Updated scientific opinion on plants developed through cisgenesis and intragenesis

Abstract In 2012, EFSA issued an opinion on plants developed through cisgenesis and intragenesis. With the development of New Genomic Techniques (NGTs) in the last decade, cisgenic and intragenic plants can now be obtained with the insertion of a desired sequence in a precise location of the genome....

Full description

Bibliographic Details
Main Authors: EFSA Panel on Genetically Modified Organisms (GMO), Ewen Mullins, Jean‐Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle M Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Hanspeter Naegeli, Fabien Nogué, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi, Josep Casacuberta, Antonio Fernandez Dumont, Andrea Gennaro, Paolo Lenzi, Aleksandra Lewandowska, Irene Pilar Munoz Guajardo, Nikoletta Papadopoulou, Nils Rostoks
Format: Article
Language:English
Published: Wiley 2022-10-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2022.7621
_version_ 1811324713235906560
author EFSA Panel on Genetically Modified Organisms (GMO)
Ewen Mullins
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Josep Casacuberta
Antonio Fernandez Dumont
Andrea Gennaro
Paolo Lenzi
Aleksandra Lewandowska
Irene Pilar Munoz Guajardo
Nikoletta Papadopoulou
Nils Rostoks
author_facet EFSA Panel on Genetically Modified Organisms (GMO)
Ewen Mullins
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Josep Casacuberta
Antonio Fernandez Dumont
Andrea Gennaro
Paolo Lenzi
Aleksandra Lewandowska
Irene Pilar Munoz Guajardo
Nikoletta Papadopoulou
Nils Rostoks
author_sort EFSA Panel on Genetically Modified Organisms (GMO)
collection DOAJ
description Abstract In 2012, EFSA issued an opinion on plants developed through cisgenesis and intragenesis. With the development of New Genomic Techniques (NGTs) in the last decade, cisgenic and intragenic plants can now be obtained with the insertion of a desired sequence in a precise location of the genome. EFSA has been requested by European Commission to provide an updated scientific opinion on the safety and the risk assessment of plants developed through cisgenesis and intragenesis, in order to (i) identify potential risks, comparing them with those posed by plants obtained by conventional breeding and Established Genomic Techniques (EGTs) and (ii) to determine the applicability of current guidelines for the risk assessment of cisgenic and intragenic plants. The conclusions of the previous EFSA opinion were reviewed, taking into consideration the new guidelines and the recent literature. The GMO panel concludes that no new risks are identified in cisgenic and intragenic plants obtained with NGTs, as compared with those already considered for plants obtained with conventional breeding and EGTs. There are no new data since the publication of the 2012 EFSA opinion that would challenge the conclusions raised in that document. The conclusions of the EFSA 2012 Scientific Opinion remain valid. The EFSA GMO Panel reiterates from these conclusions that with respect to the source of DNA and the safety of the gene product, the hazards arising from the use of a related plant‐derived gene by cisgenesis are similar to those from conventional plant breeding, whereas additional hazards may arise for intragenic plants. Furthermore, the EFSA GMO Panel considers that cisgenesis and intragenesis make use of the same transformation techniques as transgenesis, and therefore, with respect to the alterations to the host genome, cisgenic, intragenic and transgenic plants obtained by random insertion do not cause different hazards. Compared to that, the use of NGTs reduces the risks associated with potential unintended modifications of the host genome. Thus, fewer requirements may be needed for the assessment of cisgenic and intragenic plants obtained through NGTs, due to site‐directed integration of the added genetic material. Moreover, the GMO panel concludes that the current guidelines are partially applicable and sufficient. On a case‐by‐case basis, a lesser amount of data might be needed for the risk assessment of cisgenic or intragenic plants obtained through NGTs.
first_indexed 2024-04-13T14:20:22Z
format Article
id doaj.art-ffcfa141da0f46598bb1bc651b562048
institution Directory Open Access Journal
issn 1831-4732
language English
last_indexed 2024-04-13T14:20:22Z
publishDate 2022-10-01
publisher Wiley
record_format Article
series EFSA Journal
spelling doaj.art-ffcfa141da0f46598bb1bc651b5620482022-12-22T02:43:31ZengWileyEFSA Journal1831-47322022-10-012010n/an/a10.2903/j.efsa.2022.7621Updated scientific opinion on plants developed through cisgenesis and intragenesisEFSA Panel on Genetically Modified Organisms (GMO)Ewen MullinsJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoFrancisco Javier MorenoHanspeter NaegeliFabien NoguéJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiJosep CasacubertaAntonio Fernandez DumontAndrea GennaroPaolo LenziAleksandra LewandowskaIrene Pilar Munoz GuajardoNikoletta PapadopoulouNils RostoksAbstract In 2012, EFSA issued an opinion on plants developed through cisgenesis and intragenesis. With the development of New Genomic Techniques (NGTs) in the last decade, cisgenic and intragenic plants can now be obtained with the insertion of a desired sequence in a precise location of the genome. EFSA has