Sunday Evening News 417- Week 11 - 2025
Weekly report on genetic engineering, genome editing, biotechnology and legal regulation.
February 2025-03-10 - March 2025-03-16
Press Releases - Media / Presse- und Medienberichte
Council of the EU: New genomic techniques: Council agrees negotiating mandate
Today, member states' representatives (Coreper) endorsed the Council's negotiating mandate on the regulation on plants obtained by new genomic techniques (NGTs) and their food and feed.
AFBV-WGG: The Council of the European Union under the Polish Presidency has adopted by a qualified majority vote the
proposal for a Regulation on New Genomic Techniques (NGT)
https://www.wggev.de/polish-ngt-proposal-adopted-by-a-qualified-majority/
Unter polnischer Präsidentschaft hat der Rat der Europäischen Union den Vorschlag für eine Verordnung über Neue Genomische Techniken (NGT) mit qualifizierter Mehrheit angenommen
https://www.wggev.de/ngt-vorschlag-mit-qualifizierter-mehrheit-angenommen/
transgen: Neue genomische Techniken: Zähes Ringen um die Reform der Gentechnik-Gesetze auf der Zielgeraden
https://www.transgen.de/aktuell/2880.ngt-regulierung-eu-kommission-crispr-gentechnik.html
Testbiotech: Wirtschaft siegt über Wissenschaft - Ist die EU bereit für Deregulierung von NGT-Pflanzen?
https://www.testbiotech.org/aktuelles/wirtschaft-siegt-ueber-wissenschaft/
GM-Watch: Compilation of press releases on the adoption of the Polish proposal for the regulation of NGT. Mainly from critics of
genetic engineering.
More press releases also ►here: March week 11
Position of German youth organisations on the planned deregulation of New Genomic Techniques by the EU - As of March
2025
Why patents keep stalling EU rules for gene-edited crops
Seed patents: A huge challenge for the European Union - Analysis of the problem, case studies and potential solutions -
October 2024
https://www.no-patents-on-seeds.org/en/report-2024
Dunn A.: Precision plant breeding legislation passes final hurdle
https://www.fwi.co.uk/arable/precision-plant-breeding-legislation-passes-final-hurdle
Clergeau C. and Petersen k.: Who really benefits from new genomic techniques? Farmers and consumers at risk
Only some selected press releases or media reports are listed here. The daily up-date of the press releases and
media reports are ►here: March week 11
Publications – Publikationen
Positionspapier: "Aktuelle Fragen in der Analytik gentechnisch veränderter Pflanzen" wurde auf der Homepage der AG veröffentlicht
Aleksandra Hubar-Kołodziejczyk A., Purnhagen K.P. (2025): Regulatory Requirements for the Identification, Detection and
Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes: European Journal of Risk Regulation DOI: https://doi.org/10.1017/err.2025.7
The key requirement for GMO authorisation is the submission of analytical methods for the detection, identification and quantification (DIQ), which has proven challenging in the case of New Genomic Techniques (NGTs). Currently available non-analytical approaches, such as blockchain traceability and probabilistic analysis, while potentially useful for monitoring, are insufficient for authorisation purposes. The lack of reliable DIQ methods hinders the authorisation of NGT products and raises concerns for both organic and conventional agriculture, where the presence of NGT products goes undetected. Therefore, the existing GMO regulatory framework requires reevaluation to address the challenges posed by NGTs while ensuring compliance with the broader EU food law framework.
Molitorisová, A., Purnhagen K. (2025): Regulatory Sandboxes for Novel Foods. European Journal of Risk Regulation,
DOI: https://doi.org/10.1017/err.2025.10
This article conceptualises regulatory sandboxes in the food area, considering them as unique spaces with varying degrees of openness. Through an analysis of closed, semi-open and open spaces, it illustrates the regulatory landscape surrounding regulatory sandboxes of novel foods in the EU, particularly focusing on the concept of “placing on the market.” The article contends that the degree of openness of regulatory sandboxes impacts the application of the precautionary principle within these spaces. It explores scenarios where the sandbox tests various aspects of novel foods under EU soft and hard law. The characteristics of the regulatory sandbox (open, semi-open, closed) changes corresponding to what the regulatory sandbox tests in relation to a novel food, eg, a sensory characteristics or safety or other data points, such as effectiveness of labelling. This article contributes to the ongoing discourse on innovation-friendly laws surrounding regulatory frameworks applicable to novel foods in the EU.
