Global Foundation for the Care of Newborn Infants

EU Legislative Interests

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.

Communication Activities

Information regarding the implementation process, next steps and the principle of voluntary and unpaid donation, the European Commision Conference on the New Regulation on Substances of Human Origin, or the The Conference presentation on the comprehensive EU framework for safety and quality of SoHO can be found on the EFCNI website:www.efcni.org/human-milk-regulation/ - Publications: https://www.gfcni.org/campaigns/human-milk-matters Making human milk matter: the need for EU regulation. The Lancet Child and Adolescent Health 2021; 5(3):161-163. Kostenzer J et al. https://doi.org/10.1016/S2352-4642(21)00021-3

Interests Represented

Does not represent commercial interests

Member Of

GFCNI is member of: Every Newborn Action Plan, a global action plan taking against preterm birth / https://www.everynewborn.org/ PMNCH (Partnership for maternal and newborn child health)/ http://www.who.int/pmnch/en/ HNN (Healthy Newborn Network)/ http://www.healthynewbornnetwork.org/

Organisation Members

GFCNI has no direct members, but collaborates with the different stakeholders active in the field of maternal and newborn health, such as policy makers, patient representatives, healthcare experts, researchers and their respective organisations or societies, e.g. parent and patient organisations, healthcare societies and institutions. A description of our networks and partners can be found on our website https://www.gfcni.org/network/

Additional Information

With all our corporate partners, we enter into a formal agreement confirming our full independency and compliance with law, anti corruption and anti bribery.