The legislative framework of donor human milk and human milk banking in Europe.

ABSTRACT: 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 re

SUBMITTER: Klotz D 

PROVIDER: S-EPMC8932705 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature