Team:Marburg/Human Practices/EFSA

European Food and Safety Authority

The deliberate release of any GMO follows strict guidelines to access a permit from the European Commission. A key factor of the current legislation is the ERA, which is evaluated for GMOs by the EFSA.

Our objective as a team is not only to accelerate the research of transplastomic plants for new, but also for safer products. In the end the ultimate goal would be that through our platform soon more and more plants can be introduced into the actual crop production. The question now arises to what extent EFSA pays attention to the ERA concerning the positive properties of chloroplasts as a chassis.


In order to be able to provide as accurate an answer as possible, we contacted the authority directly via the Ask EFSA service. Unfortunately, an interview could not be organized due to the current Covid situation, but EFSA was able to clarify the question described above with us through a written reply.


In principle, EFSA prepares the respective risk assessment for each product submitted individually, but it follows criteria that are openly accessible in the document "Guidance on the environmental risk assessment of genetically modified plants"[1]. Under point 3.1. the "persistence and invasiveness including plant-to-plant gene flow" is evaluated. For better illustration, please regard the illustrated graph provided by EFSA.


Already in Stage 1 of the ERA, our concern about gene flow and cross-pollination is addressed under point 3. To quote the EFSA: It is possible that GM traits may move to wild relatives through hybridisation within one growing season, even if the GM plant is unable to overwinter - consequently, it is important that the hybridisation potential described in the background information is considered before concluding on stage 1 information requirements. It should thus be considered whether sexual compatibility with any relative species is altered since this may result in differences in the rate of gene flow and the establishment of transgenes in other species.


This became relevant in the case of the only GMO maize approved for cultivation in the EU to date, MON810[2]. Since cross-pollination is in principle possible in maize x teosinte hybrids[3], it was necessary to work out to what extent the hybrids could spread in the fauna of the EU. Only after this could be classified as harmless despite potential cross-pollination, was further approval possible.


This step and the associated hurdle to approval would be reliably secured by a transplastomic plant. Although no such product has yet even requested an approval procedure, the EFSA already supported the consideration of such a technology in the ERA in its written statement. The specific area of concern you are referring to is the plant-to-plant gene transfer where the case of transplastomic plants will be clearly captured in the problem formulation step of the ERA.

The specific area of concern you are referring to is the plant-to-plant gene transfer where the case of transplastomic plants will be clearly captured in the problem formulation step of the ERA

Thus we are confident to conclude that through the support of our prototyping platform, transplastomic technology will have a realistic potential to pave the way for new GMO plants in European agriculture.




Sources
  1. EFSA Panel on Genetically Modified Organisms (GMO); Guidance on the environmental risk assessment of genetically modified plants. EFSA Journal 2010;8(11):1879. [111 pp.]. doi:10.2903/j.efsa.2010.1879
  2. EFSA (European Food Safety Authority), 2016. Relevance of new scientific evidence on the occurrence of teosinte in maize fields in Spain and France for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of maize events MON810, Bt11, 1507 and GA21. EFSA supporting publication 2016:EN-1094. 13pp
  3. Chavez NB, Flores JJ, Martin J, Ellstrand NC, Guadagnuolo R, Heredia S and Welles SR, 2012. Maize×teosinte hybrid cobs do not prevent crop gene introgression. Economic Botany, 66, 132–137.