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The EFSA GMO Panel previously assessed the two single events combined to produce soybean MON 87705 × MON 89788 and did not identify safety concerns. No new data on the single events affecting the previous conclusions were identified. No differences in composition requiring further assessment were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. an altered fatty acid profile. Nutritional assessment on soybean MON 87705 × MON 89788 oil and oil-containing food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted soybean meal MON 87705 × MON 89788. The EFSA GMO Panel is of the opinion that soybean MON 87705 × MON 89788 is as safe, and at least as nutritious, as its comparator and commercial soybean varieties. 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 soybean MON 87705 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. 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 soybean MON 87705 × MON 89788 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 of the application. The EFSA GMO Panel considers that the information available for soybean MON 87705 × MON 89788 addresses the scientific comments raised by Member States. The EFSA GMO Panel concludes, considering the scope of the application, that soybean MON 87705 × MON 89788 is as safe as its comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment. The GMO Panel recommends a post-market monitoring pla

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel concludes that the data related to insect resistance monitoring does not indicate a significant and consistent decrease in susceptibility of the target pest field populations to Cry1Ab protein in Spain over the 2013 growing season. However, considering that the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the EFSA GMO Panel reiterates its previous recommendations for improvement of the insect resistance management plan of maize MON 810. The EFSA GMO Panel also recommends, as part of general surveillance, the continuation of the screening and discussion of literature on possible adverse effects of maize MON 810 on rove beetles. In the absence of information on the general surveillance of maize MON 810 in 2013, the EFSA GMO Panel cannot conclude on potential unanticipated adverse effects due to the cultivation of maize MON 810 in 2013, or on possible changes to the methodology as compared to previous growing seasons.

Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non-genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria.

Following a request from the European Commission, a set of assessment criteria was developed to support the selection of existing environmental surveillance networks for post-market environmental monitoring (PMEM) of genetically modified plants (GMPs). In compliance with these criteria, some networks and associated programmes were identified as being of potential use subject to further case-by-case analysis. When considering PMEM of GMPs, the approach would also require comparing sites monitored by the networks and the locations where GMPs are cultivated. The reporting of the sites surveyed by networks and locations of cultivated GMPs should thus follow the same standards in order to ensure interoperability and to potentially establish a causal link between a change observed and the GMPs. In this respect, technical support might be required by networks to transform their data records into workable standards. Moreover, the EFSA GMO Panel was asked by the European Commission to examine the sensitivity of statistical analyses used by the networks to detect change. A decision tree is provided for selecting the optimal method for statistical analysis based on the study design and the datasets from networks. Sufficient statistical power needs to be ensured to detect an effect for a particular indicator. Sample size is one of the main contributing factors in determining the power of any network to detect an effect of a product release into the environment. Increasing the sample size implies variable extra-costs depending on whether data are collected by volunteers or professionals. A more powerful statistical analysis can also be achieved by pooling datasets collected by different networks; this needs further investigation because of important covariates leading to differentiated responses. In general, PMEM would benefit from a move towards ‘open data’ policies for re-analysis or pooling data collected by different networks.

