Regulatory aspects of gene editing in Argentina


Argentina is a world leader in regards to regulation and adoption of genetically modified (GM) crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively by the Argentinian regulators, who implemented simple but solid pioneering regulatory criteria for gene edited crops. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol on Biosafety is of decisive importance. After some pilot cases that have been managed under this criteria, now applicants appreciate the ease, speed and predictability of the regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.

This is a preview of subscription content, access via your institution.


  1. Brookes G, Barfoot P (2017) Farm income and production impacts of using GM crop technology 1996–2015. GM Crops Food 8(3):156–193

    Article  PubMed  PubMed Central  Google Scholar 

  2. Duensing N, Sprink T, Parrott WA, Fedorova M, Lema MA, Wolt JD, Bartsch D (2018) Novel features and considerations for ERA and regulation of crops produced by genome editing. Front Bioeng Biotechnol 6:79

    Article  PubMed  PubMed Central  Google Scholar 

  3. FAO (2014) La FAO y Argentina refuerzan la seguridad en biotecnología. Accessed 26 June 2018

  4. ISAAA (2016) Global Status of Commercialized Biotech/GM Crops. Accessed 26 June 2018

  5. Petracca G, Van Eenennaam A, Lema MA (2016) Gene editing: do not forget about animal agriculture. J Adv Res Biotechnol 1(1):2

    Google Scholar 

  6. Podevin N, Davies HV, Hartung F, Nogue F, Casacuberta JM (2013) Site-directed nucleases: a paradigm shift in predictable, knowledge-based plant breeding. Trends Biotechnol 31(6):375–383

    Article  CAS  PubMed  Google Scholar 

  7. Whelan AI, Lema MA (2015) Regulatory framework for gene editing and other new breeding techniques in Argentina. GM Crops Food 6(4):253–265

    Article  PubMed  PubMed Central  Google Scholar 

  8. Whelan AI, Lema MA (2017) A research program for the socioeconomic impacts of gene editing regulation. GM Crops Food 8(1):74–83

    Article  PubMed  PubMed Central  Google Scholar 

  9. Whelan AI, Lema MA (2018) Regulation of genome editing in plant biotechnology: country report—Argentina. In: Dederer H-G, Hamburger D (eds) Regulation of genome editing in plant biotechnology: a comparative analysis of the regulatory framework for genome-edited plants in selected countries. Springer, Heidelberg, pp 1–57

    Google Scholar 

  10. WTO (2010) Measures affecting the approval and marketing of biotech products. Accessed 26 June 2018

Download references

Author information



Corresponding author

Correspondence to Martin Alfredo Lema.

Ethics declarations

Conflict of interest

The author declares no conflicts of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Disclaimer: The opinions expressed and arguments employed in this paper are the sole responsibility of the author and do not necessarily reflect those of the OECD or of the governments of its Member countries.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Lema, M.A. Regulatory aspects of gene editing in Argentina. Transgenic Res 28, 147–150 (2019).

Download citation


  • Gene editing
  • GMO regulation
  • New breeding techniques