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GUIDELINES FOR READY-TO-USE THERAPEUTIC FOODS CXS 95-2022

Document Location: Requirements and Standards - Formulation Guidance

Alternate Name: CXG 95-2022                

Date Document Last Updated: 2022

Publisher: Codex Alimentarius

Date Uploaded to Website: May 31, 2024        

Overview

CXG 95-2022 is the guideline that applies to Ready to use Therapeutic foods (RUTF). RUTF is a recommended option for the dietary management of children aged from 6 to 59 months with severe acute malnutrition (SAM) without medical complications.

The document discusses nutritional composition, raw materials and ingredients, Good Manufacturing Practices,  microbiological and chemical contaminant criteria,  methods of analysis and sampling, and packaging and labeling for RUTF. Relevant Codex documents are referenced throughout.

RUTF is a low moisture food with a water activity of 0.6 or lower, they shall comply with CXC 75-2015, Code of hygienic practice for low moisture foods. In terms of food additives, a  table can be found in this document with the different food additives that may be used in the formulation of RUTFs, along with their maximum use levels. The document provides information on  required energy density, protein, and lipid requirements. The vitamins found in RUTFS should comply with the maximum and minimum levels found in the annex of the document. When formulating RUTF, good manufacturing practices (GMP’s), good hygiene practices (GHP’s), and proper standard operating procedures (SOP’s) for microbiological testing should be followed to ensure the safety of the product.

Overall, this document aims to provide guidelines on the formulation, selection of ingredients, manufacturing facilities standard, testing requirements, packaging and labeling of RUTF.

Following this guideline a manufacturer or product developer can ensure a quality RUTF is produced  safely.

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