The European Commission’s legal initiatives
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A number of legal initiatives concerning living organisms are currently underway at European level. Inf’OGM has already published an article taking stock of these initiatives. In December 2025, many additional proposals were made by the European Commission. Here we summarize the various procedures in the form of tables. These will be updated as work progresses.
Summary of the ongoing European Commission’s legislative initiatives relating to living organisms
| Plants obtained by « NGTs » | Micro-organisms | Animals obtained by « NGTs » | |||
| Purpose | Deregulation of numerous GM plants (including micro-algae) | Regulatory status of products containing traces of GMM’s DNA Omnibus X (food / feed) | Authorising the dissemination into the environment of GMM according to 2001/18 (and deregulation) | Harmonizing the authorisation procedures of medicinal products (Pharma package) | Deregulation of numerous GM animals |
| Procedure reference | 2023/0226 | 2025/0410 | 2025/0405 | 2023/0132 | |
| Preparation | Following the consultation (End : 14/10/2025) | Requested by the European parliament on 07/02/24 | |||
| Proposal from EC | Text of the proposal (05/07/2023) | Text of the proposal (16/12/2025) | Text of the proposal (16/12/2025) | Text of the proposal (26/04/2023) | |
| EP’s committee | Text of the report (24/01/2024) | Text of the report (21/03/2024) | |||
| EP’s vote (1st reading) | Text voted (07/02/2024) | Text voted (10/04/2024) | |||
| Possible EP’s 2nd vote (1st reading) | Text voted (24/04/24) | ||||
| EU Council negotiations mandate | Mandate (07/03/25) | Mandate (04/06/2025) | |||
| EU Council’s vote (1st reading) | |||||
| Trilogue outcoming compromise text | Text of compromise (04/12/2025) | Text not public yet (11/12/2025) | |||
| EU Council agreed text | Text agreed (19/12/2025) | ||||
| EU Council’s vote (1st reading) | |||||
| EP’s vote (2nd reading) | |||||
| Final adoption | |||||
| EU ratification | |||||
| Entry into force | |||||
| Digital Sequence Information (DSI) | Patents | ||||
| UNCLOS | European Health Data Space | Genetic resources and benefits sharing | Phytopharmaceutical products | Medicinal products | |
| Purpose | Signature of the UNCLOS agreement (Genetic resources and DSI in international waters) | Access to human genetic, genomic and proteomic data | Assessment and potential updating of the 511/2014 regulation (Nagoya protocol) | Unitary supplementary protection certificate for plant protection products | Unitary supplementary certificate for medicinal products |
| Procedure reference | 2023/0353 | 2022/0140 | 2023/0126 | 2023/0127 | |
| Preparation | Call for contributions (Fin : 11 février 2026) | ||||
| Proposal from EC | 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) | |
| EP’s committee | 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) | |
| EP’s vote (1st reading) | Text voted (24/04/24) | Text voted (13/12/23) | Text voted (26 février 2024) | Text voted (28/02/24) | |
| Possible EP’s 2nd vote (1st reading) | |||||
| EU Council negotiations mandate | Text 1 of the Presidency (au 29/10/2025) Text 2 of the Presidency (au 29/10/2025) | ||||
| EU Council’s vote (1st reading) | |||||
| Trilogue outcoming compromise text | Text of compromise (22/03/24) | ||||
| EU Council agreed text | |||||
| EU Council’s vote (1st reading) | |||||
| EP’s vote (2nd reading) | Text voted (24/04/24) | ||||
| Final adoption | Text voted (19/07/2024) | ||||
| EU ratification | Text of announcement (20/09/2025) | ||||
| Entry into force | Text of the regulation (26/03/2027) | ||||
| Biotechnologies | Innovation | Plant reproductive material | ||
| Biotech Act | Regulation on Innovation | “Seed” regulation | Forest | |
| Purpose | Stimulating innovation via optimizing research and facilitating a fast access to the market for the biotechnological innovations | Set of legal intersectorial measures with an impact on Life Sciences and Bioeconomy | Production and marketing of plant reproductive material | Production and marketing of forest reproductive material |
| Procedure reference | 2025/0406 | 2023/0227 | 2023/0228 | |
| Preparation | Consultation (End : 10/11/2025) | Call for contributions (End : 03/10/2025) Public consultation (End 03/10/2025) | ||
| Proposal from EC | Text of the proposal (16/12/2025) | Text of the proposal (05/07/23) | Text of the proposal (05/07/23) | |
| EP’s committee | Text of the report (22/03/24) | Text of the report (21/03/24) | ||
| EP’s vote (1st reading) | Text voted (24/04/24) | Text voted (24/04/24) | ||
| Possible EP’s 2nd vote (1st reading) | ||||
| EU Council negotiations mandate | Mandate (10/12/2025) | Mandate (10/06/25) | ||
| EU Council’s vote (1st reading) | ||||
| Trilogue outcoming compromise text | Text of compromise (05/09/25) | |||
| EU Council agreed text | Text agreed (19/12/2025) | |||
| EU Council’s vote (1st reading) | ||||
| EP’s vote (2nd reading) | ||||
| Final adoption | ||||
| EU ratification | ||||
| Entry into force | ||||