Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐87) for the placing on the market of genetically modified herbicide tolerant oilseed rape GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape GT73 (with the exception of refined oil and food additives) under Regulation (EC) No 1829/2003 from Monsanto

Abstract

This scientific opinion is a risk assessment for the placing on the market of the genetically modified (GM) herbicide-tolerant oilseed rape (OSR) GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, OSR-GT73. OSR-GT73 contains a single insert consisting of the goxv247 and CP4 epsps expression cassettes. Both proteins confer tolerance against glyphosate-based-herbicides. Bioinformatic analyses of inserted DNA and flanking regions did not raise safety concerns. Levels of CP4 EPSPS and GOXv247 proteins in OSR-GT73 were analysed and the stability of the genetic modification was demonstrated. No biologically relevant differences were identified in the compositional/agronomic/phenotypic characteristics of OSR-GT73 compared with its conventional counterpart, except for the newly expressed proteins. No indication of potential concerns over the safety of the newly expressed CP4-EPSPS and GOXv247 proteins or the occurrence of unintended effects were identified in either OSR-GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods. An equivalent assessment with isolated seed protein could not be made because of the lack of availability of relevant consumption and safety data. There are no indications of increased establishment and spread of feral OSR-GT73 plants, or of hybridising wild relatives, unless exposed to glyphosate-based-herbicides. Potential interactions of feral plants with the biotic/abiotic environment do not raise concerns. Environmental risks of horizontal gene transfer into bacteria were not identified. The monitoring plan and reporting intervals are in line with the intended uses. The environmental risk assessment of OSR-GT73 did not identify any safety concerns, in the context of its intended uses. While the Panel is not in a position to conclude on the safety of OSR pollen as such, it concludes that the genetic modification in OSR-GT73 does not constitute an additional health risk if OSR-GT73 pollen were to replace non-GM OSR pollen. Scientific opinion on herbicide-tolerant oilseed rape GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape GT73 2 EFSA Journal 2013;11 (2) 4 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a Scientific Opinion on the safety of genetically modified (GM) herbicide tolerant oilseed rape GT73 (Unique Identifier MON-ØØØ73-7) for food containing or consisting of, and food produced from or containing ingredients produced from, GM oilseed rape GT73 (with the exception of refined oil and food additives).In delivering its Scientific Opinion, the EFSA GMO Panel considered the application EFSA-GMO-NL-2010-87, additional information supplied by the applicant, scientific comments submitted by the Member States, and relevant scientific publications. Further information was taken into account from previous applicatio...

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

“…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.…”

“…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, 2004;EFSA GMO Panel, 2013). Given the results of this analysis and the potential of the recombinant DNA in oilseed rape GT73 to confer selective advantages or increased fitness to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.…”

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

“…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 GT73 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐026/1 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73 (EFSA GMO Panel, 2013 ).…”

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

“…oilseed rape: oilseed rape. materials and consequently human exposure would have been much greater than from the oil, the GMO Panel considered that a more extensive toxicological assessment of the protein was necessary in the context of application EFSA-GMO-NL-2010-87 (EFSA GMO Panel, 2013). To this end, a 28-day toxicity study in rodents was requested.…”

“…The applicant argued that such a study was not needed to confirm the safety of GOXv247 protein 7 and did not provide the study. Consequently, the GMO Panel concluded that, in the absence of consumption data and repeated dose toxicity studies with the GOXv247 protein, it was not in the position to complete the risk assessment of products of this nature (EFSA GMO Panel, 2013).…”