO-DE-2009-66). On 8 November 2016, the European Commission received from Syngenta information on the subcombination Bt11 9 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 9 MIR162 9 MIR604 9 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 9 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 9 MIR162 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel considers that the new information for maize Bt11 9 MIR162 does not alter the conclusions of the scientific opinion on application EFSA-GMO-DE-2009-66.

Durant les dernières décennies, le secteur des semences a connu et connaît aujourd'hui de nouveau un important mouvement de concentration. Ses retombées soulèvent de nombreuses préoccupations chez beaucoup d'acteurs et de citoyens. Cependant le secteur des semences est plutôt mal connu. Aussi est-il utile de chercher à mieux le connaitre et à explorer les impacts possibles de cette concentration accrue sur la chaîne agroalimentaire. Dans une première partie l'article présente les principales caractéristiques du secteur mondial des semences, ses différents acteurs et son poids dans la chaîne agroalimentaire. Puis il examine dans une deuxième partie le mouvement de concentration des années 2015-2016. L'évolution technologique du secteur semencier est également brièvement présentée. Enfin une dernière partie analyse les retombées des récentes fusions et acquisitions sur la chaîne agroalimentaire. Des opinions opposées sont exprimées sur leurs effets : beaucoup s'inquiètent du pouvoir alimentaire acquis par les plus grandes firmes semencières tandis que certains en attendent des innovations utiles., In the past three decades, the seed sector has experienced, and is now again experiencing, corporate concentration trends. The fallout of this consolidation is the subject of numerous concerns. However, the seed sector is rather poorly understood. Thus, it is useful to understand it better and to investigate the potential impact on the agri-food chain of the trend toward increased corporate concentration. The first part of this paper presents the main characteristics of the global seed sector, its stakeholders, and its size in the agri-food chain. Next, the corporate consolidation trends of the seed industry over the past two years are examined. The technological evolution of the seed sector is also briefly presented. In the last part of this paper, the fallout of recent mergers and acquisitions in the seed industry are analyzed. Opposing views are expressed on the impact of these mergers and acquisitions in the agri-food chain: while certain stakeholders worry about the risk of food power by the biggest companies, some others expect useful innovations.

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

Technical report - Requestor: EFSA - Question number: EFSA-Q-2015-00433; The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

Les groupes Heineken et Carlsberg ont déposé deux brevets européens pour de l’orge obtenue par mutagenèse. Ce procédé biotechnologique permet selon ses opposants d’obtenir des OGM dits « cachés ». Le flou de la réglementation permettrait de les généraliser sans avertir les consommateurs.

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

Even if academics and practitioners identify coopetition as a winning strategy, a coopetition relationship appear to be difficult to sustain. Coopetition is relied to be a paradoxical and unstable interfirm relationship related with tensions. Academic works begun to study the causes and nature of tension in coopetition relationship but little is known about the way those tension is managed. The aim of this paper is to investigate, via in depth case studies, the management tools used to manage coopetition at the inter-organizational level. Through multiples case studies in the same industry (the French grain merchants industry), we reveal the existence of differing management tools of the coopetition relationships. Some tools found by our research (tacit conventions, mediation arenas, coopetition inducers) seem particularly novel in the coopetition literature. The use of tacit convention and social pressure epitomize the embeddedness and the social construction of the coopetition relationship. It shows that inter-firm coordination can exist in a direct and informal way, without being locked into a rigid structure and without collusion. Moreover, we found that an external party can induce the coopetition and bring rival firms to consider a coopetitive relationship. This finding reveals that some tools can change inter-firms dynamics and rationalities giving rise to coopetition. Those findings lead us to reveal the perspective of a managerial engineering of coopetition and to suggest some embryonic basis to open the way for its development.

