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2025/0406(COD)

European Biotech Act

Basic information

2025/0406(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Regulation 2002/178 2000/0286(COD)
Amending Regulation 2007/1394 2005/0227(COD)
Amending Regulation 2014/536 2012/0192(COD)
Amending Regulation 2019/6 2014/0257(COD)
Amending Regulation 2024/1938 2022/0216(COD)
Amending Regulation 2024/795 2023/0199(COD)

Subject

3.50.08 New technologies; biotechnology
4.20 Public health

Status

Awaiting committee decision

Please go to Documentation gateway for any follow-up documents.

Key players

Key events

Date Event Reference Summary
16/12/2025 Legislative proposal published COM(2025)1022
18/05/2026 Committee referral announced in Parliament, 1st reading

Technical information

Procedure reference 2025/0406(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Regulation
Amendments and repeals Amending Regulation 2002/178 2000/0286(COD)
Amending Regulation 2007/1394 2005/0227(COD)
Amending Regulation 2014/536 2012/0192(COD)
Amending Regulation 2019/6 2014/0257(COD)
Amending Regulation 2024/1938 2022/0216(COD)
Amending Regulation 2024/795 2023/0199(COD)
Legal basis Rules of Procedure EP 58 Treaty on the Functioning of the European Union TFEU 114 Treaty on the Functioning of the European Union TFEU 168-p4 Treaty on the Functioning of the European Union TFEU 173-p3
Mandatory consultation of other institutions European Economic and Social Committee European Committee of the Regions
Stage reached in procedure Awaiting committee decision
Committee dossier CJ53/10/04842

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE789.987 16/06/2026
  • Document type Reference Date Summary
    Legislative proposal COM(2025)1022 16/12/2025
    Document attached to the procedure SWD(2025)1055 17/12/2025
    Document attached to the procedure SWD(2026)0450 28/05/2026
  • Document type Parliament/Chamber Reference Date Summary
    Contribution IT_CHAMBER COM(2025)1022 24/06/2026
    Reasoned opinion FR_SENATE PE790.871 07/07/2026
  • Institution/body Document type Reference Date Summary
    EESC Economic and Social Committee: opinion, report CES0031/2026 18/03/2026

Additional information

Source Document Date
EP Research Service Briefing
European Commission EUR-Lex

Transparency

Meetings with interest representatives published in line with the Rules of Procedure