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This document outlines guidelines for the evaluation of probiotics in food, providing systematic approaches to substantiate health claims and ensure safety assessments.
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How to fill out Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics III Food

01
Gather relevant scientific literature and background documents on probiotics.
02
Identify the key stakeholders who will contribute to the evaluation of probiotics.
03
Draft sections of the report based on established guidelines for the evaluation of probiotics.
04
Consult with experts in microbiology, nutrition, and food safety to ensure comprehensive coverage.
05
Include a section on the safety assessment and efficacy of probiotics.
06
Review and revise the draft report based on feedback from stakeholders.
07
Prepare the final report for submission to the Joint FAO/WHO Working Group for approval.

Who needs Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics III Food?

01
Regulatory bodies and agencies involved in food safety.
02
Researchers and scientists studying probiotics.
03
Food industry professionals involved in probiotic product development.
04
Health professionals recommending probiotics to patients.
05
Consumers seeking reliable information on probiotics.
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In short, probiotic strains must be (i) sufficiently characterized; (ii) safe for the intended use; (iii) supported by at least one positive human clinical trial conducted ing to generally accepted scientific standards; and (iv) alive in sufficient numbers in the product at an efficacious dose throughout shelf
Relevant to the practice of gastroenterology, probiotics are commonly used by patients with gastrointestinal complaints or diseases. Increasingly, probiotics are also being recommended by the clinicians who treat these conditions.
The National Institute for Health and Care Excellence (NICE) recommends that if patients wish to try probiotics they should take them at a dose recommended by the manufacturer for a minimum of four weeks.
Recent studies indicate that probiotics may assist in the regulation of weight and blood glucose levels and influence metabolism and insulin sensitivity. Emerging research indicates that the “gut-brain axis” connects mental and gastrointestinal health.
The Consultation has redefined probiotics for the purpose of this meeting as 'Live microorganisms which when administered in adequate amounts confer a health benefit on the host,' but restricted its scope to discussion of 'Live microorganisms which when consumed in adequate amounts as part of food confer a health
If a probiotic is going to be marketed as a drug for treatment of a disease or disorder, it has to meet stricter requirements. It must be proven safe and effective for its intended use through clinical trials and be approved by the FDA before it can be sold.
The FAO and WHO definition of probiotics as “live micro-organisms that, when admin- istered in adequate amounts, confer a health benefit on the host” is the most widely accepted.

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The Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics III Food is a document that provides guidelines and standards for evaluating the safety and efficacy of probiotics in food products. It aims to ensure that probiotics meet specific criteria for health benefits.
Entities involved in the production, marketing, or use of probiotics in food, such as food manufacturers, researchers, and regulatory authorities, are required to adhere to or file reports in compliance with these guidelines.
To fill out the report, stakeholders should follow the structured guidelines provided by the Joint FAO/WHO Working Group, including sections that detail the probiotic strains, their intended use, safety data, efficacy studies, and any relevant regulatory compliance information.
The purpose of the report is to establish a standardized framework for the evaluation of probiotics, helping ensure their safety and effectiveness in food applications and improving consumer confidence.
The report must include information on the identity and characteristics of the probiotics, their intended health benefits, relevant safety assessments, clinical evidence supporting efficacy, and compliance with food safety regulations.
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