EFSA GMO Panel Research Articles

Statement complementing the EFSA GMO Panel scientific opinion on maize MON 89034 × 1507 × NK603 (application EFSA‐GMO‐NL‐2009‐65), to cover all sub‐combinations independently of their origin

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to complement its scientific opinion on insect resistant and herbicide tolerant genetically modified (GM) maize MON 89034 x 1507 x NK603 (application EFSA-GMO-NL-2009-65) issued in 2010, to cover all sub-combinations independently of their origin. The EFSA GMO Panel scientific opinion covered the safety assessment of maize MON 89034 x 1507 x NK603 and all sub-combinations of the individual events as present in its segregating progeny, for food and feed uses, import and processing under Regulation (EC) No 1829/2003. Each single event present in maize MON 89034 x 1507 x NK603 and two of the three possible sub-combinations, namely maize 1507 x NK603 (EFSA-GMO-UK-2004-05) and maize MON 89034 x NK603 (EFSA-GMO-NL-2007-38), were previously assessed by the EFSA GMO Panel. In view of the European Commission’s request and, having considered all relevant available information on maize MON 89034 x 1507 x NK603 and on the single maize events, the EFSA GMO Panel considers it unlikely that the sub-combinations have an adverse effect on human and animal health and the environment in the context of their intended uses, which cover food and feed uses, import and processing. This conclusion was further supported by the previous assessments of maize 1507 x NK603 and maize MON 89034 x NK603. The EFSA GMO Panel concludes that the present statement can complement the scientific opinion on maize MON 89034 x 1507 x NK603 to cover all sub-combinations independently of their origin.

Scientific Opinion on application EFSA‐GMO‐RX‐MON531 for renewal of the authorisation for continued marketing of existing cottonseed oil, food additives, feed materials and feed additives produced from MON 531 cotton that were notified under Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 from Monsanto

This scientific opinion evaluates the risk assessment for the authorisation for continued marketing of genetically 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.

Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants

The European Commission asked the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to update its 2006 scientific opinion on Post-Market Environmental Monitoring (PMEM) of Genetically Modified Plants (GMPs). For doing so, the EFSA GMO Panel made use of the experience gained from its assessment of applications on GMPs for cultivation and considered different sources of information such as the PMEM reports on cultivated GMPs, relevant scientific literature and stakeholders comments. This scientific opinion aims to clarify the objectives, tasks, tools and requirements for PMEM. Firsly, the present document explains the scientific rationale for PMEM, including the concept of developing management and monitoring strategies based on the overall conclusions and assumptions of the Environmental Risk Assessment. Secondly, it provides examples and guidance to applicants on how to develop and implement their plans for Case-Specific Monitoring (CSM), taking into account the case-by-case character of CSM. In addition, it provides guidance to applicants on the strategy, methodology and reporting of General Surveillance (GS). Different tools and approaches to implement a plan for GS are considered. The EFSA GMO Panel proposes a holistic and integrative approach for monitoring GMPs in the EU that considers GS within a framework of general environmental protection monitoring. Finally, the EFSA GMO Panel makes proposals to risk managers for the future conduct of PMEM in the EU and suggests that access to PMEM data could be facilitated by setting-up standardised and centralised reporting centres. This scientific opinion repeals the former 2006 scientific opinion of the EFSA GMO Panel on PMEM of GMPs.

Scientific Opinion on application (EFSA‐GMO‐UK‐2007‐43) for the placing on the market of herbicide tolerant genetically modified soybean 356043 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer

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.

Scientific Opinion on application (EFSA‐GMO‐BE‐2010‐79) for the placing on the market of insect resistant genetically modified soybean MON 87701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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.

Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use

Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The marketing of these products within the European Union falls under different legislative instruments, which establish the requirement for a risk assessment for the authorisation of the product. The present guidance describes the principles to be followed when conducting such a risk assessment, as well as the scientific information required in applications for authorisation to be evaluated by the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel). Products form four categories, depending on their nature and the level of scientific information required for their evaluation by the EFSA GMO Panel. The guidance details the data to be provided for the assessment of products of each category, providing reference to other guidance that is also applicable. This document draws on the experience gained by the EFSA GMO Panel in assessing applications for marketing food and feed involving GMMs and takes into account the input received from different stakeholders, and updates the “Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed”, adopted by the EFSA GMO Panel in 2006.

