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53 Milton Road w Cambridge w CB4 1XA w UK

Phone: +44 (0)1223 482766 w E-mail: [email protected] Website: www.genewatch.org

GeneWatch UK is a company limited by guarantee. Registered in England (No. 03556885).

Riina Sikkut Minister of Health and Labour Gonsiori 29 15027 Tallinn Estonia By email to: [email protected]

20th January 2026 Dear Minister Commission’s deregulatory proposals for GM micro-organisms pose major threat to human health and the environment We write concerning proposals by the European Commission to deregulate open releases of GM micro-organisms (including bacteria, fungi, algae and viruses) into the environment.145 These include proposals to:

• Create a new supposedly ‘low risk’ category of genetically modified micro-organisms (GMMs) for open release into the environment, with minimal risk assessment and the option for developers to omit post-market monitoring;

• Allow approvals for open releases of GMMs to last for an unlimited time period; • Allow amendments to risk assessment requirements to be introduced via delegated

acts. These proposals pose major risks to human health and the environment and should be rejected. Currently, GMMs are widely used to produce a variety of products in contained use bioreactors (e.g. food ingredients and enzymes for cleaning products). Open releases of GMMs have been rare, due to major concerns about the risks posed to the environment and human health. However, R&D in this area has recently increased with a few commercial products now available in the USA, including GM soil bacteria intended to fix nitrogen, marketed to farmers, and GM probiotics sold directly to consumers. These and other

145 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs. Strasbourg, 16.12.2025 COM(2025) 1031 final 2025/0405 (COD). https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A52025PC1031&qid=1768307571152

potential future products pose major challenges because they are likely to persist and evolve in the environment.146,147,148,149,150 Major concerns include:

• GM microorganisms can be spread through a variety of mechanisms, such as sewage, insects, dust storms and rain, and interact with the communities of microbes in human and animal guts and on skin;

• Uncontrolled spread of GM microorganisms could pollute all ecosystems: rivers, lakes, oceans, farmland, forests, grasslands, gardens, parks and nature reserves;

• It is impossible to predict the consequences of open releases as GM microorganisms interact and evolve with their environment, spreading novel genetic constructs into other organisms.

It is not possible to define a supposedly ‘low risk’ category of GMMs for open release because the role of most microbes is poorly understood and changes with the environment. Within the human gut, for example, the introduction of new genetic variants can alter metabolism, the breakdown of drugs, and resistance against pathogens. Novel genetic constructs are easily transferred from one microbe to another and can spread unwanted traits, such as antibiotic resistance. A particular concern is the potential creation of novel pathogens as microbes evolve. There are also substantial doubts about the efficacy of these products, due to the complexities involved in delivering and maintaining and measuring the claimed benefits. Some opportunities for future growth may lie in new ‘contained use’ products. But allowing open release of GMMs into the environment poses major unnecessary risks to human health and the environment. We urge you to reject the Commission’s proposal and instead continue to oppose the open release of GMMs into the environment. GeneWatch UK’s report on GM micro-organisms is available on: https://tinyurl.com/43jcdpsh Please do not hesitate to contact us if you would like further information. Yours sincerely,

Dr Helen Wallace Director GeneWatch UK [email protected]

146 Brewer, A. M., George, D. R., & Frow, E. K. (2026). Emerging governance considerations for the deployment of genetically engineered microbes. Current Opinion in Microbiology, 89, 102685. https://doi.org/10.1016/j.mib.2025.102685 147 Eckerstorfer, M. F., Dolezel, M., Miklau, M., Greiter, A., Heissenberger, A., Kastenhofer, K., Schulz, F., Hagen, K., Otto, M., & Engelhard, M. (2025). Environmental Applications of GM Microorganisms: Tiny Critters Posing Huge Challenges for Risk Assessment and Governance. International Journal of Molecular Sciences, 26(7), Article 7. https://doi.org/10.3390/ijms26073174 148 Eckerstorfer, M. F., Dolezel, M., Miklau, M., Greiter, A., Heissenberger, A., & Engelhard, M. (2024). Scanning the Horizon for Environmental Applications of Genetically Modified Viruses Reveals Challenges for Their Environmental Risk Assessment. International Journal of Molecular Sciences, 25(3), Article 3. https://doi.org/10.3390/ijms25031507 149 GeneWatch UK report: GM/GE Microorganisms: a new global environmental disaster in the making? 14th January 2025. https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gm-microorganisms-fin.pdf 150 GeneWatch UK briefing: Biosecurity under threat: Gene-edited animals, plants and micro-organisms. 19th November 2025. https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gw-biosecurity-briefing-fin.pdf

53 Milton Road w Cambridge w CB4 1XA w UK

Phone: +44 (0)1223 482766 w E-mail: [email protected] Website: www.genewatch.org

GeneWatch UK is a company limited by guarantee. Registered in England (No. 03556885).

