FSSAI Product Approval

FSSAI product approval is the process by which a product gets approved by the Food Safety and Standard Authority of India before they are introduced in the market. The FSSAI has set standards for various food products through the Food Safety and Standards (FSS) Act, 2006, and multiple Regulations. However, many new food products and ingredients are introduced by Food Business Operators (FBOs) every year that are not covered under the Act or Regulations. FSSAI Product Approval is mandatory for food products not covered under any FSSAI Act or Regulations.

The objective of FSSAI Product Approval

The primary objective of the FSSAI Product Approval system is to ensure that only standardized food is available across Indian Market.

Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations, 2017

To regulate such products or ingredients and provide an opportunity for the FBOs to innovate food products, FSSAI introduced the Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations, 2017. This regulation lays down the procedure and rules for granting prior approval of non-specified food products and ingredients.

Earlier Rules and Regulations for FSSAI Product Approval

The FSSAI introduced a product approval system to undertake a safety assessment of food products containing ingredients that do not have prescribed standards after implementing the FSSAI Act and the Regulations. However, continuing the product approval process for non-standardized food products or components was impossible without legitimate regulations. The product approval system for non-standardized food products/ingredients was discontinued on 26th August 2015. To address the situation arising after the discontinuation of the product approval system, the FSSAI has introduced the following regulation:

FSSAI revised the definition of proprietary food in the Food Safety and Standards (Food Product Standards and Food Additives) Ninth Amendment Regulations, 2016.
FSSAI introduced the Food Safety and Standards (Food or Health supplements, Nutraceuticals, Foods for specific dietary uses, Foods for medical purposes, Functional foods, and Novel foods) Regulations, 2016.
FSSAI notified the Food Safety and Standards (Food Product Standards and Food Additives) Seventh Amendment Regulations, 2016, relating to harmonizing food additives.

Even after introducing the above Regulations, several food products or ingredients were not covered in any of the Regulations made under the FSSAI. To regulate such products or ingredients, FSSAI introduced the Food Safety and Standards (Approval of non-specified food and ingredients) Regulations, 2017.

Benefits of FSSAI Product Approval

Below are the benefits of obtaining FSSAI product approval:

No person shall import or manufacture any non-specified food or food ingredient except with the preliminary approval of the Food Authority.
The food product will have high public confidence as it ensures that it is safe for consumption.
FBO/company that obtains product approval will be benefited from an increased network due to industry engagement across stakeholders.
Standardized inspection processes ensure minimal reputation risk and loss of time.
Since the safety and quality tests are highly accurate and benchmarked to worldwide standards, international customers will have confidence in the quality of the food product.

Who can apply?

The manufacturer or importer of non-specified food shall apply as per the 'Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, to get the FSSAI Product approval.

Food Products That Require FSSAI Product Approval

Food Business Operators who wish to manufacture/innovate/import food products with the following categories can apply for Non-specified FSSAI food approval:

Health supplements
Nutraceuticals
Foods for particular dietary uses
Foods for particular medical purposes
Functional foods
Specialty foods containing probiotics, prebiotics, or botanicals
Novel foods or novel food ingredients or foods processed with the use of novel technology
Products or ingredients that are new or being introduced in India
Proprietary product or ingredient
New processing aids, including enzymes
New additives
Articles of food and ingredients consisting of or isolated from bacteria, microorganisms, fungi, bacteria, yeast, or algae

Prescribed Fee for FSSAI Product Approval

All new applications seeking proper approval of non-specified food and food ingredients are advised to submit Form 1, dully filled along with the fees of Rs.500000 payable to the Seniors Accounts Officer, FSSAI.

Documents Required for Obtaining FSSAI Product Approval.

To seek non-specified food approval, the applicant must submit the following documents:

An FSSAI license for the food product
Demand draft, which needs to be payable to the Senior Accounts Officer of the FSSAI.
Agreement of relation between the FBO, manufacturer, and other partners involved.
The information on the manufacturing process of the food product.
The test report was obtained from the National Accreditation Board for Testing and Calibration Laboratories (NABL) or International Laboratory Accreditation Cooperation (ILAC).
Details of any new technology
The history of quantity and duration of the food product or ingredient consumption.
The regulatory status of the ingredient or food product worldwide

Process for obtaining FSSAI Product Approval

The following is the procedure for obtaining FSSAI product approval in India:

FSSAI Product Approval

Business Entity Incorporation

FSSAI product approval is an intangible asset for any business, as it gives the company the authority to manufacture or market a specific food product in India. Further, each FSSAI product approval is granted only after a considerable amount of processing time and involves payment of high processing fees to FSSAI. Therefore, it is recommended that the FSSAI product approval application be made from a corporate entity like a Private Limited Company or LLP so that business can be easily transferred at a later time along with the food product licenses if required.

Food Business Operator License

A food business operator license is required for businesses involved in manufacturing, handling, or selling food products. While applying for food product approval, a copy of the FSSAI food business operator license certificate must be submitted. Hence, a food business operator license is recommended to be obtained in the business's name if required. IndiaFilings can help you get the FSSAI Food Business License.

Test Reports

The application for food product approval must be submitted along with specific test reports from NABL-accredited labs. The NABL lab reports are used to validate the claims, label claims, ingredients, and other parameters of the food product. The type of tests for the food product will vary based on the nature of the product. The list of NABL-accredited labs in India is as under: List of NABL Labs in India

Application for Food Product Approval

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

General information (Details of Company, Authorized Person, FSSAI license, Kind of business, etc.)
Product-related information (Product details, Intended use, formulation details, Functional use, Manufacturing process)
Safety detail and combinatorial effects may include but are not limited to Toxicological studies, Allergenicity, and Pre-clinical and Clinical trials)
The regulatory status of the product in other nation
History of consumption of food in the last thirty years
Lab test reports from International Laboratory Accreditation Cooperation/National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited labs are also needed.
Any other additional details or documents which are specific to the product/ ingredient

Scrutiny of Documents

After applying for product approval, the food authorities will scrutinize the application and documents. The food authorities may ask the FBOs to submit additional supporting documents or clarifications.

Issue of FSSAI Product Approval

The food authorities can grant food product approval based on the safety assessment of the food product. FSSAI Product Approval will be issued in Form II. When permission is granted, the FBO should submit a certificate of analysis regarding the physical, microbiological, chemical, and nutritional parameters of the food imported or manufactured to the food authorities. IndiaFilings can help you get an FSSAI license. For more information, visit IndiaFilings.com and talk to an IndiaFilings Advisor.