The SOHO Regulation and the Future of European FMT Regulation
The SOHO regulation is the first European law to bring the medical use of human stool under one framework; we look at what it means for patients and stool banks.
What is the SOHO Regulation?
The SOHO (Substances of Human Origin) regulation is a European Union initiative aimed at creating a unified framework [310] for regulating substances of human origin – blood, tissues, cells, breast milk and stool. Its goal is to replace the current fragmented member state regulation and establish uniform European minimum quality and safety requirements.
For FMT, the SOHO regulation is decisive: it is the first European legislation to explicitly bring the medicinal use of human stool within a regulatory framework. The regulation initiated a legislative process in 2022, with final entry into force expected in 2024–2025, followed by an approximately 3-year transitional period before full application [310].
Key elements of the SOHO Regulation for FMT
- Uniform minimum donor selection requirements: Under the regulation, identical minimum screening panels must be met across EU member states – currently absent, and representing one of the greatest patient safety risks [310].
- Network of accredited stool banks: [310] The SOHO regulation enables EU-accredited donor banks to ship stool preparations across member states – increasing supply security and reducing the need for parallel infrastructure development.
- Traceability: Full documentation of every dose from donor-recipient matching is mandatory [310], [316] – fundamental for patient safety and retrospective investigation of potential adverse events.
- Flexible clinical exemptions: [310], [315] Current drafts of the regulation include provisions for preserving the "hospital exemption", allowing accredited institutions to apply preparations made for individual patients without meeting industrial manufacturing requirements.
In the late 1950s, Frances Kelsey, a young physician-pharmacologist at the FDA, refused to approve thalidomide for marketing in the United States – despite the drug being already widely used in Europe. The safety data that Kelsey found lacking later confirmed her concerns: thalidomide caused severe developmental abnormalities. The case became a milestone in drug safety, and the FDA has since been one of the world's most stringent drug approval authorities. A similar question arises in the context of the SOHO regulation: how can patient safety be maximally guaranteed while clinical access to innovative procedures is not unnecessarily restricted?
References
[310] European Commission. Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (SOHO Regulation). 2022. 2022. Link
The 2022 European Commission 'Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (SOHO Regulation)' is the EU's draft replacement for the 2002/98/EC Blood and 2004/23/EC Tissues and Cells Directives. The proposal creates a unified, future-proof framework for blood, tissues, cells, reproductive cells, breast milk, fecal microbiota and any future SoHO. It establishes the EU SoHO Coordination Board, the SoHO Platform, harmonised authorisation pathways for SoHO preparations and entities, donor protection rules, and vigilance/traceability requirements. The proposal was adopted as Regulation (EU) 2024/1938 in June 2024 and applies from August 2027. It is the central EU regulatory instrument for FMT and stool banks.
[315] Keller JJ, Vehreschild MJ, Stallmach A et al. FMT regulation: the EU perspective. United European Gastroenterol J. 2023. Link
This cross-sectional questionnaire study screened 434 patients with inflammatory bowel disease (IBD) at a nutrition clinic between November 2021 and April 2022 for prevalence of exclusion diets and fasting. Total exclusion was complete avoidance of a food category; partial exclusion was most-of-the-time avoidance. Patients also reported total, intermittent or partial fasting practices. The prevalence and risk factors for exclusion diets and fasting were characterized. The findings document widespread dietary self-restriction practices in IBD patients with implications for nutritional management.
[316] Cammarota G, Ianiro G, Kelly CR et al. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019. Link
This international consensus from FMT experts in Europe, North America and Australia provides statements on stool banking for FMT, covering general principles, organization, donor selection and screening, stool collection/preparation/storage, services and clients, registries, outcome monitoring, ethics and FMT's evolving clinical role. Consensus was achieved through Delphi rounds plus plenary discussion, with statements supported by best available evidence. The document guides global stool-bank development to promote safe, equitable FMT access for recurrent C. difficile infection.