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.

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) / H. Naegeli, J.-. Bresson, T. Dalmay, I.C. Dewhurst, M.M. Epstein, L.G. Firbank, P. Guerche, J. Hejatko, F.J. Moreno, E. Mullins, F. Nogue, N. Rostoks, J.J. Sanchez Serrano, G. Savoini, E. Veromann, F. Veronesi, F. Alvarez, M. Ardizzone, G. De Sanctis, Y. Devos, A. Fernandez-Dumont, A. Gennaro, J.A. Gomez Ruiz, A. Lanzoni, F.M. Neri, N. Papadopoulou, K. Paraskevopoulos. - In: EFSA JOURNAL. - ISSN 1831-4732. - 18:5(2020 May 01). [10.2903/j.efsa.2020.6112]

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)

G. Savoini;
2020

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.
Barnase; Barstar; GMO; MS11; oilseed rape (Brassica napus); PAT/bar; Regulation (EC) No 1829/2003
Settore AGR/18 - Nutrizione e Alimentazione Animale
1-mag-2020
Article (author)
File in questo prodotto:
File Dimensione Formato  
j.efsa.2020.6112 138.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 3.27 MB
Formato Adobe PDF
3.27 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/794284
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 6
  • ???jsp.display-item.citation.isi??? 3
social impact