How FSSAI Regulates Baby Food for Safe Consumption

Selecting the right infant formula is vital for a baby’s health and development. The Food Safety and Standards Authority of India (FSSAI) ensures that all infant nutrition products meet strict safety, quality, and nutritional standards. It regulates manufacturing, labeling, and marketing to prevent misleading claims and unsafe ingredients. FSSAI-approved formulas offer essential nutrients while maintaining hygiene and safety. Clear labeling helps parents understand ingredients, preparation, and storage. By enforcing these guidelines, FSSAI promotes transparency, protects consumers, and supports infant well-being.

Indian Regulation Authority and FSSAI Regulation of Infant Formula in India

The Food Safety and Standards Authority of India (FSSAI), which comes under the Ministry of Health and Family Welfare, is the body responsible for the regulation of infant food. FSSAI is a comprehensive legal framework intended to encourage the safety, quality, and nutritional adequacy of infant food items.

Infant formula products produced, imported, distributed, and sold in India fall under FSSAI regulations, including:

• The Food Safety and Standards Act, 2006.
• Infant Milk Substitutes, Infant Food, and Infant Milk Bottles (Regulation of Production, Supply, and Distribution) Act.
• The Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
• Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
• Food Safety and Standards (Food for Infant Nutrition) Regulations, 2020.
• Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011.
• Legal Metrology (Packaged Commodities) Rules, 2011.
• Food Safety and Standards (Advertising and Claims) Regulations, 2018.

Key Amendments in the FSSAI (Foods for Infant Nutrition) First Amendment Regulations, 2022

• Labeling Compliance – Infant nutrition products must follow the Food Safety and Standards (Labelling and Display) Regulations, 2020.
• New Sub-Regulation for Infant Formula – Regulation 7(3) states that powdered infant formula made without vegetable oil, linoleate, vitamin E, starch, specified food additives, or optional ingredients may be labeled as Infant Milk Food.
• Increase in Vitamin B12 Limits:
• Per 100g: Increased from 0.25 - 0.70 mcg to 0.25 - 4.0 mcg.
• Per 100 kcal: Increased from 0.05 - 0.15 mcg to 0.05 - 0.90 mcg.
• Addition of Packaging Gases – Carbon dioxide (CO?) and Nitrogen (N?) are now permitted for Follow-up Formula under Good Manufacturing Practices (GMP).

Types of Infant Food as per FSSAI Regulations

• Infant Formula

A breast milk substitute, made from cow, buffalo, or other milch animal milk (as per the Food Safety and Standards Regulations, 2011) or a scientifically prepared blend of suitable ingredients. It is meant for fulfilling the infant's nutritional needs up to six months of age.

• Conventional Infant Food

These food products contain ingredients normally used at home for infant nutrition. They are prepared and packaged for infant consumption for the age group of 6 months up to 24 months.

• Special Medical Purpose Infant Food

These are specially prepared products that can be utilized for the replacement of infant formula or human milk for babies from birth up to 24 months with specific medical conditions, illness, or dietary needs. Follow-Up Formula is a complementary part of the infant's diet from six months of age up to 24 months, if made according to the usage instructions given.

• Milk-Cereal Based Complementary Food

The infant food is made for the age group of 6 months to 24 months, with a blend of milk, cereals, legumes (pulses), millets, nuts, protein isolates, protein concentrates, and defatted edible oilseed extracts. The infant food is made for dilution with water, milk, or any other medium for administration.

• Processed Cereal-Based Complementary Food

Similar to the milk-cereal group but with no milk as the medium, this food is for 6 months up to 24 months of age. Cereals, legumes (pulses), millets, nuts, protein isolates/concentrates, and defatted edible oilseed extracts constitute the ingredients, and can be diluted with water, milk, or some other medium for feeding.

Food Regulatory Process in India

Indian manufacturers must obtain an FSSAI license as a prerequisite for manufacturing Infant Formula in India. FSSAI licenses fall under three categories:

• Basic FSSAI Registration for small-scale businesses with a turnover of less than 12 lakhs.
• State FSSAI License for companies with a turnover between 12 lakhs and 20 crores.
• Central FSSAI License for organizations with a turnover of more than 20 crores.

FSSAI grants licenses for a period of 1 to 5 years, depending on the nature of the food product and the type of food business. The registration fee ranges from INR 3000 to INR 7500 per year, depending on the category of the license.

