| Sumario: | Application EFSA-GMO-DE-2019-157 (oilseed rape LBFLFK) was submitted to EFSA to be risk assessed as full-scope, i.e. for import, processing, and food and feed uses, within the EU. Oilseed rape LBFLFK was developed to alter its fatty acid profile and to confer tolerance to imidazolinone herbicides. Oilseed rape LBFLFK contains two inserts, not genetically linked, each consisting of a single copy of the T-DNA, which contains 13 expression cassettes (coding for 11 unique proteins). The Panel on Genetically Modified Organisms (GMO Panel) was unable to conclude on the safety of oilseed rape LBFLFK when considering the full-scope of this application. The safety of the elongases and desaturases newly expressed in oilseed rape LBFLFK cannot be established. Similarly, the safety and nutritional adequacy of the oil and full-fat seeds derived from oilseed rape LBFLFK for its use in terrestrial farmed and companion animals and in aquaculture cannot be established. However, the GMO Panel concludes that the consumption of refined, bleached and deodorised (RBD) oil from oilseed rape LBFLFK is safe and does not represent any nutritional concern in humans under the conditions of use proposed by the applicant. Considering the potential safety concerns, LBFLFK oil should not be used for high-temperature applications. Post-market monitoring is appropriate to confirm the expected consumption and the application of conditions of uses in humans. Furthermore, the GMO Panel did not identify any environmental concerns related to increased persistence and invasiveness or to any potential for gene transfer from oilseed rape LBFLFK, and concludes that it poses no risks for terrestrial non-target organisms (NTOs) or biogeochemical cycles in this environment. The GMO Panel cannot conclude on the safety of oilseed rape LBFLFK to NTOs or biogeochemical cycles in the aquatic environment. Based on this, the GMO Panel is unable to conclude on the adequacy of the post-market environmental monitoring plan proposed by the applicant.
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