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

Abstract

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.

Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)

“…The updated bioinformatic analysis for oilseed rape event GT73 does not reveal any DNA sequence that could provide sufficient length and identity which could facilitate double homologous recombination (HR), confirming the previous conclusions (EFSA GMO Panel, 2013 , 2020 ). Given the results of this analysis and that the recombinant DNA in oilseed rape GT73 does not confer selective advantages to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible horizontal gene transfer.…”

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)

“…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.…”

“…The scope of the application EFSA‐GMO‐RX‐026/2 is for modifying the terms of the authorisation regarding the placing on the market of isolated seed protein from oilseed rape GT73 for food in the EU. The EFSA GMO Panel considers that the modification of the terms of the authorisation has no impact on the environmental risk assessment (ERA) of oilseed rape GT73 and confirms its previous conclusions (EFSA GMO Panel, 2013 , 2020 , 2022 ).…”

“…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.…”

“…oil, toasted meal). The GMO Panel concluded that this new information does not raise any concern for human and animal health and the environment (EFSA GMO Panel, 2020 ).…”