Documents Required for the Application Process:

• Form-B, signed and completed (in duplicate) by the partner, proprietor, or authorized signatory.
• Photo identification of the owner/director of the food business from a government authority (such as PAN card, voter ID, driver’s license, etc.).
• Proof of ownership of the food business premises (such as a sale deed, rent agreement, etc.).
• List of food items being produced, distributed, and sold.
• Details of food processing equipment and machinery.
• Information on the water source and its treatment process.
• Sanitation and hygiene certificate from a recognized institution.
• List of directors, partners, or proprietors of the business (if applicable).
• No Objection Certificate (NOC) from the local health department.
• FSSAI fee receipt (if applicable).

General Requirements

A food item intended for infants that meets special medical needs or substitutes for breast milk and whose standards are not outlined in these regulations may only be produced, displayed, or kept for sale after receiving approval from the Food Authority for the food item and its label.

Food intended for baby nourishment must be packaged in hermetically sealed, hygienic, and sound containers or in a flexible pack composed of paper, polymer, and/or metallic film to prevent degradation. It will be packaged in an inert environment in a Bisphenol A (BPA)-free packaging material. To identify any gaps in the Good Manufacturing Practice (GMP), a periodic audit of the entire system as per the SOP shall be conducted.

Nutritional Requirements

The claimed value of the nutrients or nutritional components may vary by no more than 10.0%. The maximum limitations for the nutrients listed in the composition tables must not be exceeded. Food intended for baby nourishment must use the original components for vitamins, minerals, and other nutrients wherever applicable.

Infant foods may include fish oil at a maximum of 0.5 percent or algal and fungal oil as sources of docosahexaenoic acid (DHA) and arachidonic acid (ARA) from Cryptodinium cohnii, Mortierella alpina, Schizochytrium sp., and Ulkenia sp. DHA of total fatty acids and a minimum 1:1 ARA: DHA ratio.

Lactose and glucose polymers are the recommended sources of carbohydrates. Sucrose and/or fructose may be added only if required, as long as the combined amount of these doesn't surpass 20% of the overall amount of carbohydrates.

Food needs to be homogeneous in appearance, free of lumps and coarse particles, and odor-free.

Labeling Requirements:

The FSSAI labeling requirements for infant formulas in India are comprehensive and meticulously designed to ensure that infant nutrition products are safe, nutritious, and clearly labeled. Manufacturers must adhere to these guidelines to provide transparent and reliable information to consumers. Here are some additional important labeling requirements for infant formula in India that should be included to ensure compliance with FSSAI regulations:

• Language Requirement

Labeling must be in English or Hindi to ensure consumer understanding. Other regional languages may be included but those are not mandatory.

• FSSAI Compliance Marking

The FSSAI logo and license number must be displayed on the package.

• Clear Indication of Age Group

The label must specify the intended age group (e.g., for infants aged 0–6 months or 6–24 months).

• Veg/Non-Veg Classification

A green dot (veg) or brown dot (non-veg) must be present based on the product composition.

• No Health or Nutritional Superiority Claims

Manufacturers cannot claim that the product is equivalent or superior to breast milk. Claims such as prevents allergies, boosts immunity, or enhances intelligence are strictly prohibited.

• Instructions for Disposal

Labels should provide guidance on safe disposal of packaging materials to promote environmental sustainability.

• Caution on Improper Feeding

A statement must highlight that incorrect preparation and feeding may harm the infant’s health.

• Import-Specific Requirements (for imported infant formula)

The label must mention the country of origin and include the name and address of the importer. The manufacturing and expiration dates should match those on the import documents.

These points ensure consumer safety, regulatory compliance, and transparency in labeling infant formula in India.

FSSAI Regulations for Import of Infant Formula into India

• Registration Requirements

FSSAI License – Importers must obtain a Food Safety and Standards Authority of India (FSSAI) license to legally import infant food products. This license is issued for 1 to 5 years and must be renewed at least 30 days before expiration to avoid business disruptions. Failure to renew on time results in expiration, requiring reapplication for a new license.

Importer Exporter Code (IEC) – Importers must apply for an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT). This code is mandatory for importing or exporting food products in India and is a crucial regulatory requirement.

