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. Since 2023, many proposals were made by the European Commission and a working group on the definition of a GMO launched in the Council of the European Union. 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 and other ongoing work relating to living organisms
| GMO | Biocontrol | |||||
| 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) | Establishing an “harmonised” interpretation of the GMO definition according to Directive 2001/18 | Authorisation of biocontrol products (microorganisms, molecules…) |
| Procedure reference | 2023/0226 | 2025/0410 | 2025/0405 | Report (presented by the Netherlands in 2025) Ongoing thoughts in a working group internal to the Council of the European union | 2025/0410 | |
| Preparation | Requested by the European parliament on 07/02/24 | Following the consultation (End : 14/10/2025) | Following the consultation (End : 14/10/2025) | |||
| Proposal from EC | Text of the proposal (05/07/2023) | Expected in 2026 | Text of the proposal (16/12/2025) | Text of the proposal (16/12/2025) | Text of the proposal (16/12/2025) | |
| EU Economic social committee | Opinion (26/10/23) | Opinion (29/04/2026) | Opinion (18/03/26) | Opinion (29/04/2026) | ||
| EU Committee of Regions | Opinion and amendments (17/04/24) | Renunciation to produce an opinion (04/02/26) | Renunciation to produce an opinion (04/02/26) | Renunciation to produce an opinion (04/02/26) | ||
| EP’s committee | Committee Environment Text of the report (24/01/2024) | Committee Environment Committee Agriculture (13/03/2026) Work in progress Deadline for amendments in Committee Envi / Agri : 01/07/2026 | Committee Environment Committee Public Health (24/03/2026) Work in progress Deadline for amendments in Committee Envi / Public Health : 02/07/2026 Committee report planned for 05/11/2026 | Committee Environment Committee Agriculture (13/03/2026) Work in progress Deadline for amendments in Committee Envi / Agri : 01/07/2026 | ||
| EP’s opinion (1st reading) | Text amended (07/02/2024) | |||||
| EP’s 2nd vote (1st reading) | Text voted (24/04/24) | |||||
| EU Council opinion (1st reading) | / | Work in progress Partial compromise text of the Presidency (19/03/2026) Other compromise texts are proposed but not available online | Work in progress Partial compromise text of the Presidency unavailable online (22/05/2026) | Work in progress Partial compromise text of the Presidency (27/03/2026) Other compromise texts are proposed but not available online | ||
| EU Council negotiations mandate | Mandate (07/03/25) | Possible mandate for negotiation (planned on 16/06/2026) | ||||
| Trilogue compromise text | Text of compromise (04/12/2025) | |||||
| EU Council opinion | Text agreed (19/12/2025) | |||||
| EP’s committee opinion | Vote of agreement 28/01/2026 | |||||
| EU Council’s opinion (1st reading) | Text adopted 21/04/26 | |||||
| EP’s committee opinion | 15 June 2026 (planned) | |||||
| EP’s opinion (2nd reading) | 17 June 2026 (planned) | |||||
| EU Council opinion (2nd reading) | ||||||
| Conciliation | ||||||
| EP’s opinion (3rd reading) | ||||||
| EU Council opinion (3rd reading) | ||||||
| Final adoption | ||||||
| EU ratification | ||||||
| Entry into force | ||||||
| Health | Digitisation of the Living (DSI) | Seeds | ||||
| UNCLOS | European Health Data Space | Genetic resources and benefits sharing | Plant reproductive material | Forest reproductive material | ||
| Purpose | Harmonising the authorisation procedures of medicinal products (Pharma package) | 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 | 2023/0132 | 2023/0353 | 2022/0140 | 2023/0227 | 2023/0228 | |
| Preparation | Call of evidence (End : 11 February 2026) | |||||
| Proposal from EC | Text of the proposal (26/04/2023) | 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 (25/10/23) | / | 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 Public health Text of the report (21/03/2024) | 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 opinion (1st reading) | Text amended (10/04/2024) | 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 opinion (1st reading) | / | Text voted (17/06/24) | / | / | Mandate (10/06/25) | |
| EU Council negotiations mandate | Mandate (04/06/2025) | / | Mandate (10/12/2025) | Text of compromise (05/09/25) | ||
| Trilogue compromise text | Text of compromise (11/12/2025) | / | Text of compromise (22/03/24) | In progress | Text of compromise (19/12/2025) | |
| EU Council opinion | / | Text agreed (19/12/2025) | ||||
| EP’s committee opinion | Vote of agreement 18/03/2026 | Vote of agreement (24/02/2026) | ||||
| EU Council’s opinion (1st reading) | Text adopted 21/04/2026 | / | Text voted (21/01/25) | Text adopted 21/04/2026 | ||
| EP’s committee opinion | Recommandation adopted (08/05/2026) | |||||
| EP’s opinion (2nd reading) | / | Text voted (24/04/24) | Texte adopted (19/05/2026) | |||
| EU Council opinion (2nd reading) | / | / | / | |||
| Conciliation | / | / | / | |||
| EP’s opinion (3rd reading) | / | / | / | |||
| EU Council opinion (3rd reading) | / | / | / | |||
| Final adoption | Text adopted (19/07/2024) | Text adopted (11/02/2025) | Texte adopted (awaiting for publication in the EU Journal Official) | |||
| 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 I | Biotech Act II | 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 | To guarantee that innovative biotech products and processes can quickly enter and freely circulate within the EU | Set of legal intersectorial measures with an impact on Life Sciences and Bioeconomy |
| Procedure reference | 2023/0126 | 2023/0127 | 2025/0406 | |||
| Preparation | Call of evidence (End : 14 March 2025) Public consultation (End : 20 avril 2026) | Consultation (End : 10/11/2025) | Call of evidence (End : 10 June 2026) | Call of evidence (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) | Announced for the 4th quarter of 2026 | Text of the proposal (16/12/2025) | Announced for the 3rd quarter of 2026 | |
| EU Economic social committee | Opinion (20/09/23) | Opinion (20/09/23) | Opinion (18/03/26) | |||
| EU Committee of Regions | / | / | Renunciation to produce an opinion (04/02/26) | |||
| 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) | Committee Public Health Committee Industry Research and Energy Work in progress Deadlin for amendments in Committee : 29/06/2026 Committee report planned for 01/10/2026 | |||
| EP’s opinion (1st reading) | Text amended (26/02/24) | Text amended (28/02/24) | ||||
| EP’s 2nd vote (1st reading) | / | / | ||||
| EU Council opinion (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 opinion | ||||||
| EU Council’s opinion (1st reading) | ||||||
| EP’s committee opinion | ||||||
| EP’s opinion (2nd reading) | ||||||
| EU Council opinion (2nd reading) | ||||||
| Conciliation | ||||||
| EP’s opinion (3rd reading) | ||||||
| EU Council opinion (3rd reading) | ||||||
| Final adoption | ||||||
| EU ratification | ||||||
| Entry into force | ||||||