Assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐BE‐2016‐138)

Abstract

Oilseed rape MS11 has been developed to confer male sterility and tolerance to glufosinate‐ammonium‐containing herbicides. Based on the information provided in the application and in line with the scope of application EFSA‐GMO‐BE‐2016‐138, the genetically modified organism (GMO) Panel concludes that the molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic characteristics tested between oilseed rape MS11 and its conventional counterpart needs further assessment. No conclusions can be drawn for the compositional analysis due to the lack of an appropriate compositional data set. No toxicological or allergenicity concerns are identified for the Barnase, Barstar and PAT/bar proteins expressed in oilseed rape MS11. Owing to the incompleteness of the compositional analysis, the toxicological, allergenicity and nutritional assessment of oilseed rape MS11 cannot be completed. In the case of accidental release of viable oilseed rape MS11 seeds into the environment, oilseed rape MS11 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the scope of the application. Since oilseed rape MS11 is designed to be used only for the production of hybrid seed, it is not expected to be commercialised as a stand‐alone product for food/feed uses. Thus, seeds harvested from oilseed rape MS11 are not expected to enter the food/feed chain, except accidentally. In this context, the GMO Panel notes that, oilseed rape MS11 would not pose risk to humans and animals, while the scale of environmental exposure will be substantially reduced compared to a stand‐alone product.

Statement complementing the EFSA Scientific Opinion on the assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐BE‐2016‐138)

“…According to the mandate received from the EC, this statement complements the EFSA scientific opinion on OSR MS11 (EFSA GMO Panel, 2020), which is the report requested under Articles 6(6) and 18(6) of Regulation (EC) No 1829/2003 2 and is part of the EFSA Overall Opinion in accordance with Articles 6(5) and 18(5) of that Regulation.…”

“…In the preparation of this statement, the GMO Panel took into account the additional information provided by the applicant, the additional information requested during the risk assessment, relevant peer‐reviewed scientific publications and the EFSA scientific opinion on application EFSA‐GMO‐BE‐2016‐138 (EFSA GMO Panel, 2020).…”

“…The GMO Panel acknowledges the objections of the applicant and notes, however – as explained above – that the design had been identified specifically to complement the comparative analysis data for application EFSA‐GMO‐BE‐2016‐138 and that the limitations and potential issues of the design had been carefully evaluated prior to the request and considered acceptable. In the same reply, the applicant proposed, as an alternative, to reconsider the field trials originally submitted for application EFSA‐GMO‐BE‐2016‐138 (and evaluated in EFSA GMO Panel (2020)) with the argument that the quality of the materials, including MS11 treated with the intended herbicide, was acceptable. However, the applicant did not supply any new experimental data to change the conclusions of EFSA GMO Panel (2020) on the suitability of the materials.…”

“…In its scientific opinion (EFSA GMO Panel, 2020), the GMO Panel noted that OSR MS11 is not expected to be commercialised as a stand‐alone product for food/feed uses. MS11 is designed to be used only as part of a dedicated breeding system intended to produce: (1) MS11 × RF3 hybrid seed to produce male fertile OSR plants; and (2) new OSR MS11 seed to maintain the male sterile (MS) line.…”

“…Owing to the incompleteness of the compositional analysis, the toxicological, allergenicity and nutritional assessment of OSR MS11 could not be completed. In conclusion, in the absence of an appropriate comparative assessment and considering the scope of application EFSA‐GMO‐BE‐2016‐138 as defined by the applicant (food and feed uses, import and processing), the food/feed assessment of OSR MS11 could not be completed (EFSA GMO Panel, 2020).…”