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Potato (Solanum tuberosum L.) cv. Sante was grown over 2 years under both conventional and organic fertiliser and crop protection regimes. The tuber metabolome was analysed using mass-spectrometry (MS) based approaches, principally liquid chromatography (LC)–MS and gas chromatography (GC)–MS. Data were analysed using Principal Components Analysis (PCA) and Analysis of Variance (ANOVA) to assess any differences between production practices. GC–MS analysis of non-polar metabolites did not detect any statistically significant differences, but GC–MS analysis of polar compounds identified 83 metabolites showing significant differences in the metabolome between the fertiliser treatments. Of the 62 metabolites that were less abundant in tuber samples from organic compared with conventionally fertilised crops, consistent year on year differences were dominated by free amino acids. The effect on free amino acids is associated with the lower nitrogen (N) content of the organically grown potatoes in this instance (50 % lower than for conventional production). LC–MS provided indications that levels of certain glycoalkaloids may be lower under the organic fertiliser regime in one growing season. Differences associated with the crop protection measures used were much less consistent, and relatively small, compared with the fertiliser effects found.

Acrylamide is a neurotoxin and possible carcinogen, and concern has been voiced over human exposure to acrylamide in cooked foods. Processed potato products such as crisps and French fries are often cited as being particularly high in acrylamide. In this manuscript a sub-set of clonal progeny from a specific tetraploid potato breeding population has been assessed for acrylamide forming potential in stored tubers processed into crisps. The clone with the lowest acrylamide content in crisps had both low reducing sugars and asparagine contents. Our data show that, in the segregating breeding population used, both asparagine and reducing sugars levels needed to be taken into account to explain most of the variation in acrylamide and that selection for low levels of both metabolites should be targeted for crop improvement.

Risk assessment frameworks, such as those used for GM crops, have detailed comparative analysis with appropriate non-GM counterparts as their cornerstone. Opinions have been voiced that current analytical approaches are too specific and need to be complemented by more unbiased, larger scale analysis of gene expression and protein expression using transcriptomics and proteomics, respectively. In parallel, the use of metabolomics has been advocated as an approach to expand significantly the range of metabolites that can be measured to assess more stringently the potential for any unintended effects. Transcriptomics, proteomics and metabolomics have been termed collectively “omics” technologies. This review assesses the potential for using “omics” techniques in risk assessment. Importantly, the review provides information on sources of natural variation which can result from crop management practices, from interactions between genotype and growing environment and from non-GM breeding systems. This provides an important benchmark for risk assessors and risk managers.

Three main changes to current risk analysis processes are proposed to improve their transparency, openness, and accountability. First, the addition of a formal framing stage would allow interested parties, experts and officials to work together as needed to gain an initial shared understanding of the issue, the objectives of regulatory action, and alternative risk management measures. Second, the scope of the risk assessment is expanded to include the assessment of health and environmental benefits as well as risks, and the explicit consideration of economic- and social-impacts of risk management action and their distribution. Moreover approaches were developed for deriving improved information from genomic, proteomic and metabolomic profiling methods and for probabilistic modelling of health impacts for risk assessment purposes. Third, in an added evaluation stage, interested parties, experts, and officials may compare and weigh the risks, costs, and benefits and their distribution. As part of a set of recommendations on risk communication, we propose that reports on each stage should be made public.

The challenges facing potato breeding have actually changed very little over the years with resistance to pests and pathogens remaining high on the agenda together with improvements in storability, reduction in blemishes, and novelty and consistency in cooking/processing qualities. The need to expand the range of targets for potato improvement is being driven by requirements for reduced agrochemical usage and by predictions of the effects of changing climates. Thus fertiliser and water use efficiency are moving up the political agenda. Genetic variation present in germplasm collections needs to be harnessed to provide the genes and alleles required. This paper provides examples of the functional genomics tools and approaches being developed and deployed to provide new options for advancing the breeding of next generation crops. Whilst genetic modification (GM) approaches remain contentious in Europe, this paper will also provide some recent examples of the range of potential impacts that GM approaches could make. It will also consider the value of so-called intragenic or cisgenic approaches to potato genetic engineering.

Metabolite profiling (liquid chromatography–mass spectrometry (LC–MS) and gas chromatography (GC–MS)) was used to assess the impact of light on the composition of transgenic potato (Solanum tuberosum L. cv. Desiree) with reduced glycoalkaloid content via the down-regulation of the SGT1 gene. Transgenic tubers exhibited an almost complete knock-out of α-solanine production and light had little impact on its accumulation. Levels of α-chaconine increased significantly in the peel of both the control and transgenic lines when exposed to light, particularly in the transgenic line. Major differences in metabolite profiles existed between outer and inner tuber tissues, and between light and dark-treated tubers. Many of the light-induced changes are explicable in terms of pathways known to be affected by stress responses. The impact of transgenesis on profiles was much less than that of tissue type or light and most differences were explicable in terms of the modification to the glycoalkaloid pathway.

Metabolite profiling has been used to assess the potential for unintended composition changes in potato (Solanum tuberosum L. cv. Desiree) tubers, which have been genetically modified (GM) to reduce glycoalkaloid content, via the independent down-regulation of three genes SGT1, SGT2 and SGT3 known to be involved in glycoalkaloid biosynthesis. Differences between the three groups of antisense lines and control lines were assessed using liquid chromatography-mass spectrometry (LC-MS) and gas chromatography (GC)-MS, and data analysed using principal component analysis and analysis of variance. Compared with the wild-type (WT) control, LC-MS revealed not only the expected changes in specific glycoalkaloid levels in the GM lines, but also significant changes in several other metabolites, some of which were explicable in terms of known pathways. Analysis of polar and non-polar metabolites by GC-MS revealed other significant (unintended) differences between SGT lines and the WT, but also between the WT control and other control lines used.

The antioxidant capacity of red cloudberry (Rubus chamaemorus) juice correlates well with its phenolic content. The red berries have a markedly higher content of anthocyanins, particularly cyanidin and pelargonidin derivatives, than that found in the more common yellow fruit. Conversely, the yellow juice has higher ellagitannin content. A feeding study was conducted to show the in vivo effects of the juices on lipid peroxidation in a sensitive Drosophila melanogaster stock. In young female flies there were significant (P < 0.01) effects of cloudberry juice on lipid peroxidation. In young male flies significant (P < 0.05) effects were found on primary products (hydroxyperoxides) with yellow juice and on secondary products (ketodienes) with red juice. With the red juice, a significant (P < 0.05) decrease in ketodienes was found in both young and old males. This study demonstrates that the effects of berry antioxidants on lipid peroxidation are easily and rapidly tested in vivo with the sensitive Drosophila model.