Guidance on selection of comparators for the risk assessment of genetically modified plants and derived food and feed

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.

Scientific Opinion on application (EFSA‐GMO‐NL‐2008‐52) for the placing on the market of herbicide tolerant genetically modified soybean A5547‐127 for food and feed uses, import and processing under Regulation (EC) No 1829–2003 from Bayer CropScience

This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean A5547-127 for food and feed uses, import and processing. Soybean A5547-127 was developed through particle bombardment. It contains a single insertion site consisting of a copy of the intact pat expression cassette, encoding the PAT protein that confers tolerance to glufosinate-ammonium containing herbicides. Other inserted sequences include two truncated parts of the beta-lactamase (bla) gene from the transformation vector on each side of the pat expression cassette. The stability of the inserted DNA was confirmed over multiple generations. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed protein did not raise a safety concern. The comparative analysis of compositional, phenotypic and agronomic characteristics indicated that soybean A5547-127 is not different from its conventional counterpart (A5547), except for the newly expressed protein (PAT). The safety assessment of the PAT protein and the soybean A5547-127 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that seeds of soybean A5547-127 are as nutritional as seeds of the conventional counterpart. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glufosinate-ammonium containing herbicides. The risk caused by a possible transfer of the recombinant gene from soybean A5547-127 to environmental micro-organisms is regarded to be negligible due to the lack of any advantage that would be conferred in the context of its intended uses. The potential interactions of the GM plant with target organisms, non-target organisms and the abiotic environment and biogeochemical cycles were not considered an issue by the EFSA GMO Panel. The monitoring plan and reporting intervals are in line with the intended uses of soybean A5547-127. The EFSA GMO Panel considers that the information available for soybean A5547-127 addresses the scientific comments raised by the Member States and that the soybean A5547-127, 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.

Guidance for risk assessment of food and feed from genetically modified plants

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.

Stakeholder consultation workshop between experts of the EFSA GMO Panel and non‐governmental organisations on the update of the ERA guidance document in the frame of the 4th meeting of EFSA and environmental NGOs for the EFSA stakeholders platform

Stakeholder consultation workshop between experts of the EFSA GMO Panel and non‐governmental organisations on the update of the ERA guidance document in the frame of the 4th meeting of EFSA and environmental NGOs for the EFSA stakeholders platform

Scientific Opinion on applications (EFSA‐GMO‐RX‐40‐3‐2[8‐1a/20‐1a], EFSA‐GMO‐RX‐40‐3‐2) for renewal of authorisation for the continued marketing of (1) food containing, consisting of, or produced from genetically modified soybean 40‐3‐2; (2) feed containing, consisting of, or produced from soybean 40‐3‐2; (3) other products containing or consisting of soybean 40‐3‐2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto

