FSSAI Product Approval


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FSSAI Product Approval

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 FSSAI Product Approval

FSSAI Product  Approval is basically a procedure in which FSSAI, the Food Safety and Standards Authority of India deems a product fit for consumption/ use in further food production capacity. The product approval by FSSAI is needed when the ingredients of the product do not comply with the regulations of the Food Safety and Standards Act. A Food Business Operator (FBO) might have to get the FSSAI product approval in case the food has some additives not prescribed under the regulations of FSSAI.

A product willing to enter the FSSAI approved product list, had to do so via filing the FSSAI Product approval application and a demand draft for the prescribed fee to the FSSAI office in New Delhi. This system worked well up until a few years. However, as soon as the volume of applications to FSSAI increased they decided to switch to the  FSSAI Product Approval System (FPAS) online.  This online system was also brought in to increase the transparency in the product approval procedure by FSSAI.

The Product approval by FSSAI is granted at a Central Government level.

Which Food Products require product approval ?

Food products includise of Food Ingredients or food additives for which there are no standards notified by FSSAI will require product approval. However, recently FSSAI has tried to include many categories of food products eligible for approval. Some of these include :

  • Health Supplements
  • Nutraceuticals
  • Foods for Special Dietary Uses
  • Foods for special Medical purpouses
  • Speciality foods containing or botanicals
  • Foods containing probiotics
  • Foods containing prebiotics
  • Novel Foods
  • Products/ingredients which are new
  • Propreitary Product/ Ingredient

These products have been notified for product approval under the Food Safety and Standards (Food or Health Supplements,Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpouse, Functional Foods and Novel Food) Regulation, 2016

In addition to this, following FBO’s are covered under the notification for Product Approval

  • FBOs whose food products/ingredients safety assesment has not been carried out
  • Exisiting license holder for conversion to FSS License and whose product safety assesment has not been carried out.
  • FBO’s who’s food products/ingredients are being introduced into the country for the first time.

Essential Documents for FSSAI Product Approval

  • Business Address
  • Email Address
  • Phone Number
  • Manufacturer Address
  • Type of Business
  • Product Origin
  • Country of Origin
  • Existence in the Market
  • Common Name
  • Brand Name
  • Method of Manufacturing
  • Product Claims
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  • Shelf Life
  • Pack Size
  • Serving Detail
  • Ingredients Detail
  • Label of Food Product
  • Method of Manufacturing
  • Accelerated Stability Datasheet
  • Real-time Stability Datasheet
  • End-Use Declaration Document
  • Certificate of Analysis from NABL Lab
  • Undertaking and Form-9

Process for FSSAI Product Approval

 

The procedure for the FSSAI product approval consists of the following steps:

Start a Business (Business Structure Establishment)

The approval for a food product by FSSAI is the lifeline of food businesses as it grants the business the power to manufacture and market certain types of products in India. FSSAI product approval is granted only after a considerable amount of processing and procedures and it also includes a payment of high fees to the FSSAI.   Therefore, in order to streamline the procedure of approval for a product, it is advisable to incorporate a corporate entity like a Private Limited Company, Proprietorship or an LLP.

Food Business Operator License

The Food Business Operator License or the FSSAI License as it is generally referred to is the basic necessity for businesses involved in the manufacture, handling, selling of food products. In order to get your food product approval,  a copy of the FSSAI license of the operator is needed to be attached to the food product approval application. Here, at LegalRaasta we can help you acquire the FSSAI License.

Test Reports

The food product approval procedure in India requires that along with the application, and the food license, you also submit a bunch of test reports from National Accreditation Board for Testing and Calibration Laboratories (NABL) Accredited Labs. The tests conducted on a particular product vary according to the type of the product. The NABL lab reports are used to validate the claims made by the food business about the product including label claims,  ingredients of the product along with other food safety management parameters.

Food Product Label

The application for approval of food product by FSSAI should enclose the label of the product. The label can just be a blueprint/prototype of the original label and it isn’t necessary to prin the label while the approval procedure is going on. However, it is vital that the food product label conforms to the food product labelling Standards as specified in the FSSAI Packaging and Labelling Regulation Act, 2011.

Application Submission

Once all of the above information has been compiled and put in order the application for approval of food product can be submitted online. The application can be made on the Food Product Approval System (FPAS).

This procedure can be a taxing and highly tedious while running fully functional Food Business. Consider taking professional help from the experts at LegalRaasta, where we pride ourselves in simplifying compliances and procedures for businesses. Fill up the form above or give us a ring at +91-875-000-8585.

Documents required to be enclosed with New application for license/import license to state/Central Licensing Authority

  • Form A, Form B, and Form C
  • A layout of the Manufacturing unit
  • A layout plan of the processing unit
  • List of directors
  • List of machines with names which are used in manufacturing
  • Photograph ID with address proof
  • List of food category to be manufactured
  • A letter of Authority with the name and address of the responsible person
  • NOC & License from the manufacturer
  • Certificate or Food safety management plan (if any)
  • Procurement plan for milk or source of milk including the location of milk collection centers
  • Source of Raw material
  • Pesticide residue report of water
  • Recall plan
  • Form IX
  • A certificate provided by Ministry of tourism
  • A declaration Form

Procedure of Nutraceutical License

Follow the given steps to obtain the nutraceutical license:

What Is Included In Our Package?