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2007-175; The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the two single events combined to produce soybean 305423 × 40-3-2 and did not identify safety concerns. No new data on the single events affecting the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of soybean events 305423 and 40-3-2 in the two-event stack soybean did not raise concerns regarding food and feed safety or nutrition. The combination of the newly expressed proteins in the two-event stack soybean did not raise human or animal health concerns. No compositional differences requiring further assessment were identified between soybean 305423 × 40-3-2, the non-GM comparator, additional comparators and the non-GM commercial soybean reference varieties, except for the altered fatty acid profile (consistent with the intended trait). Nutritional assessment of food products from soybean 305423 × 40-3-2 identified no concerns for human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted toasted soybean 305423 × 40-3-2 meal. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean plants, unless these are exposed to acetolactate-synthase-inhibiting or glyphosate-containing herbicides. Risks associated with the unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean 305423 × 40-3-2 to bacteria were not identified. Considering the scope of the application, interactions with biotic and abiotic environments are not considered a relevant issue. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean 305423 × 40-3-2. The GMO Panel is of the opinion that soybean 305423 × 40-3-2 is as safe as the non-GM comparator and non-GM commercial soybean varieties with respect to potential effects on human and animal health and environment in the context of its scope. The GMO panel recommends a post-market monitoring plan.

In this opinion, the EFSA GMO Panel assesses the five‐event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five‐event stack maize Bt11 × 59122 × MIR604 × 1507 × GA21 and did not identify safety concerns. No new data on the single events, leading to a modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the five‐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 five‐event stack maize. Considering the scope of the application (no cultivation), routes of exposure and limited exposure levels, the Panel concludes that this five‐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 five‐event stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. For the 20 subcombinations, the EFSA GMO Panel followed a weight‐of‐evidence approach, and concluded that they are expected to be as safe as the five‐event stack maize. No specific data were submitted for the subcombinations included in the scope of this application that could be produced by conventional crossing through targeted breeding approaches. In order to reduce the consequent uncertainties and to confirm assumptions made for their assessment, the EFSA GMO Panel considers that the applicant should provide relevant information, if these subcombinations were to be created via targeted breeding approaches and imported into the EU in the future. In this case, this information should focus on expression levels of the newly expressed proteins. A minority opinion expressed by an EFSA GMO Panel member is appended to this opinion.

Anthropogenic activities and particularly agricultural management may harm soil organisms such as enchytraeids (Enchytraeidae, Oligochaeta, Annelida), also known as potworms. These small relatives of earthworms are widely distributed in different soils and land use forms, where they play an important role due to their burrowing activity, their fecal pellet production as well as their transport, ingestion and mixing of mineral and organic soil particles. However, relatively few studies have been performed with these organisms at crop sites – and this widely scattered information has not yet been compiled. Thus, this paper aims (i) to assess the relevance of enchytraeids as indicators of agricultural practices and cropping systems, and (ii) to pinpoint the knowledge gaps and the needs for further research. Out of 250 papers identified in a literature search about 70 were reviewed in detail. Contrasted results and no clear relationships between agricultural practices and the composition and activity of enchytraeid communities have been found in this review, since rarely one factor affecting enchytraeids has been studied alone, meaning that the study context is usually very complex, with several interactions which are difficult to assess. Almost never information about all factors potentially influencing enchytraeids is available and, finally, there are very few studies which had the same aims or designs, making them very difficult to compare even without considering the heterogeneity of agricultural sites in space and time. However, this review concludes that enchytraeids can be considered as indicators of management practices (e.g. soil tillage, inorganic fertilizers) since they are sensitive to changes, both in terms of abundance and species composition. Finally, it is recommended to perform a monitoring program at representative, well documented European sites in which not only the enchytraeid communities but also as many as possible factors influencing them are measured over a period of at least five years.

International audience; The National Academies of Sciences of the USA recently published a report entitled Gene Drive on the Horizon. This commentary discusses the 'Aligning Research with Public Values' aspects in this report, the topic of public engagement, and the worrying ideological shift towards postmodernism which aims to deconstruct Enlightenment values.

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.

