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Adopted text

Standards of quality and safety for substances of human origin intended for human application

TA-9-2023-0299 · P9_TA(2023)0299 · PE738.661

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✦ In short · AI summary of this text, generated 26 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's amended version of a proposed regulation sets high quality and safety standards for substances of human origin (SoHOs) intended for human application, replacing Directives 2002/98/EC and 2004/23/EC. It requires authorisation of SoHO preparations and establishments, donor and recipient protection rules, vigilance and traceability, and rules on voluntary and unpaid donation with compensation for losses. It sets up a SoHO Coordination Board, an EU SoHO Platform, national emergency and supply plans, and a strategy for European supply autonomy. It adds rules on SoHO clinical studies, data protection, and cooperation with the EDQM and ECDC.

Key points

  1. The regulation sets high quality and safety standards for all SoHOs intended for human application and for related activities, protecting donors, recipients and offspring from medically assisted reproduction.
  2. It applies to SoHO donations intended for research for donor protection provisions, and excludes breast milk expressed solely for a mother's own child.
  3. Member States may keep or introduce more stringent measures based on scientific evidence, compatible with Union law and proportionate, and must report discriminatory restrictions to the Commission.
  4. Competent authorities must act independently and impartially, with staff declaring interests annually, and must be transparent about decisions and authorisation criteria.
  5. SoHO preparations and establishments need authorisation; authorisations are valid throughout the Union, and competent authorities may suspend or withdraw them for non-compliance.
  6. SoHO entities must protect donor health, obtain informed consent, provide specified information, and verify donation frequency and eligibility through national registries.
  7. Donation is voluntary and unpaid; compensation or reimbursement for quantifiable losses and expenses is allowed if financially neutral, must not incentivise donation, and advertising linked to financial reward is prohibited.
  8. SoHO entities must protect recipients and offspring, use validated testing and processing to reduce pathogens, avoid unnecessary or unproven applications, and prioritise therapeutic over aesthetic uses.
  9. SoHO clinical studies require prior approval from competent authorities, must prioritise participant safety, and must be registered on the EU SoHO Platform with results summaries.
  10. Member States must draw up national SoHO emergency and continuity of supply plans, promote donation, set collection targets for critical SoHOs, and submit plans to the Commission and SCB within two years.
  11. The Commission must publish a strategy for European SoHO supply autonomy within two years, including a Union list of critical SoHOs and monitoring of supply reports.
  12. A SoHO Coordination Board is set up to coordinate application, issue opinions on regulatory status, and cooperate with EDQM, ECDC and EMA; the Commission establishes an EU SoHO Platform for information exchange.

Who is affected

  • SoHO entities and establishments must obtain authorisations, follow safety and quality rules, and report on compensation and shortages.
  • SoHO donors are protected by health evaluations, informed consent rules, and voluntary unpaid donation principles with compensation for losses.
  • SoHO recipients and offspring from medically assisted reproduction benefit from safety, quality and non-discrimination provisions.
  • Member States must designate competent authorities, draw up emergency and supply plans, and regulate advertising of SoHO collection.
  • The Commission, SCB, EDQM and ECDC cooperate on guidelines, the EU SoHO Platform, and emergency coordination.

Figures and deadlines

  • Competent authorities must conclude SoHO preparation authorisation steps within 3 months from receipt of the application.
  • The interval between inspections shall not exceed 4 years.
  • The responsible person for release of SoHOs must have at least 2 years of experience in the relevant field.
  • Member States shall submit national plans to the Commission and SCB by two years after entry into force and review them every two years.
  • The Commission shall publish a strategy for European SoHO supply autonomy by two years after entry into force.
  • The Commission shall assess national conditions for voluntary and unpaid donation by two years after entry into force and every three years thereafter.
  • The Commission shall assess the application of the regulation by five years after the date of application.
  • The digital communication channel for SoHO availability must be available no later than two years after entry into force.

Legal basis: Article 168(4), point (a), TFEU