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:
The applicant must fill Form-I for applying for non-specified food approval by FSSAI.
The approval or rejection of non-specified food would be obtained by Form-II.
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:
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General information (Details of Company, Authorised Person, FSSAI license, Kind of business, etc.) |
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Product related information (Product details, formulation details, Functional use Intended use, Manufacturing process) |
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Safety Information and combinatorial effects (may include but not limited to Toxicological studies, Allergenicity, Pre-clinical and Clinical trials) |
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Regulatory status of product in other countries |
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History of consumption of food in the last 30 years |
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Lab test reports from ILAC/NABL accredited labs |
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Any other additional details or documents which are specific to the product/ ingredient |
To obtain non-specified food approval by FSSAI, the applicant is required to pay 50,000 INR per application.
This license is valid for a lifetime.
There is no official timeline specified by FSSAI, however as per our experience, they provide the final approval/rejection within 9-12 months.
To avoid any queries or delays in the approval, the applicant looking for permission for non-specified food approval must ensure these essentials are followed:
The applicant must select the food product or ingredient category carefully to reduce the chances of rejection.
The safety details of the food product or ingredients must be available. If the safety data is not sufficient, the applicant must submit human clinical trials data for safety.
The efficacy, functional use, and dosage of the product must match as per the claims.
An incorrect selection of food products or ingredients can raise the chances of queries (if the incorrect selection occurs frequently).
Incorrect interpretation of the regulatory status of the food product or ingredient can raise queries.
The applicant must not submit an in-house COA. The only COA approved by NABL/ILAC are mandatory.
The applicant must ensure that they include only the nutritional benefits of the food product or ingredient. Drug-like application of the food product or ingredient leads to rejection.
The applicant should only submit non-GM food products to the FSSAI.
If the product contains more than one ingredient, the applicant must ensure that the combinatorial effects of these ingredients are safe and efficacious.
The following food products or ingredients are covered under these regulations:
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.
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.
A processing aid is not included in FSSR, but Codex and other regulatory bodies are categorized under new processing aid.
A COA should include parameters relevant to the food product or ingredient like:
