Assessment of genetically modified soybean A5547-127 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-020)

EFSA J. 2022 Jun 20;20(6):e07340. doi: 10.2903/j.efsa.2022.7340. eCollection 2022 Jun.

Abstract

Following the submission of application EFSA-GMO-RX-020 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of the EFSA 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 A5547-127, 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-020 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean A5547-127.

Keywords: A5547‐127; Articles 11 and 23; Regulation (EC) No 1829/2003; Soybean; renewal.