Advantages of Nutraceuticals License

Following are the advantages of the Nutraceuticals license:

  • Legal Advantage
  • Many business identities often think that the process of obtaining Nutraceutical license is expensive, time-consuming and an inconvenient procedure of unnecessary documentation, ultimately try to ignore it. But, the process is not that cumbersome in reality. Our company can help you to get the license with ease. It’s better to spend some money on license rather than being caught for not having a license. It provides you the legal security. Hence, it is advisable for every businessman to first get the license before entering into a business.

  • Consumer Awareness
  • Nowadays, consumers are already so informative and alert regarding the food quality which they go out to buy. There are a lot of options even for a single food item. So, the consumers choose wisely which one to buy and which one is not safe for them. Your Nutraceutical license can give the consumer a sense of security to buy your product as it is governed by FSSAI.

  • Business expansion
  • When it comes to expending the business, Nutraceutical license can be proved an ace for easily doing it. This license will help you to maintain goodwill in the market and open a new direction to expand with ease. Not only this rather it makes it easier for you to get bank loans and for funding which is the key to expansion.

  • Enhance credibility and reliability
  • As you can use the license after registration, slowly and gradually the consumer will more rely on your outlet/business because they will get what they want in good quality. It will increase the credibility of your business in the market.

Benefits of FSSAI Product Approval

  • Your brand will be established with a high public confidence as a seller of produts completely safe for consumption.
  • Aggresive Industry Engagement across Stakeholders will benefit the business with increased outreach and networking.
  • Standardized Inspection procedure ensures minimization of time loss as well as least har to the reputaton of the products and the orgnaization.
  • Not just local but international consumers will be confident of the quality of your products as the quality testing is done compliant with worldwide standards and quality benchmarks.

Frequently Asked Questions

1. What is Product Approval?

Product Approval is essentially processing which a Food Product is approved by FSSAI. These products have ingredient(s) and/or additives which are not according to the prescribed standards in the Food Safety and Standards Act.

2. What is a No Objection Certificate(NOC)?

In the FSSAI product Approval procedure, a NOC is essentially the Interim Permission to place product (s) / additives/ ingredients on the Market.

When does a Food Business Operator (FBO) need to acquire a Food Product Approval?
An FBO needs a FSSAI product approval when the food products or their ingredients contain additives/ supplements which have not been specified in the Food Safety and Standards Act, 2006.

3. What is the procedure of the renewal of NOC?

The NOC for FSSAI product approval is valid for a time period of 1 year. This NOC will be sent to the scientific community/ panel for an assessment. Based on the positive results of the assessment, NOC can be extended further after a proper application and specified fees are submitted to the FSSAI’s Central Branch.

4. If I change the composition of my products eg. Glucose 25% to 20 %, Do I need to file for approval again?

Yes, barring only cases where FSS regulations specify otherwise.

5. Does every product with a flavour change or slight change in composition require a Product Approval?

Yes, every product which has varying ingredients and/or additives needs a separate product approval.

6. Do I need separate Product approval for products with the same composition but different names?

No, as long as the label claims are the same.

7. What are Traditional/Ethnic Foods?

Ethnic foods are those which are consumed locally in and across the country.

8. Do I need a Product Approval for Ethnic Foods?

The traditional/ ethnic foods mentioned in the regulation 3.1.1. (2) of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 namely, –Snacks of Savouries (Fried Products), such as Chiwda, Bhujia, Dalmoth, Kadubale, Kharaboondi, Spiced and fried dals, banana chips and similar fried products sold by any name, Sweets,

Carbohydrates based and Milk product based, such as Halwa, Mysore Pak, Boondi Ladoo, Jalebi, Khoya Burfi, Peda, Gulab Jamun, Rasogolla and similar milk product based sweets sold by any name
Instant Mixes Powders only of Idli mix, dosa mix, puliyogare mix, Pongal mix, Gulab jamoon mix, Jalebi mix, vada mix, Rice and Pulses based Papads, Ready-to-Serve Beverages (tea/coffee based only) are not required to get product approval, provided it contains food additives permitted in Table 2 of Appendix A of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.

9. If a Proprietary ingredient is added to a standard product, Does it also become a proprietary Product?

Yes, the final product becomes a proprietary food and will need a separate product approval.

10. Can the application for NOC/Product approval be considered for any other aspect besides ingredient safety?

The Product Approval committee examines the safety of the ingredient and grants NOC on the basis of satisfaction of overall product safety for consumption.
In case there are label claims, declarations, advertisement claims, nutritional information of the products associated with such products, the committee reviews the application for FSSI product approval with regards to :

  • Listing of ingredients
  • Nutrient Value
  • Impact on food safety
  • Claims related to new ingredients
11. How will I get to know the status of my Product Approval application?

The status of the application is sent via Speed Post within a time frame 10 days.

12. What is the status of the NOC if the panel has rejected an application for product approval?

If the panel has refused to provide the Food Business Operator with a product approval for the additives/ food ingredient(s) before or even after the validity of the NOC, the FBO is obligated to stop the manufacture /import of such food products with immediate effect.
FBO also needs to recall any product they have in the market if any.

13. Do food products for export purpouse require Product Approval?

The product approval is required for the manufacturing of food products by 100% EOI units which sell and distribute a part of the food products domestically.
Further, the units covered under the Special Economic Zones (SEZs) as defined by the Ministry of Commerce are not required to apply for the product approval.

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