Total and individual fatty acid contents were determined in raw tubers of four genotypes from each of the two species Solanum phureja and S. tuberosum. The four S. phureja genotypes contained statistically significantly higher concentrations of total fatty acids, with their average value being 37% greater than that for the mean of the four S. tuberosum cultivars. In both species, a total of 17 fatty acids were detected in quantifiable amounts, and in all genotypes the predominant fatty acid was linoleic followed by alpha-linolenic and palmitic acids. Unusually, 15-methyl hexadecanoate was present as a minor acid in both species. Although a number of statistically significant differences in the fatty acid percentage compositions were found between and within the two species, these were generally small. Averaged over all species and genotypes, tuber storage resulted in an initial small but statistically significant increase in total fatty acid content, but prolonged storage resulted in a fall to the initial values detected close to harvest. The same trend was evident for S. phureja alone (for mean values of all genotypes), but for S. tuberosum the total fatty acid content remained constant over the whole storage period. For both species, the contents (both as absolute levels and as percent compositions) of linoleic acid decreased and alpha-linolenic acid increased in tubers over the whole storage period, and possible mechanisms are discussed. Also, the absolute levels of these two acids were greater in S. phureja than in S. tuberosum, and this is discussed in relation to the development of flavor-related compounds during cooking. The polar lipids of one representative of S. tuberosum and of S. phureja were qualitatively similar. There were only minor differences in the polar lipid percentage compositions and in the corresponding fatty acid compositions of the individual polar lipids between the two species, although the absolute levels of the total, and of some individual, polar lipids were higher in S. phureja.

Twelve potato cultivars were grown as microtubers in constant environment chambers at two temperatures in total darkness for 28 days. For starch extracted from microtubers grown at 12 or 22 °C, the amylose content ranged from 25.0 to 29.0% (average 27.3 ± 1.4%) or 29.5 to 32.7% (average 30.9 ± 1.4%), the amylose/amylopectin ratio from 1:2.5 to 1:3.0 (average 1:2.7) or 1:2.1 to 1:2.4 (average 1:2.2) and the phosphorus content from 0.41 to 0.93 g kg−1 (average 0.72 g kg−1) or 0.38 to 1.67 g kg−1 (average 0.97 g kg−1) respectively. Two major fractions (F1 and F2) were obtained for isoamylase-debranched starch (amylopectin), with the chain length (CL) averaging 56 ± 3 or 55 ± 1 for F1 and 20 ± 1 or 21 ± 1 for F2 from 12 or 22 °C growth temperature respectively. Peak gelatinisation temperature (Tp) and enthalpy (ΔH) were influenced strongly by growth temperature, with Tp ranging from 60.8 to 64.5 °C (average 62.1 ± 1.0 °C) or 66.9 to 69.6 °C (average 68.2 ± 0.9 °C) and ΔH from 13.3 to 16.9 J g−1 (average 14.8 ± 1.0 J g−1) or 11.3 to 19.5 J g−1 (average 16.3 ± 2.4 J g−1) from 12 or 22 °C growth temperature respectively. The collective data generated at 12 °C were generally more comparable to data published elsewhere (but discussed in the text) for the same potato cultivars grown in field plots (Perthshire). However, there were cultivar specific responses to field or constant environment chambers which make direct comparisons between starches produced from the two systems subject to some variation. Copyright © 2004 Society of Chemical Industry

The levels of xylanolytic activities ((1→4)-β-endoxylanases, β- d -xylosidases and α- l -arabinofuranosidases) and the levels of water extractable arabinoxylans (WEAX) in hot water extracts of malts were compared during malting of four barley cultivars of differing quality. Endoxylanase activity increased from day 1 after steeping showing a slight lag compared with the development of (1→3,1→4)-β-glucanase activity. The levels of endoxylanase activity were different between the cultivars. For example, at day 4, which would be a suitable endpoint for malting of good quality cultivars, total endoxylanase activities of Static and Chariot malts were twice that of Hart and Optic. This variation in level of endoxylanase between cultivars did not correlate with the content of water extractable arabinoxylans in hot water extracts of the malts. However, those cultivars that accumulated most water extractable arabinoxylan had a different set of endoxylanase isoforms. This suggests that expression of specific endoxylanase isoforms may influence the extent of arabinoxylan solubilisation and/or degradation. The β-xylosidases and α-arabinosidases increased from low levels after steep to a plateau of activity at day 6 or 7 of germination. Total xylosidase was always higher than the arabinosidase activity. There were differences between cultivars but these were small compared with the variation in endoxylanase activity. (1→4)-β- d -Endomannanase activity was detected in all four cultivars at 2 days germination then rose to a maximum around 5 days.

Free and total limit dextrinase (LD) activity was measured in four barley varieties of differing malting quality. LD activity was not detected until 2 days after completion of steeping, at which point, total LD activity was 4–5 fold higher in Static and Chariot than in Optic or Hart. Free LD rose to higher levels in Static and Chariot than in Optic and Hart during malting. In addition, the proportion of free to total LD approached 35% in Static and Chariot whereas it did not reach 15% for Optic and Hart. Lower free LD activity was not reflected in a higher total content of branched dextrins in hot water extracts of the different varieties, but may have contributed to the persistence of branched dextrins of higher degree of polymerisation persisting in the hot water extracts of Hart and Optic. The variation in the proportion of free to total LD activity between varieties was not explained by differences in total LD activity and may be related to the presence of inhibitors of LD. Protein extracts made from the malts following steeping inhibited exogenous partially purified LD activity by >80%. After 3 days germination, Chariot, Optic and Static lost much of their inhibitory activity whereas it was retained in Hart. The increase in free LD activities during malting appeared to mirror the disappearance in inhibitory activity. Inhibitors of LD activity were also present in hot water extracts of Chariot and Hart malts. Chariot lost inhibitory activity after 3 days malting and hot water extracts from Chariot after 4 days malting caused apparent activation of LD. By contrast, hot water extracts from Hart retained inhibitory activity up to 5 days malting. These findings are discussed with reference to the availability and effectiveness of LD during malting.

Tubers of potato (Solanum tuberosum L. cv. Estima) genetically modified to reduce polyphenol oxidase (PPO) activity and enzymatic discolouration were assessed for changes in the metabolome using Liquid Chromatography–Mass Spectrometry (LC–MS) and Gas Chromatography (GC)–MS. Metabolome changes induced over a 48 hour (h) period by tuber wounding (sliced transverse sections) were also assessed using two PPO antisense lines (asPPO) and a wild-type (WT) control. Data were analysed using Principal Components Analysis and Analysis of Variance to assess differences between genotypes and temporal changes post-tuber wounding (by slicing). The levels of 15 metabolites (out of a total of 134 that were detected) differed between the WT and asPPO lines in mature tubers at harvest. A considerably higher number (63) of these metabolites changed significantly over a 48 h period following tuber wounding. For individual metabolites the magnitude of the differences between the WT and asPPO lines at harvest were small compared with the impacts of tuber wounding on metabolite levels. Some of the observed metabolite changes are explicable in terms of pathways known to be affected by wound responses. Whilst some statistically significant interactions (11 metabolites) were observed between line and time after wounding, very few profiles were consistent when comparing the WT with both asPPO lines, and the underlying metabolites appeared to be random in terms of the pathways they occupy. Overall, mechanical damage to tubers has a considerably greater impact on the metabolite profile than any potential unintended effects resulting from the down-regulation of PPO gene expression.

