New SoHO Regulations in 2027: What It Means for Donor Milk

In 2027, a new regulatory framework will come into effect in the EU with the introduction of the SoHO Regulation – a framework covering Substances of Human Origin. For the very first time, donor breast milk will be included under this regulation, on the same level as other human substances such as blood, cells, and tissues.

This marks an important breakthrough in neonatal medicine and breast milk banking. Donor milk has long been recognized for its vital importance, particularly for premature and sick newborns, but until now it has existed in a regulatory grey area. Guidelines for collection, handling, and distribution have varied between countries and have often been based on voluntary recommendations rather than legally binding requirements.

The new SoHO regulations, developed in collaboration with the World Health Organization (WHO), aim to harmonize the regulatory framework across EU member states. The goal is to ensure higher quality, increased safety, and better protection for both donors and recipients.

Some of the main changes in the regulations include:

• Unified quality and safety standards across the EU.

• Improved traceability and documentation throughout the entire process from donation to distribution.

• Enhanced protection for both donors and recipients, with clear ethical guidelines.

• Formal recognition of donor breast milk as a human substance, with requirements and status equivalent to substances such as blood and cells.

This will have an impact on hospitals, milk banks, healthcare professionals, and donors – and, most importantly, on the babies who rely on safe and accessible donor milk to survive and thrive.

In the lead-up to 2027, strong collaboration and preparation across sectors will be crucial to ensure a safe transition and continued access to high-quality donor milk throughout Europe.

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Donor milk donated in Anue is handled in a Norwegian milk bank.