SoHO traceability for human milk: a practical guide

What is the EU SoHO Regulation?

SoHO stands for substances of human origin: substances collected from the human body for use in healthcare, including blood, tissues, cells and human milk. Regulation (EU) 2024/1938 sets quality and safety requirements to protect donors and recipients.

For human milk, this means considering how milk is collected, tested, processed, stored, distributed and administered. The regulation covers more than traceability: it also addresses quality management, registration, authorisation and the reporting of safety incidents.

When does it apply?

Most provisions apply from 7 August 2027. Some provisions have different application dates, and transitional arrangements apply to certain existing organisations and activities.

Scope and responsibilities

Does SoHO apply to all human milk?

Not all human milk activities fall within the regulation. The distinction between donor human milk (DHM) and mother’s own milk (MOM) matters.

Donor human milk (DHM)

Donor milk supplied through milk banks and hospitals falls under the regulation. The responsibilities follow the milk from donation through to its use for an infant.

A mother’s milk for her own child is generally not included

Generally, milk used only to feed the mother’s own child is not covered by the SoHO Regulation. However, if a SoHO entity, such as a milk bank or hospital, processes the milk, the exclusion no longer applies—even if it is still intended only for her own child. Pasteurisation is an example of processing. Check how your specific handling steps are classified with your national regulator.

For example, a mother’s milk stored in a hospital refrigerator for her own child, without further processing, falls outside the SoHO Regulation. Other healthcare, hygiene and patient-safety requirements still apply.

MilkTrail supports donor milk and mothers’ own milk workflows, including workflows outside the regulation’s scope.

What is processing of human milk?

Processing is broader than pasteurisation. The regulation’s definition includes handling operations such as separation, preservation and packaging.

Pasteurisation

Applying a controlled heat treatment to milk.

Pooling

Combining milk from different bottles or donations.

Aliquoting

Dividing milk into smaller portions or ready-to-use containers as part of milk processing.

Other antimicrobial treatments

Using methods intended to reduce microbiological risks.

Not every activity involving milk is processing. Receiving, storage and distribution are distinct activities. Processing must follow appropriate procedures to maintain milk quality, safety and traceability.

What about preparing milk for a feed?

A milk kitchen might thaw milk, measure the prescribed quantity or transfer milk into a feeding container. Assess these steps in the context of the actual workflow. Routine preparation immediately before feeding should not automatically be equated with milk-bank processing or used alone to conclude that establishment authorisation is required.

What about feeding the infant?

Feeding milk to an infant is called human application. It is a separate SoHO activity from processing.

EDQM Guide, 6th edition — Chapters 10, 14 and 32

Milk banks and hospital teams

Does SoHO apply to hospitals and NICUs?

Yes. Hospitals that carry out covered SoHO activities are included. A hospital that stores donor milk and feeds it to infants has a role under the regulation, even if it does not operate a milk bank. Feeding the milk is called “human application” in the regulation.

The activities an organisation carries out determine its responsibilities. Two terms explain the difference:

SoHO entity

An organisation legally established in the EU that carries out at least one covered SoHO activity. This includes hospitals using donor milk, as well as milk banks. Relevant activities must be registered. Confirm whether registration is organised at hospital or another legal-entity level with your national competent authority.

SoHO establishment

A type of SoHO entity that both processes and stores SoHO, or carries out release, import or export. Establishments need authorisation as well as registration. “Release” means checking that the milk meets the required criteria before it is made available for use or supply.

For example, a milk bank that pasteurises and stores donor milk meets the establishment definition. A hospital that stores and uses milk already released by that bank is an entity; those activities alone do not make it an establishment.

Every establishment is also an entity. A hospital can include a milk bank that is an establishment. Agree the registration and authorisation arrangements for your organisation with your national regulator, who can also require establishment authorisation for other activities based on risk.

HPRA: scope, hospitals and the two types of organisation

What to plan for

What does SoHO require for human milk traceability?

Traceability means being able to follow human milk and its relevant records through the regulated chain in both directions. A concern about a donation should lead to the linked milk and recipients. A concern about milk given to an infant should lead back to its source.

Connected, identifiable records

Be able to connect the donation, milk, relevant records and organisations. The team giving the milk to an infant must be able to identify the recipient. Article 42 sets out these links.

Identification and coding

Article 42 addresses unique, generally machine-readable codes and donor confidentiality. Article 43 sets out Single European Code (SEC) requirements and exceptions. A barcode alone does not demonstrate compliance with every coding or traceability requirement.

Long-term record availability

Article 42(6) requires necessary traceability data to be safeguarded and accessible to the competent authority for at least 30 years from distribution or, where applicable, disposal or export.

Protect confidential donor and recipient information through appropriate access controls and data-protection arrangements. Other documents may have different retention periods from the necessary traceability data.

For your project, agree how identifiers, access, exports and long-term record availability will work in practice. Confirm coding compatibility and retention arrangements explicitly with each supplier.

What must a hospital receiving donor milk do?

A hospital that gives donor milk to infants has responsibilities even when it does not process the milk. EDQM calls it an organisation responsible for human application (ORHA).

Organise the work

Confirm registration, quality procedures and staff responsibilities, including recipient information and consent where applicable.

Keep the records connected

Link the milk given to each infant with the relevant milk records. Arrange record retention and access.

Respond and report

Agree how staff detect, investigate and communicate safety incidents, and complete required activity reporting.

Record the milk given to each infant

EDQM Good Practice Guideline G32.43 says the receiving hospital should document when and how milk was used and to whom it was administered. This is EDQM good-practice guidance; the underlying traceability responsibilities also come from the regulation.

Receiving teams should also check labels and accompanying information, maintain suitable storage conditions and follow the milk’s handling instructions.

EDQM Guide, 6th edition — Chapters 14, 17 and 32, including G32.43

How digital traceability helps your team prepare for SoHO

When milk moves between a milk bank, milk kitchen and neonatal ward, its records need to stay connected. Digital traceability helps teams follow that journey and retrieve the information they need for daily work, reviews and investigations.

Find the connected history

Follow the links between donations, processing batches, bottles, deliveries and recorded recipients.

Make handovers easier to follow

Connect dispatch and receipt records so participating teams can see where milk went and which records belong with it.

Support reviews and investigations

Locate relevant milk, remaining stock and linked records when a question arises. Use the same connected history to trace forwards or backwards.

MilkTrail brings these links into your team’s workflow. We agree the setup, access, training and connections with you, so the software supports the way your organisation handles milk.

EDQM Guide, 6th edition — Chapters 2, 16 and 17 — quality management, documentation and traceability

Connected records in daily work

How MilkTrail supports human milk traceability

MilkTrail is human milk traceability software for milk banks and hospital teams. It connects records across donation, processing, storage, distribution, preparation and administration. We review your current routines and agree the setup with you.

We agree responsibilities, capabilities and implementation steps before your project starts. MilkTrail supports your traceability workflow; your organisation remains responsible for its regulatory arrangements.

How do EDQM guidance and the regulation fit together?

The regulation sets the legal framework. The EDQM Guide provides technical guidance for putting quality and safety into practice. Its sixth edition distinguishes three types of statement:

Standards (S)

Requirements derived from relevant legislation. The applicable legal text is authoritative.

Good Practice Guidelines (G)

Practices for quality and safety. These should not automatically be presented as separate statutory requirements.

Recommendations (R)

Additional recommended approaches or measures.

The regulation gives technical guidelines a role in meeting its standards. Apply the relevant guidance alongside national requirements and decisions from your national regulator.

EDQM Guide, 6th edition — standards, good-practice guidelines and recommendations

Human milk SoHO questions and answers