• Product Approval

All imported infant food products must receive approval from FSSAI to ensure compliance with Indian food safety standards. Importers must provide comprehensive documentation, including ingredient lists, nutritional details, manufacturing processes, and safety data, for product approval.

• Labeling Requirements

Labels on imported infant formula must include the following details in either English or Hindi:

• • Product name.
  • List of ingredients.
  • Nutritional information.
  • Preparation and usage instructions.
  • Manufacturer’s name and address.
  • Importer’s name and address.
  • FSSAI logo and license number.
  • Batch number, manufacturing date, and expiry date.
  • Storage instructions and warnings (if applicable).
  • Veg/Non-Veg logo.
  • Category/sub-category with the generic name, nature, and composition of proprietary food.

Labels must comply with the Food Safety and Standards (Packaging and Labeling) Regulations, 2011 to ensure transparency and consumer safety.

• Customs Clearance Requirements

Importers must provide the following documents to customs authorities:

• Bill of entry.
• Commercial invoice.
• Packing list.
• Certificate of origin.
• Health certificates and analysis reports.
• FSSAI license and product approval documents.

5. Inspection and Sampling

FSSAI, in coordination with customs authorities, conducts visual inspections of imported infant food to verify compliance. Products that fail to meet standards may be rejected or subjected to additional testing.

• Inspection charges: INR 2,000.
• Laboratory testing charges: INR 12,000 per sample.

If a product fails compliance, FSSAI issues a Rejection Report to customs authorities explaining the reasons for refusal. Importers have 15 days to request re-testing if the primary laboratory finds the sample non-compliant with FSS regulations.

6. Storage and Distribution

Imported infant formula must be stored under strict conditions to maintain its safety, quality, and nutritional integrity. Key storage and distribution requirements include:

• Temperature Control – Infant formula must be kept at optimal temperatures to prevent spoilage or degradation of nutrients. Cold storage may be required for certain formulations.
• Hygiene and Sanitation – Warehouses and transportation units must maintain high standards of cleanliness to avoid contamination.
• Protection from Environmental Factors – Products should be safeguarded against moisture, direct sunlight, and air exposure to ensure stability.
• Handling During Transportation – Transport vehicles must comply with food safety standards to prevent exposure to bacteria, dust, or any external contaminants.
• FIFO (First In, First Out) System – Inventory should be managed using FIFO to ensure older stock is distributed before newer stock, reducing the risk of expired products reaching consumers.

7. Traceability

Importers must establish a comprehensive traceability system to track infant formula from the point of entry into the country to the final consumer. This ensures product authenticity, safety, and quick response to any potential issues. Key elements include:

• Batch Tracking – Every product should have a unique batch number for easy identification.
• Supply Chain Monitoring – Importers must keep detailed records of suppliers, distributors, and retailers involved in the product journey.
• Digital Documentation – A database of product movement should be maintained for rapid tracking in case of safety concerns.
• Consumer Accessibility – Clear labeling should include manufacturing details, batch numbers, and expiry dates to help consumers verify product authenticity.

8. Recall Procedures

A well-defined recall plan is essential to handle safety or quality concerns effectively. The recall process should focus on identifying the issue, alerting stakeholders, and resolving risks with minimal consumer impact. The key steps include:

• • • Detection – Identifying potential issues such as contamination, labeling errors, nutrient deviations, or safety concerns through routine testing, consumer complaints, or regulatory audits.
• • • Notification – Informing relevant authorities (such as FSSAI and customs), distributors, retailers, and consumers about the recall with clear instructions on handling affected products.
• • • Product Retrieval – Removing affected products from the market, including retail stores, warehouses, and distribution centers.
• • • Investigation and Corrective Action – Conducting an in-depth analysis of the issue to identify the root cause and implement corrective measures to prevent future occurrences.
• • • Public Communication – If necessary, issuing official statements through media, websites, and packaging recalls to keep consumers informed.
• • • Disposal of Affected Products – Ensuring safe and compliant disposal or destruction of recalled products under regulatory supervision.
• • • Post-Recall Assessment – Evaluating the effectiveness of the recall, making process improvements, and updating safety measures accordingly

By implementing these measures, importers can safeguard consumer health and comply with Indian food safety regulations effectively.

