Scientific Opinion on application (EFSA-GMO-BE-2010-81) for the placing on the market of genetically modified herbicide-tolerant oilseed rape Ms8, Rf3 and Ms8 × Rf3 for food containing or consisting of, and food produced from or containing ingredients pro

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doi:10.2903/j.efsa.2012.2875

Cited by 6 publications

(12 citation statements)

References 65 publications

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“…Since the publication of the GMO Panel Scientific Opinions on the three single oilseed rape events (EFSA, 2005(EFSA, , 2009EFSA GMO Panel, 2012, no safety issues pertaining to the single oilseed rape events have been reported by the applicant.…”

Section: Updated Information On the Eventsmentioning

confidence: 99%

“…The potential for HGT of the recombinant DNA of the single oilseed rape events MON 88302, MS8 and RF3, and the two-event stack oilseed rape MS8 9 RF3 was assessed previously by the GMO Panel (EFSA, 2005(EFSA, , 2009EFSA GMO Panel, 2010c, 2012. No concern as a result of an unlikely, but theoretically possible, HGT of the recombinant genes to bacteria in the gut or other receiving environments was identified.…”

Section: Plant-to-bacteria Gene Transfer 31mentioning

confidence: 99%

“…The two-event stack oilseed rape MS8 9 RF3 has been assessed previously by the GMO Panel, and no safety concerns were identified (EFSA GMO Panel, 2012, 2009. A literature search revealed no new scientific information relevant to the risk assessment of this two-event stack oilseed rape that became available since the validation of the application EFSA- GMO-NL-2013-119.…”

Section: Subcombination Previously Assessedmentioning

confidence: 99%

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Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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In this opinion, the GMO Panel assessed the three‐event stack oilseed rape (OSR) MON 88302 × MS8 × RF3 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the single events combined to produce this three‐event stack OSR and did not identify safety concerns; no new information that would modify the original conclusions was identified. The combination of the single OSR events and of the newly expressed proteins in the three‐event stack OSR does not give rise to food and feed safety and nutrition issues – based on the molecular, agronomic/phenotypic and compositional characteristics. In the case of accidental release of viable OSR MON 88302 × MS8 × RF3 seeds into the environment, the three‐event stack OSR would not raise environmental safety concerns. The GMO Panel therefore concluded that the three‐event stack OSR is as safe and as nutritious as its conventional counterpart and the tested non‐GM reference varieties in the context of the scope of this application. Since no new safety concerns were identified for the previously assessed two‐event stack OSR MS8 × RF3, the GMO Panel considered that its previous conclusions on this subcombination remain valid. For the two subcombinations MON 88302 × MS8 and MON 88302 × RF3 for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their different combinations would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed OSR MS8 × RF3, and OSR MON 88302 × MS8 × RF3. Since the post‐market environmental monitoring plan for the three‐event stack OSR does not include any provisions for two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

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Section: Updated Information On the Eventsmentioning

confidence: 99%

Section: Plant-to-bacteria Gene Transfer 31mentioning

confidence: 99%

Section: Subcombination Previously Assessedmentioning

confidence: 99%

See 1 more Smart Citation

Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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“…The potential for horizontal gene transfer of the recombinant DNA of the single oilseed events MS8, RF3 and GT73, and the two-event stack oilseed rape MS8 3 RF3 was assessed previously by the GMO Panel. No concern as a result of an unlikely, but theoretically possible, horizontal gene transfer of the recombinant genes to bacteria in the gut or other receiving environments was identified (EFSA, 2005;EFSA GMO Panel, 2009a, 2010b, 2012. Genes of bacterial origin expressed in the three-event stack oilseed rape include the CP4 epsps gene of Agrobacterium sp., the gox gene of O. anthropi, the bar gene of S. hygroscopicus, as well as the barstar and barnase genes of B. amyloliquefaciens, respectively.…”

Section: Plant-to-bacteria Gene Transfermentioning

confidence: 99%

Scientific Opinion on an application by Bayer CropScience and Monsanto (EFSA‐GMO‐NL‐2009‐75) for placing on the market of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MS8 × RF3 × GT73 and subcombinations, which have not been authorised previously (i.e. MS8 × GT73 and RF3 × GT73) independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food, under Regulation (EC) No 1829/2003

2016

EFS2

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The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed the three single events that are combined to produce the three‐event stack oilseed rape (OSR) MS8 × RF3 × GT73. In this Scientific Opinion, the GMO Panel assessed the three‐event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 × GT73 and RF3 × GT73), independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The combination of OSR events, MS8, RF3 and GT73, in the three‐event stack OSR does not raise issues relating to molecular, agronomic/phenotypic or compositional characteristics requiring further investigations. In line with previous assessments and considering the scope of this application, the GMO Panel did not find indications of safety concern for food and feed with trace levels of glyphosate oxidoreductase (GOX)v247 protein derived from the three‐event stack OSR; whereas, the GMO Panel cannot assess the safety of three‐event stack OSR products rich in protein, such as rapeseed protein isolates in feed. As the risk assessment of the three‐event stack OSR could not be completed for products rich in protein, such as rapeseed protein isolates, the GMO Panel is not in a position to complete the food and feed safety assessment of subcombinations within the scope of this application (i.e. MS8 × GT73 and RF3 × GT73). The two‐event stack OSR MS8 × RF3 is outside the scope of this application. Considering the scope of this application, the mode of action of the introduced traits and the data available for the three‐event and two‐event stack OSR MS8 × RF3, the GMO Panel considered that different combinations of the events, MS8, RF3 and GT73, would not raise environmental concerns.

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“…Following the submission of applications EFSA‐GMO‐BE‐2010‐81 and EFSA‐GMO‐RX‐004 and the publication of the EFSA scientific opinions (EFSA GMO Panel, 2012 , 2017a ), the placing on the market of oilseed rape MS8, RF3 and MS8 × RF3 for products containing, consisting of, or produced from this GM oilseed rape, excluding cultivation in the EU, was authorised by Commission Implementing Decision 2013/327/EU and (EU) 2019/1301 4 . A copy of these authorisations were provided by the applicant.…”

Section: Introductionmentioning

confidence: 99%

Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)

Mullins¹,

Bresson²,

Dalmay³

et al. 2023

EFS2

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Following the submission of application EFSA‐GMO‐RX‐024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant genetically modified oilseed rape MS8, RF3 and MS8 × RF3, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in oilseed rape MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3.

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Scientific Opinion on application (EFSA-GMO-BE-2010-81) for the placing on the market of genetically modified herbicide-tolerant oilseed rape Ms8, Rf3 and Ms8 × Rf3 for food containing or consisting of, and food produced from or containing ingredients pro

Cited by 6 publications

References 65 publications

Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)

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