News
In Europe, legislative developments concerning living organisms are progressing slowly
By Denis MESHAKA
Published on the 08/10/2025
Since 3 May 2022, the European Commission has launched numerous legislative initiatives relating to living organisms. The deregulation of plants and certain GMO micro-organisms, the digitisation of living organisms and patents are all topics being discussed by Member States and the European Parliament. If adopted, these projects would make it easier for companies with the means to appropriate living organisms. What is the current status of these projects? Inf’OGM takes stock.
Since the publication of our November 2024 article1, there has been little overall progress on the European legislative projects currently under discussion. Most of the issues remain under discussion within the Council or Parliament (or even at earlier stages), with no decisive progress. Technical debates on micro-organisms, traces of genetically modified micro-organism (GMM) DNA and supplementary protection certificates for plant protection products (pesticides) have not led to any final decisions. Sensitive issues, such as genetically modified animals, remain blocked due to a lack of political consensus. There is therefore a relative inertia on the part of the European Union (EU) institutions, including the Commission, which one would imagine would want to see certain issues resolved.
The main developments concern two issues in particular. On the one hand, in March 2025, the Council of the EU adopted a negotiating mandate on the regulation governing GM plants obtained through new genetic modification techniques (procedure 2023/0226), paving the way for discussions with the European Parliament and the Commission in the context of the trilogue2. Furthermore, the EU has continued its international engagement with the BBNJ Agreement on the conservation and sustainable use of marine biological diversity in areas beyond national jurisdiction. To this end, it has published an official communication on the signing and ratification of this agreement. These two developments mark important but limited steps forward in a legislative landscape that is still largely awaiting concrete decisions.
In addition, two public consultations on initiatives published by the European Commission are currently underway. The first, which concerns food safety for humans and animals, aims to simplify the administrative burdens associated with marketing authorisations, particularly for products derived from GMOs. The second, which is part of the Commission’s “Life Sciences” strategy, concerns a comprehensive regulation on biotechnology3.
The table below (which Inf’OGM will update regularly) summarises the various procedures currently underway.
Summary of the European Commission’s legislative initiatives relating to Living
| GMO DEREGULATION | |||||||
| Plants obtained by “NGT“ | GMM obtained by “NGT“ | GMM DNA in lots of additives | Pharmaceutical GMM | Animals obtained by “NGT“ | Food safety | ||
| Purpose | Deregulation of numerous GM plants | Deregulation of numerous GMM | Regulatory status of products containing GMM DNA traces | Harmonization of the authorisation procedure for medicinal products | Deregulation of numerous GM animals | Stimulate innovation by optimizing research and innovation and facilitating rapid market access for biotechnological innovations | |
| Procedure reference | 2023/0226 | Request from EP on the 07/02/24 | 2023/0132 | Request from EP on the 07/02/24 | |||
| Proposal from EC | Text of the proposal (05/07/2023) | To follow the discussions (Last meeting to date : 20/09/2021) | Text of the proposal (26/04/2023) | Consultation (End : 14/10/2025) | |||
| EP’s Commission | Text of the report (24/01/2024) | Text of the report (21/03/2024) | |||||
| EP’s vote | Decison adopted (07/02/2024) | Decison adopted (10/04/2024) | |||||
| 2nd EP’s vote | Text adopted (24/04/24) | ||||||
| EU Council vote | |||||||
| Final text | |||||||
| Commencement | |||||||
| “LIFE SCIENCES” | DSI | PATENTS | SEEDS | |||
| Biotech Regulation (Biotech Act) | UNCLOS | European Health Data Space | Phytopharmaceutical products | Medicinal products | Seed regulation | |
| Purpose | Simplification of administrative burdens related to marketing authorizations, including products derived from GMOs (omnibus package) | Signature of the BBNJ agreement (GR and DSI in international waters) | Access to genetic, genomic and proteomic human data | Unitary supplementary protection certificate for plant protection products | Unitary supplementary certificate for medicinal products | Production and marketing of plant reproductive material in the Union |
| Procedure reference | 2023/0353 | 2022/0140 | 2023/0126 | 2023/0127 | 2023/0227 | |
| Proposal from EC | Consultation (End : 10/11/2025) | Text of the proposal (12/10/2023) | Text of the proposal (03/05/22) | Text of the proposal (27/04/23) | Text of the proposal (27/04/23) | Text of the proposal (05/07/23) |
| EP’s Commission | Text of the report (19/04/24) | Text of the report (05/12/23) | Text of the report (24/01/2024) | Text of the report (31/01/2024) | Text of the report (22/03/24) | |
| EP’s vote | Decision adopted (24/04/24) | Decision adopted (13/12/23) | Decison adopted (26 février 2024) | Decison adopted (28/02/24) | Decison adopted (24/04/24) | |
| Interinstitutional negociations | Agreement adopted (22/03/24) | |||||
| 2nd EP’s vote | Text adopted (24/04/24) | |||||
| EU Council vote | ||||||
| Final text | Text adopted (19/07/2024) | |||||
| Commencement | ||||||
- Eric Meunier, « The European Commission’s legal initiatives on the Living », Inf’OGM, 13 novembre 2024. ↩︎
- Eric Meunier, « Towards the start of the trilogue on GMO deregulation? », Inf’OGM, 2 avril 2025. ↩︎
- Denis Meshaka, « The EU’s “life sciences” strategy: a pro-industry strategy », Inf’OGM, 1er août 2025. ↩︎
