The Generative Brain

Commission Directive 2004/33/EC on technical requirements for blood and blood components (EU donor eligibility, including permanent TSE deferral criteria)

Commission Directive 2004/33/EC of 22 March 2004 is the EU implementing act that sets who may give blood and blood components. It was adopted under Article 29 of the parent Blood Directive 2002/98/EC, had to be transposed by 8 February 2005, and its Article 4 requires blood establishments to make sure every donor of whole blood and blood components meets the eligibility criteria in its Annex III. For prion disease the key line is the transmissible spongiform encephalopathy row of the Annex III permanent deferral list: people with a family history placing them at risk of a TSE, people who received a corneal or dura mater graft, and people treated in the past with medicines made from human pituitary glands are permanently deferred, and for variant CJD further precautionary measures may be recommended. That last clause is the EU-level room under which countries add their own variant CJD deferrals, such as the French exclusion of people who spent more than a year in the UK between 1980 and 1996. The EMA reflection paper of 2024, which dropped the UK-stay exclusion for plasma for fractionation, leaves the directive's TSE deferrals untouched. The directive's time is limited: Regulation (EU) 2024/1938 on substances of human origin entered into force in August 2024, applies from 7 August 2027 and repeals the parent Directive 2002/98/EC from that date, with ECDC and EDQM technical guidelines taking over much of the detailed technical content. Whether and how the TSE deferral row carries over was not confirmed from the regulation text. Information only, not legal or medical advice.

Key facts

  • The directive was adopted by the Commission on 22 March 2004 to implement Directive 2002/98/EC, using points (b) to (g) of the second paragraph of its Article 29; Member States had to bring national law into line by 8 February 2005, and the directive entered into force on the twentieth day after publication.
  • It has eleven articles and five annexes: definitions, donor information, information required from donors, eligibility of donors, storage and transport, quality and safety of components, autologous donation, validation, and transposition; Annex III holds the eligibility criteria for donors of whole blood and blood components.
  • Article 4 puts the duty on blood establishments to ensure that donors of whole blood and blood components meet the Annex III criteria.
  • The Annex III permanent deferral row for transmissible spongiform encephalopathies (the Creutzfeldt-Jakob disease group) covers three groups: people with a family history placing them at risk of developing a TSE, recipients of a corneal or dura mater graft, and people treated in the past with medicines made from human pituitary glands.
  • The same row says that for variant CJD further precautionary measures may be recommended; it sets no UK-stay or country-based deferral itself.
  • At EU level, receiving a blood transfusion, a tissue or cell transplant of human origin or a flexible endoscopy is a temporary deferral of 6 months (4 months with a negative hepatitis C NAT test), listed under exposure to transfusion-transmissible infection risk, not a permanent TSE deferral.
  • Annex III also allows deferral consistent with the epidemiological situation for particular outbreaks (section 2.3).
  • The directive was amended in Annex V by Implementing Directive 2011/38/EU (platelet pH values) and in Annex III by Directive 2014/110/EU (temporary deferral criteria including West Nile virus); neither amendment touched the TSE row as shown in the revised text.
  • ECDC's current table of EU donor requirements cites Directive 2004/33/EC as the source of the TSE permanent deferral for both blood component donors and plasma for fractionation donors, with the same wording, and leaves the ECDC guideline column blank for those rows.
  • Tissue and cell donors fall under a different act, Directive 2006/17/EC, whose prion exclusion is wider: it also covers people diagnosed with CJD or variant CJD, rapidly progressive dementia or degenerative neurological disease of unknown origin, scleral grafts and undocumented neurosurgery.
  • The EMA CHMP reflection paper revision 3 of May 2024 cites these three permanent deferral criteria from Directive 2004/33/EC as the donor selection rules that remain in force, and changes neither them nor donor testing.
  • France applies stricter national permanent exclusions on top of the EU list, including a cumulative UK stay of more than one year between 1980 and 1996, growth hormone treatment before 1989, brain or eye surgery before April 2001 and past transfusion, under a ministerial order of 11 January 2022.
  • The French High Council for Public Health recommended on 24 October 2024 keeping the UK-stay and transfusion exclusions, pending new ECDC recommendations.
  • Regulation (EU) 2024/1938 on substances of human origin was published in the Official Journal on 17 July 2024, entered into force on 6 August 2024 and applies from 7 August 2027, when it repeals Directives 2002/98/EC and 2004/23/EC.
  • Until the SoHO regulation applies, the current blood and tissues directives and national transposing laws stay in force, per the European Blood Alliance.
  • Under the SoHO regulation ECDC is the expert body for technical guidelines on communicable disease risk, which SoHO entities must take into account; the guidelines published or listed so far cover HIV (29 September 2025) and hepatitis B and C (1 June 2026), and the ECDC page does not mention prions or CJD.
  • EDQM has two observers on the ECDC expert panel to avoid inconsistencies with its own guidance; the regulation text (recitals 49 and 50, Articles 27(6), 56(4)(a) and 59(4)(a)) treats following ECDC or EDQM technical guidelines as meeting its standards, with ECDC covering communicable disease transmission and EDQM other donor and recipient protection; the text never mentions prions, CJD or TSE.
  • The EDQM Blood Guide 22nd edition is dated 21 May 2025 and, per search excerpts, includes donor selection changes on Creutzfeldt-Jakob disease and refers to Directives 2002/98/EC and 2004/23/EC as in force until 7 August 2027.

Timeline

  1. 2004Commission adopts Directive 2004/33/EC implementing the Blood Directive 2002/98/EC.
  2. 2005Transposition deadline for Member States.
  3. 2011Implementing Directive 2011/38/EU amends Annex V (platelet pH).
  4. 2014Directive 2014/110/EU amends the Annex III temporary deferral criteria.
  5. 2022French ministerial order sets national donor contraindications, including prion-related exclusions beyond the EU list.
  6. 2024EMA CHMP reflection paper revision 3 drops the UK-stay exclusion for plasma for fractionation and keeps the directive's TSE deferrals.
  7. 2024Regulation (EU) 2024/1938 on substances of human origin published in the Official Journal.
  8. 2024SoHO regulation enters into force.
  9. 2024French HCSP opinion keeps the UK-stay donor exclusion.
  10. 2025EDQM publishes the 22nd edition of the Blood Guide (search excerpt).
  11. 2025First ECDC technical guideline under the SoHO regulation (HIV) listed as published.
  12. 2027SoHO regulation applies and repeals Directive 2002/98/EC, the parent act of this directive.
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