Prior Product Approval under the FSSAI Act, 2006 and Regulations.

[YAGAY andSUN]

The Food Safety and Standards Act, 2006 (FSS Act) and the regulations made thereunder, particularly the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, provide a comprehensive framework for food safety in India. One of the key aspects of this framework involves prior product approval for certain food products, particularly those that are new or have not been previously approved by the Food Safety and Standards Authority of India (FSSAI).

What is Prior Product Approval?

Prior product approval refers to the process where a food manufacturer, importer, or distributor must obtain approval from the FSSAI before introducing a new food product into the market or before using a new food additive, novel ingredient, or other substances in food products.

The FSSAI ensures that the products, ingredients, or additives meet safety, quality, and regulatory standards before they are sold or distributed to consumers.

Legal Framework for Prior Product Approval

1. Food Safety and Standards Act, 2006:
   • The FSS Act, 2006 empowers the Food Safety and Standards Authority of India (FSSAI) to regulate the safety and quality of food products in India. It lays down the legal structure for the approval process.
   • Section 22 of the FSS Act, 2006 outlines the general powers of the FSSAI, which include approving the use of food additives, food ingredients, and any new food product formulations that do not have existing standards in India.
   • Section 23 of the FSS Act, 2006 empowers the FSSAI to make rules for the approval of food products, including setting standards for food additives and ingredients.
2. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011:
   • These regulations define the standards for food products and food additives in India and specify the process for obtaining approval for new products.
   • Regulation 2.1.1 of the Food Products Standards and Food Additives Regulations, 2011 requires prior approval for food products that fall under the "novel foods" category (e.g., food products that are new to India or that have not previously been assessed for safety by the FSSAI).
   • Food additives, preservatives, colors, and any other novel substances not previously approved or listed in the regulations must undergo a safety assessment and approval process before they can be used in food products.

Categories Requiring Prior Product Approval

1. Novel Foods:
   • These are food products that do not have established standards or that have not been previously evaluated for safety. These could include:
     • New food formulations or ingredients.
     • Genetically modified foods (GMOs) or products containing GMO-derived ingredients.
     • New food additives, flavoring agents, or colors that are not yet recognized or approved.

2. Food Additives and Ingredients:
   • Any new or unapproved food additives (such as preservatives, flavor enhancers, sweeteners, colors, and emulsifiers) require prior approval.
   • New ingredients that are not part of the standard food products in India (e.g., novel plant-based ingredients, newly introduced herbal or functional food ingredients).
3. Imported Food Products:
   • Imported food products must comply with the FSSAI regulations. If they contain new ingredients or additives that are not part of existing regulations or standards, they must be submitted for prior approval before being sold in India.
   • Importers of food products need to ensure compliance with the FSSAI's Food Import Clearance process, which may involve the approval of the product ingredients and formulations.

Process of Obtaining Prior Product Approval

1. Application Submission:
   • A manufacturer, importer, or distributor must submit an application to the FSSAI for product approval. The application should include detailed information about the product or ingredient, including:
     • The complete product formulation (ingredients and their proportions).
     • Safety and efficacy data for new food additives or novel ingredients (including toxicological studies, nutritional data, and allergen information).
     • Manufacturing processes.
     • Proposed labeling and packaging information.
2. Evaluation of Application:
   • The FSSAI evaluates the application by reviewing the submitted data, which may include scientific studies, research reports, and safety certifications. The review process assesses the product's safety for human consumption.
   • The FSSAI may also refer the application to expert committees or scientific bodies for further assessment.
3. Safety Assessment:
   • For novel foods and new additives, the FSSAI conducts a safety assessment that includes toxicological testing, allergenicity studies, and data on the product's nutritional profile.
   • The applicant may be asked to submit additional information or conduct further testing depending on the type of product.
4. Approval or Rejection:
   • If the FSSAI is satisfied with the safety and quality of the product, approval is granted, and the product can be legally sold in India.
   • If the FSSAI finds the product or ingredient to be unsafe or insufficiently tested, the approval may be denied. In such cases, the applicant is typically provided with an opportunity to address concerns before resubmitting the application.
5. Issuance of Product Approval:
   • Once approved, the applicant is issued a Food Product Approval Certificate or an Import Clearance Certificate (for imported food products). The product can now be marketed, sold, and distributed in India.
   • The approval is often subject to conditions, such as labeling requirements or restrictions on usage.

Regulations for Specific Categories of Products:

• Genetically Modified (GM) Foods:
  • The approval process for genetically modified foods is particularly stringent. The applicant must provide detailed information on the genetic modification process, health safety studies, and environmental impact assessments.
  • GM food products must undergo a rigorous evaluation by the FSSAI, and approval is only granted after thorough assessment.
• Health Supplements and Functional Foods:
  • New health supplements or functional foods with claims (e.g., weight loss, improved immunity) require prior approval from the FSSAI to ensure that the claims are substantiated and that the product does not pose a risk to consumer health.

Penalty for Non-Compliance

Failure to obtain prior product approval when required can result in significant penalties, including:

• Fines: A fine can be imposed under the Food Safety and Standards Act, 2006 for non-compliance with food product approval requirements.
• Product Recall: Non-approved products may be removed from the market and recalled by FSSAI.
• Legal Action: Continued non-compliance may lead to criminal action, including prosecution of company directors or responsible officers under food safety laws.

Conclusion

Prior product approval under the Food Safety and Standards Act, 2006 and its regulations is a critical process to ensure that food products, particularly new or novel products, meet the required safety, health, and quality standards. It involves a thorough evaluation by the Food Safety and Standards Authority of India (FSSAI), which ensures that only safe products reach the market and are consumed by the public. This process is designed to protect consumer health while allowing innovation in the food industry.

For manufacturers, importers, and food distributors, it is crucial to comply with these regulatory requirements and obtain the necessary approvals before launching new products or ingredients to avoid legal consequences and to safeguard public health.