This scientific opinion is an evaluation of a risk assessment for the renewal of authorisations for continued marketing of the genetically modified herbicide tolerant soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6) for (1) food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; and (3) of other products containing or consisting of soybean 40-3-2 with the exception of cultivation. Soybean 40-3-2 has been developed for tolerance to glyphosate herbicides by the introduction, via particle gun acceleration technology, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). Molecular analyses indicated that soybean 40-3-2 contains one functional insert expressing CP4 EPSPS and a non-functional insert consisting of a fragment of the CP4 EPSPS coding sequence. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions and the levels of the newly expressed protein in soybean 40-3-2 did not raise any safety concern. The stability of the inserted DNA was confirmed over several generations. Available compositional and agronomic data show that soybean 40-3-2 is compositionally and agronomically equivalent to its conventional counterpart and to other commercial soybean varieties, except for expressing the CP4 EPSPS protein. It is estimated that the European consumers have been exposed to soybean 40-3-2 mainly via soybean oil Processed meal of soybean 40-3-2 has been given to farm animals in the EU at an estimated maximum dietary inclusion levels around 21% for broiler chickens, 18% for pigs, and 12% for dairy cattle. No adverse effects have been linked to these exposures. The safety assessment of the CP4 EPSPS protein expressed in soybean 40-3-2 and the whole soybean plant identified no concerns regarding potential toxicity and allergenicity of soybean 40-3-2. Considering the intended uses of soybean 40-3-2, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of GM soybean 40-3-2 was required. In case of accidental release of viable grains produced by soybean 40-3-2 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate herbicides. The EFSA GMO Panel considers unlikely that the recombinant DNA in soybean 40-3-2 transfers to bacteria and other micro-organisms and that the risk caused by a rare but theoretically possible transfer of the recombinant epsps gene from soybean 40-3-2 to environmental microorganisms is regarded to be negligible due to the lack of a selective advantage in the context of its intended use that would be conferred. Taking into account the scope of the application, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, indicate that the risk to non-target organisms is extremely low. The scope of the monitoring plan provided by the applicant and the reporting intervals are in line with the intended uses of soybean 40-3-2 since cultivation is excluded. In conclusion, on the basis of the information considered in the original application, updated studies in the present applications, and other peer-reviewed scientific data on soybean 40-3-2, the EFSA GMO Panel confirms that soybean 40-3-2 is as safe and nutritious as the conventional counterpart and other commercial soybean varieties.

Scientific Opinion on application (EFSA-GMO-CZ-2008-62) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and all sub-combinations of the individual events as present i

This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect resistant and herbicide tolerant maize MON 89034 x 1507 x MON 88017 x 59122 for food and feed uses, import and processing. Maize MON 89034 x 1507 x MON 88017 x 5912 was produced by conventional crossing and the F1 plant is hemizygous for all newly introduced genes. The maize contains cry1A.105, cry2Ab2, cry1F, pat, cry3Bb1, CP4 epsps, cry34Ab1 and cry35Ab1 genes conferring resistance against certain lepidopteran and coleopteran target pests and tolerance to glufosinate-ammonium- and glyphosate-based herbicides. The maize events MON 89034, 1507, MON 88017 and 59122 crossed together to create maize MON 89034 x 1507 x MON 88017 x 59122, behave as independent genetic loci. The F2 grain harvested from maize MON 89034 x 1507 x MON 88017 x 59122 is expected to contain a mixture of MON 89034 x 1507 x MON 88017 x 59122 and all combinations of the individual events which will be imported and processed for food and feed uses. The EFSA GMO Panel has evaluated the risk assessment with respect to safety concerns which might arise through any potential combination of the following events MON 89034, 1507, MON 88017, and 59122 in maize MON 89034 x 1507 x MON 88017 x 59122 and in its segregating progeny. Molecular analyses indicated that the structure of the inserts in the single events was retained in maize MON 89034 x 1507 x MON 88017 x 59122. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions did not raise any safety concern. Levels of the newly expressed proteins in maize MON 89034 x 1507 x MON 88017 x 59122 were demonstrated to be comparable with those of the single events. Comparative analyses established that maize MON 89034 x 1507 x MON 88017 x 59122 does not differ compositionally, agronomically and phenotypically from its conventional counterpart, and is equivalent to commercial maize varieties, except for the newly introduced traits. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON 89034 x 1507 x MON 88017 x 59122. A feeding study on broiler chickens confirmed the nutritional equivalence of maize MON 89034 x 1507 x MON 88017 x 59122 to its conventional counterpart and commercial maize varieties. Considering the intended uses of maize MON 89034 x 1507 x MON 88017 x 59122, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of this maize was required. In case of accidental release of viable grains produced by maize MON 89034 x 1507 x MON 88017 x 59122 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment or survival of feral maize plants, except in the presence of glufosinate-ammonium- and/or glyphosate-based herbicides and/or under infestation by target pests. It is highly unlikely that the recombinant DNA will be transferred and establish itself in the genome of bacteria in the environment or human and animal digestive tracts. In conclusion, the EFSA GMO Panel considers that the maize MON 89034 x 1507 x MON 88017 x 59122, as described in this application, is as safe as its conventional counterpart and commercial maize varieties with respect to potential effects on human and animal health and the environment. In addition, the EFSA GMO Panel is of the opinion that crossing of maize events MON 89034, 1507, MON 88017 and 59122 to produce maize MON 89034 x 1507 x MON 88017 x 59122 does not result in interactions between the events which would affect the safety of maize MON 89034 x 1507 x MON 88017 x 59122 with respect to potential effects on human and animal health and on the environment, in the context of its intended uses. Based on the data provided for maize stack MON 89034 x 1507 x MON 88017 x 59122, the single maize events and for the two parental double stacks 1507 x 59122 and MON 89034 x MON 88017, the EFSA GMO Panel is of the opinion that there is no biological reason to expect that any of the other sub-combinations of the individual events present in its segregating progeny would raise a safety concern. The EFSA GMO Panel concludes that maize MON 89034 x 1507 x MON 88017 x 59122 is unlikely to have adverse effects on human and animal health and the environment, in the context of its intended uses.

