S. No.

Compliance Area

Requirement / Obligation

Applicability / Key Point

1.

Permitted Probiotic Microorganisms

Use only probiotic cultures specified in Schedule VII or microorganisms specifically approved by the Food Authority from time to time.

FBO must verify that the probiotic strain used is permitted/approved.

2.

Use of Prebiotics

Probiotic preparations may contain permitted prebiotics.

Only prebiotics permitted under the applicable regulations may be used.

3.

Minimum Viable Count

The viable number of probiotic organisms in the food shall be ≥ 10⁸ CFU/g.

Minimum viability requirement for probiotic food.

4.

Lower Viable Count

A lower viable count may be used only where health benefits at such lower count are scientifically established and the Food Authority has given prior approval.

Scientific evidence + prior approval required.

5.

Scientific Evaluation of Probiotics

The Food Authority may specify/approve probiotic microorganisms after proper scientific evaluation.

FBO should ensure use of currently approved strains.

6.

Starter Cultures

Common starter cultures such as Lactococcus spp., Lactobacillus spp. and other microorganisms used in fermented milk/dahi are not treated as probiotics unless their probiotic properties are substantiated.

Mere presence of fermentation cultures does not establish probiotic status.

7.

Disease Claims Prohibited

Labelling, presentation and advertising shall not claim or imply that probiotic food prevents, treats or cures human disease.

Disease prevention/treatment/cure claims are prohibited.

8.

Structure/Function Claims

Statements relating to structure, function or general well-being may be made where permitted by the Food Authority and supported by generally accepted scientific data.

Claims must have scientific substantiation.

9.

Mandatory Product Declaration

Every package shall bear the words “PROBIOTIC FOOD”.

Mandatory label declaration.

10.

Identification of Probiotic Strain

Where probiotics are mentioned in the ingredients list, state genus and species, including strain designation or culture collection number, where applicable.

Enables identification and traceability of the probiotic strain.

11.

Viable Count at End of Shelf Life

Declare the viable numbers at the end of shelf life corresponding to the level at which efficacy is claimed.

Viability must support the claimed efficacy throughout shelf life.

12.

Recommended Serving Size

Label shall specify the recommended serving size capable of delivering the effective viable dose associated with the health claim.

Serving size should correspond to the substantiated effective dose.

13.

Recommended Duration of Use

Label shall state the recommended duration of use.

Mandatory consumer information.

14.

Storage Conditions

Label shall specify the proper storage temperature conditions.

Storage instructions should preserve probiotic viability.

15.

Post-Opening Use

Label shall specify the time limit for “Best Use” after opening the container.

Mandatory where applicable.

16.

Medicinal Use Warning

Prominently display the advisory: “NOT FOR MEDICINAL USE”.

Mandatory warning.

17.

Safety Warnings

Label shall include applicable warnings/precautions, known side effects, contraindications and product-drug interactions.

To be provided where applicable.

18.

Permitted Additives

No additives may be used in probiotic preparations except those specified in Schedules VA to VF.

Additives must be verified against permitted schedules.

19.

Scientific Support

Maintain scientific evidence supporting probiotic properties, viability and any structure/function or health-related claims.

Particularly important where efficacy is claimed.

20.

ICMR–DBT Guidance

Guidelines issued by ICMR and DBT regarding probiotics provide additional information on their use.

Useful supplementary guidance for formulation and substantiation.