Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)
Abstract Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the conte...
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| Format: | Article |
| Language: | English |
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Wiley
2018-11-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2018.5468 |
| _version_ | 1818426734360395776 |
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| author | EFSA Panel on Genetically Modified Organisms (GMO) 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 Konstantinos Paraskevopoulos |
| author_facet | EFSA Panel on Genetically Modified Organisms (GMO) 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 Konstantinos Paraskevopoulos |
| author_sort | EFSA Panel on Genetically Modified Organisms (GMO) |
| collection | DOAJ |
| description | Abstract Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (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 herbicide‐tolerant genetically modified soybean MON 89788, 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. Under the assumption that the DNA sequence of the event in soybean MON 89788 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‐011 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 89788. |
| first_indexed | 2024-12-14T14:34:32Z |
| format | Article |
| id | doaj.art-dce423464a7a46998b4ce20659b97293 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-14T14:34:32Z |
| publishDate | 2018-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-dce423464a7a46998b4ce20659b972932022-12-21T22:57:42ZengWileyEFSA Journal1831-47322018-11-011611n/an/a10.2903/j.efsa.2018.5468Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)EFSA Panel on Genetically Modified Organisms (GMO)Hanspeter NaegeliJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoFrancisco Javier MorenoEwen MullinsFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiFernando ÁlvarezMichele ArdizzoneKonstantinos ParaskevopoulosAbstract Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (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 herbicide‐tolerant genetically modified soybean MON 89788, 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. Under the assumption that the DNA sequence of the event in soybean MON 89788 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‐011 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 89788.https://doi.org/10.2903/j.efsa.2018.5468SoybeanMON 89788renewalArticles 11 and 23Regulation (EC) No 1829/2003 |
| spellingShingle | EFSA Panel on Genetically Modified Organisms (GMO) 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 Konstantinos Paraskevopoulos Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011) EFSA Journal Soybean MON 89788 renewal Articles 11 and 23 Regulation (EC) No 1829/2003 |
| title | Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011) |
| title_full | Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011) |
| title_fullStr | Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011) |
| title_full_unstemmed | Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011) |
| title_short | Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011) |
| title_sort | assessment of genetically modified soybean mon 89788 for renewal of authorisation under regulation ec no 1829 2003 application efsa gmo rx 011 |
| topic | Soybean MON 89788 renewal Articles 11 and 23 Regulation (EC) No 1829/2003 |
| url | https://doi.org/10.2903/j.efsa.2018.5468 |
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