Evidence map›Paper›PMID 34936203›Full record

ArticleMaternal & child nutrition2022

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

Daniel Klotz, Aleksandra Wesołowska, Enrico Bertino, Guido E Moro, Jean-Charles Picaud, Antoni Gayà, Gillian Weaver

Open access · goldAbstract read
In one paragraph

Article in Maternal & child nutrition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Cost of operating a human milk bank in the UK: a microcosting analysis.Archives of disease in childhood. Fetal and neonatal edition · 2025
    Article
  7. Understanding modifiable barriers to human milk donation in the United Kingdom.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2025
    Article
  8. Impact of mother's own milkMicrobiome research reports · 2025
    Review
  9. Article
  10. Article
  11. Conceptualizing the Commercialization of Human Milk: A Concept Analysis.Journal of human lactation : official journal of International Lactation Consultant Association · 2024
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Peer-to-Peer Human Milk-Sharing Among Israeli Milk Donors: A Mixed-Methods Study in the Land of Milk and Honey.Journal of human lactation : official journal of International Lactation Consultant Association · 2023
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 5 countries.

Daniel KlotzDepartment of Neonatology, Center for Pediatrics, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID 0000-0003-2347-3866
Aleksandra WesołowskaDepartment of Medical Biology, Faculty of Health Science, Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank at the Holy Family Hospital at Warsaw, Medical University of Warsaw, Warsaw, Poland.ORCID 0000-0002-7270-5910
Enrico BertinoCity of Health and Science, Neonatal Unit of Turin University, Turin, Italy.
Guido E MoroAssociazione Italiana delle Banche del Latte Umano Donato, Milan, Italy.
Jean-Charles PicaudDepartment of Neonatology, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.
Antoni GayàBanc de Teixit, F. Banc de Sang i Teixits de les Illes Balears, Institut d'Investigacio Sanitaria Illes Balears (IdISBa), Barcelona, Spain.
Gillian WeaverThe Human Milk Foundation, Rothamsted Institute, Hertfordshire, UK.
Associazione Italiana Di Oncologia Medica · ITHealth Research Institute of the Balearic Islands · ESMedical University of Warsaw · PLUniversité Claude Bernard Lyon 1 · FRUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 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.

Indexed as

Milk BanksCross-Sectional StudiesEuropeHumansInfantMilk, HumanTissue Donorsclassificationdonor human milkEuropelegislationmilk bankingpretermregulation

Identifiers

PMID34936203
PMCPMC8932705
OpenAlexW4200398499

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.