Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (52034/EU XXVIII.GP)

Linkart	Link
COM Kommission	COM(2019)176
COM Kommission	COM/2019/640
COM Kommission	COM/2020/381
COM Kommission	COM/2020/761
COM Kommission	COM/2021/44
COM Kommission	COM/2021/82
COM Kommission	COM(2023) 192
COM Kommission	COM(2023) 193
COM Kommission	COM(2023)196
COM Kommission	COM(2024) 137
INT Interinstitutionelle Zahl	2025/0406 (COD)
INT Interinstitutionelle Zahl	2025/2087 (INI)
RAT Rat	11/19
RAT Rat	13323/25
RAT Rat	15/31
RAT Rat	18/42
RAT Rat	20/43
RAT Rat	414/01
RAT Rat	528/02
RMA Ratsmateriencodes	AGRI 745
RMA Ratsmateriencodes	AGRILEG 215
RMA Ratsmateriencodes	CODEC 2160
RMA Ratsmateriencodes	DENLEG 68
RMA Ratsmateriencodes	ENV 1431
RMA Ratsmateriencodes	NIS 2
RMA Ratsmateriencodes	PI 230
RMA Ratsmateriencodes	RECH 565
RMA Ratsmateriencodes	VETER 134
ABL Amtsblatter	OJ C 414, 28.10.2022
ABL Amtsblatter	OJ C 528, 30.12.2021
ABL Amtsblatter	OJ L 106, 17.4.2001
ABL Amtsblatter	OJ L 106, 17.4.2001, p. 1
ABL Amtsblatter	OJ L 107, 26.3.2021
ABL Amtsblatter	OJ L 117, 5.5.2017
ABL Amtsblatter	OJ L 119, 4.5.2016
ABL Amtsblatter	OJ L 119, 4.5.2016, p. 1
ABL Amtsblatter	OJ L 124, 20.5.2003
ABL Amtsblatter	OJ L 125, 21.5.2009, p. 75
BES Beschlusse	No 1082/2013/EU
BES Beschlusse	No 1247/2002/EC
BES Beschlusse	2001/83/EC
BES Beschlusse	2010/227/EU
BES Beschlusse	2014/90/EU
BES Beschlusse	2016/797
BES Beschlusse	2017/745
BES Beschlusse	2017/746
BES Beschlusse	2018/1139
BES Beschlusse	2018/858
EMP Empfehlungen	2003/361/EC
RIL Richtlinien	(EU) 2016/797 and (EU) 2020/1828
RIL Richtlinien	(EU) 2022/2555
RIL Richtlinien	1999/45/EC
RIL Richtlinien	1999/93/EC
RIL Richtlinien	2000/21/EC
RIL Richtlinien	2000/54/EC
RIL Richtlinien	2000/60/EC
RIL Richtlinien	2001/18/EC
RIL Richtlinien	2001/20/EC
RIL Richtlinien	2001/82/EC
VER Verordnungen	1082/2013
VER Verordnungen	1169/2011
VER Verordnungen	1/2023
VER Verordnungen	1223/2009
VER Verordnungen	1290/2013
VER Verordnungen	1291/2013
VER Verordnungen	1296/2013
VER Verordnungen	1303/2013
VER Verordnungen	1394/2007
VER Verordnungen	141/2000

Datum	EU-Datenbanknr.	Dokument der EU-Vorlage	Sprache	Einstufung
21.12.2025	52033/EU XXVIII.GP	RAT: 16945/25 ADD 1 PDF	englisch	PUBLIC	EU-Vorlage: Offizielles Ratsdokument ANNEXES to the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) Eingelangt am 22.12.2025, CIxP Übermittlung
21.12.2025	52036/EU XXVIII.GP	RAT: 16945/25 ADD 2 PDF	englisch	PUBLIC	EU-Vorlage: Offizielles Ratsdokument COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) Eingelangt am 22.12.2025, CIxP Übermittlung

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
17.12.2025	RAT: 16919/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51578/EU XXVIII.GP)

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Betreff
COM: COM(2025) 1022	Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (Text with EEA relevance) (51504/EU XXVIII.GP)
COM: SWD(2025) 1055	Commission Staff Working Document/Subsidiarity Grid accompanying the document Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (51505/EU XXVIII.GP)

Dok.Nr.

Betreff

COM: COM(2025) 1022

Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (Text with EEA relevance) (51504/EU XXVIII.GP)

COM: SWD(2025) 1055

Commission Staff Working Document/Subsidiarity Grid accompanying the document Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (51505/EU XXVIII.GP)

Interinstitutionelle Zahl Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.	Link
2025/0406 COD	Legislative Observatory

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Betreff
COM: COM(2025) 1022	Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (Text with EEA relevance) (51504/EU XXVIII.GP)
COM: SWD(2025) 1055	Commission Staff Working Document/Subsidiarity Grid accompanying the document Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (51505/EU XXVIII.GP)

Dok.Nr.

Betreff

COM: COM(2025) 1022

Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (Text with EEA relevance) (51504/EU XXVIII.GP)

COM: SWD(2025) 1055

Commission Staff Working Document/Subsidiarity Grid accompanying the document Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (51505/EU XXVIII.GP)

Code	Sachgebiet
CODEC	Mitentscheidungsverfahren
RECH	Forschung (Allgemein)
BIOTECH	Biotechnologie
ENV	Umwelt
PI	Geistiges Eigentum
FOOD	Allgemeine Lebensmittelpolitik
FEED	Futtermittel
VETER	Veterinärfragen
AGRI	Allgemeine Agrarpolitik
AGRILEG	Agrarpolitik: Harmonisierung der Rechtsvorschriften
DENLEG	Lebensmittelvorschriften

Thema
Binnenmarkt und Wettbewerb
Forschung und Innovation
Gesundheitswesen
Institutionelle Fragen
Justiz und Inneres
Kultur
Landwirtschaft
Umwelt
Verbraucher- und Lebensmittelsicherheit

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Links
COM: COM(2025) 1022	EUR-Lex IPEX

EU-V: U32 Offizielles Ratsdokument

EU-Vorlage: Offizielles Ratsdokument

EU-Vorlage: Offizielles Ratsdokument