Outcome of the public consultation on the draft Scientific Opinion on the evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology

,

doi:10.2903/sp.efsa.2021.en-2000

Cited by 2 publications

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“…In particular, two opinions and the related documents on the results of the consultation processes conducted for the respective draft opinions are pertinent to the discussion of an appropriate ERA approach for GE plants: The opinion on the applicability of the previous EFSA Opinion from 2012 on SDN-3 for the assessment of plants developed using SDN-1, SDN-2 and oligonucleotide directed mutagenesis (ODM), i.e., GE methods to typically generate small-sized random (SDN-1) or template directed (SDN-2) mutations at predefined genomic loci [ 24 , 25 ]. The opinion on the evaluation of existing guidelines for their adequacy for the molecular characterization and ERA of genetically modified plants obtained through synthetic biology [ 26 , 27 ]. …”

Section: Recent Considerations For the Era Of Ge Plants At The Eu Levelmentioning

confidence: 99%

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Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

Eckerstorfer

Grabowski²,

Lener

et al. 2021

BioTech

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An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

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Section: Recent Considerations For the Era Of Ge Plants At The Eu Levelmentioning

confidence: 99%

“…The opinion on the evaluation of existing guidelines for their adequacy for the molecular characterization and ERA of genetically modified plants obtained through synthetic biology [ 26 , 27 ].…”

Section: Recent Considerations For the Era Of Ge Plants At The Eu Levelmentioning

confidence: 99%