Genetically Modified Organisms (GMOs)

Organisms with altered genetic material subject to dedicated risk assessment, authorisation, labeling, traceability, and coexistence rules.

Foresight tracks Genetically Modified Organisms (GMOs) developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.

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Last updated

5 April 2026, 19:01

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Latest Genetically Modified Organisms (GMOs) alerts

The most recent regulatory and guidance signals tracked by Foresight

Argentina Adopts Resolution 24/2026 Updating ICP Procedures for New Breeding Techniques

Argentina has updated its regulatory framework for New Breeding Techniques (NBT) through Resolution 24/2026, streamlining the process for determining if biotech-derived organisms are classified as GMOs. This shift reduces administrative burdens and timelines for developers, reinforcing a science-based, pro-innovation environment for agricultural biotechnology in the region.

boletinoficial.gob.arArgentinaArgentina

European Parliament Plans May 2026 Vote on New Genomic Techniques Regulation for Plants

EU co-legislators have reached a provisional agreement on the New Genomic Techniques (NGT) Regulation, with a final European Parliament vote tentatively scheduled for May 2026. The framework will streamline market access for "conventional-like" NGT1 plants while maintaining strict GMO-style oversight for NGT2, requiring businesses to adapt labeling, traceability, and sourcing strategies for bioengineered crops and derived products.

europarl.europa.euEuropean UnionEuropean Union

Germany (BAuA) Issues 4th Amendment to TRBA 468 Cell Line List

Germany's BAuA has updated TRBA 468, revising the classification of specific cell lines and restructuring the technical list for biological agents. Operators must update risk assessments and safety documentation for cell culture activities to ensure compliance with revised protection levels and viral infection data.

baua.deGermanyGermany

Denmark Consults on EU Amendment to Rebaudioside M (E 960c(ii)) Specifications

The EU is expanding the permitted manufacturing routes for Rebaudioside M (E 960c(ii)) while introducing new purity limits for kaurenoic acid. This update provides greater sourcing flexibility for steviol glycosides but requires manufacturers to validate supply chain compliance against the revised purity and production specifications.

prodstoragehoeringspo.blob.core.windows.netDenmarkDenmarkEuropean UnionEuropean Union

EU EFSA Panel Evaluates Extension Of Use For Food Enzyme Glucan 1,4‑α‑Maltohydrolase (NZYM‑SD)

EFSA has issued a positive safety opinion for extending the use of the food enzyme glucan 1,4-α-maltohydrolase to five food manufacturing processes, including plant-based milk analogues. This assessment clears a major technical hurdle for expanded market access and provides regulatory certainty for manufacturers using this enzyme in diverse food categories.

efsa.onlinelibrary.wiley.comEuropean UnionEuropean Union

Canada Approves Genetically Engineered PRRSV-Resistant Pigs For Food And Feed

Canada approved genetically engineered PRRSV-resistant pigs for food and feed use in January 2026. This alignment with major trading partners facilitates biotech adoption in the food supply chain and confirms that no special labeling is required for these gene-edited products.

canada.caCanadaCanada

EU Commission Working Document on Proposal To Amend Directives 2001/18/EC and 2010/53/EU on Genetically Modified Microorganisms and Organ Processing

The European Commission has detailed proposed authorization pathways for organ processing and genetically modified microorganisms under the forthcoming Biotech Act. The shift toward a centralized EU list of authorized technologies signals a move to streamline market access and reduce administrative barriers for medical and biotech operators.

data.consilium.europa.euEuropean UnionEuropean Union

USDA APHIS Grants Nonregulated Status to MON 95275 Maize (Corn)

USDA APHIS has granted nonregulated status to Bayer’s MON 95275 maize, effective March 19, 2026. This decision removes federal biotechnology restrictions on the movement and environmental release of this insect-resistant corn, facilitating its commercial adoption.

federalregister.govUnited StatesUnited States

EU Council Presidency Circulates Compromise Text On Food And Feed Safety Omnibus Proposal

The EU Council is advancing a major "Omnibus" proposal to streamline and update safety requirements across ten core food, feed, and chemical regulations, including those for pesticides and biocides. This initiative signals a move toward more harmonized enforcement and administrative simplification, requiring businesses to monitor potential shifts in compliance obligations across the agricultural and chemical supply chains.

eur-lex.europa.euEuropean UnionEuropean Union

Canada Grants CEPA Waivers of Information Requirements for Certain Living Organism Notifications

