Application (Reference EFSA-GMO-UK-2005-11) for the placing on the market of insect-resistant genetically modified maize MIR604 event, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds S.A.S on behalf of

Andersson, Hans; Arpaia, Salvatore; Bartsch, Detlef K.; Casacuberta, Josep M.; Davies, Howard V.; Jardin, Patrick du; Flachowsky, Gerhard; Jones, Huw; Herman, Lieve; Kärenlampi, Sirpa; Kiss, J.; Kleter, Gijs; Kuiper, H.A.; Messéan, Antoine; Nielsen, Kaare Magne; Perry, J. N.; Pöting, Annette; Sweet, Jeremy; Tebbe, Christoph C.; Wal, Jean‐Michel

doi:10.2903/j.efsa.2009.1193

EFSA Journal

2009

DOI: 10.2903/j.efsa.2009.1193

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Application (Reference EFSA-GMO-UK-2005-11) for the placing on the market of insect-resistant genetically modified maize MIR604 event, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds S.A.S on behalf of

Hans Andersson¹,

Salvatore Arpaia²,

Detlef K. Bartsch³

et al.

Abstract: SUMMARYFollowing a request from Syngenta Seeds S.A.S on behalf of Syngenta Crop Protection AG within the framework of Regulation (EC) No 1829/2003 on genetically modified food and feed, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the authorisation of the insect-resistant genetically modified maize MIR604 (Unique Identifier SYN-IR6Ø4-5) for food and feed uses, import and processing.In delivering its scientific op… Show more

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Cited by 5 publications

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Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2011‐99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

2016

EFS2

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In this opinion, the EFSA GMO Panel assesses the five-event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five-event stack maize Bt11 9 59122 9 MIR604 9 1507 9 GA21 and did not identify safety concerns. No new data on the single events, leading to a modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the five-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the single events impacting on the food and feed safety of the five-event stack maize. Considering the scope of the application (no cultivation), routes of exposure and limited exposure levels, the Panel concludes that this five-event stack maize would not raise safety concerns in the event of accidental release of viable grains into the environment. The EFSA GMO Panel concludes that the fiveevent stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. For the 20 subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded that they are expected to be as safe as the five-event stack maize. No specific data were submitted for the subcombinations included in the scope of this application that could be produced by conventional crossing through targeted breeding approaches. In order to reduce the consequent uncertainties and to confirm assumptions made for their assessment, the EFSA GMO Panel considers that the applicant should provide relevant information, if these subcombinations were to be created via targeted breeding approaches and imported into the EU in the future. In this case, this information should focus on expression levels of the newly expressed proteins. A minority opinion expressed by an EFSA GMO Panel member is appended to this opinion.

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Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2011‐99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

2016

EFS2

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Risk assessment of information on the subcombination Bt11 × MIR162, related to the application of Syngenta (EFSA‐GMO‐DE‐2009‐66) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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

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Assessment of genetically modified maize MZIR098 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2017‐142)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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Maize MZIR 098 was developed to confer tolerance to glufosinate‐ammonium‐containing herbicides and resistance to certain coleopteran pests. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MZIR 098 and its conventional counterpart needs further assessment, except for neutral detergent fibre ( NDF ) in grains, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the eC ry3.1Ab, mC ry3A and PAT proteins as expressed in maize MZIR 098, and finds no evidence that the genetic modification would change the overall allergenicity of maize MZIR 098. In the context of this application, the consumption of food and feed from maize MZIR 098 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MZIR 098 is as safe as the conventional counterpart and non‐ GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MZIR 098 grains into the environment, maize MZIR 098 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MZIR 098. In conclusion, the GMO Panel considers that maize MZIR 098, as described in this application, is as safe as its conventional counterpart and the non‐ GM maize reference varieties tested with respect to potential effects on human and animal health and the environment.

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Application (Reference EFSA-GMO-UK-2005-11) for the placing on the market of insect-resistant genetically modified maize MIR604 event, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds S.A.S on behalf of

Cited by 5 publications

References 27 publications

Risk assessment of information on the subcombination Bt11 × MIR162, related to the application of Syngenta (EFSA‐GMO‐DE‐2009‐66) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21

Assessment of genetically modified maize MZIR098 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2017‐142)

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