been requested by European Commission to provide an updated scientific opinion on the safety and the risk assessment of plants developed through cisgenesis and intragenesis, in order to (i) identify potential risks, comparing them with those posed by plants obtained by conventional breeding and Established Genomic Techniques (EGTs) and (ii) to determine the applicability of current guidelines for the risk assessment of cisgenic and intragenic plants. The conclusions of the previous EFSA opinion were reviewed, taking into consideration the new guidelines and the recent literature. The GMO panel concludes that no new risks are identified in cisgenic and intragenic plants obtained with NGTs, as compared with those already considered for plants obtained with conventional breeding and EGTs. There are no new data since the publication of the 2012 EFSA opinion that would challenge the conclusions raised in that document. The conclusions of the EFSA 2012 Scientific Opinion remain valid. The EFSA GMO Panel reiterates from these conclusions that with respect to the source of DNA and the safety of the gene product, the hazards arising from the use of a related plant‐derived gene by cisgenesis are similar to those from conventional plant breeding, whereas additional hazards may arise for intragenic plants. Furthermore, the EFSA GMO Panel considers that cisgenesis and intragenesis make use of the same transformation techniques as transgenesis, and therefore, with respect to the alterations to the host genome, cisgenic, intragenic and transgenic plants obtained by random insertion do not cause different hazards. Compared to that, the use of NGTs reduces the risks associated with potential unintended modifications of the host genome. Thus, fewer requirements may be needed for the assessment of cisgenic and intragenic plants obtained through NGTs, due to site‐directed integration of the added genetic material. Moreover, the GMO panel concludes that the current guidelines are partially applicable and sufficient. On a case‐by‐case basis, a lesser amount of data might be needed for the risk assessment of cisgenic or intragenic plants obtained through NGTs.https://doi.org/10.2903/j.efsa.2022.7621cisgenesisintragenesisplantsgenome editingnew genomic techniquessite‐directed nucleases
spellingShingle EFSA Panel on Genetically Modified Organisms (GMO)
Ewen Mullins
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Josep Casacuberta
Antonio Fernandez Dumont
Andrea Gennaro
Paolo Lenzi
Aleksandra Lewandowska
Irene Pilar Munoz Guajardo
Nikoletta Papadopoulou
Nils Rostoks
Updated scientific opinion on plants developed through cisgenesis and intragenesis
EFSA Journal
cisgenesis
intragenesis
plants
genome editing
new genomic techniques
site‐directed nucleases
title Updated scientific opinion on plants developed through cisgenesis and intragenesis
title_full Updated scientific opinion on plants developed through cisgenesis and intragenesis
title_fullStr Updated scientific opinion on plants developed through cisgenesis and intragenesis
title_full_unstemmed Updated scientific opinion on plants developed through cisgenesis and intragenesis
title_short Updated scientific opinion on plants developed through cisgenesis and intragenesis
title_sort updated scientific opinion on plants developed through cisgenesis and intragenesis
topic cisgenesis
intragenesis
plants
genome editing
new genomic techniques
site‐directed nucleases
url https://doi.org/10.2903/j.efsa.2022.7621
work_keys_str_mv AT efsapanelongeneticallymodifiedorganismsgmo updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT ewenmullins updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT jeanlouisbresson updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT tamasdalmay updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT iancrawforddewhurst updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT michellemepstein updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT lesliegeorgefirbank updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT philippeguerche updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT janhejatko updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT franciscojaviermoreno updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT hanspeternaegeli updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT fabiennogue updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT josejuansanchezserrano updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT giovannisavoini updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT eveveromann updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT fabioveronesi updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT josepcasacuberta updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT antoniofernandezdumont updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT andreagennaro updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT paololenzi updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT aleksandralewandowska updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT irenepilarmunozguajardo updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT nikolettapapadopoulou updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis
AT nilsrostoks updatedscientificopiniononplantsdevelopedthroughcisgenesisandintragenesis