The antioxidative capacities of a number of Rubus species of varied pigmentation have been investigated. In addition, total phenol, anthocyanin and ascorbic acid contents have been determined. Two methods to assess the antioxidant potential of fruit juices have been used. The antioxidant capacities of the fruit ranged from 0 to 25.3 mmol Trolox equivalents g ˇ1 (TEAC) or from 190 to 66000 mmol l ˇ1 ferric reducing antioxidant power (FRAP). Ascorbic acid contributes only minimally to the antioxidant potential of Rubus juices (

Potato tubers (cv Maris Piper) were grown at 10, 16, 20 and 25 °C in constant-environment chambers until maturity, whereupon the starches were extracted and subjected to rigorous chemical and physical analysis. The structure of the amylopectin molecules from the different starches post-debranching with isoamylase showed very little variation. The amylose and phosphorus content of the starches did show some variability while granule size tended to decrease as growth temperature was increased. There was, however, a marked increase in gelatinisation temperatures with a roughly constant enthalpy of gelatinisation as a function of growth temperature. The number of amylopectin double helices was determined by 13C CP/MAS-NMR and crystallinity by wide-angle X-ray diffraction and in common with the enthalpy of gelatinisation found to be almost constant. It is proposed that the differences in the gelatinisation temperatures reflect enhanced registration of the amylopectin double helices in crystallites which restricts hydration and hence elevates gelatinisation temperatures. This is probably associated with enhanced rigidity of amorphous regions. The consequence of these ordering effects is that swelling is restricted, even if there is no detectable order by DSC (post-Tc), because of steric hindrance to hydration exerted by the closer proximity/improved registration of the amylopectin chains. © 1999 Society of Chemical Industry

In screening to isolate a full-length copy of a previously isolated cDNA clone, a further three cDNAs were also isolated from a library prepared from sub-apical swelling-stolon tissue of potato (Solanum tuberosum L.). Sequence analysis showed these clones to be similar to extensin-like protein genes, acyl carrier protein thioesterase genes and high mobility group protein genes, respectively. A further cDNA, isolated by subtractive hybridisation, was similar to a tomato cDNA previously isolated on the basis of its down-regulation following nematode infection. While all the newly isolated genes were expressed in swelling stolons, for most, maximal expression was seen to be in stem tissue. Possible roles for these genes in the development of potato plants are discussed, as is the significance of gene expression in stems and stolons to the process of tuberisation.

Potato microtubers (cv Maris Piper) were grown at 10, 16 and 24°C in total darkness for 28 days. Soluble and insoluble starch synthase, ADPglucose pyrophosphorylase, sucrose synthase and fructokinase were assayed in extracts of the microtubers and, in the case of soluble and insoluble starch synthase, activity was found to be particularly sensitive to increasing growth temperature. The starch content of the microtubers increased slightly with increasing growth temperature, but with little effect on the number of granules per microtuber and a small increase in the average granule size. The microtuber starch granules were much smaller than those found in commercial potato starch (c 8–9 μm modal diameter compared to c 21 μm). Although the amylose content of the microtuber starches tended to increase with increasing growth temperature, the phosphorus content was variable. Gel permeation chromatographic elution profiles of native and debranched microtuber and a commercial potato starch showed that no differences could be detected in either amylose or amylopectin molecular size, polydispersity or unit chain distribution of amylopectin (which contained two major unit chain fractions at DP 21 and 56). The onset, peak and conclusion temperatures of the DSC gelatinisation endotherm increased linearly as a function of growth temperature whilst the enthalpy of gelatinisation decreased. It is suggested that elevated temperature during starch biosynthesis facilitates ordering of amylopectin double helices into crystalline domains. © 1998 SCI.

Calibrations are provided to relate near infrared reflectance (NIR) data to total N concentration in potato leaves, stems, and tubers, estimated by Dumas combustion. Separate calibrations are necessary for each tissue-type. the NIR models simulate Dumas [N] estimates accurately, quickly and cheaply and have been shown to be stable. The methods of deriving the calibrations, correcting them and then providing independent tests are described.

Transgenic potato plants are being generated world-wide to assess the impact of transgene expression (sense and/or antisense) on parameters as diverse as yield, quality, stress physiology and pest/disease resistance. Strategies for alternative uses of the potato crops by diverting metabolism into high value products or by expressing recombinant proteins are also being explored. Results obtained are often surprising although the science of plant molecular biology is relatively young. Whilst the outcome of any transgenic approach is by no means certain, this review provides sufficient examples to illustrate the versatility and applicability of transgenic biology in potato improvement.

EFSA’s remit in the risk assessment of GMOs is very broad encompassing genetically modified plants, microorganisms and animals and assessing their safety for humans, animals and the environment. The legal frame for GMOs is set by Directive 2001/18/EC on their release into the environment, and Regulation (EC) No 1829/2003 on GM food and feed. The main focus of EFSA’s GMO Panel and GMO Unit lies in the evaluation of the scientific risk assessment of new applications for market authorisation of GMOs, and in the development of corresponding guidelines for the applicants. The EFSA GMO Panel has elaborated comprehensive guidance documents on GM plants, GM microorganisms and GM animals, as well as on specific aspects of risk assessment such as the selection of comparators. EFSA also provides special scientific advice upon request of the European Commission; examples are post-market environmental monitoring of GMOs, and consideration of potential risks of new plant breeding techniques. The GMO Panel regularly reviews its guidance documents in the light of experience gained with the evaluation of applications, technological progress in breeding technologies and scientific developments in the diverse areas of risk assessment.

This scientific opinion reports an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant maize MIR162 for food and feed uses, import and processing. Maize MIR162 contains a single insert consisting of the vip3Aa20 and pmi expression cassettes. The Vip3Aa20 protein confers resistance against certain lepidopteran pests and phosphomannose isomerase (PMI) serves as a selection marker. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety concerns. The levels of Vip3Aa20 and PMI proteins in maize MIR162 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. Comparative analyses established that there are no biologically relevant differences in the compositional, agronomic or phenotypic characteristics of maize MIR162 compared with its conventional counterpart, and its composition falls within the range of non-GM commercial varieties, except for the expression of the Vip3Aa20 and PMI proteins. The safety assessment identified no concerns regarding potential toxicity and allergenicity of Vip3Aa20 and PMI proteins or of maize MIR162. A feeding study on broiler chickens confirmed that grain produced by maize MIR162 is as nutritious as that produced by its conventional counterpart and a non-GM commercial variety. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize MIR162 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of maize MIR162. In conclusion, the EFSA GMO Panel considers that information available for maize MIR162 addresses scientific comments raised by Member States and that maize MIR162, as described in this application, is as safe as its conventional counterpart and non-GM commercial varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.

