Where the law stands, Dossier 2025/0406(COD)
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)
Ordinary legislative procedure (COD): Parliament and the Council decide together as equals. · First reading
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
Where it stands
Committee work
In committee: ITRE (Industry, Research and Energy) is preparing the report (draft published 16 June 2026).
- Referred to committee(done) 18 May 2026
- Committee work ITRE (Industry, Research and Energy) preparing the report
- Tabled for plenary(to come)
- Plenary vote(to come)
- Negotiations with the Council(to come)
- Published as law(to come)
No plenary decision on this dossier is in our records yet.
Who works on it
- Lead committee
- Industry, Research and Energy
- The MEP who drafts the report and negotiates it on behalf of the committee.
- Vytenis Povilas Andriukaitis (S&D), Wouter Beke (EPP)
- An MEP who follows a report on behalf of their own group when another group holds the rapporteur.
- Ingeborg ter Laak (EPP), Margarita De La Pisa Carrión (Patriots), Kristoffer Storm (ECR), Marie Toussaint (Greens), Anja Hazekamp (The Left), Christine Anderson (ESN), Dario Nardella (S&D), Paolo Borchia (Patriots), Carlo Ciccioli (ECR), Katri Kulmuni (Renew), Ville Niinistö (Greens), Anthony Smith (The Left)
- Committees giving an opinion
- Environment, Climate and Food Safety· rapporteurNicolás González Casares (S&D)
- Economic and Monetary Affairs
- Internal Market and Consumer Protection
- Legal Affairs· rapporteurTiemo Wölken (S&D)
- Civil Liberties, Justice and Home Affairs
Timeline
Newest first.
Committee stage 4 steps
7 September 2026
JURI (Legal Affairs) adopted its opinion
The opinion is attached to the report for the lead committee to consider.
13 July 2026
Amendments tabled in committee (9 batches)
Members of the committee proposed changes to the draft.
CJ53-AM-790005CJ53-AM-790932CJ53-AM-790933CJ53-AM-790934CJ53-AM-790936CJ53-AM-790937CJ53-AM-790938CJ53-AM-790939CJ53-AM-790953
16 June 2026
Draft report published
The rapporteur’s first text. Members can table amendments before the committee votes.
18 May 2026
Referred to the ITRE (Industry, Research and Energy) committee
The lead committee prepares the report; ENVI (Environment, Climate and Food Safety), ECON (Economic and Monetary Affairs), IMCO (Internal Market and Consumer Protection), JURI (Legal Affairs), LIBE (Civil Liberties, Justice and Home Affairs) give an opinion.
Official record: Legislative Observatory, 2025/0406(COD)