# European Biotech Act

European Parliament procedure 2025/0406(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 10th term, committee CJ53 / ENVI). Stage: Awaiting committee decision. 1,064 committee amendments tabled by 103 Members between 2026-06-26 and 2026-07-15.

## What the amendments focus on

This procedure concerns the European Biotech Act, a regulation to strengthen the sustainability, safety and competitiveness of health biotechnology in the Union, anchored in the One Health principle and based on Articles 114, 168(4), 173(3) and 191 TFEU. Amendments define health biotechnology strategic projects, attach conditions to public support, require environmental impact assessments, and provide penalties for non-compliance affecting availability or affordability. They address Union funding and State aid, AI use in development and authorisation procedures, biosimilars, veterinary medicinal products and GMO clinical trials, phasing out animal testing with EMA guidance, the mandate of EFSA, regulatory sandboxes for novel foods under Regulation (EU) 2015/2283, and a Commission review five years after application.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Anja HAZEKAMP | Netherlands | GUE/NGL | 161 | https://amendeu.com/md/meps/125023.md |
| Anthony SMITH | France | GUE/NGL | 160 | https://amendeu.com/md/meps/256910.md |
| Vytenis Povilas ANDRIUKAITIS | Lithuania | S&D | 145 | https://amendeu.com/md/meps/119652.md |
| Emma FOURREAU | France | GUE/NGL | 127 | https://amendeu.com/md/meps/256913.md |
| Billy KELLEHER | Ireland | RE | 104 | https://amendeu.com/md/meps/197818.md |
| Katri KULMUNI | Finland | RE | 94 | https://amendeu.com/md/meps/198084.md |
| Stine BOSSE | Denmark | RE | 91 | https://amendeu.com/md/meps/257020.md |
| Dario NARDELLA | Italy | S&D | 83 | https://amendeu.com/md/meps/257111.md |
| Michele PICARO | Italy | ECR | 81 | https://amendeu.com/md/meps/257150.md |
| Ondřej KRUTÍLEK | Czechia | ECR | 80 | https://amendeu.com/md/meps/256845.md |
| Marie-Luce BRASIER-CLAIN | France | PfE | 79 | https://amendeu.com/md/meps/256878.md |
| Romana JERKOVIĆ | Croatia | S&D | 77 | https://amendeu.com/md/meps/112747.md |
| Lara MAGONI | Italy | ECR | 73 | https://amendeu.com/md/meps/257149.md |
| Francesco TORSELLI | Italy | ECR | 73 | https://amendeu.com/md/meps/257163.md |
| Carlo CICCIOLI | Italy | ECR | 73 | https://amendeu.com/md/meps/257093.md |

## Official source documents

- PE790.005: https://www.europarl.europa.eu/doceo/document/CJ53-AM-790005_EN.pdf
- PE790.221: https://www.europarl.europa.eu/doceo/document/ENVI-AM-790221_EN.pdf
- PE790.222: https://www.europarl.europa.eu/doceo/document/ENVI-AM-790222_EN.pdf
- PE790.939: https://www.europarl.europa.eu/doceo/document/CJ53-AM-790939_EN.pdf
- PE790.953: https://www.europarl.europa.eu/doceo/document/CJ53-AM-790953_EN.pdf

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2025-0406-COD · machine-readable: https://amendeu.com/data/dossiers/2025-0406-COD.json

---

Source: AmendEU (amendeu.com), built from Parltrack (ODbL), European Parliament Open Data ((c) European Union) and official Parliament documents. Aggregates CC BY 4.0.
Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2025-0406-COD
When citing, attribute to "AmendEU (amendeu.com)".