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
| GMO | Health | ||||
| Plants | Animals | Micro-organisms | |||
| Purpose | Deregulation of numerous GM plants (including micro-algae) | Deregulation of numerous GM animals | 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) | Harmonising the authorisation procedures of medicinal products (Pharma package) |
| Procedure reference | 2023/0226 | 2025/0410 | 2025/0405 | 2023/0132 | |
| Preparation | Requested by the European parliament on 07/02/24 | Following the consultation (End : 14/10/2025) | |||
| 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) | |
| EU Economic social committee | Opinion (26/10/23) | Opinion (25/10/23) | |||
| EU Committee of Regions | Opinion and amendments (17/04/24) | / | |||
| EP’s committee | Committee Environment Text of the report (24/01/2024) | To be chosen | Committee Environment Committee Public health (24/03/2026) | Committee Public health Text of the report (21/03/2024) | |
| EP’s vote (1st reading) | Text amended (07/02/2024) | Text amended (10/04/2024) | |||
| EP’s 2nd vote (1st reading) | Text voted (24/04/24) | / | |||
| EU Council Vote (1st reading) | / | / | |||
| EU Council negotiations mandate | Mandate (07/03/25) | Mandate (04/06/2025) | |||
| Trilogue compromise text | Text of compromise (04/12/2025) | Text of compromise (11/12/2025) | |||
| EU Council opinion | Text agreed (19/12/2025) | ||||
| EP’s committee vote | Vote of agreement 28/01/2026 | Vote of agreement 18/03/2026 | |||
| EU Council’s vote (1st reading) | 21/04/26 (planned) | ||||
| EP’s vote (2nd reading) | 18/05/26 (indicative date) | ||||
| EU Council vote (2nd reading) | |||||
| Conciliation | |||||
| EP’s vote (3rd reading) | |||||
| EU Council vote (3rd reading) | |||||
| Final adoption | |||||
| EU ratification | |||||
| Entry into force | |||||
| Digitisation of the Living (DSI) | Seeds | ||||
| UNCLOS | European Health Data Space | Genetic resources and benefits sharing | Plant reproductive material | Forest reproductive material | |
| 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) | Production and marketing of plant reproductive material | Production and marketing of forest reproductive material |
| Procedure reference | 2023/0353 | 2022/0140 | 2023/0227 | 2023/0228 | |
| 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) | Announced for the 1st quarter of 2027 | Text of the proposal (05/07/23) | Text of the proposal (05/07/23) |
| EU Economic social committee | / | Opinion (22/09/22) | Opinion (13/12/23) | Opinion (13/12/23) | |
| EU Committee of Regions | / | Opinion and amendments (08/02/23) | Opinion and amendments (17/04/24) | / | |
| EP’s committee | Committee Environement Text of the report (19/04/24) | Committee Environement Committee on civil liberties Text of the report (05/12/23) | Committee Agriculture Text of the report (22/03/24) | Committee Agriculture Text of the report (21/03/24) | |
| EP’s vote (1st reading) | Text voted (24/04/24) | Text amended (13/12/23) | Text amended (24/04/24) | Text amended (24/04/24) | |
| EP’s 2nd vote (1st reading) | / | / | / | / | |
| EU Council Vote (1st reading) | Text voted (17/06/24) | / | Mandate (10/12/2025) | Mandate (10/06/25) | |
| EU Council negotiations mandate | / | Text of compromise (05/09/25) | |||
| Trilogue compromise text | / | Text of compromise (22/03/24) | Text agreed (19/12/2025) | ||
| EU Council opinion | / | ||||
| EP’s committee vote | |||||
| EU Council’s vote (1st reading) | / | Text voted (21/01/25) | |||
| EP’s vote (2nd reading) | / | Text voted (24/04/24) | |||
| EU Council vote (2nd reading) | / | / | |||
| Conciliation | / | / | |||
| EP’s vote (3rd reading) | / | / | |||
| EU Council vote (3rd reading) | / | / | |||
| Final adoption | Text adopted (19/07/2024) | Text adopted (11/02/2025) | |||
| EU ratification | Text of announcement (20/09/2025) | ||||
| Entry into force | 17/06/2026 | 26/03/2027 | |||
| Industrial Property (IP) | Biotechnology | ||||
| Phytopharmaceutical products | Medicinal products | Plant variety rights | Biotech Act | Innovation Act | |
| Purpose | Unitary supplementary protection certificate for plant protection products | Unitary supplementary certificate for medicinal products | Assessment and potential update of the EU plant variety rights framework | Stimulating innovation via optimising 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 |
| Procedure reference | 2023/0126 | 2023/0127 | 2025/0406 | ||
| Preparation | Call for contributions (End : 14 March 2025) Public consultation (End : 20 avril 2026) | 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 (27/04/23) | Text of the proposal (27/04/23) | Text of the proposal (16/12/2025) | ||
| EU Economic social committee | Opinion (20/09/23) | Opinion (20/09/23) | |||
| EU Committee of Regions | / | / | |||
| EP’s committee | Committee on legal affairs Text of the report (24/01/2024) | Committee on legal affairs Text of the report (31/01/2024) | To be chosen | ||
| EP’s vote (1st reading) | Text amended (26/02/24) | Text amended (28/02/24) | |||
| EP’s 2nd vote (1st reading) | / | / | |||
| EU Council Vote (1st reading) | / | / | |||
| EU Council negotiations mandate | Text 1 of the Presidency (as of 29/10/2025) Text 2 of the Presidency (as of 29/10/2025) | ||||
| Trilogue compromise text | |||||
| EU Council opinion | |||||
| EP’s committee vote | |||||
| EU Council’s vote (1st reading) | |||||
| EP’s vote (2nd reading) | |||||
| EU Council vote (2nd reading) | |||||
| Conciliation | |||||
| EP’s vote (3rd reading) | |||||
| EU Council vote (3rd reading) | |||||
| Final adoption | |||||
| EU ratification | |||||
| Entry into force | |||||