This Scientific Opinion reports on an evaluation of a risk assessment for the placing on the market for cultivation of genetically modified soybean 40-3-2, and updates the previous EFSA GMO Panel Scientific Opinion on the renewal applications for the continued marketing of soybean 40-3-2. The EFSA GMO Panel considered that soybean 40-3-2 is unlikely to raise additional environmental safety concerns compared with conventional soybean, but that the management of its cultivation could result in environmental harm under certain conditions. The Panel therefore recommended managing the use of glyphosate on soybean 40-3-2 in ways that result in similar or reduced environmental impacts compared with conventional soybean cultivation. There is no evidence of adverse effects on non-target organisms (including pollinators) due to the expression of the CP4 EPSPS protein, and there are no indications of the occurrence of adverse effects on non-target predators, herbivores and decomposers due to potential unintended changes in soybean 40-3-2. Owing to the lack of event-specific data on plant-pollinator interactions, scientific uncertainty on the occurrence of adverse effects on pollinators, due to potential unintended changes in soybean 40-3-2, remains, and strategies for resolving this uncertainty are discussed. The Panel recommended the deployment of case-specific monitoring to address: (1) changes in weed community diversity; and (2) the evolution of resistance to glyphosate in weeds due to changes in herbicide and cutivation regimes. The Panel agreed with the general surveillance plan of the applicant, but requested that the Panel‟s proposals to strengthen general surveillance are implemented. The Panel concluded that the information available for soybean 40-3-2 addresses the scientific comments raised by Member States and that soybean 40-3-2, as described in this application, is as safe as its conventional counterpart and commercial non-GM soybean varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation of soybean 40-3-2 is unlikely to have environmental effects any more adverse than those associated with conventional soybean cultivation.

Steroidal glycoalkaloids (GAs) are toxins, produced by plants of the Solanaceae family. The potato plant (Solanum tuberosum L.) and its tubers predominantly contain the two GAs α-chaconine and α-solanine. These compounds are believed to act in synergy, and the degree of toxicity may therefore depend on their ratio in the potato. To determine the influence of α-solanine: α-chaconine ratio in potatoes on toxicity, a GM potato line (SGT 9-2) with reduced α-solanine content, and the parental control line (Desiree wild-type) having a traditional α-solanine: α-chaconine ratio were (1) studied for compositional similarity by analysing for a range of potato constituents, and (2) used in a 90-day feeding trial with the Syrian Golden hamster to study differential toxicity. The animal feeding study used diets with up to 60% freeze-dried potato powder from either line. Whilst data indicated some compositional differences between the GM line and its wildtype control these did not raise concerns related to nutritional value or safety. Results of the feeding trials showed a low number of significant differences between potato lines with different α-solanine: α-chaconine ratio but none were considered to raise safety concerns with regard to human (or animal) consumption.

Austria notified to the European Commission its ordinance implementing a national safeguard measure prohibiting the placing on the market of GM potato EH92‐527‐1 for cultivation purposes in Austria, after which the European Commission asked the European Food Safety Authority to assess the scientific elements supporting the prohibition. Having considered the information package provided by Austria and all relevant scientific publications, the GMO and BIOHAZ Panels concluded that: i) no new data specific to the safety of the nptII gene have been provided; ii) the risk posed by the formation of mosaic structures of aminoglycoside phosphotransferase genes could not be assessed without data documenting the existence of such structures among the existing gene variants and such data were not provided; iii) the therapeutic relevance of kanamycin and neomycin was already addressed in the EFSA's opinion on ARM genes and as of yet there is no evidence to indicate that resistance to these antibiotics in clinically‐relevant bacteria has developed as a result of acquisition of the nptII gene; iv) the knowledge gaps and uncertainties highlighted in the Austrian document have already been considered in the EFSA's opinion on ARM genes. Austria did not provide any new or additional information on the molecular characterisation or PMEM of potato EH92‐527‐1 after the date of consent for this GM event that would require the reassessment of existing information. The EFSA GMO Panel reiterates its scientific opinion on the 2010 monitoring report of GM potato EH92‐527‐1 in which it provides specific recommendations to improve the methodology of the PMEM of the GM potato. Further, 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.

This scientific opinion evaluates the risk assessment for the authorisation for (continued) marketing of genetically modified insect‐resistant and herbicide‐tolerant cotton MON 531 × MON 1445 for food and feed produced from it. Cotton MON 531 × MON 1445 was produced by conventional crossing methods, and the stack is homozygous for the newly introduced traits. The integrity and the stable co‐inheritance of the parental events were demonstrated in the stack. Molecular characterisation did not reveal safety issues. No biologically relevant differences were identified in the compositional, phenotypic and agronomic characteristics of cotton MON 531 × MON 1445 in comparison with its conventional counterpart and its composition fell within the range of non‐GM cotton varieties, except for the Cry1Ac, CP4 EPSPS and NPTII proteins. No safety issues were identified with regard to toxicity and allergenicity of food and feed produced from cotton MON 531 × MON 1445. A feeding study in catfish confirmed that toasted cottonseed meal from MON 531 × MON 1445 is as nutritious as toasted cottonseed meal from its conventional counterpart and four commercial non‐GM cotton varieties. Products from cotton MON 531 × MON 1445 do not contain viable plant parts. The insert structure in cotton MON 531 × MON 1445 may facilitate the stabilisation of the nptII gene in plasmids of environmental bacteria through double homologous recombination. However, considering the overall limited occurrence of horizontal transfer of DNA in plant material to bacteria, and the very low exposure to DNA from cotton MON 531 × MON 1445, the EFSA GMO Panel concludes that it is highly unlikely that cotton MON 531 × MON 1445 will contribute to the environmental prevalence of nptII genes. Potential interactions of cotton MON 531 × MON 1445 with non‐target organisms and the abiotic environment were not considered to be an issue because of low exposure levels. A post‐market environmental monitoring plan is not required.

Metabolism of labelled precursors by potato tubers from two cultivars with high (cv. Record) or low (cv. Brodick) capacity for cold-induced sweetening was investigated. Tubers were stored for 8 weeks at 3°C or 15°C. Subsequently, discs were excised and incubated with a range of labelled precursors at the storage temperatures. With either [U- 14 C]glucose or [1- 14 C]ribose, less radioactivity was recovered in glycolytic products (CO 2 , organic acids, and aminoacids) in discs from cold-stored tubers than from warm-stored tubers in both culitvars. Genotypic differences were observed in the partitioning of metabolised label between starch and sucrose at low temperature: relatively more radioactivity was recovered in starch with discs of cv. Brodick while more label was recovered in sucrose with discs of cv. Record. No genotypic differences were observed in the capacity for triose-P recycling (as assessed by 13 C-NMR spectroscopy) or metabolism via PPP (as assessed by C 1 :C 6 ratio) between discs of the two culitvars at low temperature. It is concluded that low storage temperature has a detrimental effect on glycolytic metabolism by potato tubers. Genotypic variation in the partitioning of excess carbon into starch or sucrose at low temperature may ultimately determine the extent of cold-induced sweetening in different potato cultivars.

