S. No.

Compliance Requirement

Applicability / Key Requirement

Records / Evidence

1

Capsule-format foods

Food sold in hard/soft capsules, including vegetarian capsules, shall comply with the applicable general monograph and quality requirements of Indian Pharmacopoeia (IP).

Product specifications, IP compliance documents

2

Permitted colours & additives

Only approved colours and additives permitted under Schedule VF may be used.

Ingredient/additive specifications, formulation records

3

Flavouring substances

Natural, nature-identical or synthetic flavours may be used in accordance with Regulation 3.3.1 of FSS (Food Product Standards and Food Additives) Regulations, 2011.

Flavour specifications, formulation records

4

Declaration of flavour

Where flavour is added, its declaration on the label shall comply with applicable Labelling and Packaging Regulations.

Approved product label/artwork

5

Tablets, capsules & syrups

Tablets, capsules and syrups shall meet the general quality requirements/standards of IP, British Pharmacopoeia (BP) or United States Pharmacopoeia (USP).

Certificate of Analysis, product specifications

6

Maximum nutrient addition

Nutrients added shall not exceed the Recommended Daily Allowance (RDA) specified by ICMR. Where ICMR standards are unavailable, applicable Codex standards shall be followed.

Formulation sheet, nutrient calculation

7

Minimum nutrient content – health supplements

Where a nutrient content claim is made, the individual nutrient content shall be at least 15% of RDA.

Nutritional analysis, laboratory reports

8

Higher nutrient content claim

If a claim of higher nutrient content is made, the nutrient content shall be at least 30% of RDA.

Lab reports, claim substantiation

9

Food colours

Food colours may be added only where permitted by the Food Authority and within the prescribed levels under the applicable food additive regulations.

Formulation records, additive specifications

10

Standard nutrient / nutritionally complete formulation

Composition must provide the required levels of energy, protein, vitamins, minerals and other essential nutrients appropriate to the relevant age, gender and physiological stage, as per ICMR guidelines.

Product formulation, nutrient profile

11

Purity criteria – specified ingredients

Ingredients shall comply with purity criteria determined and notified by the Food Authority from time to time.

Supplier specifications, COA, test reports

12

Purity criteria – where not specified

Where no specific purity standard exists, recognised standards such as IP, Ayurvedic Pharmacopoeia, BIS, Quality Standards of Indian Medicinal Plants, ICMR, BP, USP, Food Chemical Codex, JECFA or Codex may be adopted.

Adopted standard/specification

13

Intimation to Food Authority

FBO shall intimate the purity criteria adopted for ingredients to the Food Authority, including any subsequent change in the adopted criteria.

Intimation/communication records

14

Finished-product tolerance

Analytical variation in declared nutrients/nutritional ingredients shall not be more than (-)10% of the declared value on the label.

Finished-product test reports, COA

15

Good Manufacturing Practices (GMP)

Manufacturing of ingredients and products covered under these regulations shall comply with established GMP requirements.

GMP SOPs, batch records, audit reports

16

Permitted ingredients & additives

Ingredients listed in Schedules I, II, III, IV, VI, VII and VIII may be used subject to the applicable regulatory conditions. Relevant additives from Schedules VA–VF may be used as applicable.

Formulation/master formula, ingredient register