Online first; Les cultures OGM demeurent un sujet de controverse malgré leur adoption rapide là où elles ont été autorisées. Depuis 20 ans, un important thème de débat a été leur impact sur les quantités de pesticides épandus, notamment pour les cultures tolérantes à un herbicide (TH). Pour les uns, elles entraînent, par comparaison aux cultures conventionnelles, une diminution des herbicides employés tandis que pour d'autres, c'est l'opposé. Depuis 1996, les OGM les plus répandus ont été les cultures TH, qui impliquent l'usage d'un herbicide associé, en général le glyphosate. Lors des toutes premières années de leur diffusion, les cultures TH ont souvent conduit à une légère réduction des herbicides. Mais la répétition de ces cultures et des épandages de glyphosate sans alternance ni diversité suffisantes a contribué depuis plus de 10 ans à l'apparition d'adventices résistantes au glyphosate qui induisent une hausse des quantités de glyphosate et d'autres herbicides. Utilisant des données récentes et une approche multidisciplinaire, l'article analyse cette situation et les impacts des adventices résistantes aux herbicides. Sont examinées l'expansion des OGM tolérants aux herbicides dans le monde et leurs répercussions en matière de traitements herbicides, en particulier aux Etats-Unis. La progression mondiale des adventices résistantes au glyphosate et leurs impacts notamment sur la culture du soja aux États-Unis sont étudiés ensuite. La dernière partie explore comment les grandes firmes semencières, les agriculteurs et les spécialistes en malherbologie cherchent à faire face à cette propagation d'adventices résistantes. Enfin la conclusion aborde de façon plus large les tendances des cultures OGM

International audience; In light of the ongoing discussion in the EU whether new plant varieties generated by genome editing are genetically modified organisms (GMOs) or not, we propose a novel approach for regulating plant breeding in general. Our proposal involves a flexible and scalable system that is capable of adapting to the rapid evolution of new technologies such as genome editing. It proposes an operational method that accounts for traditional and novel technologies, and a dynamically scalable risk assessment, which focuses on the phenotype of a novel breed instead of the method used to generate it. This approach would also resolve various dichotomies in the current debate, namely declaring new genome editing methods as highly efficient, while ignoring the impact of yet unknown risks, and proposing exemptions from regulation on the basis of the type of DNA created, whereas an older technology with fully characterized risks would still carry a heavy regulatory burden. Our proposal also takes into account that any new risk paradigm must be understood and accepted by the public, suggesting a greater role for farmers in ensuring the safe use of new breeding technologies.DefinitionsThere are various guidelines and regulations worldwide used to assess the risks of genetically modified crops (see Further Reading Box 1 for USA and Canada), but the EU's regulatory framework arguably has the biggest impact given the size of the market and given its influence on other jurisdictions around the world. In 1990, the EU adopted its first regulatory framework, replaced in 2001 by Directive 2001/18/EC “on the deliberate release into the environment of genetically modified organisms” (GMO). According to Article 2, a GMO “means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”. However, “the techniques listed in Annex I A, part 2, are not considered to result in genetic modification” (namely, in vitro fertilization, and “natural” processes such as conjugation, transduction, transformation, and polyploidy induction). Article 3 lists further exceptions for which the Directive shall not apply, namely mutagenesis, and “cell fusion of plant cells of organisms which can exchange genetic material through traditional breeding methods”.

Efsa Panel On Genetically Modified Organisms (gmo) StatementRequestor: European CommissionQuestion number: EFSA-Q-2016-00506; The EFSA Panel on Genetically Modified Organisms (GMO Panel) has previously assessed genetically modified (GM) maize DAS-59122-7 as a single event as well as part of several stacked events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health, and the environment. On 26 July 2016, the European Commission received from Pioneer new nucleic acid sequencing data on maize event DAS-59122-7 and updated bioinformatic analyses using the new sequencing data. The European Commission tasked EFSA to analyse these data and to indicate whether the previous conclusions of the GMO Panel on the previously assessed GM maize events remain valid. The GMO Panel used the appropriate principles described in its guidelines for the risk assessment of GM plants to analyse the received data. The new sequencing data indicated three base pair (bp) differences compared to the sequencing data originally provided; two located in a non-coding region of the insert and one located in the 50 genomic flanking region. These base pairs reported as differences in the new nucleic acid sequencing data on maize event DAS-59122-7 had already 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 new sequencing data and 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 DAS-59122-7 as a single and as a part of stacked events remains valid.