Sharma, N., Thakur, K., Zinta, R. et al. (2025): Genome editing research initiatives and regulatory landscape of genome
edited crops in India. Transgenic Res 34, 13 (2025). https://doi.org/10.1007/s11248-025-00432-1
Food and nutritional security are the top priorities in Indian agriculture. Exponential population growth coupled with climate change effects has become a serious challenge for sustainable agriculture. Genome editing has revolutionized the agricultural sector because of its ability to create precise, stable and predictable modifications in the genome and therefore, offers great opportunities for crop improvement in India. However, for harvesting the real benefits of this technology in agriculture sector, there is a strong need of creating awareness among the end users and development of suitable policies for regularization of genome edited products. Many regulatory agencies around the world have been modernizing their regulatory approaches to be more risk proportionate and to reflect a more science-based approach. In this article, recent research initiatives and developments undertaken by different Indian institutes/organizations for the genetic improvement of agricultural and horticultural crops via genome editing technologies are summarized. Furthermore, to benefit from this potential technology in our country, regulatory policies must be clear, science-based and proportionate. Therefore, in the present review, the regulatory policies related to the genome editing of crop products in India are discussed in detail. This review will sensitize researchers and stakeholders to the application of genome editing techniques in crop improvement and various biosafety committees involved in the development and regulation of genome edited crops.
https://link.springer.com/article/10.1007/s11248-025-00432-1
Howell, B.F.; Newcomb, E.M.; Loh, D.W.; Jackson, A.R.; Dunn, M.L. Jefferies, L.K. (2025): Shaping Consumer Perceptions of
Genetically Modified Foods: The Influence o f Engineering, Science, and Design Signifiers in Packaging Disclosure Statements. Foods 2025, 14, 909.| https://doi.org/10.3390/foods14060909
Genetically modified (GM) foods have existed for decades, and governments internationally have legislated packaging disclosure statement language that typically incorporates the words genetic, modified, and organism. In 2018, the United States implemented the National Bioengineered Food Disclosure Standard (NBFDS) and introduced the term Bioengineered (BE) into GM disclosure language to help clarify consumer uncertainty regarding GM foods. Since then, the US consumer attitudes, perceptions, and knowledge of genetically modified foods remain negative, reflecting a contaminated interaction. Current mandated disclosure labels, utilizing engineering and science-based signifiers, are associated with this negative interaction. This research assesses whether food disclosure labels based on the signifier Design, unassociated with current contaminations, can positively impact the consumer perception of GM foods compared to the negatively contaminated science and engineering signifiers currently used. Two online studies of 1931 participants analyzed GM/BE food disclosure labels comparing four existing and six newly created engineering and science-based signifiers against four new design-based signifiers across fifteen attributes, including Price, Purchase Likelihood, Environmental Impact, Fair Trade, Safety, Nutrition, Healthfulness, Quality, Eating Experience, Comforting, Inviting, Frightening, Understandable, Ethical, and Sustainable. Across both studies, design-related labels consistently outperformed traditional engineering/science-based terms in fostering positive perceptions. However, even the best-performing labels did not fully overcome the entrenched skepticism associated with GM foods, underscoring the need for complementary strategies beyond linguistic changes.
https://www.mdpi.com/2304-8158/14/6/909
Arif, M., Haroon, M., Nawaz, A.F. et al. (2025): Enhancing wheat resilience: biotechnological advances in combating heat
stress and environmental challenges. Plant Mol Biol 115, 41 | https://doi.org/10.1007/s11103-025-01569-7
Climate change, with its increasing temperatures, is significantly disrupting global agricultural systems, and wheat, a key cereal crop faces severe challenges. Heat stress has emerged as a critical threat, accelerating wheat growth, leading to premature maturation, reduced grain filling, and ultimately lower yields. The situation is exacerbated by more frequent and intense heat waves, particularly in regions already struggling with water scarcity. Maintaining the delicate balance of temperature and water necessary for optimal wheat production is becoming challenging, posing a serious risk to global food security. Therefore, there is an urgent need to develop adaptive strategies with innovations in breeding and transgenic technologies crucial to improving wheat resilience to environmental stresses, especially to combat the growing impacts of heat stress. Modern tools like CRISPR/Cas9, Transcription Activator-Like Effector Nucleases, and Zinc Finger Nucleases have been instrumental in developing wheat varieties with improved traits. However, the future of wheat cultivation requires more than just resistance to a single stressor. As climate change intensifies, there is an urgent need for wheat varieties that can withstand multiple stresses, including heat, drought, and pests. Developing these multi-stress-tolerant cultivars is crucial for ensuring food security in a rapidly changing climate.
https://link.springer.com/article/10.1007/s11103-025-01569-7
Raza A., Anas M., Bhardwaj S., Mir R.A. et al. (2025): Harnessing metabolomics for enhanced crop drought tolerance.