The European Commission asked the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to address the objections of Cyprus to the placing on the market of the genetically modified (GM) carnation SHD-27531-4. The GM carnation cut flowers, with a modified petal colour, are intended to be imported and distributed in the European Union for ornamental use only. The EFSA GMO Panel responded to the objections of Cyprus, taking into account the limited intended use of carnation SHD-27531-4 and the information available. First, the EFSA GMO Panel concludes that the propagation of carnation SHD-27531-4 by individuals cannot be excluded. However, should this occur, carnation SHD-27531-4 would not show any potential for increased survival, fitness or weediness compared with its parental line. Second, the EFSA GMO Panel is of the opinion that the potential spread of pollen of the GM carnation SHD-27531-4 by Lepidoptera to wild Dianthus species cannot be eliminated but is highly unlikely to occur and, if it did occur, it is very unlikely that viable hybrids would be produced, survive and result in adverse environmental effects. Third, considering the very low potentials for hybridisation and/or seed production of (GM) carnations, the EFSA GMO Panel concludes that plant-to-plant gene transfer of the introduced genes is very unlikely and, if it did occur, it is unlikely to result in viable seed production leading to adverse environmental effects.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report, provided by BASF, on the genetically modified (GM) potato EH92-527-1 (variety Amflora) for the 2012 growing season. Because of the discontinuation of the GM potato cultivation in the European Union in 2012, the 2012 monitoring report contained a limited information package, mainly the results of the 2012 monitoring study for volunteers within and around the fields cropped with the GM potato in 2010. The EFSA GMO Panel concludes that GM potato volunteers can be controlled by the applied weed control practices but cannot conclude on the absence of enhanced fitness of the GM potato due to data limitations and flaws in the study design. Hence, the EFSA GMO Panel makes appropriate recommendations. Accounting for the biology of the crop, the GM trait and the common management practices in potato cropping, the EFSA GMO Panel considers it is unlikely that a potential change in fitness or persistence would significantly alter the ability of GM volunteers to establish. Moreover, the EFSA GMO Panel does not consider the occurrence of potato volunteers as an environmental concern but rather as a crop management issue. Therefore, the EFSA GMO Panel concludes that the information provided in the 2012 monitoring report does not indicate any adverse effects of potato EH92-527-1 on the environment or human and animal health. Therefore, the outcomes of the 2012 monitoring report do not invalidate the conclusions of the EFSA GMO Panel‟s previous opinions on potato EH92-527-1

Soybean 305423 was developed through particle bombardment and contains gm-fad2-1 and gm-hra expression cassettes, conferring a high oleic acid profile and tolerance to acetolactate synthase (ALS)-inhibiting herbicides. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the GM-HRA protein in soybean 305423 have been sufficiently analysed. Soybean 305423 differs from the conventional counterpart in the seed fatty acid profile and for the presence of the GM-HRA protein. It is agronomically equivalent to non-GM reference soybeans. The safety assessment of GM-HRA identified no concerns regarding potential toxicity and allergenicity. There are no indications that the overall allergenicity of soybean 305423 has changed. Nutritional assessment on soybean 305423 oil and derived food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feeding stuffs derived from soybean 305423. There are no indications of an increased likelihood of establishment and spread of feral GM soybean plants. Environmental risks associated with an unlikely, but theoretically possible, horizontal gene transfer from soybean 305423 to bacteria have not been identified. Potential biotic and abiotic interactions of soybean 305423 were not considered to be an issue owing to the low level of environmental exposure. The post-market environmental monitoring plan is in line with the scope of soybean 305423. The EFSA GMO Panel considers that the information available for soybean 305423 addresses the scientific comments raised by the Member States and states that the soybean 305423, as described in the 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. The GMO Panel recommends a post-market monitoring plan, focusing on the collection of consumption data for the European population, for the marketed foods

This scientific opinion is a risk assessment for the placing on the market of the genetically modified (GM) herbicide-tolerant oilseed rape (OSR) GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, OSR-GT73. OSR-GT73 contains a single insert consisting of the goxv247 and CP4 epsps expression cassettes. Both proteins confer tolerance against glyphosate-based-herbicides. Bioinformatic analyses of inserted DNA and flanking regions did not raise safety concerns. Levels of CP4 EPSPS and GOXv247 proteins in OSR-GT73 were analysed and the stability of the genetic modification was demonstrated. No biologically relevant differences were identified in the compositional/agronomic/phenotypic characteristics of OSR-GT73 compared with its conventional counterpart, except for the newly expressed proteins. No indication of potential concerns over the safety of the newly expressed CP4-EPSPS and GOXv247 proteins or the occurrence of unintended effects were identified in either OSR-GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods. An equivalent assessment with isolated seed protein could not be made because of the lack of availability of relevant consumption and safety data. There are no indications of increased establishment and spread of feral OSR-GT73 plants, or of hybridising wild relatives, unless exposed to glyphosate-based-herbicides. Potential interactions of feral plants with the biotic/abiotic environment do not raise concerns. Environmental risks of horizontal gene transfer into bacteria were not identified. The monitoring plan and reporting intervals are in line with the intended uses. The environmental risk assessment of OSR-GT73 did not identify any safety concerns, in the context of its intended uses. While the Panel is not in a position to conclude on the safety of OSR pollen as such, it concludes that the genetic modification in OSR-GT73 does no

