2012
DOI: 10.2903/j.efsa.2012.2943
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Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site‐Directed Nucleases with similar function

Abstract: The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of plants developed using the zinc finger nuclease 3 technique (ZFN-3) which allows the integration of gene(s) in a predefined insertion site in the genome of the recipient species. Since other nucleases with a similar function to ZFN are considered in this opinion the term site-directed nuclease 3 (SDN-3) is used to describe the technique rather than ZFN-3 specificall… Show more

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Cited by 101 publications
(38 citation statements)
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“…EFSA's opinion on SDN-3 from 2012 [26] considers that genome editing can "minimize hazards" or that offtarget changes would be "fewer than those occurring with most mutagenesis techniques" and be "of the same types as those produced by conventional breeding techniques". However, as described above, a large number of publications since 2012 demonstrate that several types of genomic irregularities can often be generated using SDN-1, SDN-2 and SDN-3 applications.…”
Section: Risk Assessment Related To the Genome Editing Processmentioning
confidence: 99%
See 1 more Smart Citation
“…EFSA's opinion on SDN-3 from 2012 [26] considers that genome editing can "minimize hazards" or that offtarget changes would be "fewer than those occurring with most mutagenesis techniques" and be "of the same types as those produced by conventional breeding techniques". However, as described above, a large number of publications since 2012 demonstrate that several types of genomic irregularities can often be generated using SDN-1, SDN-2 and SDN-3 applications.…”
Section: Risk Assessment Related To the Genome Editing Processmentioning
confidence: 99%
“…Therefore, risk assessment guidelines will have to be examined, and potentially revised to ensure they capture unintended effects caused by the genome editing process. EFSA has issued an opinion on the risk assessment for the genome editing of plants where genes are inserted using site directed nuclease-3 (SDN-3) techniques [26] and has received a mandate from the Commission to produce an opinion on whether these risks are applicable to genome-edited plants not carrying novel genes, i.e. using site-directed nuclease-1 (SDN-1) and site-directed nuclease-2 techniques (SDN-2).…”
Section: Introductionmentioning
confidence: 99%
“…The EFSA GMO Panel opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease and other Site-Directed Nucleases with similar function (EFSA Panel on Genetically modified organisms (GMO), 2012) and the Institute for Prospective Technological Studies and Institute for Health and Consumer Protection (both from the Joint Research Centre at the European Commission) (Lusser et al, 2011) have set forth three major categories of new and emerging gene-editing techniques (Box 1).…”
Section: Overview Of the Regulatory Landscapes For Gmosmentioning
confidence: 99%
“…Products of new and emerging techniques, according to the ECJ ruling, are all classified as GMOs, thus, raising a question of how the framework will be implemented. In particularly, an open question remains how to adapt guidance to support assessment of products arising from new and emerging gene-editing techniques (Lusser et al, 2011; EFSA Panel on Genetically modified organisms (GMO), 2012; Jones, 2015a; The Norwegian Biotechnology Advisory Board, 2018).…”
Section: Suitability Of Current Risk Governance Of Gmo Plantsmentioning
confidence: 99%
“…The use of transgene-free methods can lead to genome-edited plants (SDN1 and SDN2 on case-by-case), which are indistinguishable by spontaneously mutated crops or mutants obtained by classical mutagenesis approaches (i.e., ethyl methanesulfonate, ionizing radiation) [115]. Therefore, in the European Union, a distinction in the legislation supporting the approval route toward commercialization of the edited plants deriving by SDN1, SDN2, and SDN3 methods was proposed [127,128]. However, the latest ruling by the European Court of Justice [129] requires that crops generated by using gene-editing techniques such as CRISPR must go through the same lengthy approval process as conventional genetically modified (GM) plants [130].…”
Section: Genome Editingmentioning
confidence: 99%