IMAGINE-HMB Project
An EU-funded initiative which aims at developing harmonized, evidence-based guidelines that ensure the safety and quality of donor human milk (DHM) in alignment with the new EU SoHO Regulation.
In May 2024, the EU Council has adopted new rules aimed at improving the safety and quality of substances of human origin (SoHO). The new Regulation on standards of quality and safety for substances of human origin intended for human application has been published on the Official Journal of the EU in July 2024, and will entry into force in August 2027.
Our Objectives
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Our first objective is to create an inclusive Forum of experts, bringing together top professionals in human milk science, neonatal nutrition, and human milk banking. This multidisciplinary forum will oversight the development of EU evidence-based guidelines for Donor Human Milk.
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Our Team will review existing evidence and survey current HMB practices. The Expert Forum will analyse this information, and, by involving relevant Stakeholders, will draft new EU guidelines, to be used as a reference to implement technical standards ensuring the highest safety and quality in Human Milk Banking practices.
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Our Teams will review existing guidelines and identify potential additional requirements which are needed to comply with the new technical guidelines produced during the project. We will draft EU guidelines to be used as reference to comply with oversight requirements.
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We will develop and launch a comprehensive plan to assist human milk banks in complying with technical and oversight standards, making the new guidelines accessible and actionable across diverse settings.
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When the project will be completed, our Teams and Forum of expert will continue updating the guidelines according to new evidence. Ongoing support to human milk banks will be provided, and regular reports to relevant competent authorities will be sent out.
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We will develop a targeted training program for human milk bank professionals. This will empower SoHO entities/establishments to fully adopt best practices in Donor Human Milk handling and quality control.