Assessment of genetically modified cotton GHB614 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA–GMO–RX–018)

EFSA Panel on Genetically Modified Organisms; 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; Fernando Álvarez; Michele Ardizzone; Tommaso Raffaello

Assessment of genetically modified cotton GHB614 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA–GMO–RX–018)

2021

Abstract Following the submission of application EFSA–GMO–RX–018 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, 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 cotton GHB614, 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. The GMO Panel concludes that there is no evidence in renewal application EFSA–GMO–RX–018 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614.

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