In Europe and worldwide, preterm birth, low birthweight, asphyxia, congenital abnormalities, infections and birth trauma are the main causes of neonatal death. This project sheds light on the special care that the extremely vulnerable category of patients – preterm, sick, and low birthweight infants – need, especially from a nutritional perspective. Mother’s own milk is the preferred option for infant nutrition to achieve optimal growth, development, and health. When mother’s own milk is not available, donor human milk is the next best alternative, especially for preterm, sick and low birthweight infants; the next and last option is a specifically designed infant formula.

Together with international high-level experts in the field of human milk, we are advocating the need for regulation in the European Union.

Today, human milk and its donation are not regulated at the level of the EU. A common regulatory framework, however, would make sure that human milk’s procurement, storage, processing and distribution meet high quality and safety standards in a harmonised manner. This would furthermore ensure a minimum standard and equitable access to safe donor human milk for preterm, sick and low birthweight infants and would contribute towards better health outcomes for this highly vulnerable group of patients. In that regard, and in line with evidence-based and internationally acknowledged recommendations, a human milk diet should be promoted and a uniform regulatory framework on human milk and its donation should be adopted to this end.


One-pager: Preterm infant health and human milk

Policy Recommendations: Human Milk Matters – The need for regulation in the European Union Link to policy recommendations


In cooperation with


EFCNI has received an unrestricted educational grant by Prolacta Bioscience (1800 Highland Ave, Duarte, CA 91010, USA).