FSSAI Product Approval in India

FSSAI product approval is specifically for 'non-specified' foods, products containing new ingredients, additives, or using unique manufacturing processes not already covered by existing FSSAI regulations.

However, if your product uses standard ingredients and processes, you would likely only need a standard FSSAI License, not separate product approval.

The approval process is done online. You’ll need to provide details like ingredients, manufacturing methods, and safety test results. FSSAI experts will review your submission. If everything checks out, you’ll receive approval to sell your product legally in India.

Rules and Regulations for FSSAI Product Approval

The Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017, outline the guidelines for product approval. These regulations specify:

• Which food products need approval
• What documents you must submit
• How to apply for approval
• How to renew your approval after it expires

These regulations help ensure food safety and protect consumers.

According to the 2017 regulations, non-specified foods include:

• New additives that haven’t been approved by FSSAI
• Novel foods or genetically modified ingredients
• Foods with new sources of ingredients
• Foods that don’t fit into standard categories covered by FSSAI’s main regulations

If your product falls under these categories, FSSAI approval is mandatory before you can sell it.

Why Is FSSAI Product Approval Required?

FSSAI product approval is needed to protect people’s health. It makes sure that new or unusual food products are safe to eat. You are not allowed to sell such products in India without this approval. Approval also helps customers trust your product and lets you sell it across the country without legal problems.

Here are some key benefits of having FSSAI product approval:

• Food Safety: The main benefit is that your food product is tested and confirmed safe for people to eat. This helps protect public health.
• Trust from Customers: When your product has FSSAI approval, customers feel confident buying it. They know it meets quality and safety standards.
• Legal Permission: Without FSSAI product approval, selling certain food products is illegal. With this approval, you gain the legal authorization to sell your product.
• Pan-India Market Access: Approval allows you to sell your product anywhere in India. It opens doors to bigger markets and more customers.
• Brand Value: Having FSSAI approval adds value to your brand. FSSAI approval demonstrates your commitment to quality and safety.
• Avoid Penalties: Selling food without approval can lead to fines or business closure. Approval helps you avoid these problems.
• Better Business Growth: With approval, you can expand your business confidently, knowing your products meet all standards.

FSSAI product approval is not mandatory for everyone. It is mainly for those who make or sell food products that are new or not covered under existing standards. Here’s who can apply:

• Food Manufacturers: Companies or individuals who produce new food products or use new ingredients.
• Importers: Businesses that bring food products from other countries that are not already approved in India.
• Food Business Operators: Anyone involved in selling or distributing non-standard food items.
• Startups and Entrepreneurs: New food businesses launching innovative or unique food products.
• Research Institutions: Organizations developing new food products for commercial use.

If your product is not listed in the FSSAI-approved products list, you must apply for product approval under FSSAI.

Not all food products need FSSAI product approval. Many common foods already have standards and do not require separate approval. However, you need approval if your product falls into these categories:

• New Food Products: Foods that are not mentioned in the existing FSSAI food standards.
  Example: Plant-based meat alternatives (e.g., Beyond Meat)
• Non-Specified Foods: Items that use new ingredients or additives not listed in the regulations.
  Example: Foods with new, unapproved additives like certain artificial sweeteners or flavor enhancers.
• Imported Foods: Food products brought from outside India that do not match Indian standards.
  Example: Imported snacks like European chips or health bars that don’t meet Indian nutritional labeling standards.
• Foods with Health Claims: Products that claim to improve health or nutrition but do not have prior approval.
  Example: Energy bars claiming to boost immunity or weight loss shakes without prior FSSAI approval.
• Novel Foods: Foods made using new technology or processes that are not yet regulated.
  Example: Foods created using gene-editing technology (e.g., CRISPR-modified crops).
• Proprietary Foods: Foods with a unique recipe or formulation that are not part of the standard FSSAI categories.
  Example: Custom protein powders or unique herbal teas not listed in standard food categories.
• Functional or Nutraceutical Foods: Foods that provide health benefits beyond basic nutrition, including supplements or enhanced foods.
  Example: Probiotic yogurt or omega-3-enriched drinks.

Before applying, always check the FSSAI-approved products list to ensure your product requires approval.

To apply for FSSAI product approval, it's essential to gather the right information and documents. Being well-prepared will help streamline the approval process. Here's a combined checklist of the key details you need to submit:

• Product Name & Description: Provide clear details about the product, including its purpose and features.
• Ingredients List: Include all ingredients, their sources, and quantities.
• Manufacturing Process: Describe the step-by-step process of how the product is made, possibly with a flow chart.
• Safety Data: Provide test reports from certified labs (e.g., NABL) confirming the product is safe.
• Nutritional Information: Include data on calories, vitamins, minerals, and other essential nutrients.
• Packaging & Labeling: Provide sample labels that comply with FSSAI’s rules, showing ingredients and nutritional facts.
• Shelf Life: Specify how long the product remains safe and fresh.
• Quality Control Measures: Explain the methods you use to ensure consistent quality throughout production.
• Scientific Evidence: Submit studies or research supporting the safety and health benefits of your product.
• Import Documents (if applicable): Include documents proving the legal import of ingredients or finished products.
• Category/Sub-category Mapping: Classify your product under the correct FSSAI food category and sub-category.
• Food Additive Details: If applicable, list any additives used, their source, and approval status.
• Declaration & Undertaking: Provide a signed statement confirming the accuracy of all the submitted details.

Additional Key Documents Required

• Application Form: Complete and accurate FSSAI product approval application form.
• Product Label and Artwork: Include clear images of the product label with required nutritional and ingredient details.
• Certificate of Analysis: Test results from an accredited lab showing the product meets safety standards.
• Safety & Efficacy Data: Include scientific proof of the product's safety and benefits.
• Packaging Details: Provide information on the packaging material and how it protects the product.
• Shelf Life Data: Indicate how long the product remains fresh and safe for consumption.