The Crop Journal | https://doi.org/10.1016/j.cj.2025.01.001
Global crop productivity faces a significant threat from climate change-induced drought stress (DS), which is vital for sustainable agriculture and global food security. Uncovering DS adaptation and tolerance mechanisms in crops is necessary to alleviate climate challenges. Innovative plant breeding demands revolutionary approaches to develop stress-smart plants. Metabolomics, a promising field in plant breeding, offers a predictive tool to identify metabolic markers associated with plant performance under DS, enabling accelerated crop improvement. Central to DS adaptation is metabolomics-driven metabolic regulation, which is critical for maintaining cell osmotic potential in crops. Recent innovations allow rapid mapping of specific metabolites to their genetic pathways, providing a valuable resource for plant scientists. Metabolomics-driven molecular breeding, integrating techniques such as mQTL and mGWAS, enhances our ability to discover key genetic elements linked to stress-responsive metabolites. This integration offers a beneficial platform for plant scientists, yielding significant insights into the complex metabolic networks underlying DS tolerance. Therefore, this review discusses (1) insights into metabolic regulation for DS adaptation, (2) the multifaceted role of metabolites in DS tolerance and nutritional/yield trait improvement, (3) the potential of single-cell metabolomics and imaging, (4) metabolomics-driven molecular breeding, and (5) the application of metabolic and genetic engineering for DS-tolerant crops. We finally propose that the metabolomics-driven approach positions drought-smart crops as key contributors to future food production, supporting the vital goal of achieving “zero hunger”.
Livneh, Y., Leor-Librach, E., Agmon, D., Makov-Bouaniche, T., Tiwari, V. et al. (2025): Combined enhancement of ascorbic acid,
β-carotene and zeaxanthin in gene-edited lettuce, Plant Biotechnology Journal | DOI: 10.1111/pbi.70018
Lettuce is widely grown and consumed but provides lower nutritional value compared to other leafy greens, particularly in the essential vitamins A and C. To address this, major control points in carotenoid and ascorbic acid (AsA) production were targeted using a viral-based CRISPR/Cas9 system in the commercial lettuce cultivar ‘Noga’. Knockout of lycopene ε-cyclase (LCY-ε), the enzymatic gatekeeper opposing production of β-branch carotenoids, increased β-carotene (provitamin A) levels up to 2.7-fold and facilitated zeaxanthin accumulation up to 4.3 μg/g fresh weight. Chlorophyll fluorescence measurements revealed that photosystem II efficiency was unaffected in LCY-ε mutants, though their non-photochemical quenching (NPQ) capacity decreased at light intensities above 400 μmol m2 s-1. However, the gene-edited plants exhibited normal growth and comparable plant mass, despite the absence of two major lettuce xanthophylls, lutein and lactucaxanthin. Modifications in a regulatory region in the upstream ORF of GDP-L-galactose phosphorylase 1 and 2 (uGGP1 and uGGP2), the rate-limiting enzyme in AsA production, resulted in an average 6.9-fold increase in AsA levels. The mutation in uGGP2 was found to dominantly influence AsA over-accumulation. Knockout lines that combined the mutations in LCY-ε, uGGP1, uGGP2 and in carotenoid cleavage dioxygenase 4a (CCD4a), an isozyme involved in β-carotene degradation in lettuce, exhibited significantly enhanced content of AsA, β-carotene and zeaxanthin. Our results demonstrate the potential of multi-pathway gene editing to ‘supercharge’ economically important crops such as lettuce as a means to address micronutrient deficiencies in modern diets.
https://onlinelibrary.wiley.com/doi/10.1111/pbi.70018
Majumder, S., Datta, K. & Datta, S.K. (202): 25 Years of Pesticidal Cry1Ab/Ac Fusion Proteins in Crop Protection: Advances
in Bt Crop Development, Target Pest Management, Safety, Environmental Impact, and Regulatory Frameworks. Journal of Crop Health 77, 55 | https://doi.org/10.1007/s10343-025-01119-7
Cry (crystal) proteins from Bacillus thuringiensis (Bt) have been pivotal in integrated pest management (IPM) for lepidopteran insects. Genetically engineered Bt crops with cry genes are grown in 27 countries, significantly reducing pest infestations and chemical insecticide use. However, improper cultivation practices, such as repeated use of the same Bt crops over large areas, have led to insect adaptation to Cry proteins, raising global concern for crop protection.
