S. No.

Compliance Requirement

Particulars

1

Permitted Prebiotics

Manufacture food containing prebiotics only using prebiotics specified in Schedule VIII or those approved by the Food Authority from time to time.

2

Characterisation of Prebiotic

Characterise the prebiotic component for the relevant product by specifying its source, origin, purity, chemical composition and structure, vehicle, concentration and quantity to be delivered to the host.

3

Disease-related Claims Prohibited

Labelling, presentation and advertising shall not claim or imply that the prebiotic prevents, treats or cures any human disease.

4

Structure/Function Claims

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

5

Mandatory Label Declaration

Every package shall bear the words “PREBIOTIC FOOD”.

6

Name of Prebiotic

The name of the prebiotic shall be declared on the label.

7

Serving Size / Effective Dose

The suggested or recommended serving size shall be stated and should deliver the effective dose of the prebiotic relevant to the health claim.

8

Medicinal Use Warning

The statement “NOT FOR MEDICINAL USE” shall be prominently displayed on the label.

9

Warnings & Precautions

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

10

Use of Additives

Additives in prebiotic preparations may be used only if they are specified in Schedules VA to VF.