Following a request from the European Food Safety Authority (EFSA), the Panel on Genetically Modified Organisms (GMO Panel) was asked to supplement its environmental risk assessment conclusions and risk management recommendations on maize 59122 for cultivation in the light of new scientific information on non-target organisms and regionally sensitive areas. Having considered additional information relevant to the assessment of potential adverse effects of maize 59122 on non-target organisms, the Panel must revise two of its previous environmental risk assessment conclusions, invalidating its earlier statement on the environmental safety of maize 59122 in its 2013 Scientific Opinion. A gap in the event-specific data on the honeybee study performed by Maggi (2001) was identified, as a result of which uncertainty over the occurrence of adverse effects on pollinators due to potential unintended changes in maize 59122 remains. Therefore, the Panel is no longer in a position to complete its assessment on the occurrence of adverse effects on pollinators. The Panel reassessed the available dataset on ladybirds, including the Califf and Ostrem (2009) study, and considers the latter study does not enable resolving the remaining scientific uncertainty on the potential toxicity of the binary Cry34Ab1/Cry35Ab1 proteins on Coccinella septempunctata or other ladybirds. In both cases, the Panel recommends that an additional laboratory study is performed prior to authorisation. The Panel considered regionally sensitive areas in its assessment, but regards it as premature to recommend specific risk management strategies for susceptible insect species potentially found within and nearby such areas owing to the inconclusive nature of the assessment of potential adverse effects of maize 59122 on non-target organisms

Maize 3272 contains a single insert consisting of the amy797E and the pmi cassettes, expressing a thermotolerant alpha-amylase (AMY797E) and a phosphamannose isomerase (PMI). Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the AMY797E and PMI proteins in maize 3272 have been sufficiently analysed. In the absence of an appropriately performed comparative assessment, the EFSA Panel on Genetically Modified Organisms (GMO) was not in the position to conclude either on the compositional, agronomic and phenotypic characteristics of maize 3272 or on its nutritional assessment, on the basis of the data provided. The safety assessment could therefore not be completed, and has focused mainly on the newly expressed proteins. No indications of safety concern over the toxicity of the AMY797E and PMI proteins and over the allergenicity of the PMI protein were identified. The Panel could not conclude on the potential for de novo allergic sensitisation of the AMY797E protein. The Panel has identified a gap in the data on the agronomic and phenotypic characterisation of GM maize 3272 and considers that uncertainty over these characteristics remains. However, considering the scope of this application, a weight of evidence approach from different sources of available data and the poor ability of maize to survive outside cultivated land, the Panel concluded that there is very little likelihood of any adverse environmental impacts due to the accidental release into the environment of viable grains from maize 3272. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with a theoretically possible horizontal gene transfer from maize 3272 to prokaryotes have been analysed and did not raise safety concerns. The monitoring plan and reporting intervals were in line with the intended uses of maize 3272

