Regulation of Donor Human Milk at European level: a new bridge for successful breastfeeding of sick preterm infants

At present, in the EU, there is a specific Legislation on Blood, Tissue and Cells (BTC), but there is a lack of regulation on Donor Human Milk and Human Milk Banks. This legal uncertainty regarding the status and handling of Donor Human Milk is a hindrance to the use of human milk in preterm newborns feeding. We are now in the first phase of the Legislative Process for the Revision of the European BTC Legislation that is expected to include Donor Human Milk and human milk banking regulation. The European Milk Bank Association (EMBA) and the other stakeholders are following this process very carefully: we are confident we will have this regulation by the end of 2022 to improve the availability, quality and safety of Donor Human Milk for preterm and sick infants.