2. Product Categories

Food with Added Prebiotics
India

This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.

2.1 Category Name & Definition

Category Name

Prebiotic Food 

Definition

Prebiotic Food is food that contains added ingredients which are non-viable food components that confer health benefits to the consumer by modulation of gut microbiota. (Section 3 (j) of [1])

Specifications/Target Age

Target age: above the age of 2 years old. The products covered intended for children of 2 to 5 years of age, shall only be given under medical advice by a recognized medical doctor or dietitian or nutritionist. [1]

Delivery format [3]: Section 5 (1) a)

Products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly, and other dosage forms but not parenteral, and are meant for oral administration; in the form of powders, granules, tablets, capsules, liquids, semi-solids, drops, pills, gummies, jelly, chewable and mouth dissolving strips, bars, biscuits, candies that are intended to be consumed orally in defined quantities and duration.

However, some of these formats, namely tablet/capsule/pills/liquid drops are permitted only with prior approval of Food Authority.

General and Specific category requirements can be refered in Annexure 1 per advisory inputs on the draft notifications of Food Safety and Standards (Health Supplements, Nutraceuticals, Food for special dietary use, Food for special medical purpose, Functional food and Novel food) Regulations, 2022 [1].  

Only the prebiotics specified in Schedule IV or those prebiotic approved by the Food Authority from time to time should be used. The maximum limit for prebiotic per day shall not exceed 40g/day for adults. 

Schedule – IV- List of prebiotic compounds [1]

1. Polydextrose 
2. Soya poly-saccharides and soya oligosaccharides
3. Isomalto-oligosaccharides 
4. Isomalto-oligosaccharides
5. Gluco-oligosaccharides
6. Xylo-oligosaccharides 
7. Inulin
8. Isomaltulose
9. Gentio-ologsaccharides
10. Lactulose
11. Lactoferrin
12. Sugar alcohols such as lactitol, sorbitol, maltitol, inositol, isomalt
13. Galacto-oligosaccharides 
14. Partially Hydrolyzed Guar Gum (Guar gum derivative 
15. Pectin
16. Resistant dextrin 

Additional Information

These are non-viable food components that confer health benefits by modulating gut microflora under Section 6 (5) [1].

2.2 Product & Definition

N/A

2.3 References

1. Direction under Section 16(5) of the Food Safety and Standards Act, 2006 regarding Operationalization of FSS ( Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special medical Purpose and Prebiotics and Probiotic Food) Regulations [FSS (Nutra) Regulations 2022

https://www.fssai.gov.in/upload/advisories/2022/04/624ac1be799dbDirection_Nutra_30_03_2022.pdf