Open AccessAssessment of genetically modified oilseed rape MS 8, RF 3 and MS 8×RF3 for renewal of authorisation under regulation ( EC ) No 1829/2003 (application EFSA ‐ GMO ‐ RX ‐004)
Author(s) -
Naegeli Hanspeter,
Birch Andrew Nicholas,
Casacuberta Josep,
De Schrijver Adinda,
Gralak Mikołaj Antoni,
Guerche Philippe,
Jones Huw,
Manachini Barbara,
Messéan Antoine,
Nielsen Elsa Ebbesen,
Nogué Fabien,
Robaglia Christophe,
Rostoks Nils,
Sweet Jeremy,
Tebbe Christoph,
Visioli Francesco,
Wal JeanMichel,
Ardizzone Michele,
Devos Yann,
Paraskevopoulos Konstantinos
Publication year - 2017
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.2017.5067
Subject(s) - authorization , context (archaeology) , risk assessment , microbiology and biotechnology , biology , computer science , computer security , paleontology
Abstract Following the submission of application EFSA ‐ GMO ‐ RX ‐004 under Regulation ( EC ) No 1829/2003 from Bayer CropScience, the Panel on Genetically Modified Organisms of the European Food Safety Authority ( GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the genetically modified ( GM ) herbicide‐tolerant oilseed rape MS 8, RF 3 and MS 8× RF 3. The data received in the context of this renewal application contain post‐market environmental monitoring reports, systematic searches and evaluation of literature, updated bioinformatics analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape MS 8, RF 3 and MS 8× RF 3 considered for renewed authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the context of this renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS 8, RF 3 and MS 8× RF 3.