2. Product Categories

Food with Added Probiotics
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

Probiotic Food 

Definition

Probiotic Food is food with live micro-organisms beneficial to human health, which when ingested in adequate numbers as a single strain or as a combination of cultures, confer one or more specified or demonstrated health benefits in human beings. (Section 3 (k) 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 dietician or nutritionist. [1]

Delivery format [1]: 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 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 probiotic culture of the microorganisms specified in Schedule IV [1] or those probiotic microorganisms approved by the Food Authority from time to time should be used. The viable number of added probiotic organisms in food shall be ≥108 CFU in the recommended serving size per day.

Probiotic preparations may contain added prebiotics permitted under these regulations.

Schedule –IV- List of probiotics [1]

1. Lactobacillus acidophilus
2. Lactiplantibacillus plantarum
3. Limosilactobacillus reuteri
4. Lacticaseibacillus rhamnosus
5. Ligilactobacillus salivarius
6. Lacticaseibacillus casei
7. Levilactobacillus brevis
8. Lactobacillus johnsonii
9. Lactobacillus delbrueckii sub- sp. bulgaricus
10. Bacillus coagulans
11. Limosilactobacillus fermentum
12. Lactobacillus caucasicus
13. Lactobacillus helveticus
14. Lactobacillus lactis
15. Lactobacillus amylovorus
16. Lactobacillus gallinarum
17. Lactobacillus delbrueckii (Lactobacillus delbrueckii subsp. delbrueckii)
18. Bifidobacterium bifidum
19. Bifidobacterium lactis (Bifidobacterium animalis subsp. lactis)
20. Bifidobacterium breve
21. Bifidobacterium longum (Bifidobacterium longum subsp. longum)
22. Bifidobacterium animalis (Bifidobacterium animalis subsp. animalis)
23. Bifidobacterium infantis (Bifidobacterium longum subsp. infantis)
24. Streptococcus thermophilus (Streptococcus salivarius subsp. thermophilus)
25. Saccharomyces boulardii (Saccharomyces cerevisiae subsp. boulardii)
26. Saccharomyces cerevisiae (Saccharomyces cerevisiae subsp. cerevisiae)
27. Lacticaseibacillus paracasei
28. Lactobacillus gasseri
29. Bacillus clausii
30. Established probiotic strains of Bacillus subtilis
31. Bacillus indicus

These organisms may be used either singly or in combination but shall be declared on the label with full information and has to be Non-GMO.

Guidelines issued by the Indian Council of Medical Research and Department of Biotechnology [Guidelines for Evaluation of Probiotics in Food] [2] provide additional information on their use.

Additional Information

Probiotic food means foods with added viable microorganisms which when consumed in adequate amount confer health benefits. Provided that the presence of the commonly used starter cultures of lactic acid producing bacteria such as Lactococcus spp., earlier known as Streptococcus spp., Lactobacillus spp. and other such microorganisms used in the preparation of fermented milk (dahi) and related products shall not be considered as probiotics, if the probiotic properties have not been substantiated. (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

2. Guidelines issued by the Indian Council of Medical Research and Department of Biotechnology. Guidelines for Evaluation of Probiotics in Food

https://dbtindia.gov.in/sites/default/files/PROBIOTICS-GUIDELINES-PDF_0.pdf