Overview

This document explains the intended use of F-75, a 200mL carton of therapeutic milk intended for the initial phase of treatment of children diagnosed with Severe Acute Malnutrition (SAM). This product must be used under medical supervision.

The document outlines the instructions for product use, target population, technical specifications including specific nutrition/vitamin/mineral composition per unit, the international standards, processing methods, food safety and risk assessment at manufacturing premises, hygiene and microbiology requirements, analytical requirements, and specific packaging and labeling details. Additionally, the final product shall be of a medium viscosity, free flowing and has a uniform consistency and appearance. F-75 should possess a white to light cream color and is uniformly coloured throughout. Information regarding proper product storage, shelf life, and stability are also included. Relevant Codex documents are referenced throughout the document. If the manufacturer uses a mineral and vitamin premix(es), they must source it from a specialized premix manufacturer.

Vitamins and minerals shall be in such forms that they are easily absorbed by patients with SAM who are often achlorhydric. Additionally, this product should not alter the acid-base metabolism of its recipients. In particular, it shall have a moderate positive non metabolisable base sufficient to eliminate the risk of metabolic acidosis. The non-metabolisable base can be estimated using a formula included within the specification document. Overall, this document can be used by suppliers and manufacturers to ensure their product meets the indicated specifications.

Link to Document

Product Specification-F-75, Therapeutic milk -200ml