Riina Sikkut Minister of Health and Labour Gonsiori 29 15027 Tallinn Estonia By email to: [email protected]

20th January 2026 Dear Minister Commission’s deregulatory proposals for GM micro-organisms pose major threat to human health and the environment We write concerning proposals by the European Commission to deregulate open releases of GM micro-organisms (including bacteria, fungi, algae and viruses) into the environment.145 These include proposals to:

• Create a new supposedly ‘low risk’ category of genetically modified micro-organisms (GMMs) for open release into the environment, with minimal risk assessment and the option for developers to omit post-market monitoring;

• Allow approvals for open releases of GMMs to last for an unlimited time period; • Allow amendments to risk assessment requirements to be introduced via delegated

acts. These proposals pose major risks to human health and the environment and should be rejected. Currently, GMMs are widely used to produce a variety of products in contained use bioreactors (e.g. food ingredients and enzymes for cleaning products). Open releases of GMMs have been rare, due to major concerns about the risks posed to the environment and human health. However, R&D in this area has recently increased with a few commercial products now available in the USA, including GM soil bacteria intended to fix nitrogen, marketed to farmers, and GM probiotics sold directly to consumers. These and other

145 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs. Strasbourg, 16.12.2025 COM(2025) 1031 final 2025/0405 (COD). https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A52025PC1031&qid=1768307571152

potential future products pose major challenges because they are likely to persist and evolve in the environment.146,147,148,149,150 Major concerns include:

• GM microorganisms can be spread through a variety of mechanisms, such as sewage, insects, dust storms and rain, and interact with the communities of microbes in human and animal guts and on skin;

• Uncontrolled spread of GM microorganisms could pollute all ecosystems: rivers, lakes, oceans, farmland, forests, grasslands, gardens, parks and nature reserves;

• It is impossible to predict the consequences of open releases as GM microorganisms interact and evolve with their environment, spreading novel genetic constructs into other organisms.

It is not possible to define a supposedly ‘low risk’ category of GMMs for open release because the role of most microbes is poorly understood and changes with the environment. Within the human gut, for example, the introduction of new genetic variants can alter metabolism, the breakdown of drugs, and resistance against pathogens. Novel genetic constructs are easily transferred from one microbe to another and can spread unwanted traits, such as antibiotic resistance. A particular concern is the potential creation of novel pathogens as microbes evolve. There are also substantial doubts about the efficacy of these products, due to the complexities involved in delivering and maintaining and measuring the claimed benefits. Some opportunities for future growth may lie in new ‘contained use’ products. But allowing open release of GMMs into the environment poses major unnecessary risks to human health and the environment. We urge you to reject the Commission’s proposal and instead continue to oppose the open release of GMMs into the environment. GeneWatch UK’s report on GM micro-organisms is available on: https://tinyurl.com/43jcdpsh Please do not hesitate to contact us if you would like further information. Yours sincerely,

Dr Helen Wallace Director GeneWatch UK [email protected]

146 Brewer, A. M., George, D. R., & Frow, E. K. (2026). Emerging governance considerations for the deployment of genetically engineered microbes. Current Opinion in Microbiology, 89, 102685. https://doi.org/10.1016/j.mib.2025.102685 147 Eckerstorfer, M. F., Dolezel, M., Miklau, M., Greiter, A., Heissenberger, A., Kastenhofer, K., Schulz, F., Hagen, K., Otto, M., & Engelhard, M. (2025). Environmental Applications of GM Microorganisms: Tiny Critters Posing Huge Challenges for Risk Assessment and Governance. International Journal of Molecular Sciences, 26(7), Article 7. https://doi.org/10.3390/ijms26073174 148 Eckerstorfer, M. F., Dolezel, M., Miklau, M., Greiter, A., Heissenberger, A., & Engelhard, M. (2024). Scanning the Horizon for Environmental Applications of Genetically Modified Viruses Reveals Challenges for Their Environmental Risk Assessment. International Journal of Molecular Sciences, 25(3), Article 3. https://doi.org/10.3390/ijms25031507 149 GeneWatch UK report: GM/GE Microorganisms: a new global environmental disaster in the making? 14th January 2025. https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gm-microorganisms-fin.pdf 150 GeneWatch UK briefing: Biosecurity under threat: Gene-edited animals, plants and micro-organisms. 19th November 2025. https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gw-biosecurity-briefing-fin.pdf