Scientific Opinion on an application (EFSA-GMO-NL-2009-65) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × NK603 and all sub-combinations of the individual events as present in its seg

This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect resistant and herbicide tolerant maize MON 89034 × 1507 × NK603 for food and feed uses, import and processing. Maize MON 89034 × 1507 × NK603 was produced by conventional crossing methods and the F1 plant is hemizygous for all newly introduced traits. The maize contains cry1A.105, cry2Ab2, cry1F, pat, CP4 epsps and CP4 epsps l214p genes conferring resistance against certain lepidopteran target pests and tolerance to glufosinate-ammonium- and glyphosate-based herbicides. The maize events MON 89034, 1507 and NK603, crossed together to create maize MON 89034 × 1507 × NK603, behave as independent genetic loci. The F2 grain harvested from maize MON 89034 × 1507 × NK603 and assessed for safety is expected to contain a mixture of MON 89034 × 1507 × NK603 and all sub-combinations of the individual events which will be imported and processed for food and feed uses. The EFSA GMO Panel has evaluated the risk assessment with respect to safety concerns which might arise through any potential combination of the following events MON 89034, 1507 and NK603 in maize MON 89034 × 1507 × NK603 and in its segregating progeny. Molecular analyses indicated that the structure of the inserts in the single events was retained in maize MON 89034 × 1507 × NK603. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions did not raise any safety concern. Levels of the newly expressed proteins in maize MON 89034 × 1507 × NK603 were demonstrated to be comparable with those of the single events. Comparative analyses established that maize MON 89034 × 1507 × NK603 is compositionally, phenotypically and agronomically comparable to its conventional counterpart and equivalent to commercial maize varieties, except for the newly expressed proteins. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON 89034 × 1507 × NK603. Considering the intended uses of maize MON 89034 × 1507 × NK603, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of this maize was required. In case of accidental release of viable grains from maize MON 89034 × 1507 × NK603 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment or survival of feral maize plants, except in the presence of glufosinate-ammonium- and/or glyphosatebased herbicides and/or under infestation of target pests. It is highly unlikely that the recombinant DNA will be transferred and establish itself 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 MON 89034 × 1507 × NK603 addresses the scientific comments raised by the Member States and concludes that the maize MON 89034 × 1507 × NK603, 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 addition, the EFSA GMO Panel is of the opinion that crossing of single maize events MON 89034, 1507 and NK603 to produce maize MON 89034 × 1507 × NK603 does not result in interactions between the events which would affect the safety of maize MON 89034 × 1507 × NK603 with respect to potential effects on human and animal health and on the environment, in the context of its intended uses. Based on data provided for maize stack MON 89034 × 1507 × NK603, the single maize events (MON 89034, 1507 and NK603), and for the two double stacks 1507 × NK603 and MON 89034 × NK603, the EFSA GMO Panel is of the opinion that there is no biological reason to expect that any of the other sub-combinations of the individual events as present in its segregating progeny would raise a safety concern. The EFSA GMO Panel concludes that maize MON 89034 × 1507 × NK603 is unlikely to have adverse effects on human and animal health and the environment, in the context of its intended uses.

