Human Milk Regulation
In Europe and worldwide, preterm birth, low birth weight, 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 group of patients – preterm, sick, and low birthweight infants – need, especially from a nutritional point of view. 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 birth weight infants; the next and last option is a specifically designed infant formula.
Together with high-level international experts in the field of human milk, we have been successfully advocating the need for regulation in the European Union.
The Regulation on Substances of Human Origin (SoHO) has been officially adopted by the EU Institutions on 27 May 2024 and will come into effect in mid-2027.
Finally, there is a regulation on EU level that covers human milk and its donation. The Regulation was introduced to provide better protection for donors, recipients, and preterm, sick and low birth weight infants. It therefore aims to enhance the safety and quality of blood, tissues, and cells used in healthcare and to facilitate their cross-border movement within the EU. The new rules are designed to reinforce the current legal framework while offering greater flexibility to adapt to scientific and technological advancements and further innovation in this field. It will also help to promote a human milk diet, which is scientifically proven and internationally recommended for this very vulnerable group of patients.
The Regulation aims to improve harmonisation and make it easier to exchange and access SoHO across borders, for example by creating an EU-level SoHO coordination board to help Member States implement the rules. Additionally, it introduces new approval and inspection requirements for establishments involved in the processing, storage, release, import, or export of SoHO.
EU legislation
Information regarding the implementation process, next steps and the principle of voluntary and unpaid donation can be found HERE
View the European Commision Conference on the New Regulation on Substances of Human Origin HERE
The Conference presentation on the comprehensive EU framework for safety and quality of SoHO 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.
