The Generative Brain

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO Regulation)

Regulation (EU) 2024/1938, the SoHO Regulation, is the single EU law that will govern the quality and safety of blood, tissues, cells, reproductive cells and other substances of human origin used in people. It was signed on 13 June 2024, published in the Official Journal on 17 July 2024, entered into force twenty days later (6 August 2024) and applies from 7 August 2027. On that date its Article 85 repeals the Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC; it names no other act, so the Commission implementing directives that hold today's donor eligibility rules, among them Directive 2004/33/EC with its permanent TSE (Creutzfeldt-Jakob disease group) deferral row and Directive 2006/17/EC for tissue and cell donors, are not repealed by name. Instead of detailed annexes, the regulation tells SoHO entities to take into account technical guidelines listed on the EU SoHO Platform: ECDC guidelines for preventing communicable disease transmission and EDQM guidelines for other donor and recipient protection; following them counts as meeting the standards at inspection. The text never mentions prions, CJD or TSE. Member States may keep stricter national measures if proportionate and published. Information only, not legal or medical advice.

Key facts

  • The regulation was signed in Brussels on 13 June 2024 and published as OJ L, 2024/1938 of 17 July 2024; Parliament approved it on 24 April 2024 and the Council adopted it on 27 May 2024, after a Commission proposal of July 2022 (procedure 2022/0216(COD)).
  • Article 87 sets entry into force on the twentieth day after publication, which the Parliament summary gives as 6 August 2024, and general application from 7 August 2027; the 13 June 2024 date sometimes given as entry into force is the signature date.
  • Article 87 also makes some parts apply earlier or later: the Commission's powers for certain delegated and implementing acts from 6 August 2024, the SoHO Coordination Board (Article 68) and one of its tasks (Article 69(1)(b)) from 7 August 2024, and penalties (Article 80) and parts of Articles 81 and 82 from 7 August 2028.
  • Article 85 repeals Directives 2002/98/EC and 2004/23/EC with effect from 7 August 2027 and names no other act; recitals 5 and 6 say the same two directives are replaced by a regulation.
  • The official text does not name Directive 2004/33/EC, Directive 2006/17/EC or the other implementing directives (2005/61/EC, 2005/62/EC, 2015/565, 2015/566); the only implementing directive cited is 2006/86/EC, for moving the EU Tissue Establishment Compendium to the EU SoHO Platform under Article 81(4)(b).
  • Until 7 August 2027 the current blood and tissues directives and national laws transposing them stay in force, and ECDC's current EU requirements table still cites Directive 2004/33/EC as the source of the permanent TSE deferral for blood and plasma donors.
  • Articles 81 to 84 are transitional: establishments approved under the old directives are deemed registered SoHO entities and authorised SoHO establishments subject to verification, previously approved preparations are deemed authorised, SoHO activities not covered by the old directives get a transition period, and SoHO already in storage get a run-off period.
  • The transitional dates in the OJ text as read (for example 7 August 2024, 8 August 2025, 8 August 2026) were corrected by a corrigendum of 26 July 2024 that, per search excerpts, moves them to 2027 and 2029 and the Article 86 evaluation to 2032; a German mirror shows 7 August 2027 for blood establishments in Article 81(1).
  • Articles 1 and 2 cover all SoHO for human application and related activities, protecting donors, recipients and offspring from medically assisted reproduction; organs (Directive 2010/53/EU) are excluded.
  • Under Article 4 Member States may keep or adopt stricter measures that are compatible with Union law and proportionate to the risk, and must publish them and submit them to the EU SoHO Platform.
  • Articles 56(4) and 59(4) say that, where no implementing act sets a standard, SoHO entities shall take into account the latest technical guidelines on the EU SoHO Platform: ECDC guidelines on preventing communicable disease transmission and EDQM guidelines on protection other than from communicable disease; Article 27(6) tells inspectors to treat the standards as met where those guidelines are followed.
  • Recital 49 calls following ECDC guidelines an appropriate way to show compliance and says that where no rule exists entities should apply a locally defined rule in line with internationally recognised guidelines; recital 50 says EDQM guidelines may set donor eligibility criteria against cancer and other non-communicable diseases.
  • The words prion, Creutzfeldt, spongiform and TSE do not appear in the regulation text.
  • Donor eligibility must be verified through a documented donor health evaluation (Article 53), including by interview (Article 58(13)); donation is voluntary and unpaid, with no financial incentives, though Member States may allow capped compensation (Article 54).
  • Article 82(2) deems blood components already checked against the blood component monographs of the EDQM Blood Guide edition shown on the EU SoHO Platform to be authorised SoHO preparations.
  • ECDC is the technical guideline body for communicable disease: its HIV guideline was listed as published on 29 September 2025 and its hepatitis B and C guideline on 1 June 2026; its SoHO pages do not mention CJD, and EDQM has two observers and EMA one observer on its panels.
  • The Commission released a first version of the EU SoHO Platform on 15 September 2026, and the SoHO Coordination Board (two members per Member State) met in March, May and September 2026.
  • The EDQM Blood Guide 22nd edition (May 2025), which changed CJD donor selection criteria, is described as referring to Directives 2002/98/EC and 2004/23/EC as in force until 7 August 2027 under the regulation's transitional provisions (search excerpt).

Timeline

  1. 2022Commission proposes the SoHO Regulation (procedure 2022/0216(COD)).
  2. 2024European Parliament approves the text.
  3. 2024Council adopts the regulation.
  4. 2024Regulation signed in Brussels.
  5. 2024Published in the Official Journal (OJ L, 2024/1938).
  6. 2024Corrigendum corrects transitional dates (search excerpt).
  7. 2024Entry into force.
  8. 2025First ECDC technical guideline under the regulation (HIV) listed as published.
  9. 2026ECDC hepatitis B and C guideline listed.
  10. 2026First version of the EU SoHO Platform released.
  11. 2027Regulation applies; Directives 2002/98/EC and 2004/23/EC repealed.
  12. 2028Penalties article and parts of Articles 81 and 82 apply.
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