Amino acid release from roots of sterile and non-sterile, solution-grown, 7-, 21- and 60-days-old forage rape plants (Brassica napus L.), was measured over periods of up to 6 hours. With sterile plants, release of amino acids into a fixed volume of collection medium (6, 12, 70 mL) was concentration-limited, giving rise to similar convex accumulation profiles for individual acids. In contrast, amino acid accumulation in continuously circulating collection medium was not concentration limited, giving a linear accumulation pattern. The compositions of accumulating amino acids, which were similar to those measured in root extracts, did not change significantly. However, the proportions of ALA, GABA, GLU and ILE in both root extracts and root-derived amino acids increased as plants aged. Older plants released more amino acids per plant, while younger plants released more amino acids g-1 root DW. Using non-sterile plants, the patterns of change in amino acid concentration and composition in the collection medium were completely different from those determined with sterile plants. In general, with 7-days-old plants, and 60-days-old plants that had recently become non-sterile, an initial rise in the concentration of all acids was followed by a fall to low levels. The loss of amino acids was apparently due to microbial consumption. Individual amino acids attained maximum concentration at different times during the collection process. This is attributed mainly to concentration-dependent differential assimilation of amino acids, since those with the highest initial concentrations, the major components of the mixtures released from roots, declined the earliest. When calculated rates of amino acid release from roots (Rr) and microbial consumption of amino acids (Rc) were compared (for 7-days-old plants), the highest ratios of Rc/Rr were found for ASN, ARG, GLU, GLN, and LYS. This suggests a degree of selectivity for glutamate and nitrogen-rich acids on the part of the consuming micro-organisms. With 21-days old plants and 60-days old plants grown entirely under non-sterile conditions, fluctuations in amino acid concentration were similar for all acids.

In this Scientific Opinion, the EFSA GMO Panel supplements its previous evaluations of the potential impact of maize 1507 cultivation on a range of non‐target lepidopteran species using existing data on species susceptibility and considering various scenarios of exposure which may occur across Europe. The mathematical model, developed for maize MON 810, was recalibrated and extended to estimate the efficacy of certain mitigation measures. In situations where highly sensitive non‐target Lepidoptera populations might be at risk, the EFSA GMO Panel recommends that mitigation measures are adopted to reduce exposure. Risk managers are provided with tools to estimate global and, where needed local, mortality of exposed non‐target Lepidoptera, both before and after different mitigation measures are put in place, and for different host‐plant densities. Mitigation measures are only needed when the proportion of maize and uptake of maize 1507 are sufficiently high, regardless of the other parameters. If maize 1507 cultivation remains below 5% of the Utilized Agricultural Area, then risk mitigation measures are not required. In addition, the EFSA GMO Panel recommends case‐specific monitoring to assess the efficacy of risk mitigation measures put in place to reduce levels of risk and scientific uncertainty for (1) the possible resistance evolution to the Cry1F protein in target pests, and (2) the risk to sensitive non‐target Lepidoptera from maize 1507 pollen. The EFSA GMO Panel also considers that the plan for general surveillance, and in particular the methodology, needs further details according to the requirements of its 2011 Guidance Document on post‐market environmental monitoring of generically modified plants, as well as its Scientific Opinion on the annual 2009 monitoring report on maize MON 810. The EFSA GMO Panel concludes that, subject to appropriate management measures, maize 1507 cultivation is unlikely to raise safety concerns for the environment.

This Scientific Opinion reports on an evaluation of a risk assessment for placing on the market of genetically modified maize MON 88017 for cultivation. The EFSA GMO Panel considers that maize MON 88017 is unlikely to have any adverse effect on the environment, except for the possible resistance evolution to the Cry3Bb1 protein in coleopteran target pests; resistance evolution may lead to altered pest control practices that may cause adverse environmental effects. The cultivation management of maize MON 88017 could result in environmental harm. The EFSA GMO Panel therefore recommends managing the use of glyphosate on maize MON 88017 within diversified cropping regimes that have similar or reduced environmental impacts compared with conventional maize cultivation. The EFSA GMO Panel recommends the deployment of insect resistance management strategies and case‐specific monitoring to address (1) the possible resistance evolution to the Cry3Bb1 protein in coleopteran target pests, (2) changes in botanical diversity within fields due to novel herbicide regimes, and (3) resistance evolution to glyphosate in weeds due to novel herbicide regimes. The EFSA GMO Panel agrees with the general surveillance plan of the applicant, but requests that the proposals made to strengthen general surveillance are implemented. Whilst the scope of this application only covers the cultivation of maize MON 88017, this Scientific Opinion also updates the previous EFSA GMO Panel safety evaluation of the food and feed uses, import and processing of maize MON 88017 and derived products. The EFSA GMO Panel concludes that the information available for maize MON 88017 addresses the scientific comments raised by Member States and that maize MON 88017, as described in this application, is as safe as its conventional counterpart and commercial maize varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation management of maize MON 88017 is unlikely to raise safety concerns for the environment.

In this statement the EFSA GMO Panel responds to a request from the European Commission on whether data provided within application RX‐MON810 on maize MON810 are sufficient to conclude on the safety of MON810 pollen as or in food and, if it is the case, to confirm MON810 pollen safety. Data on molecular characterisation did not identify features of maize MON810 pollen with a potential to raise any safety concerns. The EFSA GMO Panel has previously assessed the safety of the Cry1Ab protein in MON810 and the assessment and conclusions of the GMO Panel on safety of the protein Cry1Ab (including toxicity and allergenicity) reached for food/feed aspects also apply to pollen. While the EFSA GMO Panel is not in a position to conclude on the safety of maize pollen in or as food in general, it concludes that the genetic modification in MON810 maize does not constitute an additional health risk if MON810 maize pollen were to replace maize pollen from non‐GM maize in or as food.

modified insect resistant cotton MON531 for food and feed produced from it. MON531 was transformed via Agrobacterium. It contains single copies of functional Cry1Ac and NPTII expression cassettes; two fragments of the Cry1Ac cassette and aadA as non-functional elements. Stability of the inserted DNA was confirmed over several generations. Bioinformatic analyses and the levels of recombinant proteins did not reveal safety concerns. Analysis of compositional, phenotypic and agronomic characteristics indicated that MON531 is not different from its conventional counterpart and is compositionally within the range observed among conventional cotton varieties, except for Cry1Ac and NPTII. Safety assessment of Cry1Ac and NPTII proteins and cotton MON531 identified no concerns regarding potential toxicity and allergenicity. Products from MON531 do not contain viable plant parts. The aadA and oriV sequences in MON531 may facilitate the stabilisation of nptII through double homologous recombination in plasmid sequences in the environment. However, considering the expected low frequency of gene transfer from MON531 to bacteria compared to that between bacteria, and the very low exposure to MON531 DNA, the GMO Panel concludes that gene transfer from MON531 to bacteria does not indicate a risk to human or animal health or to the environment in the context of its intended uses. The exposure of potentially sensitive non-target organisms to Cry1Ac protein is likely to be low and of no biological relevance. A PMEM plan is not required. The EFSA GMO Panel considers that information available for cotton MON531 addresses the questions raised by the Member States and that cotton MON531, as described in this application, is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of its intended uses.

