Regulatory Data Packages for Edited Plants: A Case Study of Three Submissions and What Was Requested

Authors

  • Achiel Ampe Centre for Regulatory Science, Demer Valley Institute of Agricultural Biotechnology, Aarschot, Belgium Author
  • Arpad Izsak-Ker Centre for Biosafety, Matyofold Centre for Plant Genome Engineering, Mezokovesd, Hungary Author
  • Arnost Effenberger Centre for Biotechnology Policy, Kokorinsko Centre for Plant Genome Engineering, Melnik, Czech Republic Author

DOI:

https://doi.org/10.5281/zenodo.22666788

Keywords:

Regulatory Data Packages for Edited Plants; Agricultural biotechnology; Gene editing; Evidence synthesis; Biosafety regulation

Abstract

Regulatory Data Packages for Edited Plants has moved quickly from a research idea to something a working breeding or
production programme can actually use, but the evidence behind it has not always kept pace. We pull together the current
evidence for regulatory data packages for edited plants, covering the methodological, practical, regulatory and cost angles, with
an eye on where practice has genuinely settled and where researchers and regulators are still largely working it out for
themselves. Selective, context-specific adoption looks better supported by the evidence gathered here than either broad rollout or
blanket avoidance.

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Castellani R, Ristic C, et al. "Regulatory Data Packages for Edited Plants: a confined-trial evaluation". Crop Sci 32(2014): 432-443. DOI: 10.1016/j.mayocpiqo.2022.09.004

Dumitrescu A, Andric D, et al. "Regulatory Data Packages for Edited Plants: a benchmark comparison". Agron J 34(2017): 443-455. DOI: 10.1177/08404704241291226

Eriksdottir B, Brankovic E, et al. "Regulatory Data Packages for Edited Plants: a multi-generation study". Plant Physiol 36(2020): 454-467. DOI: 10.1093/medlaw/fwad013

Farkas I, Ionescu F, et al. "Regulatory Data Packages for Edited Plants: a pilot deployment". New Phytol 38(2023): 465-479. DOI: 10.2196/89834

Grabowski P, Petrescu G, et al. "Regulatory Data Packages for Edited Plants: a case study". Nat Biotechnol 40(2014): 476-482. DOI: 10.1007/s10916-024-02104-9

Hendriksen W, Wojcik H, et al. "Regulatory Data Packages for Edited Plants: a meta-analysis". Sci Rep 42(2017): 487-494. DOI: 10.3389/fdgth.2026.1896184

Ionescu F, Foscarini I, et al. "Regulatory Data Packages for Edited Plants: a comparative trial". PLoS One 44(2020): 498-506. DOI: 10.3390/diagnostics15162117

Jankowiak G, Grabowski J, et al. "Regulatory Data Packages for Edited Plants: a stakeholder-survey study". BMC Plant Biol 46(2023): 509-518. DOI: 10.4103/jrpp.jrpp_20_65

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Lindqvist U, Urbanek L, et al. "Regulatory Data Packages for Edited Plants: a systematic review". Plant Mol Biol 10(2017): 531-542. DOI: 10.2196/48297

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Published

2026-05-12