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PRODUCT APPROVAL - Non –Specified Food Ingredients/ Products

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  • PRODUCT APPROVAL - Non –Specified Food Ingredients/ Products

Non Specified Product / Ingredient Approval

As per the Food Safety and Standards Authority of India (FSSAI) provisions, an importer or manufacturer who wishes to initiate food business on any premises is required to take FSSAI license. The importer or manufacturer needs to obtain a Form C to carry out any food-related business. The process for obtaining FSSAI permission is as follows:

  • 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.
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What is

Form I and II

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Form Names

(I) The applicant must fill Form-I for applying for non-specified food approval by FSSAI.

(II) The approval or rejection of non-specified food would be obtained by Form-II.

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.

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.

food safety a shared responsibility

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