Sr. No.

Compliance Requirement

Applicability / Key Details

Records / Documents

1.

Use of specified plant/botanical ingredients

Only plant or botanical ingredients specified in Schedule IV may be used.

Schedule IV ingredient list; formulation records

2.

Use of non-specified ingredients

A plant/botanical ingredient not specified in Schedule IV may be manufactured or sold only after prior approval of the Food Authority, where safety has been established in India or another country.

Food Authority approval

3.

History of safe usage

Application for approval must be supported by documented history of usage of at least 15 years in India or 30 years in the country of origin.

Documentary evidence of usage history

4.

Permitted food formats

Ingredients may be formulated alone or in combination with other ingredients/botanicals/extracts, in approved processed or unprocessed forms.

Product formulation

5.

Permitted presentation formats

May be presented in regular/conventional food formats such as liquid, syrup, suspension, powder, granule, tablet, capsule, or another format approved by the Food Authority.

Product specifications; approval, where applicable

6.

Product Information File (PIF)

Every manufacturer/importer must prepare and maintain a PIF for the specialty food.

Product Information File

7.

PIF – ingredient information

PIF must contain information regarding the Schedule IV ingredients used.

Ingredient specifications and source details

8.

Finished-product quality confirmation

PIF must include confirmation of the quality of the finished product.

COA, quality specifications, test reports

9.

Active-ingredient testing

Test methods must demonstrate the presence of the active ingredient in the food.

Validated/established test methods; analytical reports

10.

Maximum usage level

Usage level of plant/botanical ingredients must not exceed the level specified in Schedule IV.

Formulation and dosage calculations

11.

Daily portioning

The permitted usage level may be provided in one daily portion or divided into multiple portions during the day.

Serving-size/dosage specification

12.

Prior approval for other botanicals

For any plant/botanical ingredient not specified in Schedule IV, prior approval of the Food Authority must be obtained.

Approval application and supporting dossier

13.

PIF for non-specified ingredient approval

Application must include information on the material, quality confirmation, test methods, scientific/technical literature, human intervention studies and other relevant information.

Complete approval dossier/PIF

14.

Scientific literature

Relevant published literature concerning safety and health benefits must be submitted for non-specified ingredients.

Published research papers/literature review

15.

Human intervention studies

Published or conducted human intervention studies, where available, must be submitted.

Study reports/publications

16.

Production of PIF for inspection

PIF must be maintained and produced before the Food Authority whenever called for inspection/review.

Updated PIF and supporting records

17.

Raw-material quality information

PIF must contain quality information for all raw ingredients along with their official scientific/botanical names.

Raw-material specifications; botanical identification

18.

Formulation & process details

PIF must contain formulation details/block diagram and a brief description of processing methods/steps.

Master formula; process flow chart; SOPs

19.

Shelf-life data

Shelf-life study data must be maintained.

Stability/shelf-life study reports

20.

Finished-product specifications

Quality specifications and analytical test methods for the finished product must be documented.

Finished-product specification sheet; test methods

21.

Safety & pharmacological information

PIF must include safety/pharmacological information, literature and additional studies, where conducted.

Safety dossier; literature; study reports

22.

Human-study information

Information on human studies, where conducted, must be maintained.

Clinical/human study documentation

23.

Foreign regulatory status

Regulatory status of the product/ingredient in other countries, where applicable, should be documented.

Foreign approvals/authorisations or regulatory status

24.

Other relevant information

Any other relevant product information should form part of the PIF.

Supporting technical/regulatory documents

25.

Permitted additives

Additives may be used only if specified in Schedule VE or Schedule VF.

Additive specifications; formulation records