Requestor: Competent Authority of the NetherlandsQuestion number: EFSA-Q-2009-00491; The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the three single events combined to produce a three-event stack cotton 281-24-236 × 3006-210-23 × MON 88913 and did not identify safety concerns. In this opinion, the GMO Panel assesses only the three-event stack cotton. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The combination of cotton events 281-24-236, 3006-210-23 and MON 88913 in the three-event stack cotton did not give rise to issues – based on the molecular, agronomic, phenotypic or compositional characteristics – regarding food and feed safety and nutrition. The combination of the newly expressed proteins in the three-event stack cotton did not raise concerns for human and animal health. Considering the introduced traits and the outcome of the comparative analysis, the routes of exposure and limited exposure levels, the GMO Panel concludes that this three-event stack cotton would not raise safety concerns in case of accidental release of viable cottonseeds into the environment. The post-market environmental monitoring plans provided by the applicant are in line with the scope of the three-event stack cotton. No post-market monitoring of food/feed derived from the three-event stack cotton is considered necessary. The GMO Panel concludes that the three-event stack cotton is as safe and as nutritious as its conventional counterpart in the context of its scope.

Les cultures transgéniques été adoptées rapidement là où elles ont été autorisées. Parmi elles, celles tolérantes aux herbicides sont les plus cultivées depuis 1996. Elles entraînent l'utilisation d'un herbicide associé, généralement du glyphosate. La répétition sur les mêmes parcelles de cultures tolérantes au glyphosate et des traitements avec ce désherbant sans alternance suffisante ni diversité des herbicides utilisés a contribué à l'apparition d'adventices résistantes au glyphosate, qui sont maintenant un problème notable. Cet article examine la diffusion des cultures OGM tolérantes aux herbicides dans le monde entier et leurs impacts en matière d'emploi des herbicides dans le cas des États-Unis. Il analyse ensuite le développement des mauvaises herbes résistantes au glyphosate dans le monde et leur impact, en particulier aux États-Unis où elles sont devenues un problème considérable. Enfin on étudie la façon dont les acteurs impliqués font face à la propagation de ces adventices résistantes. Cela illustre que le progrès scientifique nécessite une orientation, une mise en œuvre et une utilisation appropriées pour contribuer de manière pérenne et durable à une meilleure productivité.

International audience; This paper addresses the question of controversy in a recent and harsh environmental and healthcare dispute regarding GMO and food safety, and the consequences of this controversy on public confidence in scientists, media and institutions. More specifically, with a case study on the “Séralini Affair” of 2012 – an international controversy over genetically modified foods and science mediatisation – we analyzed how key players engaged themselves in a conflict. Using a qualitative methodology, we observed media and communication strategies during the polemic and conducted more than fifteen interviews. We therefore investigated the profound cultural questions raised by the antagonism between scientists, media, institutions, civil society and lobbies. The goals of this research are to propose new ethics for dispute and conflict resolution under the umbrella of the Foucaudian concept parrhesia – frankness – and to understand how effective can mediation be in environmental and healthcare dispute contexts.

Concerns have been raised about the possibility of the negative impact of transgenic crops on the environment. If wild plants accidentally pick up transgenes through pollen exchange with genetically modified crops, they could gain new environmental advantages or conversely suffer genetic homogenization and loss of biodiversity. This could cause weeds that might create new problems in farmers' fields and wild habitats and change biological equilibriums. Examples of gene flow are given for several cases of crop/ancestor pairs and two cases of more distantly related species. The main concern is that introgression between transgenic, insect-resistant crops and their wild relatives could lead to a progressive increase of the frequency of insect-resistant plants in wild populations. However, data are presently scarce to establish a firm scenario of the fate of such insect-resistant populations.

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.

How has animal testing become as controversial as the GMOs that are evaluated by testing them on animals ? This has happened because the tests are designed by players involved in the GMO controversy in order to influence its outcome. The history of GMO evaluation methods outlined here tells us much about the limitations of the scientific language of proof and model, when its objet is publicly and durably pervaded by very different assumptions that are deliberately used to promote or undermine as much as to evaluate., Comment les tests animaux sont-ils devenus aussi controversés que les OGM qu’ils servent à évaluer ? Ils le sont car ils ont été conçus par des acteurs engagés dans la controverse sur les OGM pour peser sur celle-ci. L’histoire des méthodes d’évaluation des OGM retracée ici renseigne sur la limite du langage scientifique, celui de la preuve et du modèle, lorsque l’objet en question est publiquement et durablement investi d’hypothèses hétérogènes, par volonté de le valoriser ou de dévaloriser autant que de l’évaluer.

