Probiotics in Food Supplements: Understanding Official Authorization and Guidelines

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What is a probiotic?

Probiotics and prebiotics are both types of dietary supplements that are used to promote gut health, but they have different functions and characteristics.

  • Probiotics: Probiotics are live microorganisms, typically bacteria or yeasts, that are ingested in adequate amounts and are beneficial to the health of the host when consumed. Probiotics are often referred to as "good bacteria" because they can help restore and maintain a healthy balance of gut microbiota, which are the trillions of microorganisms that naturally live in the human gut. Probiotics can be found in various food products, such as yogurt, kefir, sauerkraut, and kimchi, as well as in the form of dietary supplements. Some common strains of probiotics include Lactobacillus and Bifidobacterium.

  • Prebiotics: Prebiotics, on the other hand, are non-digestible dietary fibers that serve as food for probiotics, helping them grow and thrive in the gut. Prebiotics are typically carbohydrates that resist digestion in the upper gastrointestinal tract and reach the colon intact, where they are fermented by gut bacteria, including probiotics. This fermentation process produces short-chain fatty acids, which are important for maintaining gut health. Common types of prebiotics include inulin, fructooligosaccharides (FOS), and galactooligosaccharides (GOS). Prebiotics can be found naturally in certain foods, such as chicory root, Jerusalem artichoke, onions, garlic, and bananas, and they can also be taken as dietary supplements.

In recent years, the popularity of probiotics as a dietary supplement has increased rapidly. However, the use of the term "probiotics" in food supplements has been the subject of debate, with concerns raised over their safety and efficacy..

In this article, we will explore the official authorization of the term "probiotics" for food supplements, with reference to the guidelines set out by the Direction générale de la Concurrence, de la Consommation et de la Répression des Fraudes (DGCCRF).

Background

The term "probiotics" has been in use for several decades and is generally understood to refer to live microorganisms that provide health benefits when consumed in adequate amounts. Probiotic supplements have become increasingly popular in recent years, with many individuals incorporating them into their diet to support digestive health, enhance immunity, and potentially alleviate specific health concerns.

However, the use of the term "probiotics" in food supplements has raised concerns over their safety and efficacy. There are concerns that the use of live microorganisms in food supplements could pose a risk to human health, particularly if they are not properly regulated.

Official Authorization of the Term "Probiotics" for Food Supplements

The DGCCRF is the French regulatory body responsible for ensuring the safety and quality of food supplements. In 2018, the DGCCRF issued guidelines on the use of the term "probiotics" in food supplements.

The DGCCRF (French Directorate-General for Competition, Consumer Affairs and Fraud Control) has reminded everyone that the ban on using the term "probiotics" was due to the European Commission classifying it as a health claim. However, France has noticed that many other Member States, such as the Netherlands, Poland, Spain, Italy, Czech Republic, Denmark, and Greece, have not followed this decision by the Commission.

The conditions

To use the term "probiotics" on food supplement labels, the products must meet certain requirements. These requirements are based on Article 6(3)(a) of Directive 2002/46/EC.

Firstly, the food supplement must contain a minimum of 107-109 live cells of one strain per day. This is to ensure that a significant amount of live microorganisms reach the gastrointestinal tract and grow.

Secondly, no claims other than the balance of the intestinal flora can be made on the product label or in advertising. However, the label can include the phrase "contributes to the balance of the intestinal flora" if the food supplement contains probiotics and meets the above criteria.

There is some flexibility in how this phrase can be worded, and the terms "participation" or "maintenance" of these living microorganisms to "a normal constitution of the intestinal flora" are considered equivalent. The terms "reinforcement" or "increase" of the intestinal flora are not allowed.

Therefore, the term "Probiotics" can be used on food supplement labels as a category name with a reference to balancing intestinal flora. However, it is the responsibility of operators to ensure that their products are safe and comply with regulations. Operators must ensure that the probiotic strains used in their products have a consumption history, are not classified as Novel Food not authorized, are well-characterized, and are not resistant to antibiotics.

Who is EcoMundo ?

Providing regulatory compliance services to the food supplement industry we offer a range of services related to regulatory compliance for food supplements, including risk assessment, labeling and packaging compliance, and product registration. 

We help food supplement manufacturers and distributors ensure that their products meet regulatory requirements and are safe for consumption. We also provide guidance on the use of ingredients, claims, and labeling requirements in various countries around the world. Overall, helping companies navigate the complex regulatory landscape for food supplements and ensure that their products are compliant with applicable regulations is at the heart of our expertise.

For more information, please contact us!

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