To combat this, plants expressing multiple Cry proteins, including fusion proteins like Cry1Ab/Ac, have been developed and extensively studied in crops such as rice (Oryza sativa), jute (Corchorus capsularis), chickpea (Cicer arietinum), and jatropha (Jatropha Curcas). Comprehensive biosafety analyses have confirmed the safety of Cry1Ab/Ac for non-target insects, beneficial insects, soil microbes, water quality, and the environment. Food safety analyses have also validated its safety for human consumption.
In 2009, China approved Cry1Ab/Ac rice lines Huahui‑1 and Bt-Shanyou-63 for cultivation, and in 2018, the United States approved Bt-Shanyou-63 rice for human consumption. The large-scale adoption of Cry1Ab/Ac crops promises to reduce chemical pesticide use and increase farm profitability.
This review highlights the advancements and applications of Cry1Ab/Ac fusion proteins in crop protection from 1998 to 2024, with a special focus on Bt (Cry1Ab/Ac) rice, emphasizing their potential to address key challenges in modern agriculture, ensuring food security, and promoting environmental sustainability.
https://link.springer.com/article/10.1007/s10343-025-01119-7
Lee M.S., Dolek M., Otto M., Lang A. (2025): Larval consumption of Cry1F maize pollen causes adverse effects in four
non-target Lepidoptera species. Science of The Total Environment 970, 178951 | https://doi.org/10.1016/j.scitotenv.2025.178951
The cultivation of genetically modified maize expressing Bt proteins against Lepidopteran pests poses a risk for non-target (NT) Lepidoptera, particularly for species inhabiting agroecosystems and whose larvae are susceptible to Bt toxins expressed in maize pollen. Here, laboratory studies were conducted to determine the adverse effects of larval exposure to Cry1F pollen (event TC1507) on host plants on two butterfly (Pieris napi, Aglais io) and two moth species (Plutella xylostella, Ematurga atomaria). All NT Lepidoptera tested were affected by the Cry1F toxin in the pollen, albeit in different degrees depending on the species and the recorded parameter. Adverse sublethal effects of increasing Bt pollen concentrations included reduced larval feeding, lower larval body weight and prolonged development times, but no significant effects on adult size or fecundity were observed. Dose-response mortality, measured when all survivors reached adult stage, showed that three species were susceptible to field-realistic pollen concentrations (LC50 = 76, 126 and 171 Cry1F pollen grains/cm2 on host plants for P. xylostella, E. atomaria, and A. io, respectively), whereas P. napi was only affected by higher concentrations (5070 Cry1F pollen grains/cm2). Assessing mortality at day seven substantially underestimated effects compared to the end of the larval period highlighting the importance of experiment duration until adulthood to detect delayed effects, and stressing the need for more ecologically realistic testing conditions for risk assessment. Given the fact that only few data exist on the susceptibility of non-pest Lepidoptera to Cry1F, our results indicate that NT Lepidoptera populations may be more vulnerable to the cultivation of Cry1F maize TC1507 than previously assumed.
https://www.sciencedirect.com/science/article/pii/S0048969725005868
Diaz C, Ayobahan SU, Simon S, Zühl L, Schiermeyer A, Eilebrecht E and Eilebrecht S (2025): Classification of and detection
techniques for RNAi-induced effects in GM plants. Front. Plant Sci. 16: 1535384. | https://doi.org/10.3389/fpls.2025.1535384
RNA interference (RNAi) is a biotechnological tool used for gene silencing in plants, with both endogenous and exogenous applications. Endogenous approaches, such as host-induced gene silencing (HIGS), involve genetically modified (GM) plants, while exogenous methods include spray-induced gene silencing (SIGS). The RNAi mechanism hinges on the introduction of double-stranded RNA (dsRNA), which is processed into short interfering RNAs (siRNAs) that degrade specific messenger RNAs (mRNAs). However, unintended effects on non-target organisms and GM plants are a concern due to sequence homologies or siRNA-induced epigenetic changes. Regulatory bodies such as the EPA and EFSA emphasize the need for comprehensive risk assessments. Detecting unintended effects is complex, often relying on bioinformatic tools and untargeted analyses like transcriptomics and metabolomics, though these methods require extensive genomic data. This review aims to classify mechanisms of RNAi effects induced by short interfering RNA from different sources in plants and to identify technologies that can be used to detect these effects. In addition, practical case studies are summarized and discussed in which previously unintended RNAi effects in genetically modified plants have been investigated. Current literature is limited but suggests RNAi is relatively specific, with few unintended effects observed in GM crops. However, further studies are needed to fully understand and mitigate potential risks, particularly those related to transcriptional gene silencing (TGS) mechanisms, which are less predictable than post-transcriptional gene silencing (PTGS). Particularly the application of untargeted approaches such as small RNA sequencing and transcriptomics is recommended for thorough and comprehensive risk assessments.
https://www.frontiersin.org/journals/plant-science/articles/10.3389/fpls.2025.1535384/full
Brant E., Zuniga‐Soto E., Altpeter F. (2025): RNAi and genome editing of sugarcane: Progress and prospects.
