Open AccessStatement complementing the EFSA Scientific Opinion on application ( EFSA ‐ GMO ‐ NL ‐2009‐75) for placing on the market of genetically modified oilseed rape Ms8 × Rf3 × GT 73 and subcombinations, which have not been authorised previously (i.e. Ms8 × GT 73 and Rf3 × GT 73) 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
Author(s) -
Naegeli Hanspeter,
Bresson JeanLouis,
Dalmay Tamas,
Dewhurst Ian Crawford,
Epstein Michelle M,
Firbank Leslie George,
Guerche Philippe,
Hejatko Jan,
Moreno Francisco Javier,
Mullins Ewen,
Nogué Fabien,
Rostoks Nils,
Sánchez Serrano Jose Juan,
Savoini Giovanni,
Veromann Eve,
Veronesi Fabio,
Ardizzone Michele,
Lanzoni Anna,
Paraskevopoulos Konstantinos
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6200
Subject(s) - genetically modified organism , food safety , microbiology and biotechnology , toxicity , european commission , biology , food science , chemistry , european union , business , biochemistry , organic chemistry , gene , economic policy
The EFSA Panel on Genetically Modified Organisms ( GMO ) previously assessed oilseed rape Ms8 × Rf3 × GT 73 and its subcombinations Ms8 × GT 73 and Rf3 × GT 73 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 ( GOX v247) protein, provided to complement information related to application EFSA ‐ GMO ‐ NL ‐2009‐75 for the placing on the market of oilseed rape Ms8 × Rf3 × GT 73 and its subcombinations Ms8 × GT 73 and Rf3 × GT 73, 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 GOX v247 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 GOX v247 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 × GT 73 and its sub combinations Ms8 × GT 73 and Rf3 × GT 73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSA ‐ GMO ‐ NL ‐2009‐75.