Classification of human milk as a ‘Substance of Human Origin’ under the new European legislation and its implications for human milk banks and collection centers

Czech version

Authors: M. Jandová ^1,2; P. Měřička ¹; J. Malý ^3,4
Authors‘ workplace: Tkáňová ústředna, Mléčná banka Fakultní nemocnice Hradec Králové ¹; Katedra histologie a embryologie, Lékařská fakulta v Hradci Králové, Univerzita Karlova v Praze ²; Dětská klinika, Fakultní nemocnice Hradec Králové ³; Univerzita Karlova, Lékařská fakulta v Hradci Králové ⁴
Published in: Čes-slov Neonat 2025; 31 (2): 112-115.
Category: Original Paper

Overview

Regulation (EU) 2024/1938 of the European Parliament and of the Council newly classifies donor human milk as a substance of human origin (SoHO). This change introduces stricter requirements for the donation, processing, storage, and distribution of milk with the aim of increasing safety, quality, and traceability. Human milk banks will become official standard healthcare facilities, allowing for funding from European sources and participation in international research projects. After August 2027, only milk banks registered at the level of the European Commission (EC) and certified by the national competent authority based on demonstrated compliance with European standards will be allowed to operate. The new requirements include: a) verification of donors in the national SoHO donor registry;

b) serological testing for infectious markers every 3 months; c) standardization of pasteurization and related microbiological controls; d) introduction of standards for product labeling; e) implementation of a biovigilance system and monitoring of adverse events and reactions. All of these steps aim to standardize quality, increase the safety of neonatal care, and strengthen trust in the milk donation system.

Keywords:

pasteurization – biovigilance – substances of human origin (SoHO)

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