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

Česká verze

Authors: M. Jandová ^1,2; P. Měřička ¹; J. Malý ^3,4
Authors place of work: 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 the journal: Čes-slov Neonat 2025; 31 (2): 112-115.
Category: Původní práce

Summary

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)

Zdroje

1. Billeaud C. High hydrostatic pressure treatment ensures the
microbiological safety of human milk including Bacillus cereus
and preservation of bioactive proteins including lipase and im-
muno-proteins: A narrative review. Foods 2021; 10 : 1327.

2. European Commission. Regulation (EC) No 2073/2005 of 15
November 2005 on microbiological criteria for foodstuffs. Offi-
cial Journal of the European Union L338 2005 : 1–26.

3. European Directorate for the Quality of Medicines Council of Eu-
rope. Guide to the quality and safety of tissues and cells for hu-
man application [online]. 5th ed. Strasbourg, France, 2022 [cit.
2022-04-13]. Dostupné z: https://freepub.edqm.eu/publicati-
ons/AUTOPUB_17/detail. ISBN 9789287189455.

4. EU Regulation (EU) 2024/1938 of the European Parliament and
of the Council of 13 June 2024 on standards of quality and safe-
ty for substances of human origin intended for human applica-
tion and repealing Directives 2002/98/EC and 2004/23/EC.

5. Fakultní nemocnice Hradec Králové. N 001 Příručka kritických
bodů pro pasterované zmrazené mateřské mléko. 1. 7. 2022. In-
terní dokument.

6. International Council for Commonality in Blood Banking Auto-
mation. ISBT 128 Standard: Labeling of human milk banking
products [online]. 6th ed. ICCBBA, San Bernardino, USA 2016.
[cit. 2022-04-13]. 22 s. Dostupné z: https://www.isbt128.org/_fi-
les/ugd/1a7593_d827257749b7485580d41bb986203cb7.pdf.
ISBN-13 : 978-1-933243-59-7.

7. Jandová M, Měřička P, Fišerová M, Landfeld A, Paterová P,
Hobzová L, et al. Quantitative risk assessment of bacillus ce-
reus growth during the warming of thawed pasteurized human
banked milk using a predictive mathematical model. Foods
2022; 11(7): 1037.

8. Jandová M, Fišerová M, Paterová P, Měřička P, Malý J, Kace-
rovský M, et al. Effect of pasteurisation and high-pressure pro-
cessing on selected bioactive components in human milk: An
experimental study. Czech J Food Sci 2025; 43(3): 170–178.

9. Landfeld A, Strohalm J, Kýhos K, Průchová J, Houška M,
Novotná P, et al. High pressure inactivation of Enterococcus
faecium: Modelling and verification. Czech J Food Sci 2009; 27:
134–141.

10. Mullié C, Obin O, Outurquin G, Grognet S, Léké A, Adjidé C.
Breastmilk donations: Bacteriological assessment, analysis of
causes of non-compliance and suggestions for improvement.
Arch Pédiatr 2018; 25 : 263–268.

11. Schlemmerová L, Houška M, Špelina V, Strohalm J, Landfeld
A, Měřička P. Baroinactivation of Staphylococcus epidermidis:
Mathematical model and its verification using human and cow
milk. Czech J Food Sci 2009; 27 : 118–126.

12. Vyhláška č. 137/2004 Sb., o hygienických požadavcích na stravo-
vací služby a o zásadách osobní a provozní hygieny při činnos-
tech epidemiologicky závažných, ve znění vyhlášky č. 602/2006
Sb. In: Sbírka zákonů České republiky 2004, č. 44.

13. Weaver G, Bertino E, Gebauer C, Grovslien A, Mileusnic-
-Milenovic R, Arslanoglu S, et al. Recommendations for the
establishment and operation of human milk banks in Europe:
A consensus statement from the European Milk Bank Associati-
on (EMBA). Front Pediatr 2019; 7 : 53.