Header

UZH-Logo

Maintenance Infos

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)


Abstract

Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., 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 A2704‐12, for food and feed uses, import and processing, 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. In addition, the applicant provided sequence data on the soybean A2704‐12 event using material from a commercial variety currently on the market and intended to be marketed in the coming years. 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 the renewal application EFSA‐GMO‐RX‐009 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean A2704‐12.

Abstract

Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., 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 A2704‐12, for food and feed uses, import and processing, 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. In addition, the applicant provided sequence data on the soybean A2704‐12 event using material from a commercial variety currently on the market and intended to be marketed in the coming years. 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 the renewal application EFSA‐GMO‐RX‐009 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean A2704‐12.

Statistics

Citations

Dimensions.ai Metrics

Altmetrics

Downloads

12 downloads since deposited on 20 Jan 2020
12 downloads since 12 months
Detailed statistics

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:1 January 2019
Deposited On:20 Jan 2020 16:56
Last Modified:21 Jan 2020 02:45
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.2019.5523

Download

Gold Open Access

Download PDF  'Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)'.
Preview
Content: Published Version
Language: English
Filetype: PDF
Size: 1MB
View at publisher
Licence: Creative Commons: Attribution-No Derivatives 4.0 International (CC BY-ND 4.0)