Colloque de la SFER, Société Française d'Economie Rurale; L’article analyse le secteur semencier, notamment les grands groupes internationaux impliqués dans les semences transgéniques, dont le pouvoir préoccupe divers acteurs. Dans un premier temps, ce secteur est exploré : importance et poids économique des grandes firmes semencières, leur positionnement respectif, concentration du secteur, son poids relatif dans la chaîne agroalimentaire. Une deuxième partie examine la part croissante des semences transgéniques et leur structure de prix, et identifie les principaux acteurs qui investissent dans ce secteur. La dernière partie analyse les domaines de pouvoir des grandes firmes semencières et les vues divergentes sur leurs impacts. Un domaine essentiel est notamment concerné : les orientations de l'agriculture pour les prochaines décennies. Pour faire face aux défis alimentaires, environnementaux et climatiques du 21ème siècle, certains mettent en avant l'impératif d’utiliser des OGM alors que d’autres plaident pour des approches participatives et l’agroécologie. La conclusion souligne la nécessité d'une pluralité d'acteurs en amélioration des plantes et innovation variétale.

No English summary available., Il n’est guère de principe juridique ayant acquis, ces dernières années, une notoriété plus forte que le principe de précaution. Cette aura déborde largement le cercle des juristes pour atteindre le grand public, lequel ne peut ignorer l’existence de ce principe régulièrement invoqué par les médias, pas toujours à bon escient, à l’occasion de controverses environnementales ou sanitaires. De fait, le principe de précaution doit sa renommée à ses aspects révolutionnaires, tant du point de vue juridique que philosophique et sociologique, également à ce qu’il révèle de l’appréhension du risque par nos sociétés, mais aussi et tout autant aux débats qu’il a suscités. Né de la controverse scientifique, ce principe est lui-même controversé en raison de questionnements relatifs à la liberté d’entreprise et à la liberté de recherche. Ces deux libertés sont souvent évoquées, ensemble, pour déplorer les contraintes que le principe de précaution leur opposerait, comme si elles partageaient une même cause - cet aspect devra être précisé. Le droit communautaire et le droit national reconnaissent pleinement le principe de précaution, tout en s’attachant à « concilier » sa mise en œuvre avec les libertés économiques. Dans ce contexte, les organismes génétiquement modifiés (OGM) représentent un cas tout à fait singulier, marqué à la fois par l’ambition de leur régime juridique au regard de la précaution, et par l’ampleur des controverses et blocages qui persistent depuis plus de vingt ans. Avant de présenter le cadre général du régime juridique dédié aux OGM et les réflexions qu’appelle son étude au regard des libertés (II), il importe, après avoir précisé le contenu du principe de précaution et les critiques dont il fait l’objet, de placer le sujet en perspective : le débat opposant libertés économiques et principe de précaution se déroule en effet dans une arène plus vaste, celle de la question de la conciliation entre libertés économiques versus protection de valeurs non marchandes, dans un contexte de remise en cause de certains fondements classiques de notre société : foi en la science et au progrès technique, objectivité de la science, de l’économie et du droit (I).

Communication à la conférence "GMCC-13, 6th International Conference on Coexistence between GM and non-GM based Agricultural Supply Chains". Lisbon, Portugal, 12-15/11/2013.; Les cultures génétiquement modifiées (GM) tolérantes à un herbicide ont été largement adoptées là où elles ont été autorisées. Leur culture implique l'emploi d'un herbicide, généralement du glyphosate. Mais la répétition sur les mêmes parcelles de cultures tolérantes au glyphosate et de désherbages avec cet herbicide avec une alternance insuffisante a contribué à l'apparition d'adventices résistantes au glyphosate qui représentent maintenant un problème notable dans un nombre croissant de régions du monde. Après une discussion préalable sur les liens entre cultures tolérantes au glyphosate et adventices résistantes à ce désherbant, l'article examine l'expansion des cultures GM tolérantes à un herbicide dans le monde et leurs conséquences en matière d'emploi des herbicides dans le cas des États-Unis. Il analyse ensuite le développement des adventices résistantes au glyphosate dans le monde et ses répercussions, en particulier aux États-Unis, où elles représentent un problème important. Enfin, une dernière partie présente comment les firmes concernées, les malherbologues et les agriculteurs font face à cette propagation d'adventices résistantes au glyphosate, ainsi qu'à certains problèmes de coexistence liés.