Scientific Opinion on application (EFSA‐GMO‐NL‐2005‐16) for the placing on the market of insect resistant genetically modified cotton (Gossypium hirsutum L.) 281‐24‐236 × 3006‐210‐23 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Dow AgroSciences

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.

Scientific Opinion on the revised molecular characterisation for Rf3 oilseed rape received from the Competent Authority of Belgium under Article 20(3) of Directive 2001/18/EC

The DG Environment of the European Commission has requested the EFSA Panel on Genetically Modified Organisms to deliver a scientific opinion on the revised molecular characterisation for Rf3 oilseed rape received from the Competent Authority of Belgium under Article 20(3) of Directive 2001/18/EC. The GMO Panel was asked to consider whether the new information received in respect of oilseed rape Rf3 could have consequences for the risks of this GMO to human health or the environment within the scope of Directive 2001/18/EC. In particular, EFSA was requested to take account of the objections raised by the Competent Authority of Austria in this context. Based on the revised molecular characterisation and on the additional information submitted in the frame of assessment of application EFSA-GMO-RX-Ms8-Rf3, the GMO Panel concludes that (1) the new information received on oilseed rape Rf3 does not have consequences for the risks of this GMO to human health or the environment within the scope of Directive 2001/18/EC and (2) the points raised by the Competent Authority of Austria are addressed in the opinion of the EFSA GMO Panel on application EFSA-GMO-RX-Ms8-Rf3.

Scientific Opinion on applications (EFSA‐GMO‐RX‐MON863) for renewal of the authorisation for continued marketing of existing feed materials, feed additives and food additives produced from maize MON863, under Regulation (EC) No 1829/2003 from Monsanto

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 npt II 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).

Scientific Opinion on applications (EFSA-GMO-RX-GT73) for renewal of the authorisation for continued marketing of existing (1) food and food ingredients produced from oilseed rape GT73; and of (2) feed materials, feed additives and food additives produced

This scientific opinion reports on an evaluation of a risk assessment for renewal of the authorisation for continued marketing of existing food and feed ingredients, feed materials, feed additives and food additives produced from hybrid oilseed rape GT73. Oilseed rape GT73 has been modified with two genes encoding the CP4 EPSPS and GOX proteins that confer glyphosate tolerance and resistance, respectively. In 2004 the EFSA GMO Panel had issued a scientific opinion on the safety of glyphosate-tolerant oilseed rape GT73 for import and processing uses. In delivering the present opinion, the EFSA GMO Panel considered the information provided in the applications EFSA-GMO-RX-GT73[8.1.a] and EFSA-GMO-RX-GT73[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 and toxic proteins.The EFSA GMO Panel reiterates the conclusions of its previous scientific opinion of 2004 that GM oilseed rape GT73 is unlikely to have an adverse effect on human and animal health and on the environment, in the context of its proposed uses. This also applies to the products which are the subject of the present application.

Statement on a scientific publication on vertical gene flow in rice and its potential ecological consequences by Lu & Yang (2009)

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.

Application (EFSA‐GMO‐RX‐MS8‐RF3) for renewal of the authorisation for continued marketing of existing (1) food and food ingredients produced from genetically modified glufosinate‐tolerant oilseed rape Ms8, Rf3 and Ms8 × Rf3, and (2) feed materials produced from genetically modified glufosinate‐tolerant oilseed rape Ms8, Rf3 and Ms8 × Rf3, under Regulation (EC) No 1829/2003 from Bayer CropScience

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.

Application (Reference EFSA-GMO-CZ-2006-33) for the placing on themarket of the insect-resistant and glyphosate-tolerant genetically modifiedmaize MON 88017 x MON 810, for food and feed uses, import andprocessing under Regulation (EC) No 1829/2003 from Monsanto

Application (Reference EFSA-GMO-CZ-2006-33) for the placing on themarket of the insect-resistant and glyphosate-tolerant genetically modifiedmaize MON 88017 x MON 810, for food and feed uses, import andprocessing under Regulation (EC) No 1829/2003 from Monsanto