This scientific opinion is an evaluation of a risk assessment of the genetically modified, insect resistant, soybean MON 87701 for food and feed uses, import and processing. Soybean MON 87701 was developed through Agrobacterium‐mediated transformation. It contains a single insert consisting of a cry1Ac expression cassette, encoding the Cry1Ac protein that confers resistance against specific lepidopteran insects. The stability of the insert was confirmed over multiple generations. Bioinformatic analyses of the insert and its flanking regions, and levels of newly expressed protein did not raise safety concerns. Comparative analyses of compositional, phenotypic and agronomic characteristics indicated that soybean MON 87701 is not different from its conventional counterpart (A5547) and equivalent to commercial soybean varieties, except for having an increased vitamin E content (still within normal ranges) and expressing the Cry1Ac protein. The safety assessment of the Cry1Ac protein and soybean MON 87701 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that defatted soybean MON 87701 meal is as nutritious as conventional defatted soybean meal. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated of an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 to bacteria have not been identified. Potential interactions of soybean MON 87701 with the biotic and abiotic environment were not considered due to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701. The EFSA GMO Panel considers that the soybean MON 87701, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses.

This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean 356043 for food and feed uses, import and processing. Soybean 356043 contains a single copy of intact gat4601 and Glycine max‐hra cassettes at a single insertion locus. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed proteins did not raise a safety concern. The comparative analysis of phenotypic and agronomic characteristics indicated that soybean 356043 is not different from its conventional counterpart. In the composition, differences were identified between 356043 soybean and its conventional counterpart in the newly expressed proteins Glycine max‐HRA and GAT4601, and the levels of the fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acid and the acetylated amino acids N‐acetylaspartate (NAA) and N‐acetylglutamate (NAG). The safety assessment of the newly expressed proteins Glycine max‐HRA and GAT4601 identified no concerns regarding potential toxicity and allergenicity. Heptadecanoic, heptadecenoic and heptadecadienoic acid are present in the diet and the intake of small amounts of these fatty acids via food or feed is not expected to produce adverse effects. NAA and NAG are normal constituents in the mammalian metabolism and the estimated increases in their intake are considered low when related to the normal intake of L‐aspartic acid and L‐glutamic acid. Further toxicological, allergenicity and nutritional analysis provided no indications of adverse effects. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate and ALS‐inhibiting herbicides neither a risk caused by a possible transfer of the recombinant gene from soybean 356043 to environmental micro‐organisms. The EFSA GMO Panel considers that the information available for soybean 356043 addresses the scientific comments raised by the Member States and states that the soybean 356043, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses.

This opinion provides guidance in the area of comparators taking into account the requirements for the molecular characterisation, the food and feed and the environmental risk assessments. A key step in the risk assessment of genetically modified (GM) plants and derived food and feed is the identification of intended and unintended differences and equivalences between the GM plant and its comparator(s), taking into account the range of natural variation. In line with Regulation (EC) No 1829/2003 and Directive 2001/18/EC, the EFSA GMO Panel has, to date, required the use of non-GM lines with comparable genetic background as comparators. In the case of vegetatively propagated crops, these are the isogenic lines. In the case of sexually propagated crops these are non-GM lines as close as possible genetically to the GM plant under assessment. The identification and production of such comparators is becoming increasingly challenging due to the increasing complexity of GM plants, e.g. those developed by combining (stacking) events through conventional crosses, or those in which extensive compositional changes are targeted. Consequently, the EFSA GMO Panel has developed this guidance on the selection of comparators for the risk assessment of GM plants and derived food and feed. Whilst considering the requirements of Directive 2001/18/EC and Regulation (EC) No 1829/2003, the EFSA GMO Panel provides options which introduce flexibility in the selection of comparators based on sound scientific principles. This document addresses the selection of comparators for GM plants containing single or multiple events stacked by either conventional breeding, or by other approaches such as re-transformation, co-transformation and the use of multiple gene cassettes. The EFSA GMO Panel also considers situations where additional comparators may be required on a case-by-case basis and scenarios where appropriate comparators are not available (e.g. where extensive compositional changes are targeted). The EFSA GMO Panel recognises the different requirements for comparators for the molecular characterisation, food and feed and environmental components of the risk assessment.

This document provides updated guidance for the risk assessment of food and feed containing, consisting or produced from genetically modified (GM) plants, submitted within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The risk assessment strategy for GM plants and derived food and feed proposed seeks to deploy appropriate approaches to compare GM plants and derived food and feed with their respective comparators. The underlying assumption of this comparative approach is that traditionally cultivated crops have gained a history of safe use for consumers and/or domesticated animals. The document provides guidance on how to perform the comparative analysis of the relevant characteristics of the GM plant. The document addresses the details of the different components of the risk assessment: the molecular characterisation, which provides information on the structure and expression of the insert(s) and on the stability of the intended trait(s); the toxicological assessment, which addresses the impact of biologically relevant change(s) in the GM plant and/or derived food and feed resulting from the genetic modification; the assessment of potential allergenicity, of the novel protein(s) as well as of the whole food derived from the GM plant; the nutritional assessment to evaluate whether food and feed derived from a GM plant is not nutritionally disadvantageous to humans and/or animals. In addition every section of the document addresses specifically the requirements for GM plants containing a combination of transformation events, providing guidance on how to establish that the combination is stable and that no interactions occurs between the events that may raise safety concerns. The document does not cover the environmental risk assessment of GM plants which is addressed in a stand-alone environmental risk assessment (ERA) guidance document developed by the EFSA GMO Panel.

This scientific opinion reports an evaluation of a risk assessment for placing on the market of insect resistant genetically modified (GM) cotton (Gossypium hirsutum L.) 281‐24‐236 × 3006‐210‐23 (Unique Identifier DAS‐24236‐5 × DAS‐21Ø23‐5) for food and feed uses, import and processing. The GM cotton 281‐24‐236 × 3006‐210‐23 has been produced by conventional crossing between lines of the single cotton events 281‐24‐236 and 3006‐210‐23. The cotton 281‐24‐236 × 3006‐210‐23 expresses combined traits encoded by cry1F in event 281‐24‐236 and by cry1Ac in event 3006‐210‐23, both genes conferring resistance to certain lepidopteran pests. Both single events contain pat genes used as a selectable marker. The structure of the inserts in the single cotton events was retained in the stack 281‐24‐236 × 3006‐210‐23. Expression levels of Cry1Ac, Cry1F and PAT proteins were demonstrated to be comparable to those of the respective single events. The results of comparative analyses indicated that cotton 281‐24‐236 × 3006‐210‐23 and its respective single events are compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the expression of Cry1Ac, Cry1F and PAT proteins. The safety assessment identified no concerns regarding toxicity and allergenicity of cotton 281‐24‐236 × 3006‐210‐23. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM cotton to its conventional counterpart and two commercial non‐GM cotton varieties. The intended uses of cotton 281‐24‐236 × 3006‐210‐23 exclude cultivation within the European Union. The environmental risk assessment is therefore restricted to the indirect exposure through manure and faeces mainly from animals fed with cotton products of 281‐24‐236 × 3006‐210‐23 and with the accidental release into the environment of cotton 281‐24‐236 × 3006‐210‐23 grains during transportation and processing. There are no indications of increased likelihood of establishment or survival of feral cotton plants. If accidental spillage and subsequent release into the environment of cotton 281‐24‐236 × 3006‐210‐23 seeds occur, cotton 281‐24‐236 × 3006‐210‐23 plants would have a selective advantage only under infestation of target pest species or in presence of glufosinate‐ammonium herbicides, which are not commonly used on cultivated cotton or in most areas where the GM cotton might be spilled. In conclusion, the EFSA GMO Panel considers that information available for cotton 281‐24‐236 × 3006‐210‐23 addresses the scientific comments raised by Member States and that the cotton 281‐24‐236 × 3006‐210‐23 as described in this application is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment in the context of its intended uses. The EFSA GMO Panel concludes that cotton 281‐24‐236 × 3006‐210‐23 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.