Plant J. 121(5):e70048. |doi: 10.1111/tpj.70048
Sugarcane, which provides 80% of global table sugar and 40% of biofuel, presents unique breeding challenges due to its highly polyploid, heterozygous, and frequently aneuploid genome. Significant progress has been made in developing genetic resources, including the recently completed reference genome of the sugarcane cultivar R570 and pan‐genomic resources from sorghum, a closely related diploid species. Biotechnological approaches including RNA interference (RNAi), overexpression of transgenes, and gene editing technologies offer promising avenues for accelerating sugarcane improvement. These methods have successfully targeted genes involved in important traits such as sucrose accumulation, lignin biosynthesis, biomass oil accumulation, and stress response. One of the main transformation methods—biolistic gene transfer or Agrobacterium‐mediated transformation—coupled with efficient tissue culture protocols, is typically used for implementing these biotechnology approaches. Emerging technologies show promise for overcoming current limitations. The use of morphogenic genes can help address genotype constraints and improve transformation efficiency. Tissue culture‐free technologies, such as spray‐induced gene silencing, virus‐induced gene silencing, or virus‐induced gene editing, offer potential for accelerating functional genomics studies. Additionally, novel approaches including base and prime editing, orthogonal synthetic transcription factors, and synthetic directed evolution present opportunities for enhancing sugarcane traits. These advances collectively aim to improve sugarcane's efficiency as a crop for both sugar and biofuel production. This review aims to discuss the progress made in sugarcane methodologies, with a focus on RNAi and gene editing approaches, how RNAi can be used to inform functional gene targets, and future improvements and applications.
https://pmc.ncbi.nlm.nih.gov/articles/PMC11886501/
Cierzniak, A., Małodobra-Mazur, M. & Tokarski, M. (2025): A new approach for the detection of genetic alterations utilizing
modified loop-mediated isothermal amplification reaction (LAMP). Sci Rep 15, 8071 | https://doi.org/10.1038/s41598-025-93086-2
The increasing use of genetic testing for personalised therapy, highlights the need for rapid, reliable diagnostics. Current methods are hindered by complex workflows, requiring advanced equipment, skilled personnel, and invasive tissue sampling. Loop-mediated isothermal amplification (LAMP) has emerged as a more efficient alternative to traditional PCR. LAMP eliminates thermal cycling, allowing faster, more cost-effective tests, and is less sensitive to inhibitors, enabling testing from minimally processed samples. Although LAMP is newer and has a longer assay development time than PCR, its potential in oncology, particularly for detecting genetic changes, is promising. We have developed a LAMP-based method for detecting genetic variations, optimized for point-of-care testing. This technique uses modified primers with alterations at the 3’ end of either F2 or B2 primers, ensuring specificity for altered sequences. The assay only produces a positive signal when the genetic variant is present, distinguishing it from wild-type DNA. Our findings demonstrate that this method has high specificity and sensitivity, even in samples with both wild-type and mutated material. Paired with a portable device, this LAMP-based diagnostic method could revolutionize genetic alteration detection, offering quicker results and improving treatment outcomes, particularly for targeted therapies.
https://www.nature.com/articles/s41598-025-93086-2
EFSA
FEZ Panel (2025): Revised safety evaluation of the food enzyme aqualysin 1 from the genetically modified Bacillus subtilis strain
LMG S-25520 produced by a modified process. EFSA Journal, 23(3), e9288. https://doi.org/10.2903/j.efsa.2025.9288
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9288
FEZ Panel (2025): Safety evaluation of the food enzyme β-fructofuranosidase from the genetically modified Trichoderma reesei
strain AR-996. EFSA Journal, 23(3), e9287. https://doi.org/10.2903/j.efsa.2025.9287
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9287
FEZ Panel (2025). Safety evaluation of the food enzyme aspergillopepsin I from the non-genetically modified Aspergillus luchuensis
strain APTC 3C-290. EFSA Journal, 23(3), e9286. https://doi.org/10.2903/j.efsa.2025.9286
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9286