Proposed Regulation on Substances of Human Origin (SoHO)

News Category: Regulatory news

Date: 10/08/2022

The European Commission has published the proposed Regulation on standards of quality and safety for substances of human origin (blood, tissues and cells) for use on or in human recipients.

When it is agreed, the Regulation will replace the current legislation for blood (Directive 2002/98/EC) and tissues and cells (Directive 2004/23/EC). 

What are the benefits of the Regulation? 

The new Regulation will ensure that:

  • technical rules on quality and safety can adapt to emerging risks and new technologies;
  • protections for donors and offspring are strengthened;
  • oversight across Europe is harmonised;
  • innovation is supported;
  • measures to prevent shortages of blood, tissues and cells are introduced.

Providing feedback

If you wish to provide feedback on the proposal, you can do so on the Have your Say Portal before 8 September 2022. 

When would the proposed Regulation come into force? 

The European Council and Parliament will now discuss the proposal put forward by the European Commission. Once it has been agreed and adopted, it will come into force. There will be a 2-year transition period before most provisions will apply, and a 3-year period for some particular provisions.

« Back