This scientific opinion reports on an evaluation of an application (reference EFSA-GMO-RX-MON863[8.1.b/20.1.b]) for renewal of the authorisation for continued marketing of existing feed materials, feed additives and food additives produced from genetically modified (GM) insect resistant maize MON863. Maize MON863 has been modified with a gene encoding the Cry3Bb1 protein which confers protection against coleopteran pests, principally the corn rootworm (Diabrotica spp.). In addition, a selectable marker gene nptII encoding neomycin phosphotransferase II has been introduced. In 2004 the EFSA GMO Panel issued scientific opinions on a Notification for the placing on the market of GM maize MON863 for import and processing and on a request from the European Commission for the placing on the market of foods and food ingredients derived from GM maize MON863. In delivering the present opinion, the EFSA GMO Panel considered the information provided in the application EFSA-GMO-RX-MON863[8.1.b/20.1.b] as well as additional information provided by the applicant and information published in the scientific literature. The new data in the application included bioinformatic analyses using updated databases which confirmed that no relevant similarities exist between the newly expressed proteins and known allergens or proteins toxic to mammals. The EFSA GMO Panel has evaluated the new information provided by the applicant and the scientific literature and concluded that there was no new information that would require changes of its previous scientific opinions on maize MON863 (EFSA, 2004a,b). Therefore, the EFSA GMO Panel reiterates its previous conclusions that GM maize MON863 and its products which are the subject of this application are unlikely to have an adverse effect on human and animal health or the environment in the context of its intended uses (EFSA, 2004a,b).

According to Article 95(5) of the EC Treaty, Portugal notified to the European Commission its intention to declare the Autonomous Region of Madeira as a region free from the cultivation of GM plants. Portugal therefore proposed to introduce a regional decree to prohibit the cultivation of GM seeds and propagating plant material in the Autonomous Region of Madeira. Two reports were provided in support of the national measure. Following the notification of Portugal, the European Commission requested a scientific opinion from the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) to investigate whether the information mentioned in the supporting documents contains any new scientific evidence in terms of protection of the environment in the Autonomous Region of Madeira, that would justify such a prohibition of the use of GMOs, including those that have already been authorised under Directive 90/220/EEC or Directive 2001/18/EC. In its evaluation, the EFSA GMO Panel only investigated and commented on aspects that relate to the protection of human and animal health and the environment. Socio-economic aspects related to the cultivation of GM plants and the coexistence between cropping systems fall outside the remit of EFSA, and are not addressed in this scientific opinion. Following investigation of the evidence presented in the Portuguese submission, the EFSA GMO Panel did not identify new scientific information on the environmental or human and animal health impacts of EU approved GM plants. The EFSA GMO Panel therefore concludes that, based on the supporting documents submitted by Portugal, no new scientific evidence, in terms of risk to human and animal health and the environment, was provided that would justify a prohibition of the cultivation of GM plants in the Autonomous Region of Madeira.

This paper describes the current EU regulatory framework for risk analysis of genetically modified (GM) crop cultivation and market introduction of derived food/feed. Furthermore the risk assessment strategies for GM crops and derived food/feed as designed by the European Food Safety Authority (EFSA) are described on which international agreement exists. Existing flaws in the EU regulatory framework for GMOs have been identified and proposals are put forward to improve current risk analysis procedures for GMOs by taking the SAFE FOODS Risk Analysis Framework into account. The SAFE FOODS framework describes an iterative decision-making process with four distinct stages i.e. framing, risk–benefit assessment, evaluation, and risk management which includes decision-making, and implementation, and a final review stage. Three major changes compared to current risk analyses practices are proposed, i.e. (i) the addition of a formal framing stage, during which problem formulation and the objectives of the risk analysis are established, (ii) enlargement of the scope of the risk assessment, by including the assessment of potential benefits, and an impact analysis of social and economic aspects, and (iii) addition of a formal evaluation stage, in order to weigh risks, costs and benefits and their distribution. Furthermore a broader participation of certain entities, organisations and individual citizens in specific segments of the risk analysis process, in particular in the framing and evaluation stage, is proposed. The proposed changes in current risk analyses practises may contribute to restore consumer confidence in risk analysis process of GMOs in the EU.

A sensitive, rapid and inexpensive method has been developed for quantifying the glucose, fructose and sucrose content of potato tubers. The method, based on selective enzyme-coupled reaction systems and the reduction of NAD to NADH, uses a microplate reader fitted with a 340 nm filter. In one microtiter plate 96 samples can be analysed for all three sugars in less than two hours. Several plates can be processed in parallel.

Following a request from the European Commission, the Panel on Genetically Modified Organisms was asked to review the published scientific paper of Lu & Yang (2009) and to indicate whether this paper contains new information that would alter the previous EFSA GMO Panel environmental safety conclusions on the genetically modified rice event LLRice62. This scientific paper reviews vertical gene flow between cultivated GM rice and cross-compatible wild/weedy rice relatives and the potential ecological consequences thereof. In 2007, the EFSA GMO Panel issued a scientific opinion on the risk assessment evaluation of application EFSA/GMO/UK/2004/04 for the market authorisation of LLRice62 for food/feed uses, import and processing in the EU. In light of the new scientific paper provided by the European Commission and, having considered relevant scientific publications on vertical gene flow in rice, the EFSA GMO Panel concludes that, in terms of risk to the environment, no new scientific evidence has been provided that invalidates the previous environmental risk assessment evaluation of LLRice62 for its intended uses, which exclude cultivation.

