European Parliament committees are considering draft legislation to amend EU rules on genetically modified micro-organisms and organ processing, with co-rapporteurs Marta Temido and Adam Jarubas leading the file. The proposal has drawn criticism from civil society groups warning of weakened biosafety standards, while the European Commission argues current regulations block market access for novel biotech tools.
European Parliament committees examine biotechnology directives
A joint meeting of the European Parliament’s Committee on the Environment, Climate and Food Safety (ENVI) and the Committee on Public Health (SANT) convened on Wednesday, 2 September 2026, in Brussels to consider a draft report on amending Directives 2001/18/EC and 2010/53/EU regarding the placing on the market of genetically modified micro-organisms (GMMs) and the processing of human organs intended for transplantation.
According to the European Parliament’s press briefing, the session formed part of the SANT committee’s agenda for the day, with the biotechnology file listed under debates alongside other public health priorities including a study on the health effects of fine particulate matter. The co-rapporteurs for the procedure are Marta Temido (S&D, Portugal) and Adam Jarubas (EPP, Poland), who are steering the Parliament’s position through the legislative process.
The legislative file, registered under procedure number 2025/0405(COD), seeks to update two existing directives: Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment, and Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation. The proposal comes as the EU moves towards relaxing certain GMO-related rules, following the European Parliament’s adoption in June 2026 of a new regulation on plants obtained by New Genomic Techniques (NGTs), which will apply from mid-2028.
Commission argues current GMO rules block market access
The European Commission has justified its proposal to relax rules for genetically modified micro-organisms deliberately released into the environment by claiming that existing EU GMO regulations are blocking market access for products available in third countries. In a Staff Working Document published in May, the Commission argued that the EU’s GMO framework has
“resulted in no market authorisations for deliberate release …, effectively excluding the EU from the specific parts of global markets in biofertilisation, biocontrol, bioremediation, and bioleaching using GMMs.”
However, critics point out that even in countries with less stringent GMO rules, only a handful of non-medicinal GMM products have reached the market, suggesting that regulation is not the only obstacle to commercialisation. According to the Commission’s own overview, just four relevant GMM products or product families are currently on the market outside the EU: two long-established biopesticides, including a genetically engineered strain of Bacillus thuringiensis from Certis Bio approved in the United States in 1996, and a modified Rhizobium rhizogenes from BioCare Technology authorised in Australia as early as 1993.
Two more recent products are a biofertiliser from Pivot Bio, marketed in the United States since 2019, and Lumina, a genetically modified dental-care product from Lantern Bioworks, which entered the US market in 2023. Since these products have reached the market without meaningful regulatory scrutiny, there is practically no safety information publicly available to judge their potential adverse effects.
Civil society warns of weakened biosafety standards
As reported by Save Our Seeds, an organisation focused on seed sovereignty and agro-biodiversity, the EU is moving towards weaker rules for genetically modified micro-organisms deliberately released into the environment. The group warned that the Commission’s latest proposal would remove the requirement to renew authorisations after ten years and reduce requirements relating to risk assessment and analytical detection. It would also create a new category of so-called “low-risk GMMs” for which regulatory requirements could be reduced further.
Scientists from the Germany Ecological Society have warned that the proposed changes, particularly the introduction of a “low-risk GMM” category, are not consistent with current scientific knowledge and could create major environmental risks. Professor Gabriele Berg, a leading microbiome researcher, similarly warned that
“the growing pressure to lower barriers for environmental GMM application should not compromise robust, science-based safeguards”.
She stressed:
“It is important to foster innovation but not at the expense of health, environmental integrity, or long-term biosafety. Once GMMs are released, control and recall are inherently limited.”
The proposed changes are particularly concerning because engineered micro-organisms pose specific challenges when deliberately released into the environment. Many micro-organisms reproduce rapidly and can evolve quickly, live within complex microbial communities whose interactions are still only partly understood, and some exchange genetic material with other organisms. Once released, engineered microbes may spread beyond the site where they were intended to act and interact with organisms and ecological networks in ways that are difficult to predict in advance.
Organ donation directive update under consideration
Alongside the GMM file, the joint ENVI-SANT meeting also considered amendments to Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation. The directive, originally adopted on 7 July 2010, establishes quality and safety standards for organs donated and transplanted within the EU to ensure a high level of human health protection.
Recent research published in the journal Transplant International has highlighted that a substantial proportion of recovered donor organs are not transplanted, pointing to the need for improved standards and processes in organ donation and transplantation systems. The proposed amendments under consideration by MEPs aim to modernise the directive in light of advances in medical science and changes in transplantation practices across member states.
The organ donation file is being handled jointly with the GMM proposal under a single legislative procedure, reflecting the broader biotechnology and public health policy context in which both files sit. The co-rapporteurs Temido and Jarubas are responsible for steering Parliament’s position on both elements of the package.
Legislative timeline and next steps
The Council of Ministers already adopted its position on the Commission’s GMM proposal on 16 June 2026, with minor amendments. The European Parliament is still debating the text, with a committee vote planned for 5 November 2026, and a plenary vote potentially following soon afterwards. Parliament and the Council will ultimately have to agree on a common text before the legislation can be adopted.
For the NGT regulation on gene-edited plants, which was adopted by the European Parliament on 17 June 2026, the rules will not apply until mid-2028, allowing for a two-year implementation period during which the European Commission will develop the necessary secondary legislation and implementing acts. The new framework establishes two distinct regulatory pathways based on a plant’s genetic equivalence to conventionally bred varieties, with Category 1 plants following a simplified pathway and Category 2 plants remaining subject to existing strict GMO rules.
Broader biotechnology policy context
The biotechnology directives under consideration form part of a wider EU policy push to update regulations governing genetic engineering and novel genomic techniques. Under the new NGT framework, plants obtained with certain new genomic techniques and involving limited genetic changes will be regulated in the same way as conventionally bred varieties from 2028 onwards.
However, neither NGT-1 nor NGT-2 plants will be allowed in organic production, maintaining a distinction between organic farming and gene-edited crops. The European Parliament’s adoption of the NGT regulation on 17 June 2026 marked a significant shift in EU agricultural biotechnology policy, with the regulation now proceeding to signature and publication in the Official Journal.
Critics argue that the EU should lead with rigorous science and effective oversight rather than race to remove rules designed to protect people and ecosystems. As Professor Berg noted, once GMMs are released into the environment, control and recall are inherently limited, underscoring the importance of robust pre-market assessment and post-market monitoring.