Ensure all these documents and information are accurate and complete before submitting your application. Missing or incorrect details can delay the approval process. Following this checklist will help you secure FSSAI product approval faster, allowing you to legally market your product and gain trust from customers. Always check the latest FSSAI guidelines to stay updated on any changes.

Navigating the FSSAI product approval process is straightforward with a clear, step-by-step approach.

• Step 1: Check if Your Product Needs Approval: First, check the FSSAI-approved products list. If your product is not listed, you need to apply for approval.
• Step 2: Prepare Documents: Collect all the documents listed above. Use the FSSAI product approval checklist to be sure nothing is missing.
• Step 3: Fill the Application Form Online: Visit the official FSSAI website and fill out the FSSAI product approval application form. Provide all product details and upload the required documents.
• Step 4: Pay the Fees: Pay the FSSAI product approval fees online. The fee depends on the type of product and application.
• Step 5: Application Review: FSSAI experts will review your application. They may ask for more information or product samples.
• Step 6: Product Testing (If Needed): Sometimes, FSSAI may test your product in a lab to check safety.
• Step 7: Get Approval: If everything is fine, FSSAI will issue the product approval certificate. You can check your FSSAI product approval status online anytime.
• Step 8: Renew Approval: Product approval is valid for a certain time. Renew it before expiry to continue selling your product legally.

The FSSAI product approval charges vary depending on the product and application type. Here are some important points about the fees:

• The basic fee for product approval is usually around ₹50,000 per application (for non-specified food products).
• Additional charges may apply for lab testing or special reviews.
• Fees must be paid online during the application process.
• Renewal fees are generally lower but must be paid on time to keep approval active.

Paying the correct fees on time helps avoid delays or rejection of your application.

Remembering to renew your FSSAI product approval is crucial, as it is only valid for a limited time. FSSAI product approval can be obtained or renewed for a period ranging from 1 year up to a maximum of 5 years, depending on the choice of the food business operator. This flexibility allows businesses to select the validity duration that best suits their needs while ensuring compliance with all regulatory requirements.

To continue operating legally, it is important to renew the approval for the product before it expires. Failure to renew on time may require the business to apply for a fresh license, which can delay operations.

The renewal process is quite similar to the initial application. Here’s what you need to do:

• Apply Early: Start the renewal process well before your current approval expires. This helps avoid any gaps in your legal permission to sell the product.
• Update Documents: If there have been any changes in your product’s ingredients, manufacturing process, packaging, or labeling, you must submit updated documents. This keeps FSSAI informed and ensures your product remains compliant.
• Pay Renewal Fees: Renewal fees are usually lower than the initial application fees, but they must be paid on time. Late payments can cause delays or even cancellation of your approval.
• Submit Online: Use the official FSSAI online portal to submit your renewal application. Upload all required documents and pay the fees electronically.

Failing to renew your product approval on time can lead to serious consequences. If your approval expires, you cannot legally sell your product, and you may face fines or legal action. In some cases, you might have to apply for fresh approval, which means going through the entire process again. This can cause delays and loss of business.

The FSSAI product approval process can be challenging, especially for new food businesses. Many applicants face common problems that slow down or block approval. Understanding these challenges and knowing how to solve them can save time and effort.

Challenge 1: Missing or Incorrect Documents

One of the biggest reasons for delays is incomplete or wrong paperwork. If you miss any required documents or provide incorrect details, FSSAI will ask for corrections, which slows down approval.

Solution: Use a detailed FSSAI product approval checklist before applying. Carefully check every document and fact. Double-check labels, ingredient lists, and test reports. This reduces mistakes and speeds up approval.

Challenge 2: Confusing Rules and Guidelines

FSSAI rules can be hard to understand. Many people get confused about which products need approval and what documents to submit.

Solution: Always read the latest FSSAI guidelines for product approval. These guidelines explain the process clearly. If you are unsure, seek help from experts or consultants who know the rules well.

Challenge 3: Technical Issues with Online Portal

Sometimes, the FSSAI online system may have glitches or be slow. This can cause errors during application submission.

Solution: Try submitting your application during off-peak hours when the website is less busy. Keep copies of all your documents and payment receipts. If you face problems, contact FSSAI support quickly.

Challenge 4: Long Waiting Time

Sometimes, approval takes longer because FSSAI asks for extra tests or more information.

Solution: Submit complete and accurate documents the first time. Respond quickly and clearly to any FSSAI requests. This helps speed up the review.

Getting FSSAI product approval is just the beginning. After approval, you must follow certain rules to keep your approval valid and your product safe in the market.

• Follow the Approved Recipe: Always produce your food exactly as approved by FSSAI. Changing ingredients or process without permission can cause problems.
• Use Approved Labels: Your product packaging must match the approved label design. This includes ingredient lists, nutritional info, and FSSAI license number.
• Maintain Records: Keep detailed records of your production, sales, and quality checks. This helps if FSSAI inspects your business.
• Inform FSSAI About Changes: If you want to change ingredients, packaging, or manufacturing methods, inform FSSAI and get approval for the changes.
• Renew on Time: Don’t forget to renew your approval before it expires to avoid legal issues.
• Follow Food Safety Rules: Always maintain hygiene and safety standards in your production and storage.
• Handle Complaints and Safety Concerns: If you receive consumer complaints, experience adverse effects, or face safety issues, it’s your responsibility to report these immediately to FSSAI. If needed, take action, including product recall, as advised by FSSAI.

Following these rules helps you avoid fines, product recalls, or cancellation of your approval. It also builds trust with your customers and authorities.