FSSAI Product Approval

FSSAI Product Approval via FSSAI Online System

The FSSAI product approval application can be submitted online through the FPAS (Food Product Approval System). The entire application process, from document submission to the payment of fees and tracking of the status, can be done via the FSSAI Online System.

FSSAI Product Approval Background

The FSSAI introduced a product approval process to conduct a safety assessment of the ingredients and food products that do not have prescribed standards. However, without proper legitimate regulations, it was difficult to continue the approval process for non-standardized food products. Therefore, the FSSAI issued three regulations in 2016 for FSSAI product approval background.

• Food Product Standards and Food Additives, Ninth Amendment Regulations, 2016.
• Food or Health supplements, Nutraceuticals, Foods for specific dietary uses, Foods for medical purposes, Functional foods and Novel foods Regulations, 2016.
• Food Product Standards and Food Additives Seventh Amendment Regulations, 2016

Even after the introduction of the above regulations, several food products were not included under the FSS Act, 2006. Therefore, to regulate such food products, FSSAI introduced the Food Safety and Standards (Approval of non-specified food and ingredients) Regulations, 2017.

What are the Food and Ingredients that Require FSSAI Product Approval Online?

The general list of food products that require FSSAI product approval online includes:

• Health supplements.
• Foods used for special dietary purposes.
• Foods for medical purposes.
• Functional foods.
• Food products made with novel ingredients or using novel technology.
• Foods containing botanicals, probiotics, or prebiotics.
• New ingredients or products being introduced in India.
• Proprietary ingredients or products.
• New food additives.
• New processing aids, including enzymes.
• Food articles and ingredients consisting of, or isolated from, bacteria, microorganisms, fungi, or algae.

What are the Documents Required for Obtaining the FSSAI Product Approval?

The list of documents required to apply for the FSSAI product approval is as follows:

Online retail and shopping stores.

• Layout plan of the processing unit and manufacturing unit.
• List of machinery used in the manufacturing process.
• List of directors.
• Address proof of the directors.
• List of food categories proposed to be manufactured.
• No Objection Certificate (NOC) and license from the manufacturer.
• Pesticide residue analysis report of water.
• Food safety management system plan or relevant certification.
• Product recall plan.
• Declaration form.
• Test certificate issued by a NABL-accredited laboratory.

Know the FSSAI Product Approval Process?

The following is the detailed FSSAI product approval process.

• Business Entity Incorporation
  It is advisable to first incorporate a business entity such as a private limited company or a public limited company before applying for FSSAI product approval, as it simplifies the transfer of the license in the future.
• Food Business Operator (FBO) License
  Obtaining an FBO license is legally mandatory for companies involved in manufacturing, handling, or selling food products in India. A copy of the valid FBO license must be submitted while applying for product approval.
• Test Reports from NABL-Accredited Labs
  Applicants must submit relevant test reports issued by NABL-accredited laboratories. For products with health or nutritional claims, additional lab reports are required to substantiate the label claims.
• Food Product Label
  The application must include the food product label. It is essential to ensure that the label strictly complies with the FSSAI Food Product Labelling Regulations applicable in India.
• Application for Food Product Approval
  The Food Business Operator (FBO) must apply for product approval through the FoSCoS online portal by selecting the appropriate state, food category, and uploading the required documents.
• Scrutiny of Documents
  After submission, the Food Authority will review the application and documents. If necessary, the authority may request additional information or clarification from the FBO.
• Final FSSAI Product Approval
  Based on the safety assessment, the Food Authority may approve or reject the application. Upon approval, the FBO must submit the certificate of analysis to obtain the final FSSAI product approval.

When do you need FSSAI Product Approval in India?

Corpbiz is India’s No.1 LegalTech platform empowering food entrepreneurs PAN India. From securing a FSSAI license to offering FSSAI product approval services, we provide end-to-end support. The key reasons why you need the FSSAI product approval in India are:

• When a Food Business Operator (FBO) plans to introduce new food products or ingredients into the market.
• If the food product or ingredient does not fall under the existing FSSAI safety regulations.
• When the product has not undergone a safety evaluation by the FSSAI authorities.
• Before launching a proprietary food product in the market, product approval is mandatory.
• When the product or ingredient has never been used or manufactured in any country.