Guide

New or substantially changed infant formula: prepare the pre-market submission

Check first

This pathway is for manufacturers. It provides no infant-formula recipe or advice on substituting infant feeds.

Confirm the right process

Determine whether this is a new formula, a major change or another product requiring a separate regulatory route.

Prepare the dossier

Gather formulation, manufacturing, controls, stability, labels and nutritional and safety evidence required by the current guidance.

Submit the application

Prepare the cover letter, checklists and online application; seek a pre-submission consultation for unresolved technical questions.

Follow up

Answer review comments and await the required decision before sale; maintain compliance, traceability and change control afterward.

Official procedure

Requirements and supporting information

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Official sources consulted August 30, 2026. Orientation guide: confirm current rules, documents, deadlines and conditions with the responsible authority.

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