On July 14, the European Commission formally published its proposal updating the BTC legislation. Under the Commission’s proposal, the two Directives (2002/98/EC, for blood and blood components and 2004/23/EC, for tissues and cells) will be rolled into one Regulation, the SoHO (Substances of Human Origin) Regulation. The new regulation has a broader scope, the final proposal (the text is not available yet) will be presented by the EC and will follow the procedure of approval EP-Council (co-decision)
IPA Europe members see a risk of confusion, since the SoHO proposal of Regulation could have an impact on microorganisms used for food production. IPAEU contributes to the consultation in providing information to distinguish the activity of isolation of probiotic strains, and the regulatory references that already apply to them.