How to Get FSSAI Product Approval?

What is Food Product Approval System (FPAS)?

The Food Product Approval System (FPAS) is an online tool that helps food businesses (FBOs) determine if their products require approval from FSSAI under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. This simplifies the process for FBOs, making it easier to do business.

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Categories of Products that Require FSSAI Product Approval

The food products or ingredients necessitating product approval or prior sanction from the Food Safety and Standards Authority of India (FSSAI) encompass the following categories:

• Health supplements
• Nutraceuticals
• Foods for special dietary uses
• Foods for special medical purposes
• Functional foods
• Specialty foods containing probiotics, prebiotics, or botanicals
• Newly introduced food items, experimental food ingredients, or products prepared using cutting-edge culinary technologies
• Novel products or ingredients making their debut in the Indian market
• Proprietary products or ingredients
• New processing aids, including enzymes
• New additives
• Articles of food and ingredients consisting of or isolated from bacteria, microorganisms, fungi, yeast, or algae.

Additionally, the following Food Business Operators (FBOs) are mandated to secure product approval:

• FBOs whose food products or ingredients have not undergone safety assessment.
• Existing license holders seeking conversion to FSSAI license, whose product safety assessment has not been conducted.

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How to Get FSSAI Product Approval in India

The procedure for acquiring FSSAI product approval in India is outlined as follows:

• Business Entity Incorporation: It is imperative for a business entity to be established as a company or Limited Liability Partnership (LLP) prior to seeking FSSAI product approval. This approval, whether for a specified or non-specified food product or ingredient, is a valuable asset, granting the entity the authority to market or manufacture a specific product.
• Food Business Operator Licence: Businesses engaged in the manufacturing, selling, or handling of food products must obtain an FBO license. The FSSAI FBO license certificate should be submitted during the application for food product approval.
• Test Reports: The application for food product approval must be accompanied by specific test reports from laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL). These reports, particularly important for products with health claims, validate label claims, ingredients, and other parameters. Especially when a food product has a health claim, the FBO must apply for product approval with an accredited lab test report.
• Food Product Label: The application for food product approval should feature the product label, although it is optional to physically print the label. It is crucial to ensure that the food product label adheres to the FSSAI Food Product Labeling Standards.
• Application for Food Product Approval: FBOs can conveniently submit the application for product approval online through the Food Safety Compliance System (FoSCoS) website. This involves selecting the state and category of the food product and submitting the application along with the necessary documents, accompanied by the requisite fees.
• Scrutiny of Documents: Following the submission of the application, food authorities will meticulously scrutinize the provided documents. If necessary, they may request additional supporting documents or clarifications from the FBOs.
• Issue of FSSAI Product Approval: Based on the safety assessment of the food product, the food authorities will either grant approval or reject the application. In case of approval, the FBO is required to submit a certificate of analysis, detailing the physical, microbiological, chemical, and nutritional parameters of the imported or manufactured food product to the relevant authorities.

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A Checklist of Information required for FSSAI Product Approval

Getting your products approved by the FSSAI needs some information as below:

• Business name
• Business address
• Brand name
• Method of manufacturing
• Name of the food product, additive, ingredient, processing aid, enzyme, and proprietary name, if any.
• Claim, if any
• Product’s shelf life
• Pack size
• Serving details
• List of ingredients and their sources
• Nutritional information
• Label and packaging details
• Certificate of analysis from an accredited laboratory
• Safety data sheet
• Relevant scientific literature or evidence to support the claim or safety of the product

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Documents Required for FSSAI Product Approval

You required some documents to get your product approved by the FSSAI as below:

• Processing unit layout plan.
• Manufacturing unit layout.
• Directorial list.
• Address verification for directors.
• Comprehensive list of food categories for production.
• Inventory of manufacturing machinery.
• Manufacturer's No Objection Certificate (NOC) and license.
• Source documentation for raw materials.
• Water pesticide residue report.
• Certification or food safety management plan.
• Recall plan.
• Declaration form.

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Benefits of FSSAI Product Approval

There are many benefits to obtaining FSSAI Product Approval for both consumers and businesses.

For consumers:

• Increased confidence in the safety of food products: The FSSAI approval process is rigorous and includes testing for safety and quality. This means that consumers can be confident that the food products they are buying are safe to eat.
• Improved access to a wider variety of food products: The FSSAI approval process makes it easier for new and innovative food products to enter the market. This means that consumers have a wider variety of food products to choose from.
• Reduced risk of foodborne illness: The FSSAI approval process helps to prevent foodborne illness by ensuring that food products are produced under safe and hygienic conditions.

For businesses:

• Market access: FSSAI Product Approval is mandatory for selling non-specified food products in India. This means that obtaining approval is essential for any business that wants to sell these products in the Indian market.
• Brand protection: The FSSAI approval process helps to protect businesses from reputational damage caused by food safety issues. By ensuring that their products are safe, businesses can build trust with consumers and protect their brand reputation.
• Reduced costs: The FSSAI approval process can help businesses reduce costs by preventing product recalls and other food safety issues.

Here are some additional benefits of FSSAI Product Approval:

• Standardized inspection processes: FSSAI approval means that your business will be subject to standardized inspection processes. This can help to reduce the risk of being fined or shut down by the FSSAI.
• Increased export opportunities: FSSAI approval can make it easier for your business to export your products to other countries. This is because many countries require that imported food products meet their own food safety standards.
• Access to government grants and subsidies: The Indian government offers a number of grants and subsidies to businesses that are FSSAI approved. This can help to reduce the cost of doing business and make your business more competitive.

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Post-Approval Compliance

Once you’ve gotten FSSAI product approval, your journey does not end here; you have to maintain post-compliance to ensure your product remains in the market afterward. Here are some key post-approval compliance steps:

• Renew Your FSSAI License on Time: Always ensure timely renewal of your FSSAI license to steer clear of any legal complications or interruptions in your operations.
• Comply with FSSAI Regulations: Stay updated and adhere to all FSSAI regulations, including any amendments or new guidelines issued, to maintain compliance.
• Follow Product Labeling and Packaging Standards: Ensure your product labeling and packaging align with FSSAI standards to avoid penalties and foster consumer trust.
• Implement Food Safety Management Systems (FSMS): Establish and maintain effective food safety management systems to ensure consistent compliance with FSSAI requirements.
• Be Prepared for Regular Monitoring and Surveillance: FSSAI frequently conducts monitoring and surveillance to verify that your products meet approved standards, so continuous quality assurance is essential.

Facing delays in getting your product approved by FSSAI? Let our experts handle it for you. Contact us now.

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