![Standards of quality and safety for substances of human origin intended for human application [EU Legislation in Progress]](https://i0.wp.com/epthinktank.eu/wp-content/uploads/2023/09/EPRS-AaG-751448-Quality-standards-substances-human-origin-FINAL.png?fit=1000%2C666&ssl=1)
Written by Laurence Amand-Eeckhout (2nd edition, updated on 12.02.2024).
On 14 July 2022, the European Commission tabled a proposal to update and expand EU legislation on blood, tissues and cells. The aim is to establish high standards of quality and safety for substances of human origin (SoHOs) intended for human application, to improve the protection of donors, recipients, and offspring born from medically assisted reproduction, and to ensure that the legislation can respond to future challenges.
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopted its report on the proposal on 18 July 2023. On 12 September 2023, Parliament adopted amendments to the proposal, forming its negotiating mandate. Interinstitutional negotiations began on 6 November 2023. On 14 December 2023, Parliament and Council reached a provisional agreement on the proposal.
Complete version
- February 2024: Standards of quality and safety for substances of human origin intended for human application (2nd edition)
| Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC | ||
| Committee responsible: | Environment, Public Health and Food Safety (ENVI) | COM(2022)338 14.7.2022 |
| Rapporteur: | Nathalie Colin-Oesterlé (EPP, France) | 2022/0216 (COD) |
| Shadow rapporteurs: | Nicolás González Casares (S&D, Spain) Andreas Glueck (Renew, Germany) Tilly Metz (Greens/EFA, Luxembourg) Joanna Kopcińska (ECR, Poland) Kateřina Konečná (The Left, Czechia) | Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’) |
| Next steps expected: | Plenary vote on trilogue agreement | |
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