Center For Food Safety

Fssai License and Registration

Form C– Overview

As per the Food Safety and Standards Authority of India (FSSAI) new provisions, an individual will require non-specified food/ingredient approval for other food products or ingredients. This includes food products or ingredients that are not covered under regulations listed by FSSAI, are not native to India, are novel, or have a new processing technology. The applicant who wishes to obtain the non-specified food approval must follow these steps:

Collect the list of necessary documents and their receipts
GAP analysis performed by the CE team.A dossier that is compiled as per Form-I.
The applicant must submit a demand draft of INR 50,000 along with Form-I, which is in favor of the Senior Accounts Officer or FSSAI.
After submission, the FSSAI will go through the application and respond in cases of queries.
The applicant must respond to these queries within 15-30 days (or within the stipulated time).
After addressing the queries, the FSSAI will discuss the application with the scientific panel.
The FSSAI approves grants non-specified food/ingredient approval if the scientific panel finds the detains convincing or vice versa.

Who Can Apply?

Food Business Operator who wants to manufacture / innovate /import food products which are not specified by FSSAI (and are other than proprietary foods), the Non Specified Product / Ingredient approval will have to be obtained from FSSAI. Precisely, the products with the following categories can apply for Non-specified food approval:

Transparency and Flexibility
New additives
New processing aids including enzymes
Articles of food and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae.

How To Apply?

FBOs need to file an Application for approval of non-specified food/ food ingredient in the FORM – I along with following necessary documents and government fee (50,000 INR) to the Food Authority.:

General information (Details of Company, Authorised Person, FSSAI license, Kind of business, etc.)

Product related information (Product details, formulation details, Functional use Intended use, Manufacturing process)

Safety Information and combinatorial effects (may include but not limited to Toxicological studies, Allergenicity, Pre-clinical and Clinical trials)

Regulatory status of product in other countries

History of consumption of food in the last 30 years

Lab test reports from ILAC/NABL accredited labs

Any other additional details or documents which are specific to the product/ ingredient

The Food Authority may either grant approval or reject the application, as per FORM-II, on the basis of the safety assessment of the article of food.

Fee Involved

INR 100 year is the registration fee for taking the FSSAI license to begin any food business on any premises whereas INR 2000/ 3000/ 5000 per year are the fees prescribed for obtaining a State License for the food business activities and INR 7500 per year for obtaining Central License.

Validity

Depending upon the fees paid for obtaining an FSSAI license, the license will be approved for one to five years.

Important Documents

The following documents are required to be submitted by the applicant for the registration purpose of the FSSAI license:

Timeline to get Form C from FSSAI

The Government Timeline for grant of Form C is 30-45 days.

Essential Tips

To avoid any queries, the importer or manufacturer seeking permission for an FSSAI license to start food business activity should ensure the following:

The category of business and license required are applied correctly.
The category, details, and end-use of the product should be submitted.
Address and proof of possession of the premises must be filed in sync as the details do not match most of the time.
A NABL accredited water test report should not be older than three months. The category and ingredients of the food product must be filed correctly as most of the time, the details are inappropriate.

Frequently Asked Questions

What types of food products or ingredients are covered under these regulations?

The following food products or ingredients are covered under these regulations:

Novel food or novel food ingredients.

New additives or new processing aids (including enzymes).

Articles/papers of food products or ingredients that contain or are isolated from microorganisms, bacteria, yeast, fungi, or algae.

Other non-specified food.

What is a novel food or food ingredient as per the FSSAI?

A novel food or food ingredient is the one that itself or any ingredient used in it does not have any history of human consumption. This also includes the food product or ingredients derived from any innovative engineering process, which changes the composition or structure of food, thereby altering the nutritional content, metabolism, or the levels of unwanted substances.

What is a new additive as per the FSSAI?

A new additive can be defined as an ingredient that has not been included in any specific food category per the Food Safety and Standards Regulations (FSSR). The products listed under this category also include the additive assessed for safety by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The food additive is included in Codex and approved by other regulatory authorities.

What is a processing aid as per the FSSAI?

A processing aid is not included in FSSR, but Codex and other regulatory bodies are categorized under new processing aid.

What does the COA should include?

A COA should include parameters relevant to the food product or ingredient like:

Physical parameters

Nutritional details

Active ingredient

Heavy metals

Residues

Microbiological parameters

Pesticide residues

Naturally occurring toxicants

Validated test method

Other tests method

References, wherever applicable.

Fssai License and Registration

What is

Form Names

Who Can Apply?

How To Apply?

Fee Involved

Validity

Important Documents

Timeline to get Form C from FSSAI

Essential Tips

Expert Advise

Frequently Asked Questions

food safety a shared responsibility

fssai-license-and-registration

Fssai License and Registration

What is

Form Names

Who Can Apply?

How To Apply?

Fee Involved

Validity

Important Documents

Timeline to get Form C from FSSAI

Essential Tips

Expert Advise

Frequently Asked Questions

food safety a shared responsibility