Canada has granted information waivers to 15 companies for new living organism notifications, exempting them from specific ecotoxicity and pathogenicity testing. This reflects the continued use of regulatory flexibility to streamline market access for biotechnology and pharmaceutical innovations under CEPA.

gazette.gc.caCanadaCanada

EU Commission Revokes Authorisation for GM Maize MON 87419 and Repeals Decision (EU) 2023/2134

The European Commission has revoked the market authorisation for GM maize MON 87419, effectively repealing the 2023 approval. Businesses must identify and remove affected products from EU supply chains to maintain compliance and mitigate enforcement risks.

ec.europa.euEuropean UnionEuropean Union

EU Commission Revokes Authorisation for GM Maize MON 87403

The European Commission has revoked the market authorization for genetically modified maize MON 87403, ending its legal status for the EU market. Impacted operators must immediately review supply chains and prepare for the withdrawal of MON 87403-derived products to ensure continued regulatory compliance.

ec.europa.euEuropean UnionEuropean Union

EFSA Consults on Extension of Use of Alpha-Amylase Food Enzyme (GM Bacillus licheniformis NZYM-AV)

EFSA is consulting on the expanded use of alpha-amylase derived from genetically modified Bacillus licheniformis through April 2, 2026. Successful authorization would broaden market access for this specific enzyme, necessitating updates to food formulation compliance and labeling strategies.

open.efsa.europa.euEuropean UnionEuropean Union

EFSA Consults on Extension of Use for Food Enzyme Endo-1,4-β-Xylanase (Bacillus licheniformis NZYM-CE)

EFSA is consulting on extending the authorized uses for the food enzyme endo-1,4-β-xylanase (produced via GM strain) until April 3, 2026. Food and enzyme manufacturers should assess the proposed extensions to ensure alignment with product development and future EU market access requirements.

open.efsa.europa.euEuropean UnionEuropean Union

EFSA Adopts Opinion on Extension of Use of Cellulase Food Enzyme From GM Trichoderma reesei AR-852

EFSA published a positive safety opinion on March 26, 2026, supporting the extension of use and revised levels for the cellulase food enzyme from GM Trichoderma reesei. This assessment clears the path for the European Commission to formally authorize expanded applications in food and beverage processing, including cereals, brewing, and juices.

doi.orgEuropean UnionEuropean Union

EU EFSA Updates Safety Evaluation Of Cellulase Food Enzyme From GM Trichoderma reesei AR-852

EFSA has issued a positive safety opinion for the expanded use and revised concentration levels of cellulase from GM Trichoderma reesei in food manufacturing. This scientific endorsement facilitates the formal EU authorization process, potentially allowing broader application of the enzyme in food processing operations.

efsa.europa.euEuropean UnionEuropean Union

US EPA Announces NovoFly GE Screwworm Biopesticide Registration Application and Section 18 Emergency Exemption

The US EPA is reviewing a registration application and emergency exemption for NovoFly, a novel genetically engineered biopesticide, with comments due by April 26, 2026. This signals a move toward large-scale deployment of GE insect technology, requiring stakeholders to monitor evolving biopesticide approval pathways and environmental impact standards.

public-inspection.federalregister.govUnited StatesUnited States

EFSA Intake of Application for Alpha-Amylase Food Enzyme From GM Komagataella Phaffii

EFSA has initiated the safety assessment process for a new alpha-amylase food enzyme produced from a genetically modified strain of Komagataella phaffii. Manufacturers should monitor this dossier as its eventual approval will expand the list of authorized food enzymes and define specific purity and safety criteria for market access.

open.efsa.europa.euEuropean UnionEuropean Union

Japan Food Safety Commission Announces 1020th Meeting on Pesticides, Feed Additives and GMO Soybean DBN9004

Japan’s Food Safety Commission is conducting safety reviews for the insecticide Fenmezoditiaz, GMO soybean DBN9004, and various feed additives during its March 2026 plenary. These assessments are critical for market access, as they form the basis for upcoming revisions to food and feed standards and substance approvals.

fsc.go.jpJapanJapan

EU Council Circulates Final Compromise Text for New Medicinal Products and EMA Regulation

The EU Council has finalized the compromise text for the new Pharmaceutical Regulation, consolidating the authorization and supervision framework for human medicines and advanced therapies. Marketing authorization holders must adapt to more stringent supply chain transparency requirements, mandatory shortage prevention plans, and a recalibrated system of market exclusivity incentives.

data.consilium.europa.euEuropean UnionEuropean Union

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