Scientific Opinion on an application by Dow Agrosciences LLC (EFSA‐GMO‐NL‐2009‐68) for placing on the market of cotton 281‐24‐236 × 3006‐210‐23 × MON 88913 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Birch, Andrew Nicholas; Casacuberta, Josep; Schrijver, Adinda De; Gathmann, Achim; Gralak, Mikołaj Antoni; Guerche, Philippe; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Naegeli, Hanspeter; Nielsen, Elsa; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy; Tebbe, Christoph C.; Visioli, Francesco; Wal, Jean‐Michel

doi:10.2903/j.efsa.2016.4430

Cited by 3 publications

(3 citation statements)

References 33 publications

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“…The GMO Panel regularly reviews the available publications on food allergy to cottonseed (EFSA GMO Panel, 2016). However, to date, cotton has not been considered to be a common allergenic food 56 (OECD, 2009).…”

Section: B) Assessment Of Allergenicity Of Gm Plant Productsmentioning

confidence: 99%

“…As additional information was requested by the GMO Panel, the time limit of 6 months was extended accordingly, in line with Articles 6(1), 6(2), 18(1) and 18(2) of Regulation (EC) No 1829/2003 According to Regulation (EC) No 1829/2003, this scientific opinion is to be seen as the report requested under Articles 6(6) and 18(6) of that Regulation and thus will be part of the EFSA overall opinion in accordance with Articles 6(5) and 18(5). As additional information was requested by the GMO Panel, the time limit of 6 months was extended accordingly, in line with Articles 6(1), 6(2), 18(1) and 18(2) of Regulation (EC) No 1829/2003 According to Regulation (EC) No 1829/2003, this scientific opinion is to be seen as the report requested under Articles 6(6) and 18(6) of that Regulation and thus will be part of the EFSA overall opinion in accordance with Articles 6(5) and 18(5).…”

Section: Introductionmentioning

confidence: 99%

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Scientific opinion on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Baye

Birch¹,

Casacuberta²,

Schrijver³

et al. 2016

EFSA Journal

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Cotton GHB119 was developed by Agrobacterium tumefaciens-mediated transformation. It expresses the Cry2Ae and phosphinothricin acetyltransferase (PAT) proteins which, respectively, confer resistance to certain lepidopteran species and tolerance to glufosinate ammonium-based herbicides. The molecular characterisation of cotton GHB119 did not give rise to safety issues. The agronomic, phenotypic and compositional characteristics of cotton GHB119 tested under field conditions revealed no relevant differences between cotton GHB119 and its conventional counterpart that would give rise to any food and feed or environmental safety concern. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry2Ae and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of cotton GHB119. The nutritional characteristics of cotton GHB119 are not expected to differ from those of non-GM cotton varieties. There are no indications of an increased likelihood of establishment and spread of feral cotton GHB119 plants. Considering the scope of this application, 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 cotton GHB119 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for cotton GHB119 addresses the scientific comments raised by the Member States and that cotton GHB119, 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 the scope of this application.

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Section: B) Assessment Of Allergenicity Of Gm Plant Productsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Scientific opinion on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Baye

Birch¹,

Casacuberta²,

Schrijver³

et al. 2016

EFSA Journal

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Section: Assessment Of Allergenicity Of the Whole Gm Plant Or Crop 25mentioning

confidence: 99%

Scientific opinion on an application by Monsanto (EFSA‐GMO‐NL‐2013‐114) for the placing on the market of a herbicide‐tolerant genetically modified cotton MON 88701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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Cotton MON 88701 was developed through Agrobacterium tumefaciens-mediated transformation to express the dicamba mono-oxygenase (DMO) protein, conferring tolerance to dicamba, and the phosphinothricin N-acetyltransferase PAT protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between cotton MON 88701 and its conventional counterpart. Since complete compositional results were reported for only three sites, the EFSA Panel on Genetically Modified Organisms (GMO Panel) is not in the position to complete the assessment of the compositional analysis. Moreover, as no 28-day toxicity study in rodents on the MON 88701 DMO protein was provided, the GMO Panel is not in the position to complete the safety assessment of this protein in cotton MON 88701. Consequently, the GMO Panel cannot complete the toxicological, allergenicity and nutritional assessment of food/feed derived from cotton MON 88701. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the PAT protein newly expressed in cotton MON 88701. Considering the routes of exposure and limited exposure levels, the GMO Panel concludes that cotton MON 88701 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88701. In conclusion, in the absence of an appropriate comparative assessment and an appropriate assessment of the MON 88701 DMO protein, the GMO Panel is not in a position to complete its food/feed risk assessment of cotton MON 88701. The GMO Panel concludes that the cotton MON 88701 is unlikely to have any adverse effect on the environment in the context of the scope of the application.

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Relevance of new scientific information (Santos‐Vigil et al., 2018[Link]) in relation to the risk assessment of genetically modified crops with Cry1Ac

Dumont¹,

Lanzoni²,

Waigmann³

et al. 2018

EFS3

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Following a request from the European Commission, EFSA assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the new scientific information contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on genetically modified crops expressing Cry1Ac protein. Santos‐Vigil et al. (2018) investigated the allergenic potential and immunological effects of the Cry1Ac protein and compared it with ovalbumin after intragastric administration to BALB/c mice, using a specific model of food‐allergy. Shortcomings in the study design and data interpretation limit the possibility to attribute findings to the intrinsic properties of the Cry1Ac protein. The publication by Santos‐Vigil et al. (2018) does not bring new elements that would lead the EFSA GMO Panel to reconsider the outcome of its previous scientific opinions on genetically modified crops with Cry1Ac. Therefore, EFSA considers that the previous risk assessment conclusions on GM crops with Cry1Ac remain valid and applicable.

show abstract

Scientific Opinion on an application by Dow Agrosciences LLC (EFSA‐GMO‐NL‐2009‐68) for placing on the market of cotton 281‐24‐236 × 3006‐210‐23 × MON 88913 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Cited by 3 publications

References 33 publications

Scientific opinion on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Baye

Scientific opinion on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Baye

Scientific opinion on an application by Monsanto (EFSA‐GMO‐NL‐2013‐114) for the placing on the market of a herbicide‐tolerant genetically modified cotton MON 88701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Relevance of new scientific information (Santos‐Vigil et al., 2018[Link]) in relation to the risk assessment of genetically modified crops with Cry1Ac

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