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FAQ's on FSSAI compliance requirements
FAQ’s on Food compliance management in India - Vol 1
FAQs on FSSAI Compliance
1. What permits are required to start a food business?
In Indian context, there is a complex governance structure between state and central departments, hence the requirements vary from the place one operate the business. Besides, GST, local body (trade, municipal body) license, FSSAI (food) license is required for starting a food business. Based on the size and reach of the business the requirements too can vary
2. What are the types of food licenses in India?
Based on the turnover and production capacity FSSAI license was classified into 3 types. First and foremost, is central license awarded for those units with production capacity (or installed capacity too) of more than 2 Metric Tonnes (MT) per day. Secondly, state license is awarded for production capacity above 1 MT per day less than 2 MT per day. Lastly, for business like petty vendors, hawkers, street food vendors registration category
3. What is a standard product?
Standard products are the food items that are defined in the FSS regulations i.e. the product definition covers the description, method of manufacturing, permitted ingredients, quality parameters for each category.
For instance a fruit beverage manufacturer should review the definition of 126.96.36.199 - thermally processed fruit juices for claiming the product to be standardized. Definition includes ingredients, processing methods and compliance to quality compliance parameters i.e. Total soluble solids (TSS) and Acidity. Only such holistic consideration of the definition would make the product standardized
4. Which category of license is required for standard product?
Since, for a standard product necessary risk assessment is already performed by the food authority before lodging them in the regulations, the food business operators (FBOs) can either apply license from central authority or state authority based on the installed capacity
5. Which products are approved by Indian food authority (FSSAI)?
While it is not possible to list the entire list of approved products in this forum, we would let you the sources from where one can get the list of standard (approved) by FSSAI
a.Link for food product standards (Click here) - FSSAI updates this file every 6 months, for the amendments issued during this period has to be viewed separately in the gazette notification tab
b.Link for other product standards (Click here) – Besides above link, FSSAI has published standards for few functional foods like supplements, nutraceuticals, food for special dietary and medical purposes etc., which would also be considered as standard products too
c.Lastly, on a frequent basis the authority considering the representations from stakeholders would enhance the database of the approved products
6. What are non standardized products?
Any product that doesn’t have standards prescribed in FSS regulations are treated as non standardized products
7. How to categorize non standardized products?
The Indian food regulator has adapted the below two pronged approach in addressing the non-standardized products
a. Proprietary foods: Any non-standardized product that contain ingredients other than additives which are either standardised or permitted for use in the preparation of food products under the Food Safety Standards and Regulations can be recognized as proprietary foods
b. Food not specified: a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances.
8. How to manage compliance of proprietary foods?
As the name suggests proprietary food formulation is owned by brands. As a result, FSSAI has made food business responsible for the safety of the product composition unlike standard products. Hence, it is important for food business to assess the product composition with the approved databases listed in question 5 and also get the product tested for safety parameters
9. Does a Proprietary food require a central license?
Yes, as per the schedule I of licensing regulations, all proprietary foods irrespective of turnover and production capacity the manufacturer of proprietary foods shall obtain license from central licensing authority
10. Does proprietary food require any additional label declaration?
Yes, as per 2.12.1 every proprietary food shall bear a declaration of sub category, nature and composition of the product.
11. How to manage compliance of food not specified or novel products?
As indicated in the earlier sections, manufacture of new ingredient, additive and process other than the ones prescribed in the FSS regulations would make the product novel (or new or not specified). Hence, as per section 2 of novel food regulations, no person shall import, manufacture and market novel products without prior approval from food authority (FSSAI). Hence, the brand owner of the novel food manufacturer should file a manual application with the authority for obtaining a go ahead
12.What is the process involved in evaluating novel foods or food not specified? Or what is the process of product approval?
High level process flow of FSSAI new product approval process
Above provided is a high level process flow of the product approval function. Although, there could be slight changes* in the flow, the broad functionality of the process remains as prescribed in the above diagram
(*at times approval would be awarded without referring to scientific panel or the application can move in parallel between screening committee and scientific panel depends on the nature and complexity of the product)
13.What is the fee for product approval and what documents are required for filing application?
Currently, the process of approving product is offline. Hence a demand draft of INR 50,000 is required along with form I. This application form should be accompanied with Ingredient details (source, composition), End Use, Market Existence (export market), Manufacturing process, Certificate of analysis and other safety information pertaining to the product (or ingredient/ additive) that help the authority in evaluating and taking decision regarding the approval
14. What is the time frame for issuing approvals for new products?
Like any government department in India, the timelines for issuing approvals were not prescribed by food authority. Rather the applicant can optimize the delays by providing accurate and relevant information to the authority. Moreover lack of online application make this process more tedious and more obscure
15.What happens when the approval is awarded for the ingredient or additive or product?
Once the approval or rejection is awarded, the product (or ingredient or additive) would fall in the respective databases of FSSAI i.e. approved or not approved. In case of positive result, the manufacturer has to update the license with the approved product from the central licensing division. For a rejection case, at present there is no mechanism to challenge the decision of the authority
Please use Ask an expert option (on the homepage) to get a free response on compliance matters. We undertake corporate workshops on product categorization, labelling requirements, enforcement responses and other legal compliance matters (different from the usual FOSTAC training sessions). Please write us at firstname.lastname@example.org
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