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Keywords: European integration, EU regulatory framework for plant breeding, EU legislation on new genomic techniques, premarket approval of CRISPR-edited plants, EU status of CRISPR-edited plants Author: Leire Escajedo San-Epifanio Creator: Arbortext Advanced Print Publisher 10.0.1306/W Unicode Producer: Acrobat Distiller 7.0 (Windows) CreationDate: Mon Mar 13 10:54:19 2023 CET ModDate: Mon Mar 13 11:42:17 2023 CET Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 13 Encrypted: no Page size: 595.389 x 841.663 pts (A4) Page rot: 0 File size: 564817 bytes Optimized: no PDF version: 1.4 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- JIBHFN+AdvTTd3a5f740 Type 1C WinAnsi yes yes no 456 0 JIBHFO+AdvTT749c1f5a.I Type 1C WinAnsi yes yes no 457 0 JIBHFP+AdvPSA18C Type 1C WinAnsi yes yes no 458 0 JIBHGA+AdvTT9b12cd41 Type 1C WinAnsi yes yes no 459 0 JIBHHB+AdvTT9b12cd41+fb Type 1C Custom yes yes yes 460 0 JIBHHC+AdvTTd168d80a.I Type 1C WinAnsi yes yes no 466 0 JIBHHD+AdvTT9b12cd41+20 Type 1C WinAnsi yes yes no 467 0 JIBHHE+AdvTT2c8ce45a Type 1C WinAnsi yes yes no 468 0 JIBIFP+AdvPSA323 Type 1C WinAnsi yes yes no 470 0 JIBIIB+AdvOT7d6df7ab.I Type 1C WinAnsi yes yes no 254 0 JIBIIC+AdvOT1ef757c0+fb Type 1C Custom yes yes yes 255 0 JIBIJD+AdvTT58d178b9+03 Type 1C Custom yes yes yes 240 0 JIBIHP+AdvOT1ef757c0 Type 1C WinAnsi yes yes no 257 0 JIBIIA+AdvOT1ef757c0+20 Type 1C WinAnsi yes yes no 245 0 JIBIMD+AdvOT7d6df7ab.I+20 Type 1C WinAnsi yes yes no 258 0 JIBIND+AdvOT7d6df7ab.I+fb Type 1C Custom yes yes yes 264 0 JIBIOE+AdvTTd3a5f740+20 Type 1C WinAnsi yes yes no 266 0 JIBJAE+AdvTTd3a5f740+fb Type 1C Custom yes yes yes 272 0 JIBJFD+AdvTT749c1f5a.I+20 Type 1C WinAnsi yes yes no 273 0 JIBJMB+AdvOT1ef757c0+01 Type 1C MacRoman yes yes no 274 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-02-02 02:35:54 CET RepresentationInformation: pmc_10061071.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2023-09-22 02:16:38 CEST Size: 564817 Format: PDF Version: 1.4 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 532 FreeObjects: 2 IncrementalUpdates: 2 DocumentCatalog: PageLayout: SinglePage PageMode: UseOutlines Outlines: Item: Title: Possible EU futures for CRISPR-edited plants: Little margin for optimism? Destination: bmark_898147135 Children: Item: Title: 1 Introduction Destination: s1 Item: Title: 2 Two possible near-term regulatory futures for CRISPR-edited plants in the EU Destination: s2 Children: Item: Title: 2.1 New times are here Destination: s2_1 Item: Title: 2.2 First possible future: Specific legislation for plants obtained by means of CRISPR? Destination: s2_2 Item: Title: 2.3 Second possible future for CRISPR-edited plants: A future by default Destination: s2_3 Children: Item: Title: 2.3.1 An observation on the dividing lines used by this old regulatory framework Destination: s2_3_1 Item: Title: 2.3.2 A “not sufficiently evidence-based nor proportionate” regulation Destination: s2_3_2 Item: Title: 3 The second possible future for CRISPR-edited plants: “frozen” since 2001 Destination: s3 Children: Item: Title: 3.1 The evolution of this frozen regulatory framework Destination: s3_1 Item: Title: 3.2 The decision-making model or Achilles’ heel of the EU regulatory framework to be applied by default to CRISPR-edited plants Destination: s3_2 Item: Title: 4 The first (and only truly) possible EU future for CRISPR-edited plants: A new regulation Destination: s4 Item: Title: 5 Conclusion: A milestone in the history of EU plant breeding is approaching, but it is not the end of the journey Destination: s5 Item: Title: 6 Legal provisions cited in the text Destination: s6 Item: Title: 7 EU MS lists, by date Destination: s7 Item: Title: Data availability statement Destination: s8 Item: Title: Author contributions Destination: s9 Item: Title: Funding Destination: bmark_1865464027 Item: Title: References Destination: bmark_2090415954 Info: Title: Possible EU futures for CRISPR-edited plants: Little margin for optimism? Author: Leire Escajedo San-Epifanio Subject: This article addresses the scenarios that may be encountered by the first application for pre-market approval of a CRISPR-edited plant in the EU. 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Possible EU futures for CRISPR-edited plants: Little margin for optimism? 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