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General information Notification Number B/DK/24/23110 Member State to which the notification was sent Denmark Date of acknowledgement from the Member State Competent Authority 13/02/2024 Title of the Project CrisprCAS modified potato with altered sensitvity to blight Proposed period of release: 10/04/2024 to 30/09/2026 Name of the Institute(s) or Company(ies) KMC Amba , Herningvej 60 Denmark 7330
Is the same GMPt been notified elsewhere by the same notifier? No Has the same GMPt been notified elsewhere by the same notifier? No Genetically modified plant Complete name of the recipient or parental plant(s):

Common Name	Family Name	Genus	Species	Subspecies	Cultivar/breeding line
potato	solanaceae	solanum	solanum tuberosum	tuberosum	Ydun

Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications: StDMR6-1 LOF YdunThe CrisprCAS modified potato, StDMR6-1 Loss Of Function (LOF) in Ydun, hereafter StDMR6-1 LOF Ydun, was generated at the University of Copenhagen, Thorvaldsensvej 40, 1871 Frederiksberg C, Denmark. Using the CrisprCAS technology, small targeted mutations have been introduced in a so-called susceptibility gene, here in the StDMR6-1 gene, in the variety Ydun, which the pathogen, e.g. Phythoftora infestans, uses/high-jacks as part of the infection of the plant, whereby the StDMR6-1 gene product is now non-functional. As a result, the CrisprCAS modified plant has potentially become less susceptible to e.g. the potato late blight pest, with expectation that the usage of fungicides to control infection will be less. Genetic modification Type of genetic modification: Other; Other

The CrisprCAS modified potato was generated according to our previously published protocol (Johansen et al 2019), with the modification that here we have used Crispr/Cas in the form of the DNA-free so-called RiboNucleoProtein (RNP) (Carlsen et. al. 2022), which excludes the insertion of any (transgenic) DNA in the transformation/gene editing process and thus in the regenerated CrisprCAS modified ex-plants. Only the intended targeted changes will therefore be in focus and relevant in relation to the CrisprCAS modified plant. Johansen IE, Liu Y, Jrgensen B, Nielsen KL, Andreasson E, Bennett EP, Nielsen KL, Blennow A, Petersen BL (2019) High efficacy full allelic CRISPR/Cas9 gene editing in tetraploid potato (2019) Sci Rep 9, 17715 https ://doi.org/10.1038/s41598-019-54126-w.For DMR6-1, 2 RNPs were use to create a 450 base pair deletion (two gRNA target sites creating a 450 bp deletion). 3 (full allelic loss-of-function) plant lines of StDMR6-1 were selected. Brief description of the method used for the genetic modification: For RNP mediated mutagenesis of the StDMR6-1 gene in Ydun:Carlsen FM, Johansen IE, Yang Z, Liu Y, Westberg IN, Kieu NP, Jrgensen B, Lenman M, Andreasson E, Nielsen KL, Blennow A, Petersen BL (2022) Strategies for Efficient Gene Editing in Protoplasts of Solanum tuberosum, Theme : Determining gRNA Efficiency Design by Utilizing Protoplast', Frontiers in Genome Editing. doi: 10.3389/fgeed.2021.795644 If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination: Not applicable Experimental Release Purpose of the release: Short term goal is to evaluate the changed sensitivity to blight under field conditions with the expectation of a long term goal of reducing the use of fungicides in potatoes. Long term goal would reduce the impact on the environment, working environment and climate. The trial under field condition will evaluate the use of CrisprCAS as a method to improve potato varieties sensitivity to blight. Geographical location of the site: Denmark, Herning, Arnborg Size of the site (m2): Below 2500 m2 Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release: In 2023, lines with targeted mutations on StDMR6-1 LOF Ydun have been tested in trials at Arnborg, Herning, Denmark, in order to investigate a possible improved sensitivity against Phytopthora under field conditions. The lines were tested against wild types of Ydun, without the use of pesticides to control Phytopthora infestans. The first year's results showed a moderately improved sensitivity against Phytopthora. Environmental Impact and Risk Management Summary of the potential environmental impact from the release of the GMPts: Note especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any signifant expected environmental benefitsNote especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any signifant expected environmental benefits Potatoes are grown all over the Union and are used for consumption, french fries, chips, alcohol and starch production.Potatoes are not known as a colonizer of wild ecosystems (OECD 1997), and does not occur outside the field. Very rarely does potato waste plants occur in the cultivated landscape since tubers are destroyed during the next years tillage, use of herbicides and competition of subsequent crops Brief description of any measures taken for the management of risks: Most modern potato varieties have low pollen fertility and the formation of potato berries and seeds is extremely low. According to the literature, the distance of the spread of potato pollen is maximum of ten meters. A safety distance of min.15 meters will be held. All flower buds from the CrisprCAS modified plants will be removed. Cleaning of machinery, tools, and transportation vehicles will be done after contact with the modified lines. The field will be checked, post-harvest for growth of surviving tubers. The field will not be used to plant potatoes again in 4 years and until at least one growing season without surviving potatoes is observed. Potential waste tubers will be documented and eliminated.Transport of harvested potatoes will take place by car or truck in sealed double bags. Transport will not take place with other cultivated potatoes. When transporting, documentation must be included, stating that it is GM and the name and telephone number of a contact person. Analyses of the material will be in KMCs premises and leftover crop residues will be destroyed by autoclaving or incineration. Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release: Not applicable Final report - European Commission administrative Information Consent given by the Member State Competent Authority: Yes
04/25/2024