Overview

This document is a specification of F-75, a therapeutic milk diet with added vegetable fat, carbohydrates, vitamins, and minerals. This product is intended for the initial phase of treatment of children diagnosed with Severe Acute Malnutrition (SAM) to stabilize the child’s metabolism and support rehydration. F-75 must be used under medical supervision. This product is not intended for weight gain.

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 a homogenous liquid that does not separate into oil/liquid phases or leaves a solid sediment upon standing in a refrigerator. Other product characteristics are provided along with information regarding proper product storage, shelf life, and stability. Relevant Codex documents are referenced throughout the specification sheet. 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. The added minerals shall be water-soluble and shall not form insoluble compounds when mixed. Iron salts are not to be added. 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 food, 800 g canister