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In Europe, an increasing number of human milk banks (HMBs) collect donor human milk to feed preterm infants when their mother's milk is not available or not enough. Moreover, donor milk is a bridge to breastfeeding, with positive clinical and psychological advantages for both mother and infant. Italy, with 41 HMBs actively operating in 2022, has the highest number of HMBs in Europe. The process of human milk donation is complex, so activity of HMBs must be regulated according to well-established rules. The present recommendations have been prepared as a tool to standardize the organization, management, and procedures of HMBs operating in Italy and to determine the minimal essential requirements to establish new HMBs. This article covers all the aspects of human milk donation and human milk banking, including general recommendations, donor recruitment and screening, expression, handling and storage of donor human milk, milk screening, and milk treatment (pasteurization). A pragmatic approach was taken to drafting the recommendations. Items for which there was consensus or robust published evidence on which to base recommendations were included. When there were differences that could not be resolved by reference to published research, a statement of explanation based on the expert opinion of the authors (all members of the Italian Association of Human Milk Banks) was included. Implementation of these recommendations can contribute to promotion of breastfeeding., (© The Author(s) 2023. Published by Oxford University Press on behalf of the International Life Sciences Institute.)

Data about the regulatory approaches to donor human milk (DHM) in European countries are lacking. The aim of this study is to describe the various regulations of DHM within European countries, to assess its legislative context and its impact in relation to donor milk banking. We performed a cross-sectional survey using a semistructured online questionnaire addressing 29 national European milk-banking representatives from June 2020 to February 2021. Representatives of 26 national DHM services participated in this study. The legal classification and regulatory status of DHM were defined in 9 out of 26 areas of jurisdiction (35%) as either food product (n = 6), product of human origin according to a blood, tissue, cell regulation (n = 2), or medicinal product (n = 1). In the remainder, DHM remains unclassified. Most legislations did not provide a comprehensive framework concerning DHM and costs to cover milk bank operations were rarely reimbursed. In general, the lack of national legislative governance and the actual legislative regulations in place do not support the use of DHM in European countries. National medical guidelines for the use of DHM have been issued in only 11 countries. The current number and distribution of milk banks (n = 239) within participating countries may not provide an equitable access to DHM for eligible infants. These findings could guide stakeholders aiming to establish a regulatory framework for DHM., (© 2021 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.)