Human Milk Regulation

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.

EU legislation

Information regarding the revision process of the EU legislation on blood, tissues and cells can be found HERE

The proposal by the European Commission for a regulation on substances of human origin can be found HERE

The EFCNI statement on the EC Proposal for a Regulation on Standards of Quality and Safety for Substances of Human Origin intended for Human Application can be found HERE


Download One-pager Preterm infant health and human milk

Download Policy Recommendations Policy Recommendations: Making Human Milk Matter – The need for regulation in the European Union

Commentary Making human milk matter: the need for EU regulation, The Lancet Child & Adolescent Health


In cooperation with


Transparency: EFCNI has received an educational grant by Prolacta Bioscience. The policy recommendations have been independently developed by the EFCNI Working Group on Human Milk Regulation. We warmly thank all 46 professional healthcare societies and the 32 parent organisations for supporting these recommendations.