Opinion of the Scientific Panel on genetically modified organisms [GMO] on a request from the Commission related to the Notification (Reference C/NL/98/11) for the placing on the market of herbicide-tolerant oilseed rape GT73, for import and processing, u

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doi:10.2903/j.efsa.2004.29

Cited by 10 publications

(7 citation statements)

References 15 publications

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“…As previously described (EFSA GMO Panel, 2004 , 2013 , 2020 , 2022 ), the molecular characterisation data establish that oilseed rape GT73 contains a single insert consisting of one copy of the goxv247 and the CP4 epsps expression cassettes. Bioinformatics analyses of the sequences encoding the NEPs and other ORFs within the insert or spanning the junctions between the insert and genomic DNA do not raise concerns.…”

Section: Assessmentsupporting

confidence: 64%

“…In its previous opinions, the GMO Panel concluded that 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 NEPs (EFSA GMO Panel, 2004 , 2013 ). The scope of the application EFSA‐GMO‐RX‐026/2 is for the placing on the market of isolated seed protein from oilseed rape GT73 for food in the EU.…”

Section: Assessmentmentioning

confidence: 99%

“…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%

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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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Section: Assessmentsupporting

confidence: 64%

Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…There was no indication of neurological effects based on the routine observations of clinical signs in either the 28-day toxicity study or a previously evaluated acute toxicity study (EFSA, 2004). 16 Therefore, the GMO Panel concludes that this deviation from OECD TG407 (2008) does not compromise the safety assessment of the GOXv247 protein.…”

mentioning

confidence: 99%

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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Feral genetically modified herbicide tolerant oilseed rape from seed import spills: are concerns scientifically justified?

Devos

Hails

Messéan³

et al. 2011

Transgenic Res

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Contact CEH NORA team at noraceh@ceh.ac.ukThe NERC and CEH trademarks and logos ('the Trademarks') are registered trademarks of NERC in the UK and other countries, and may not be used without the prior written consent of the Trademark owner.1 | P a g e KEYWORDSGenetically modified oilseed rape, herbicide tolerance, seed spillage, ferality, persistence, invasiveness, coexistence, introgression 2 | P a g e ABSTRACTOne of the concerns surrounding the import (for food and feed uses or processing) of genetically modified herbicide tolerant (GMHT) oilseed rape is that, through seed spillage, the herbicide tolerance (HT) trait will escape into agricultural or semi-natural habitats, causing environmental or economic problems. Based on these concerns, three EU countries have invoked national safeguard clauses to ban the marketing of specific GMHT oilseed rape events on their territory. However, the scientific basis for the environmental and economic concerns posed by feral GMHT oilseed rape resulting from seed import spills is debatable.While oilseed rape has characteristics such as secondary dormancy and small seed size that enable it to persist and be redistributed in the landscape, the presence of ferals is not in itself an environmental or economic problem. Crucially, feral oilseed rape has not become invasive outside cultivated and ruderal habitats, and HT traits are not likely to result in increased invasiveness. Feral GMHT oilseed rape has the potential to introduce HT traits to volunteer weeds in agricultural fields, but would only be amplified if the herbicides to which HT volunteers are tolerant were used routinely in the field. However, this worst-case scenario is most unlikely, as seed import spills are mostly confined to port areas. Economic concerns revolve around the potential for feral GMHT oilseed rape to contribute to GM admixtures in non-GM crops. Since feral plants derived from cultivation (as distinct from import) occur at too low a frequency to affect the coexistence threshold of 0.9% in the EU, it can be concluded that feral GMHT plants resulting from seed import spills will have little relevance as a potential source of pollen or seed for GM admixture. This paper concludes that feral oilseed rape in Europe should not be routinely managed, and certainly not in semi-natural habitats, as the benefits of such action would not outweigh the negative effects of management.3 | P a g e INTRODUCTIONThe global area cropped with genetically modified (GM) crops has consistently increased each year since they were first commercially cultivated in 1996 (1.7 million hectares), reaching 148 million hectares in 2010 (James, 2010). The advent of GM crops and their rapid expansion in terms of cropping area evoked intense debate about their safety (Hails, 2000; Devos et al., 2008b;Waltz, 2009; Gaskell et al., 2011). Concerns have been raised that the commercial release of GM crops could result in adverse environmental and economic effects.Environmental concerns include the potential for altered fitness of the crop ...

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Opinion of the Scientific Panel on genetically modified organisms [GMO] on a request from the Commission related to the Notification (Reference C/NL/98/11) for the placing on the market of herbicide-tolerant oilseed rape GT73, for import and processing, u

Cited by 10 publications

References 15 publications

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)

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)

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

Feral genetically modified herbicide tolerant oilseed rape from seed import spills: are concerns scientifically justified?

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