How to get FSSAI product approval

Read about the objectives, requirements, documents, and benefits related to FSSAI product approval.
Business Loan
3 min
17-July-2024

What is an FSSAI?

The Food Safety and Standards Authority of India (FSSAI) is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. FSSAI is responsible for protecting and promoting public health through the regulation and supervision of food safety. It was formed under the Food Safety and Standards Act, of 2006, which consolidates various acts and orders that have hitherto handled food-related issues in various Ministries and Departments. 

The primary aim of FSSAI is to ensure that the food products distributed in India are safe, hygienic, and nutritious. FSSAI is also responsible for setting standards for food articles and enforcing these standards through regular monitoring and inspections. The FSSAI's mandate includes laying down science-based standards for food articles and regulating their manufacture, storage, distribution, sale, and import to ensure the availability of safe and wholesome food for human consumption. In essence, FSSAI plays a crucial role in maintaining food safety standards and ensuring public health.

Objectives of FSSAI product approval

1. Ensuring food safety

The primary objective of FSSAI product approval is to ensure that all food products available in the market are safe for consumption. This includes verifying that products meet established safety standards and do not pose any risk to public health.

2. Promoting fair trade practices

By mandating product approval, FSSAI aims to promote fair trade practices in the food industry. This helps in maintaining a level playing field for all businesses, ensuring that no substandard or unsafe products are marketed.

3. Facilitating food quality

FSSAI product approval ensures that food products are of high quality. This involves rigorous testing and evaluation of products to verify their nutritional content, purity, and adherence to specified standards.

4. Preventing misleading claims

Another objective is to prevent misleading claims about food products. FSSAI ensures that labels and advertisements provide accurate information about the product, thus protecting consumers from false or exaggerated claims.

5. Supporting public health

By regulating and approving food products, FSSAI supports public health initiatives. It ensures that food products contribute to a healthy diet and do not contain harmful substances.

6. Encouraging innovation

FSSAI product approval encourages innovation in the food industry. By setting clear standards and guidelines, it allows businesses to develop new products that meet safety and quality criteria, thereby fostering innovation.

7. Protecting consumer interests

FSSAI product approval also aims to protect consumer interests. By ensuring that food products are safe, of high quality, and accurately labelled, it helps consumers make informed choices.

Food products that require FSSAI product approval

Any new food product introduced to the market requires FSSAI product approval to ensure it meets the established safety and quality standards. For instance, functional foods and nutraceuticals, which are designed to offer additional health benefits beyond basic nutrition, require FSSAI registration before being marketed.

  • Functional foods
    Functional foods, such as fortified cereals, probiotic yoghurts, and omega-3-enriched products, must undergo rigorous testing to verify their health claims and nutritional benefits. This process involves scientific evaluation to ensure that the added ingredients do not pose any health risks and deliver the promised benefits.
  • Nutraceuticals
    Nutraceuticals, including dietary supplements and health supplements, also require FSSAI product approval. These products, often in the form of capsules, tablets, or powders, must be scrutinised for their ingredient safety, dosage levels, and claimed health benefits.
  • Infant foods
    Infant foods, which cater to the nutritional needs of babies and toddlers, are another category requiring FSSAI registration. Given the vulnerability of infants, these products undergo stringent testing to ensure they provide essential nutrients without harmful additives or contaminants.
  • Novel foods
    Novel foods, which include newly developed or engineered food products, also need FSSAI approval. These could be food items developed through new technology or production processes that do not have a history of consumption.

FSSAI approval process

  • Application submission
    The approval process begins with the submission of an application. This application must include detailed information about the food product, including its composition, intended use, and manufacturing process.
  • Preliminary scrutiny
    Upon receiving the application, FSSAI conducts a preliminary scrutiny. This involves checking the completeness and accuracy of the submitted documents and ensuring they meet the required standards.
  • Risk assessment
    The next step involves a thorough risk assessment. This is done by a panel of experts who evaluate the safety, quality, and potential health impact of the food product. They examine scientific evidence and data provided by the applicant.
  • Product testing
    Product testing is a crucial part of the approval process. Samples of the food product are tested in accredited laboratories to verify their safety, nutritional content, and compliance with established standards.
  • Evaluation and approval
    After the risk assessment and testing, the findings are reviewed by the FSSAI. If the product meets all safety and quality standards, it is granted approval. If not, the applicant is informed of the necessary modifications.
  • Issuance of approval
    Once approved, FSSAI issues a product approval certificate. This certificate is valid for a specified period and must be renewed periodically.
  • Monitoring and surveillance
    Post-approval, FSSAI conducts regular monitoring and surveillance to ensure that the product continues to comply with the approved standards.

