“Prebiotics” – A case of disharmony in regulations and markets?

‘Prebiotic’ as defined by FAO refers to ‘a nonviable food component that confers a health benefit on the host associated with modulation of the microbiota. Prebiotics occur naturally in foods like onions, garlic, banana etc. but commercially available ingredients in the market include both naturally derived and synthetic ingredients. The most widely studied and accepted prebiotics in the food industry are Fructo-Oligosaccharides (FOS), Inulin and Galacto- Oligosaccharide (GOS).There is a growing list of other prebiotic candidates such as Xylo- Oligosaccharides (XOS), Isomalto- Oligosaccharides (IMO), Gluco-Oligosaccharides, soybean oligosaccharide, Gentio-oligosaccharides, few starch derivatives and sugar alcohols (such as lactitol).

The evidence of the prebiotic efficacy for all the candidates, especially in humans, is not as well advanced as it is for inulin, FOS and GOS and hence many of them have not been approved as food ingredients by various regulators. In the United States, GOS, FOS, IMO and XOS have been granted GRAS status and in most of the countries, Inulin and FOS are the only approved prebiotic ingredients. In EU, Inulin and FOS have entered the food market as ingredients but EFSA has rejected the health claims citing ‘cause and effect relationshipbeing not established’. Many manufacturers refer to prebiotics as fibre, because the consumer is more familiar with it. Both fibre and prebiotics are typically non-digestible carbohydrates, and both are fermented by gut bacteria. A prebiotic is distinguished from fibre in its selective utilization in the gut by only beneficial members of the existing microbial communityof the gut.

Indian regulator FSSAI in its draft Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations, 2015,has definedfoods containing prebiotic ingredients as foods that contain approved prebiotics. FSSAI regulations state that only prebiotics specified in Schedule XI or those approved by the Food Authority from time to time may be used in the manufacture of foods containing prebiotics. India must be the only country to give blanket approval for a bunch of prebiotic candidates at this time. Most of the Schedule XI listed prebiotics have not been approved as ingredients in other countries. For many of the prebiotic candidates, promising data exists but sufficient evidence for prebiotic effects is lacking.

Table. List of Prebiotic Compounds in schedule – XI of Food Safety and Standards Regulations, 2015

S.NoPrebiotic Compounds ;
2Soybean Oligosaccharides
12Sugar alcohols such as lactitol, sorbitol, maltitol, etc.

There are no concerns of adverse events with any of the listed prebiotic candidates and the overall consensus is that these oligosaccharides are safe for human. If this is the case, the rational for exclusion of Galacto – Oligosaccharide (GOS), for which sufficient data exists and approved elsewhere, from the approved list of prebiotics in schedule XI is not clear. Lack of harmony in the regulatory approaches toward prebiotics and lack of uniform usage guidelines for prebiotics does create confusion among consumers about these ingredients and their health benefits.


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