Making human milk matter: the need for EU regulation

Bertino, Enrico; Cassidy, Tanya; Daly, Mandy; Domellöf, Magnus; Gayà, Antoni; Goudoever, Johannes B. van; Kostenzer, Johanna; Mader, Silke; Moro, Guido E.; Picaud, Jean-Charles; Pipaón, Miguel Sáenz de; Gawrońska, Małgorzata; Taylor, James S.; Vavouraki, Eleni; Wesołowska, Aleksandra; Zimmermann, Luc J. I.

doi:10.1016/s2352-4642(21)00021-3

Cited by 2 publications

(2 citation statements)

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“…However, the lack of clear regulatory guidance has been identified as a barrier to provide donor human milk to premature infants in need and to establish new milk banks (Klotz et al, 2020). From a practical point of view regulatory oversight authorities and health care providers are reliant on a clear framework guiding good manufacturing practice, harmonisation and standardisation when using DHM or establishing HMB (Kostenzer et al, 2021). This framework, however, is defined by the classification of its subject and should aim to set out rules and regulations for authorisation for procuring, manufacturing practice, allocation, and reimbursement of DHM.…”

Section: The Need For Regulation Of Donor Human Milkmentioning

confidence: 99%

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

Klotz

Wesołowska

Bertino³

et al. 2021

Maternal & Child Nutrition

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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

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Section: The Need For Regulation Of Donor Human Milkmentioning

confidence: 99%

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

Klotz

Wesołowska

Bertino³

et al. 2021

Maternal & Child Nutrition

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“…Currently, DHM is not under EU legislation. In Austria, the existing recommendations are legally binding and only in France and Italy federal authorities are closely regulating DHM services [ 7 , 8 ]. Differences among existing guidelines are mainly due to variations in practices, organization and regulation of HMBs throughout Europe.…”

Section: Introductionmentioning

confidence: 99%

“Donor milk banking: Improving the future”. A survey on the operation of the European donor human milk banks

et al. 2021

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Background Provision of donor human milk is handled by established human milk banks that implement all required measures to ensure its safety and quality. Detailed human milk banking guidelines on a European level are currently lacking, while the information available on the actual practices followed by the European human milk banks, remains limited. The aim of this study was to collect detailed data on the actual milk banking practices across Europe with particular emphasis on the practices affecting the safety and quality of donor human milk. Materials and methods A web-based questionnaire was developed by the European Milk Bank Association (EMBA) Survey Group, for distribution to the European human milk banks. The questionnaire included 35 questions covering every step from donor recruitment to provision of donor human milk to each recipient. To assess the variation in practices, all responses were then analyzed for each country individually and for all human milk banks together. Results A total of 123 human milk banks completed the questionnaire, representing 85% of the European countries that have a milk bank. Both inter- and intra-country variation was documented for most milk banking practices. The highest variability was observed in pasteurization practices, storage and milk screening, both pre- and post-pasteurization. Conclusion We show that there is a wide variability in milk banking practices across Europe, including practices that could further improve the efficacy of donor human milk banking. The findings of this study could serve as a tool for a global discussion on the efficacy and development of additional evidence-based guidelines that could further improve those practices.

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Making human milk matter: the need for EU regulation

Cited by 2 publications

References 5 publications

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

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

“Donor milk banking: Improving the future”. A survey on the operation of the European donor human milk banks

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