Standards of quality and safety for substances of human origin

EESC opinion: Standards of quality and safety for substances of human origin

Key points


  • supports the European Commission's proposal for a regulation of the European Parliament and of the Council on standards of quality and safety of substances of human origin (SoHOs) intended for human use and repealing Directives 2002/98/EC and 2004/23/EC;
  • considers it appropriate to define the scope of the regulation in such a way that it will take into account not only SoHOs not yet regulated at European level (e.g. breast milk) but also any SoHO that may be used in the future;
  • supports legislative changes that will reduce the costs for the EU institutions, Member States and citizens, in particular by removing outdated tests and systematic screening tests from legislation. The effectiveness of the regulation's provisions should be continuously monitored, taking into account the need to preserve the safety and quality of SoHOs and to respect the standards deriving from the Charter of Fundamental Rights of the European Union;
  • welcomes the introduction of uniform basic standards for keeping registers of SoHO entities. These will be reinforced by the creation of an EU SoHO Platform, which will help improve the EU's public health security through the continuous and rapid exchange of information;
  • supports the adoption of solutions which strengthen the rights of SoHO donors and address shortcomings in the existing rules. In this regard, the EESC stresses that the reaffirmation in the draft of the principle of free SoHO donation is essential for the elimination of abuse and the safety of SoHO sourcing;
  • considers that particular attention should be paid to the need for reliable and systematic monitoring of SoHO entities in relation to safety, quality and the way in which SoHOs are sourced. Of particular importance is the continuous monitoring and control of the correct operation of entities that import SoHOs. SoHOs imported from outside the European Union should meet the same quality and safety standards as those sourced within the EU.