Regulatory Excellence

FSSAI Food Regulations

Your trusted partner for seamless food import and manufacturing compliance in India with expert guidance through every step of the FSSAI approval process.

What id FOOD?

Legal definition under Indian law

"Food includes any substance, whether processed, partially processed, or unprocessed, intended for human consumption. This covers primary food (from agriculture, horticulture, animal husbandry, etc.), genetically modified or engineered food, infant food, packaged drinking water, alcoholic beverages, chewing gum, and any substance added during food production. It excludes animal feed, live animals (unless processed for consumption), unharvested plants, drugs, cosmetics, and narcotic substances. RegaCats assist clients in navigating the challenging, complex, and frequently evolving regulatory landscape for Foods, Food Products, Health Supplement/Nutraceutical. Regulatory Authority: All the licenses and registration pertaining to Foods are regulated by Food Safety and Standards Authority of India (FSSAI). For Food, Health Supplements & Nutraceutical Manufacturing in India
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Regulatory Authority:


All the licenses and registration pertaining to Foods are regulated by Food Safety and Standards Authority of India (FSSAI).

—Food Safety and Standard Act, 2006

Key Information

Essential regulatory details

Governing Laws

    For Food, Health Supplements & Nutraceutical Manufacturing in India
  • Registration: Food business operators whose annual turnover is up to 12 lacs fall under the registration criteria.
  • State License: Food business operators whose annual turnover is more than 12 lacs and up to 20 crores falls under the state licensing regime.
  • Central License: Food Business Operators whose annual turnover is more than 20 crores falls under the central licensing regime. Central license is mandatory for Proprietary food, Non-specified food, Importers, Exporters, E-commerce, Head Office/ Registered Office, Products fall under FSSR (Health Supplements, Nutraceuticals, FSDU, FSMP, and Prebiotic and Probiotic Food), 2022.
  • Government fees: Registration: Rs. 100 State License: Rs. 2000/3000/5000 Central license: 7500 + GST
  • Manufacturing Registration Certificate from Department of Consumer Affairs
  • EPR Authorization from Central Pollution control Board
  • Ingredient Verification: Ensure all ingredients used are approved under FSSAI regulations.
  • Permissible Limits Check: Cross-check nutrients, vitamins, minerals, botanicals, and other actives for compliance with RDA and maximum limit guidelines.
    • For Food, Health Supplements & Nutraceutical Import in India
  • Import NOC from FSSAI (FICS Portal)
  • Import Registration Certificate from Department of Consumer Affairs
  • EPR Authorization from Central Pollution control Board-
  • Labeling Complaince
  • Formulation Compliance

Eligible Applicants

Manufacturer having registered office in India
Subsidiary of foreign Manufacturer in India
An Authorized Indian Agent of the Foreign Manufacturer
An Indian Importer on behalf on Foreign Company

Fee Structure

Statutory fees for cosmetic import registration

Registration Fees
Government Fees
INR 100
State License
INR 2000/3000/5000
Central license
INR 7500 + GST

Note: Approximately 80 categories are listed in the Third Schedule. Fees apply only to unregistered categories and sites.

Required Documents

Complete documentation checklist For Manufacturing

1
Blueprint or Layout Plan of the processing unit
2
List of Directors/Partners/Proprietor or Executive Members (for Society/Trust)
3
List of Equipment and Machinery installed at the facility
4
Water Testing Report from a certified laboratory
5
Government-issued Photo ID and Address Proof of Proprietor/Partner/Director/Authorized Signatory
6
Proof of Possession of Premises (e.g., Rent Agreement, Sale Deed, Electricity Bill)
7
Partnership Deed/Self-Declaration for Proprietorship/Memorandum & Articles of Association (MOA & AOA)
8
Form IX – Nomination of Authorized Signatory (Not required for Proprietorship firms)
9
Food Recall Plan
10
Photographs of the Production Unit

Required Documents

Complete documentation checklist For Import

1
Importer FSSAI license copy
2
IEC Certificate
3
Bill of Entry
4
Airway Bill / Bill of lading (sea)
5
Certificate of country of Origin
6
Commercial Invoice
7
Packing List
8
Product Label
9
Ingredient List
10
Certificate of Analysis
11
Foreign Food Manufacturing Facilities(FFMF) registration on ReFoM portal

Labeling Compliance

Label Review

We thoroughly assess product labels to ensure compliance with FSSAI, Legal Metrology and Plastic Waste Management Rules.

Ingredient & Nutritional Declaration:

Accurate formulation of ingredient lists, nutrition facts, RDA values, and additive classifications.

Mandatory Disclosures & Warnings:

Inclusion of legally required statements such as “Not for Medicinal Use,” “Store in a Cool, Dry Place,” or allergen warnings for gluten, nuts, soy, etc.

Health Claims & Labelling Claims Validation:

We validate functional claims, nutritional claims, and structure-function claims to ensure they are scientifically justified and legally permissible.

Imported Product Labelling:

Support for modifying foreign product labels to align with Indian regulatory norms, including affixing compliant stickers or over-labels.

Periodic Regulatory Updates:

We keep you informed on changes to FSSAI labelling rules, helping you stay compliant and avoid costly reformulations or recalls.

Product Category-Specific Guidance:

Specialized labelling solutions for Nutraceuticals, Health supplements, Prebiotc, Probiotic and more.

Formulation Compliance

Prohibited Substances Screening:

Identify and eliminate any banned or restricted substances as per FSSAI’s negative list.

Ingredient Verification:

Ensure all ingredients used are approved under FSSAI regulations.

Permissible Limits Check:

Cross-check nutrients, vitamins, minerals, botanicals, and other actives for compliance with RDA and maximum limit guidelines.

RDA Compliance:

Validate formulations against the latest ICMR Recommended Dietary Allowances to ensure safe consumption levels.

Category Classification:

Correct classification of the product—Health Supplement, Nutraceutical, Food for special dietary use, Food for Special Medical Purpose, Prebiotic/Probiotic, Nearest category for Proprietary Foods—as per FSSAI definition.

Nutrient Source Validation:

Verify the use of permitted chemical forms and sources of nutrients, as listed under FSSAI guidelines.

Why Choose RegaCats Solutions?

Your trusted regulatory catalyst for FSSAI Compliance in India

Expert Navigation

Through complex FSSAI procedures

Customized Solutions

Documentation, labeling, and compliance

One-Stop Service

From review to import approval

Global Support

For foreign brands and Indian importers