PRI, the Pharmabiotic Research Institute, and IPA Europe, representing the European probiotic industry, provide supporting information and legal references on the status of isolated microbial strains to avoid unintended impacts on research, innovation, and European competitiveness.
The associations have submitted a joint position paper to the European Commission and to the Substances of Human Origin Coordination Board (SCB), clarifying the status of isolated microbial strains and providing technical elements to maintain them outside the scope of the Substances of Human Origin (SoHO) Regulation (Regulation (EU) 2024/1938).
PRI and IPA Europe stress that microbial strain isolation is an early-stage scientific activity that supports innovation across multiple sectors. The use of human microbiome samples solely for the isolation of strains does not fall within the scope of the SoHO Regulation. In fact, such isolated strains may subsequently be used to manufacture a wide range of finished products, including medicinal products, medical devices, foods, food supplements, foods for special medical purposes (FSMPs), cosmetics, and other applications.
The paper explains that isolated microbial strains are already comprehensively regulated under existing EU sector-specific frameworks setting up the requirements and standards to place products on the European market. All finished products incorporating such strains must comply with stringent safety and quality requirements prior to market authorisation.
Using supporting information and legal references, the position paper demonstrates that isolated microbial strains should not be considered SoHO or SoHO preparations, and that organisations carrying out strain isolation activities should not be classified as SoHO entities or establishments.
