{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T01:16:44Z","timestamp":1775265404180,"version":"3.50.1"},"reference-count":51,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T00:00:00Z","timestamp":1624320000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003338","name":"Bundesamt f\u00fcr Umwelt","doi-asserted-by":"publisher","award":["110011894\/8T10\/00.5005.PZ\/0027"],"award-info":[{"award-number":["110011894\/8T10\/00.5005.PZ\/0027"]}],"id":[{"id":"10.13039\/501100003338","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BioTech"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3390\/biotech10030010","type":"journal-article","created":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T23:44:02Z","timestamp":1624405442000},"page":"10","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6827-904X","authenticated-orcid":false,"given":"Michael F.","family":"Eckerstorfer","sequence":"first","affiliation":[{"name":"Umweltbundesamt\u2013Environment Agency Austria (EAA), Landuse & Biosafety Unit, Spittelauer L\u00e4nde 5, 1090 Vienna, Austria"}]},{"given":"Marcin","family":"Grabowski","sequence":"additional","affiliation":[{"name":"Ministry of Climate and Environment, Department Nature Conservation, GMO Unit, Wawelska 52\/54, 00-922 Warszawa, Poland"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3778-2491","authenticated-orcid":false,"given":"Matteo","family":"Lener","sequence":"additional","affiliation":[{"name":"ISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Roma, Italy"}]},{"given":"Margret","family":"Engelhard","sequence":"additional","affiliation":[{"name":"Federal Agency for Nature Conservation, Division of Assessment of GMOs\/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, Germany"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6102-444X","authenticated-orcid":false,"given":"Samson","family":"Simon","sequence":"additional","affiliation":[{"name":"Federal Agency for Nature Conservation, Division of Assessment of GMOs\/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, Germany"}]},{"given":"Marion","family":"Dolezel","sequence":"additional","affiliation":[{"name":"Umweltbundesamt\u2013Environment Agency Austria (EAA), Landuse & Biosafety Unit, Spittelauer L\u00e4nde 5, 1090 Vienna, Austria"}]},{"given":"Andreas","family":"Heissenberger","sequence":"additional","affiliation":[{"name":"Umweltbundesamt\u2013Environment Agency Austria (EAA), Landuse & Biosafety Unit, Spittelauer L\u00e4nde 5, 1090 Vienna, Austria"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3228-7424","authenticated-orcid":false,"given":"Christoph","family":"L\u00fcthi","sequence":"additional","affiliation":[{"name":"Federal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, BAFU, CH-3003 Bern, Switzerland"}]}],"member":"1968","published-online":{"date-parts":[[2021,6,22]]},"reference":[{"key":"ref_1","first-page":"173","article-title":"Case C-528\/16: Questions Raised by the ECJ\u2019s Judgement on Gene Editing Technology","volume":"1","author":"Spranger","year":"2018","journal-title":"Int. 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