EFSA Journal (Dec 2022)

Assessment of genetically modified soybean 40‐3‐2 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐023)

  • EFSA Panel on Genetically Modified Organisms (GMO),
  • Ewen Mullins,
  • Jean‐Louis Bresson,
  • Tamas Dalmay,
  • Ian Crawford Dewhurst,
  • Michelle M Epstein,
  • Leslie George Firbank,
  • Philippe Guerche,
  • Jan Hejatko,
  • Francisco Javier Moreno,
  • Hanspeter Naegeli,
  • Fabien Nogué,
  • Nils Rostoks,
  • Jose Juan Sánchez Serrano,
  • Giovanni Savoini,
  • Eve Veromann,
  • Fabio Veronesi,
  • Ana M Camargo,
  • Tilemachos Goumperis,
  • Paolo Lenzi,
  • Aleksandra Lewandowska,
  • Tommaso Raffaello,
  • Franz Streissl

DOI
https://doi.org/10.2903/j.efsa.2022.7685
Journal volume & issue
Vol. 20, no. 12
pp. n/a – n/a

Abstract

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Abstract Following the submission of application EFSA‐GMO‐RX‐023 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV on behalf of Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean 40‐3‐2, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic 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 soybean 40‐3‐2 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐023 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean 40‐3‐2.

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