Hybrid oilseed rape Ms8 x Rf3 has been produced by conventional crossing between the genetically modified (GM) parental lines Ms8 and Rf3. The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes into two separate oilseed rape lines; each gene is linked to the bar gene conferring tolerance to glufosinate-containing herbicides. The scope of this application covers the continued marketing of existing food (processed oil) and feeds produced from oilseed rape Ms8, Rf3 and Ms8 x Rf3 which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. In 2005 the EFSA GMO Panel had issued a scientific opinion on the safety of glufosinate-tolerant oilseed rape Ms8 x Rf3 derived from parental lines Ms8 and Rf3 for import and processing for feed and industrial uses. In delivering the present opinion, the EFSA GMO Panel considered the information provided in the application EFSA-GMO-RX-MS8-RF3 as well as additional information submitted by the applicant. The new data included molecular and bioinformatic analyses and a 42-day feeding study on chickens. The animal study showed that the tested material of oilseed rape Ms8 x Rf3 was nutritionally equivalent to its non-GM counterpart. In addition, bioinformatic studies using updated databases confirmed that no relevant similarities exist between the newly expressed proteins and known allergens or toxic proteins. Therefore, the EFSA GMO Panel reiterates the conclusions of its previous scientific opinion of 2005 that GM oilseed rape Ms8, Rf3 and Ms8 x Rf3 is unlikely to have an adverse effect on human and animal health or, in the context of its proposed uses, on the environment. This also applies to the products which are the subject of the present application.

This scientific opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified insect resistant and herbicide tolerant maize Bt11 x MIR604 x GA21 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize Bt11 x MIR604 x GA21 from lines of the respective single maize events. The structure of the inserts in the single maize events as well as the phenotypes were both retained in the stacked maize events. The expression levels of the Cry1Ab, PAT, mCry3A, PMI and mEPSPS proteins in maize Bt11 x MIR604 x GA21 were demonstrated to be comparable with those of the respective single maize events. The comparative analysis of ompositional, phenotypic and agronomic characteristics indicated equivalence of maize Bt11 x MIR604 x GA21 with its conventional counterpart except for the newly expressed proteins which provided resistance to certain lepidopteran and coleopteran target pests and tolerance to glufosinate-ammonium- and/or glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11 x MIR604 x GA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its conventional counterpart and a commercial non-GM maize variety. Considering the intended uses of maize Bt11 x MIR604 x GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11 x MIR604 x GA21 was required. In case of accidental release of viable maize Bt11 x MIR604 x GA21 grains into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants except in the presence of the glufosinate-ammonium- and/or glyphosate-based herbicides. It is highly unlikely that the recombinant DNA will transfer and establish in the genome of bacteria in the environment or human and animal digestive tracts. In conclusion, the EFSA GMO Panel considers that the information available for maize Bt11 x MIR604 x GA21 addresses the scientific comments raised by Member States and that the maize Bt11 x MIR604 x GA21, as assessed in this application, is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment, in the context of its intended uses. The EFSA GMO Panel concludes that maize Bt11 x MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and the environment, in the context of its intended uses.

This scientific opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified insect resistant and herbicide tolerant maize Bt11xGA21 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize Bt11xGA21 from inbred lines of the respective parental events. The structural integrity of the inserts in the single maize events as well as the phenotypes were retained in the stacked maize event. The expression levels of the Cry1Ab, PAT and mEPSPS proteins in maize Bt11xGA21 were demonstrated to be comparable with those of the single maize events. The comparative analysis of phenotypic, agronomic and compositional characteristics of this GM maize indicated equivalence with its non-GM maize counterpart and conventional maize, except for the expression of the target proteins Cry1Ab, PAT and mEPSPS, providing resistance to certain lepidopteran pests and tolerance to glufosinate-ammonium- and glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11xGA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its non-GM maize counterpart and conventional maize. Considering the intended uses of maize Bt11xGA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11xGA21 was required. In case of accidental release of viable maize Bt11xGA21 grains into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants, except in the presence of glufosinte-ammonium- and/or glyphosate-based herbicides. The EFSA GMO Panel concludes that maize Bt11xGA21 is as safe as its non-GM maize counterpart with respect to effects on human and animal health and the environment, and is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.

Reducing sugar and sucrose contents of potato tubers (Solanum tuberosum L.) from six cultivars were monitored both during the growing season and after a four months storage period at 10°C. Significant correlations were found between tuber sugar contents (sucrose, reducing and total) measured at harvest and the reducing sugar content after storage. Similarly, in five of the six cultivars, the sucrose loss and the corresponding reducing sugar gain during storage were significantly correlated.

Reducing sugar and sucrose content of potato tubers (cv. Record) grown in Tayside (northern United Kingdom (UK)) and Lincolnshire (southern UK) were monitored during the 1984 growing season and after two months storage at 10°C. Neither latitude nor agronomic factors were shown to affect sugar content. Significant correlations were found between the post storage reducing sugar content and the sugar contents measured at harvest. Regression analyses indicated that in immature tubers sucrose breakdown was responsible for reducing sugar accumulation during storage.

The commercialisation of GM crops in Europe is practically non-existent at the present time. The European Commission has instigated changes to the regulatory process to address the concerns of consumers and member states and to pave the way for removing the current moratorium. With regard to the safety of GM crops and products, the current risk assessment process pays particular attention to potential adverse effects on human and animal health and the environment. This document deals with the concept of unintended effects in GM crops and products, i.e. effects that go beyond that of the original modification and that might impact primarily on health. The document first deals with the potential for unintended effects caused by the processes of transgene insertion (DNA rearrangements) and makes comparisons with genetic recombination events and DNA rearrangements in traditional breeding. The document then focuses on the potential value of evolving "profiling" or "omics" technologies as non-targeted, unbiased approaches, to detect unintended effects. These technologies include metabolomics (parallel analysis of a range of primary and secondary metabolites), proteomics (analysis of polypeptide complement) and transcriptomics (parallel analysis of gene expression). The technologies are described, together with their current limitations. Importantly, the significance of unintended effects on consumer health are discussed and conclusions and recommendations presented on the various approaches outlined.

Considerable genotypic variation was found with respect to susceptibility of potato ( Solanum tuberosum ) tubers to internal rust spot (IRS), a Ca 2+ -related physiological disorder. However, no correlation was observed between incidence of IRS and membrane permeability in discs of tubers from a range of growth conditions. An analysis of the fatty acid and sterol composition of tuber membrane lipids from genotypes Desiree (IRS resistant) and 10337de40 (IRS susceptible), which had undergone long-term Ca 2+ deficiency, also revealed similar lipid profiles.

Following a request of the European Commission, the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) evaluated the documentation submitted by France in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 34 of Regulation (EC) No 1829/2003. The EFSA GMO Panel notes that some publications referred to by France were already part of the submission package by France for its safeguard clause and emergency measure on maize MON 810 in 2008. Those publications were addressed previously by the EFSA GMO Panel in its 2008 Scientific Opinion on the safeguard clause and emergency measure notified by France on maize MON 810. In the remaining documentation provided by France in support of the current emergency measure on maize MON 810, the EFSA GMO Panel could not identify any new science-based evidence indicating that maize MON 810 cultivation in the EU poses a significant and imminent risk to the human and animal health or the environment. With regard to issues related to management and monitoring of maize MON 810, the EFSA GMO Panel refers to its recent recommendations for management and monitoring measures of maize MON 810. In conclusion, the EFSA GMO Panel considers that, based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 34 of Regulation (EC) No 1829/2003 and that would invalidate its previous risk assessments of maize MON 810.