International audience; Literature on the Community regulation has shown how the European Model faces foundational tensions between State sovereignty and integration. The principle of subsidiarity has been coined to regulate the exercise of power and to determine whether, in an area where there is joint competence, the Union can take action or should leave the matter to the Member States. The subsidiarity principle is based on the idea that decisions must be taken as closely as possible to the citizen: the Union should not undertake action, except on matters for which it alone is responsible, unless EU action is more effective than action taken at other levels. As far as regulation of technological objects is concerned, the traditional vision is that, as knowledge is supposed to be universal and harmonization of the European market is a key driver, the European level is the relevant level of governance. However, the analysis of subsidiarity in practice shows that we can hardly see a general rational at play. For instance, why nuclear energy production is considered as an issue of national sovereignty as monetary policy is now a European competence? Drawing upon two emblematic cases, this paper aims to go beyond an instrumental understanding of subsidiarity and to explore a set of interrelated questions: Who produces the knowledge used for regulating technological objects? How is knowledge translated and adapted to various local situations? What are the processes that contribute to the credibility of regulatory knowledge at national and European level? How are the boundaries between science and politics negotiated?

We discuss, by a philosophical method inspired of Quine, the nature of the risk posed by GMOs. Our analysis concludes to the religious origin of the belief of researchers to overall resilience of nature to perturbations of the genetic molecular combination., Nous discutons, par une méthode philosophique inspirée de Quine, la nature du risque que représentent les OGM. Notre analyse conclut à la nature religieuse de la croyance des chercheurs à une résilience globale de la nature aux perturbations de la combinatoire génétique moléculaire.

International audience; In February 2012, the French government, at that time headed by Nicolas Sarkozy, sent a document (‘emergency measures’; Supplementary Note 1) to the European Commission (EC), supposedly providing new information on environmental risks of genetically modified (GM) MON810 maize varieties (MON810 expresses the Cry1Ab insecticidal protein isolated from Bacillus thuringiensis (Bt) and was developed by Monsanto (St. Louis) to control certain Lepidoptera insects). The release of this document was followed by the publication in March 2012 of a national ruling prolonging the existing ban on their cultivation. Despite canceling many other actions of the Sarkozy government, the new French government under François Hollande has elected to continue with the MON810 ban. This correspondence examines the emergency measures document to analyze its scientific validity and consider the widespread implications for science-based risk assessment. Such an analysis is warranted because not only the French Government, but also several other European governments (that is, Austria, Germany, Greece, Hungary, Luxembourg and, most recently, Italy) invoked ‘scientific’ data to justify their bans.

Postmodernism is a philosophical, political, social and artistic movement. It is mainly defined by its suspicion towards the Enlightenment's faith in science, progress and the universality of reason. It has become a powerful movement that exerts a strong influence on academic thought in American and European societies, especially as it has become hegemonic in some institutions. Considering its influence on so‐called ‘science–society debates’ and its criticisms formulated against the scientific method, it is legitimate, in turn, to analyse critically its claims and the consequences of these claims, especially those from the ‘science studies’—also called ‘science and technology studies’. This postmodernist, mainly sociological, discipline has gained momentum in the past few decades in its appreciation of science and technology; it uses specific concepts that create a specific vision of scientific research as a social activity. An initial reflection concerns the shift from ‘public understanding’ of science to ‘public engagement’ in science. A typical delusion of the ‘science studies’ community is the belief that “knowledge co‐production beyond the classic expert communities… can substantially benefit scientific design.” In fact, science has become so complex and specialized that co‐production among scientists from various fields is becoming a difficult task. Therefore, when it comes to the layperson, even with the involvement of social scientists, co‐production of knowledge is nothing more than a myth. Of course, examples of collaboration between professional scientists and ‘amateurs’ do exist, and can be mutually beneficial—when botanists collect seeds from plant species for conservation purposes or when amateur astronomers detect interesting phenomena in the sky. But note that in both cases there is no hidden political agenda. By contrast, for genetically modified organisms (GMOs), which are criticized for their industrial and commercial use, and for the alleged political consequences of their use, there are powerful political forces at work. Collaboration between …