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Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)


Abstract

Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No1829/2003 from Syngenta Crop Protection NV/SA, the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMOPanel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant genetically modified maizeGA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatics analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panelassessed 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 maize GA21 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panelconcludes that there is no evidence in the renewal application EFSA-GMO-RX-005 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize GA21.

Abstract

Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No1829/2003 from Syngenta Crop Protection NV/SA, the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMOPanel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant genetically modified maizeGA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatics analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panelassessed 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 maize GA21 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panelconcludes that there is no evidence in the renewal application EFSA-GMO-RX-005 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize GA21.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:05 Vetsuisse Faculty > Institute of Veterinary Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
Language:English
Date:2017
Deposited On:27 Jan 2018 10:30
Last Modified:19 Feb 2018 10:06
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
OA Status:Hybrid
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.2903/j.efsa.2017.5006

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