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Assessment of genetically modified maize MON 89034 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐015)


Naegeli, Hanspeter; Bresson, Jean‐Louis; Dalmay, Tamas; Dewhurst, Ian Crawford; Epstein, Michelle M; Firbank, Leslie George; Guerche, Philippe; Hejatko, Jan; Moreno, Francisco Javier; Mullins, Ewen; Nogué, Fabien; Rostoks, Nils; Sánchez Serrano, Jose Juan; Savoini, Giovanni; Veromann, Eve; Veronesi, Fabio; Álvarez, Fernando; Ardizzone, Michele; Raffaello, Tommaso (2019). Assessment of genetically modified maize MON 89034 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐015). EFSA Journal, 17(11):e05845.

Abstract

Following the submission of application EFSA‐GMO‐RX‐015 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA, the EFSA Panel on Genetically Modified Organisms (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect‐resistant genetically modified maize MON 89034, for food and feed uses, excluding cultivation within the EU. 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 maize MON 89034 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‐015 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034.

Abstract

Following the submission of application EFSA‐GMO‐RX‐015 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA, the EFSA Panel on Genetically Modified Organisms (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect‐resistant genetically modified maize MON 89034, for food and feed uses, excluding cultivation within the EU. 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 maize MON 89034 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‐015 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034.

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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
Scopus Subject Areas:Life Sciences > Parasitology
Life Sciences > Food Science
Life Sciences > Microbiology
Life Sciences > Animal Science and Zoology
Health Sciences > Veterinary (miscellaneous)
Life Sciences > Plant Science
Language:English
Date:1 November 2019
Deposited On:20 Jan 2020 16:22
Last Modified:20 May 2020 20:41
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
OA Status:Gold
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.2903/j.efsa.2019.5845

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