Hungary notified to the European Commission its scientific arguments justifying the implementation of a national safeguard measure prohibiting the placing on the market of GM potato EH92-527-1 for cultivation purposes in Hungary, after which the European Commission asked the European Food Safety Authority (EFSA) to assess the scientific information supporting the prohibition. Having considered the information package provided by Hungary and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that (i) no new data specific to the safety of the nptII gene have been provided; (ii) the therapeutic relevance of kanamycin and neomycin was already addressed in the previous EFSA opinion on antibiotic resistance marker genes and kanamycin resistance in Mycobacterium tuberculosis results largely from chromosomal mutations and not from the transfer of aminoglycoside resistance genes such as nptII; (iii) the knowledge gaps and uncertainties highlighted in the Hungarian document have already been considered in the previous EFSA opinion on antibiotic resistance marker genes, and no new information on the safety of nptII gene as present in the GM potato EH92-527-1 has been identified in the scientific literature that would cause the GMO Panel to change its previous conclusions. Therefore, the EFSA GMO Panel concludes that no grounds exist to date that would lead to reconsideration of its opinion on GM potato EH92-527-1.

The EFSA GMO Panel was asked by the European Commission to apply its mathematical model to simulate and assess potential adverse effects resulting from the exposure of non-target Lepidoptera to maize Bt11 or MON 810 pollen under hypothetical agricultural conditions, and to provide information on the factors affecting the insect resistance management plan, additional to that in its 2011 Statement supplementing the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize Bt11 for cultivation. Here, risk managers are provided with additional evidence and further clarifications to those previous conclusions and risk management recommendations. This Scientific Opinion provides background scientific information to inform the decision-making process; the EFSA GMO Panel reiterates that risk managers should choose risk mitigation and management measures that are proportionate to the level of identified risk according to the protection goals pertaining to their regions.

This scientific opinion is a risk assessment of the genetically modified, herbicide-tolerant, increased oleic acid soybean MON 87705 for food and feed uses, import and processing. MON 87705 contains the soybean FAD2-1A/FATB1-A gene fragments down-regulating endogenous FAD2 and FATB enzymes and the CP4 epsps gene cassette conferring tolerance to glyphosate-containing herbicides. Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the CP4 EPSPS protein in soybean MON 87705 have been sufficiently analysed. MON 87705 differs from the conventional counterpart in the fatty acid profile (proportion of (C18:1) oleic acid increased and proportions of (C18:2) linoleic acid and (C16:0) palmitic acid decreased) in seeds and the presence of the CP4 EPSPS protein. Scientific risk assessment of soybean MON 87705 was carried out in the context of the intended use as specified by the applicant, namely its use for food and feed as any conventional soybean except for the oil derived from soybean MON 87705, which is to be used in margarine, salad dressing, mayonnaise and home-use liquid vegetable oil, excluding the use of soybean MON 87705 oil for commercial frying. The safety assessment identified no concerns regarding potential toxicity and allergenicity of the CP4 EPSPS protein. The altered fatty acid profile did not raise concerns regarding toxicity. The overall allergenicity of the whole plant was not changed by the genetic modification. The estimated changes in intake levels of these fatty acids do not raise nutritional concerns in the context of the intended use as specified by the applicant. A feeding study on broiler chickens confirmed that defatted meal of soybean MON 87705 is as nutritious as meals produced from its conventional counterpart and non-GM reference varieties. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended uses, environmental risks associ

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) compiled its previous risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize Bt11, and considered their validity in the light of new relevant scientific publications published from 2005 onwards. Following a search of the scientific literature published between 2005 and October 2012, the EFSA GMO Panel identified 287 peer-reviewed publications containing evidence specific to the risk assessment and/or management of maize Bt11, of which 270 publications were previously discussed and cited in relevant GM maize-related applications and/or the numerous EFSA GMO Panel scientific outputs. From the remaining 17 publications, three were relevant for the food and feed safety assessment, and 14 for the environmental risk assessment and/or risk management of maize Bt11. None of these publications reported new information that would invalidate the previous conclusions on the safety of maize Bt11 made by the EFSA GMO Panel. Therefore, the EFSA GMO Panel considers that its previous risk assessment conclusions on maize Bt11, as well as its previous recommendations on risk mitigation measures and monitoring, remain valid and applicable.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape GT73. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape GT73 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import and processing of oilseed rape GT73 for feed uses in the EU pose a significant and imminent risk to the environment. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape GT73.