Proposal for EU regulation on substances of human origin OUT NOW!

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The European Commission has published a proposal for a regulation on substances of human origin – including human milk.

EFCNI welcomes the proposal for a regulation on substances of human origin – including human milk – which has the potential to bring important improvements for vulnerable infants in need of donor human milk. In case this proposal gets adopted by the European Parliament and the Council, the regulation will replace the Tissues and Cells Directive from 2004.

Numerous organisations and expert bodies have been involved in the development of the proposal, including EFCNI. We are happy about the good cooperation with the European Commission during the drafting of the regulation and appreciate the involvement of patient organisations and the consideration and inclusion of our comments.

We furthermore highly appreciate the close cooperation with renowned international experts in the field of infant nutrition and human milk – the EFCNI Working Group on Human Milk Regulation – who have co-authored the EFCNI Policy Recommendations “Making Human Milk Matter – The need for regulation in the European Union”. This document has guided our advocacy activities during the consultation process with the European Commission. Finally, we are thankful for the support of EMBA, ESPGHAN, ESPR and UENPS, and all the 46 professional healthcare societies and 32 national parent organisations that have endorsed our policy recommendations.

We will now continue with an in-depth analysis of the proposal and seek out to relevant expert bodies and policy makers to ensure that the legislation brings a maximum benefit to one of the most vulnerable groups of society: infants born sick or preterm and their families.

For more information please take a look at our project page.

You can find the proposal for the regulation here.