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. Here we summarize the various procedures in the form of tables. These will be updated as work progresses.

Summary of the European Commission’s legislative initiatives relating to Living


GMO DEREGULATION

Plants obtained by “NGTGMM obtained by “NGTGMM DNA in lots of additivesPharmaceutical GMMAnimals obtained by “NGTFood safety
PurposeDeregulation of numerous GM plantsDeregulation of numerous GMMRegulatory status of products containing GMM DNA tracesHarmonization of the authorisation procedure for medicinal productsDeregulation of numerous GM animalsStimulate innovation by optimizing research and innovation and facilitating rapid market access for biotechnological innovations
Procedure reference2023/0226Request from EP on the 07/02/24
2023/0132Request from EP on the 07/02/24
Proposal from ECText 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 CommissionText of the report (24/01/2024)

Text of the report (21/03/2024)

EP’s voteDecison adopted (07/02/2024)

Decison adopted (10/04/2024)

2nd EP’s voteText adopted (24/04/24)




EU Council vote





Final text


Commencement




LIFE SCIENCESDSIPATENTSSEEDS

Biotech Regulation (Biotech Act)UNCLOSEuropean Health Data SpacePhytopharmaceutical productsMedicinal productsSeed regulation
PurposeSimplification 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 dataUnitary supplementary protection certificate for plant protection productsUnitary supplementary certificate for medicinal productsProduction and marketing of plant reproductive material in the Union
Procedure reference
2023/03532022/01402023/01262023/01272023/0227
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