Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2009-75) for placing on the market of genetically modified 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), taking into consideration additional information

EFSA Panel on Genetically Modified Organisms (GMO); Hanspeter Naegeli; Jean-Louis Bresson; Tamas Dalmay; Ian Crawford Dewhurst; Michelle M Epstein; Leslie George Firbank; Philippe Guerche; Jan Hejatko; Francisco Javier Moreno; Ewen Mullins; Fabien Nogué; Nils Rostoks; Jose Juan Sánchez Serrano; Giovanni Savoini; Eve Veromann; Fabio Veronesi; Michele Ardizzone; Anna Lanzoni; Konstantinos Paraskevopoulos

doi:10.2903/j.efsa.2020.6200

Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2009-75) for placing on the market of genetically modified 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), taking into consideration additional information

EFSA J. 2020 Jul 30;18(7):e06200. doi: 10.2903/j.efsa.2020.6200. eCollection 2020 Jul.

Abstract

The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73 according to the scope as defined in the application EFSA-GMO-NL-2009-75, and was not in the position to complete the safety assessment of products rich in protein, such as rapeseed protein isolates or products of this nature in animal feeding. Following a mandate from the European Commission, the GMO Panel assessed a 28-day toxicity study in mice with the glyphosate oxidoreductase (GOXv247) protein, provided to complement information related to application EFSA-GMO-NL-2009-75 for the placing on the market of oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The 28-day toxicity study on Escherichia coli- produced GOXv247 protein did not show adverse effects in mice, at the gavage doses up to 1000 mg/kg body weight (bw) per day. Taking into account its previous assessment on EFSA-GMO-NL-2009-75 and the outcome of the 28-day toxicity study in mice with the GOXv247 protein provided in this mandate, the GMO Panel, based on a weight of evidence approach, concludes that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 × Rf3 × GT73 and its sub combinations Ms8 × GT73 and Rf3 × GT73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSA-GMO-NL-2009-75.

Keywords: 28‐day toxicity study; GMO; food and feed safety; glyphosate oxidoreductase (GOXv247) protein; import and processing; oilseed rape Ms8 × Rf3 × GT73; subcombinations Ms8 × Rf3 and Ms8 × GT73.