Information required for FSSAI product approval

  • Product details
    Applicants must provide comprehensive details about the food product, including its name, category, and description. This helps in identifying the product and its intended use.
  • Composition and ingredients
    A detailed breakdown of the product's composition and ingredients is required. This includes information on the source of each ingredient, its percentage in the product, and its safety profile.
  • Manufacturing process
    The manufacturing process must be thoroughly documented. This includes details on the production methods, quality control measures, and safety protocols followed during manufacturing.
  • Nutritional information
    Nutritional information, including the product's calorie content, vitamins, minerals, and other nutrients, must be provided. This helps in assessing the product's health benefits and compliance with nutritional standards.
  • Labelling information
    Labelling information, including the product's packaging, labels, and claims, must be submitted. This ensures that the product provides accurate information to consumers and adheres to labelling regulations.
  • Safety data
    Safety data, including toxicological and microbiological test results, must be submitted. This helps in evaluating the product's safety for consumption.
  • Regulatory compliance
    Information on regulatory compliance, including adherence to national and international standards, must be provided. This ensures that the product meets all legal requirements for food safety according to the business license.

Documents required for obtaining FSSAI product approval

  • Application form
    A duly filled application form is the first document required. This form must include detailed information about the food product and the applicant.
  • Product formulation
    A detailed product formulation document must be submitted. This includes information on the ingredients used, their sources, and their respective quantities.
  • Manufacturing process
    A comprehensive document outlining the manufacturing process is required. This should include details on production methods, quality control measures, and safety protocols.
  • Safety and toxicological data
    Safety and toxicological data must be provided. This includes results from toxicological studies and safety assessments to ensure that the product is safe for consumption.
  • Nutritional information
    A detailed nutritional information document is required. This should include information on the product's calorie content, vitamins, minerals, and other nutrients.
  • Labelling information
    Labelling information, including the product's packaging and labels, must be submitted. This ensures that the product provides accurate information to consumers and complies with labelling regulations.
  • Test reports
    Test reports from accredited laboratories must be submitted. These reports should include results from microbiological, chemical, and physical tests conducted on the product.
  • Business licence
    A copy of the applicant's business licence must be provided. This ensures that the applicant is a legitimate business entity.
  • Declaration
    A declaration form, stating that the information provided is accurate and true, must be signed and submitted.

Benefits of FSSAI product approval

  • Ensuring food safety
    One of the primary benefits of FSSAI product approval is ensuring food safety. Approved products meet stringent safety standards, reducing the risk of food-borne illnesses.
  • Enhancing consumer trust
    FSSAI approval enhances consumer trust in the product. Consumers are more likely to purchase and consume products that have been vetted and approved by a reputable authority.
  • Promoting quality
    FSSAI approval promotes high-quality standards in the food industry. Products that receive approval have undergone rigorous testing and evaluation, ensuring they meet quality benchmarks.
  • Supporting public health
    Approved products contribute to public health by providing safe and nutritious food options. This supports the overall health and well-being in the community.
  • Facilitating market access
    FSSAI approval facilitates market access for food products. Approved products can be sold in various markets, including domestic and international, without regulatory hurdles.
  • Encouraging innovation
    The approval process encourages innovation in the food industry. By setting clear guidelines and standards, FSSAI allows businesses to develop new products that meet safety and quality requirements.
  • Protecting business interests
    FSSAI product approval protects business interests by ensuring fair competition. It prevents the marketing of substandard or unsafe products, thus maintaining a level playing field.

Conclusion

FSSAI product approval is essential for ensuring the safety, quality, and integrity of food products in the market. It benefits both consumers and businesses by promoting trust, enhancing public health, and encouraging innovation. Obtaining FSSAI approval involves a thorough process, requiring detailed documentation and compliance with regulatory standards. For businesses, this approval not only facilitates market access but also enhances brand reputation and consumer confidence. In the competitive food industry, FSSAI approval is a crucial factor that can significantly impact a business's success and eligibility for a business loan.

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Frequently asked questions

What is the cost of FSSAI approval?
The cost of FSSAI approval varies depending on the type and scale of the food business. For a basic registration, fees are typically around Rs. 100 per year. State licences for medium-sized businesses can range from Rs. 2,000 to Rs. 5,000 annually. For larger enterprises requiring a central licence, the cost can be between Rs. 7,500 and Rs. 10,000 per year. Additional expenses may include testing and documentation fees, which vary based on specific requirements.
How to get FSSAI product approval?
To obtain FSSAI product approval, submit an application on the FSSAI online portal, including detailed product information, composition, and manufacturing process. Provide necessary documents such as safety data, nutritional information, labelling details, and test reports from accredited laboratories. FSSAI will conduct a preliminary scrutiny, followed by risk assessment and product testing. If the product meets safety and quality standards, FSSAI grants approval. Regular monitoring ensures continued compliance with these standards.
Who is eligible for FSSAI registration?
FSSAI registration is mandatory for all Food Business Operators (FBOs) in India, including manufacturers, processors, packers, distributors, wholesalers, retailers, and food service establishments like restaurants and caterers. Small food businesses with an annual turnover below Rs. 12 lakh need basic registration, while larger businesses require a state or central licence based on their turnover and operational scale. This ensures that all food businesses adhere to safety standards and regulations set by the Food Safety and Standards Authority of India.
Is it easy to get an FSSAI license?
Obtaining an FSSAI licence could be a straightforward process if you follow the required steps meticulously. The application process involves submitting necessary documents, including business details, product specifics, and safety information. If your documentation is complete and accurate, the approval process is generally smooth. However, it may be time-consuming and requires attention to detail to ensure compliance with all regulations. Consulting with a professional can further simplify the procedure and ensure a successful application.
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