How to Get FSSAI Product Approval?

FSSAI product approval means the procedure through which a product gets approved as fit for consumption or use by the Food Safety and Standard Authority of India (FSSAI) before they are introduced in the market. The FSSAI has set standards for various food products throughout India through the Food Safety and Standards (FSS) Act, 2006 and various Regulations.

The FSS Act and Regulations cover a wide range of food products. However, there are many food products, ingredients or new food products introduced by Food Business Operators (FBOs) that are not covered under the FSS Act or Regulations. Since FSSAI is responsible for ensuring that standardised food is available across India, the food products not covered under any Regulations or the FSS Act require food product approval.

Background of FSSAI Product Approval

The FSSAI introduced a product approval system to undertake a safety assessment of the food products containing ingredients that do not have any prescribed standards after implementing the FSS Act and the Regulations. However, it was impossible to continue the product approval process for non-standardised food products or ingredients without legitimate regulations.

For addressing 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 harmonisation of food additives.  

Under these Regulations, many non-standardised food products or ingredients that would have required specific product approval from FSSAI got covered. Even after introducing the above Regulations, several food products or ingredients were not covered in any of the Regulations made under the FSS Act, 2006. 

To regulate such products or ingredients and provide an opportunity to 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.

Food Products That Require FSSAI Product Approval

Generally, the food products or ingredients that require product approval or prior approval from FSSAI are as follows:

• Health supplements.
• Nutraceuticals.
• Foods for special dietary uses.
• Foods for special medical purposes.
• Functional foods.
• Speciality 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 for the first time 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.

The following FBOs are also required to obtain product approval:

• FBOs whose food products or ingredients safety assessment has not been carried out.
• Existing licence holder for conversion to FSSAI licence and whose product safety assessment has not been carried out. 

Process for Obtaining FSSAI Product Approval

The process for obtaining the FSSAI product approval in India are as follows:

Business Entity Incorporation

The FSSAI product approval or prior approval for non-specified food products or ingredients is an intangible asset for any business entity. It provides the business entity with the authority to market or manufacture a specific type of product. Therefore, it is recommended that the business entity be established as a company or Limited Liability Partnership (LLP) before applying for prior approval.

Food Business Operator Licence

An FBO licence is required for businesses involved in manufacturing, selling, or handling food products. The FSSAI FBO licence certificate must be submitted while applying for food product approval. 

Test Reports

The application for food product approval should be submitted with certain test reports from the National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited labs. The NABL lab reports are used to validate the label claims, ingredients and other food product parameters. Especially when a food product has a health claim, the FBO must apply for product approval with a NABL accredited lab test report.

Food Product Label

The food product approval application should contain the label of the product. It is not necessary to print the label. It is essential to ensure that the food product label conforms to the FSSAI Food Product Labelling Standards.

Application for Food Product Approval

The FBOs can submit the application for product approval online through the FoSCoS website. The FBOs can select the state, category of food product, and submit the application along with the required documents on the FoSCoS website by paying the required fees. 

Scrutiny of Documents

After submitting the application for product approval, the food authorities will scrutinise 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 either grant food product approval or reject the application based on the safety assessment of the food product. When the approval 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.

Information Required for FSSAI Product Approval

The FBOs must submit the following information relating to the product or company in the product approval application:

• Business name, address, contact information and email.
• Nature of business.
• Manufacturers address.
• Method of manufacturing.
• Name of the food product, additive, ingredient, processing aid, enzyme and proprietary name, if any.
• Shelf life of the product.
• Ingredients details.
• Label for the food product.
• Certificate of analysis from NABL lab.
• Source of food ingredients.
• Functional use and intended use.
• Safety information.

Documents Required for Obtaining FSSAI Product Approval

The documents you need to be upload with the application are as follows:

• The layout of the manufacturing unit.
• Layout plan of the processing unit.
• List of directors.
• List of machines used in manufacturing.
• Address proof of directors.
• List of food categories to be manufactured.
• NOC (No Objection Certificate) and licence from the manufacturer.
• Certificate or food safety management plan. 
• Source of raw material.
• Pesticide residue report of water.
• Recall plan.
• Declaration form.

Benefits of FSSAI Product Approval

Below are the benefits of obtaining FSSAI product approval:

• The food product will have high public confidence as it ensures that the products are completely safe for consumption.
• FBO/company that obtains product approval will be benefited from an increased network due to industry engagement across stakeholders.
• Standardised 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 about the quality of the food product.

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