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

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

doi:10.2903/j.efsa.2009.1417

Cited by 6 publications

(5 citation statements)

References 4 publications

(5 reference statements)

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“…Analyses of the amino acid sequence of the newly expressed CP4 EPSPS and GOXv247 proteins show no relevant similarities to toxins or allergens. In addition, bioinformatic analyses of the newly created ORFs within the insert or spanning the junctions with genomic DNA confirm previous conclusions indicating no similarities to toxins or allergens for the event GT73 (EFSA, 2004; EFSA GMO Panel, 2009, 2013.…”

Section: Evaluation Of the Updated Bioinformatic Datasupporting

confidence: 82%

“…The results of the updated bioinformatic analyses of oilseed rape GT73 confirm previous analyses indicating that no known endogenous genes were disrupted by the insert (EFSA, 2004; EFSA GMO Panel, 2009, 2013. Analyses of the amino acid sequence of the newly expressed CP4 EPSPS and GOXv247 proteins show no relevant similarities to toxins or allergens.…”

Section: Evaluation Of the Updated Bioinformatic Datasupporting

confidence: 69%

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Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐002)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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Following the submission of application EFSA‐GMO‐RX‐002 under Regulation (EC) No 1829/2003 from Monsanto Company, the Panel on Genetically Modified Organisms of EFSA (GMO) 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 GT73. 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 sequence of the event in oilseed rape GT73 considered for renewal of authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐002 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73.

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Section: Evaluation Of the Updated Bioinformatic Datasupporting

confidence: 82%

Section: Evaluation Of the Updated Bioinformatic Datasupporting

confidence: 69%

Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐002)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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“…The safety of oilseed rape GT73 expressing the GOXv247 protein has been previously considered, originally under Regulation (EC) No 258/97 (ACNFP Annual Report, 1995), and subsequently by EFSA GMO Panel in 2004(EFSA, 2004 and in a renewal opinion in 2009 (EFSA GMO Panel, 2009b). In essence, these assessments were product-driven, recognising that the GOXv247 was absent in the oil used for human consumption and was present only in trace amounts in the toasted meal used in animal feeding.…”

Section: Introductionmentioning

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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“…The GMO Panel did not identify indications of safety concerns regarding toxicity, allergenicity or adjuvanticity related to the presence of the newly expressed CP4 EPSPS and GOXv247 proteins in oilseed rape GT73. The GMO Panel considered previous opinions on oilseed rape GT73 (EFSA GMO Panel, 2004 , 2009 , 2013 , 2020 , 2022 ), which comprised the outcome of a 28‐day oral repeated dose toxicity study in mice on GOXv247 (EFSA GMO Panel, 2020 ). The GMO Panel also considered new information provided in the context of this application (see Section 2 ) that included updated bioinformatics analyses of the NEPs, recently assessed by the GMO Panel (EFSA GMO Panel, 2022 ), and human dietary exposure to CP4 EPSPS and GOXv247 proteins.…”

Section: Assessmentmentioning

confidence: 99%

“…Oilseed rape GT73 has previously been risk assessed by the EFSA GMO Panel. Briefly, the initial scope of the evaluations of the GMO Panel involved the (i) import and processing of oilseed rape GT73 for feed use (EFSA GMO Panel, 2004 ), and (ii) renewal of the authorisation for continued marketing of existing food and food ingredients produced from oilseed rape GT73, and feed materials, feed additives and food additives produced from oilseed rape GT73 (EFSA GMO Panel, 2009 ). The EFSA GMO Panel concluded in its scientific opinions 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.…”

Section: Introductionmentioning

confidence: 99%

Assessment of genetically modified oilseed rape GT73 for placing on the market of isolated seed protein for food under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/2)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

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Genetically modified oilseed rape GT73 was developed to confer herbicide tolerance; this property was achieved by introducing the single insert containing one copy of goxv247 and the CP4 epsps expression cassettes. The scope of the application EFSA‐GMO‐RX‐026/2 is for the modification of the terms of the authorisation regarding the placing on the market of isolated seed protein from oilseed rape GT73 for food. Considering previous opinions on this event of the GMO Panel, the molecular characterisation data do not identify issues requiring additional food safety assessment. Based on previous assessments, no biologically relevant differences were identified in the compositional, agronomic and phenotypic characteristics of oilseed rape GT73 compared with its conventional counterpart, except for the newly expressed proteins. No new agronomic, phenotypic and compositional data in support of the comparative analysis were considered necessary in the context of this application. The GMO Panel did not identify indications of safety concern regarding toxicity, allergenicity or adjuvanticity related to the presence of the newly expressed proteins CP4 EPSPS and GOXv247 in oilseed rape GT73. Therefore, the GMO Panel concludes that in the context of this application, the consumption of oilseed rape GT73 does not represent any nutritional concern and is as safe as the conventional counterpart. No post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable oilseed rape GT73 into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape GT73. The GMO Panel concludes that oilseed rape GT73 is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment. These conclusions also apply to the placing on the food market of isolated seed protein produced from oilseed rape GT73.

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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

Cited by 6 publications

References 4 publications

Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐002)

Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐002)

Assessment of genetically modified oilseed rape GT73 for placing on the market of isolated seed protein for food under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/2)

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