X Pro- And Prebiotics Products That Can Be Sold In India

The nutraceutical and health supplement industries are growing at a rapid pace in India. Probiotic and prebiotic products especially are in great demand owing to their exceptional health benefits and for this reason, many new food product companies are trying to launch their own brands. But not all of them have been certified by the Food Safety and Standards Authority of India (FSSAI), which has defined specific guidelines for probiotic and prebiotic products.

Probiotics

Food with added probiotic ingredients contains live microorganisms that are beneficial to human health. It may have adequate numbers of a single strain or a combination of cultures.

Probiotics that meet the following regulations can be sold in India after approval from FSSAI:

• The microorganisms should be declared on the label with full information and have to be non-GMO
• Only approved strains of microorganisms as specified in Schedule VII can be added in probiotic product (see Table 1)
• The viable number of microorganisms in food with added probiotic ingredients shall be ≥10⁸ CFU in the recommended serving size per day.
• The probiotic food shall not claim or refer to have any property of preventing, curing, or treating a human disease
• The Food Authority will allow a statement related to structure or function or the general well-being of the body only if it is supported with  by scientific evidence
• The packaging of the probiotic food should have the following information:
  • ‘PROBIOTIC FOOD’ to be mentioned clearly on the label
  • Genus and species including strain designation or culture collection number, if applicable, in the list of ingredients
  • Viable numbers at the end of the shelf-life of the probiotic strain
  • Recommended serving size, duration of use, storage conditions, and ‘best by’ date after the container is opened
  • ‘NOT FOR MEDICINAL USE’ written prominently
  • Any other warning or precaution to be taken while consuming, known side effects, contraindications, and product-drug interactions, as applicable

• Only additives specified in Schedule VA to Schedule VF can be used in probiotic preparations

Table 1: List of strains approved by FSSAI as probiotics (live microorganisms) 

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

This list may be updated by the Food Authority to add any new strain of microorganism that possesses probiotic properties, after proper scientific evaluation. Probiotic preparations may contain added prebiotics permitted under these regulations.

Prebiotics 

Prebiotics contain nonviable food components that when consumed, confer health benefits to the consumer by modulation of gut microbiota.

Prebiotics that meet the following regulations can be sold in India after approval from FSSAI:

• Only approved prebiotics as specified in Schedule VIII can be used in making food containing prebiotics (see Table 2)
• The prebiotic component (not an organism) should be specified by providing details such as origin, purity, source, chemical composition and structure, vehicle, concentration, and amount in which it is to be delivered to the host
• The prebiotic food shall not claim or refer to have any property of preventing, curing, or treating a human disease
• The Food Authority will allow a statement related to the structure or function or the general well-being of the body only if it is backed by scientific evidence
• The packaging should have the following information:

• • ‘PREBIOTIC FOOD’ mentioned on the label
  • Name of prebiotic
  • Suggested or recommended serving size
  • ‘NOT FOR MEDICINAL USE’ written prominently
  • Any other warning or precaution to be taken while consuming, known side effects, contraindications, and product-drug interactions, as applicable

• Only additives specified in Schedule VA to Schedule VF can be used in prebiotic preparations

Table 2: List of compounds approved by FSSAI as prebiotics

1. Polydextrose	6. Xylo-oligosaccharides	11. Lactoferrin
2. Soya poly-saccharides and soya oligosaccharides	7. Inulin	12. Sugar alcohols such as lactitol, sorbitol, maltitol, inositol, isomalt
3. Isomalto-oligosaccharides	8. Isomaltulose	13. Galacto-oligosaccharides
4. Fructo-oligosaccharides	9. Gentio-oligosaccharides
5. Gluco-oligosaccharides	10. Lactulose

The Food Authority may add any new specific prebiotic in this list after proper scientific evaluation.

References:

1. FSSAI Gazette Notification related to the standards of Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Food. (Uploaded on: 06.01.2017) – fssai.gov.in/dam/jcr:c0b36c0c-ccc9-446d-ada6-5b164de27460/Gazette_Notification_Functional_Foods_06_01_2017.pdf
2. FSSAI released order on regulations related to Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purposes, Functional Foods and Novel Food. (Uploaded on: 29.12.2017) – https://www.fssai.gov.in/dam/jcr:82196a3a-c40d-461c-a9a1-caf07c0d7ba4/Implementation_Health_Suppliments_29_12_2017.pdf