How FSSAI Helps to Choose the Right Infant Formula

The Food Safety and Standards Authority of India (FSSAI) ensures that all infant formulas in the market meet strict safety, quality, and nutritional standards. Here is how FSSAI helps consumers make informed choices:

• Approval and Regulation of Infant Formulas

FSSAI ensures that only approved infant formulas are manufactured, imported, distributed, and sold in India. Products must comply with strict food safety regulations before they can enter the market, ensuring they are safe and free from harmful contaminants. No infant formula can be sold without meeting the nutritional and safety requirements set by FSSAI.

• Clear and Standardized Labeling for Easy Understanding

Infant formula labels must comply with the Food Safety and Standards (Packaging and Labeling) Regulations, 2011 it ensures clear and accurate product information. Labels must specify nutritional composition, preparation instructions, and age group recommendations to help parents make the right choice. Labels must include the FSSAI license number to verify compliance with food safety regulations.

• Ensure Nutritional Adequacy

FSSAI sets minimum and maximum limits for essential nutrients like proteins, carbohydrates, fats, vitamins, and minerals to ensure proper infant growth and development. Only ingredients approved for infant nutrition can be used, ensuring formulas are scientifically designed to meet the dietary needs of babies.

• Prohibition of False or Misleading Claims

Manufacturers cannot claim that their formula is equal to or better than breast milk which reinforce the importance of breastfeeding as the best source of nutrition. Misleading health claims, such as boosts immunity, enhances brain development, or prevents allergies, are strictly prohibited. No advertisements or promotional tactics can discourage breastfeeding or mislead parents into believing that formula is a superior alternative.

• Age-Specific Categorization for Proper Infant Nutrition

Infant formula must clearly indicate the intended age group to ensure parents select the right product for their baby’s needs. Categories include:

5. • Infant Formula (0–6 months) – Breast milk substitute for newborns.
   • Follow-up Formula (6–24 months) – Complementary formula alongside solid foods.
   • Special Medical Purpose Infant Formula – For babies with specific medical conditions.

• Allergen Warnings and Safety Precautions

Labels must clearly mention allergenic ingredients such as lactose, soy, or nuts, helping parents avoid products that may cause adverse reactions. Instructions must warn against improper preparation, such as incorrect water-to-powder ratios that can harm an infant’s health. The packaging must include statements like:

6. • Boiled and cooled water must be used to prepare this product.
   • Discard any leftover feed to prevent bacterial contamination.

• Traceability and Recall Mechanisms for Consumer Safety

FSSAI mandates batch tracking to ensure that every product can be traced from the manufacturer to the consumer. If a product is found to be unsafe, FSSAI has strict recall procedures in place to remove it from the market quickly. In case of contamination or mislabeling, FSSAI works with manufacturers, importers, and retailers to alert consumers and prevent any health risks.

• Ensure Storage and Distribution Standards

• Infant formulas must be stored and transported under controlled conditions to maintain their nutritional quality. Labels must provide proper storage instructions, such as:

• Store in a cool and dry place in an airtight container.

• Keep away from direct sunlight and moisture.

• This helps parents maintain the product’s safety and effectiveness after purchase.

• Import Regulations for Foreign Infant Formulas

• Imported infant formulas must comply with FSSAI regulations and undergo testing and approval before being sold in India. Labels must include:

• • Country of origin.
  • Importer’s name and FSSAI license number.
  • Manufacturing and expiry dates matching import documentation.

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  Therefore, FSSAI plays a crucial role in ensuring safe, high-quality, and nutritionally balanced infant formulas in India. Through strict regulations, clear labeling, and ingredient safety standards, it empowers parents to make informed choices while safeguarding infant health. By prohibiting misleading claims and enforcing traceability and recall mechanisms, FSSAI promotes transparency and builds consumer confidence. With these guidelines in place, parents can trust that the formula they choose meets the highest standards—supporting their baby’s growth, development, and overall well-being.

  Why Online Legal India is the best choice for FSSAI License?

  Applying for a license and registration can be a tedious and time-consuming task, but with Online Legal India, it’s as easy as pie! Backed by a team of experienced legal experts and over 1 lakh satisfied clients, we are your one-stop solution for registering your food business and obtaining your FSSAI License. In addition to food licensing, our professionals offer 24x7 assistance with GST registration and tax filing, company registration, trademark registration, and complete support for incorporating your trading business, ensuring a hassle-free compliance journey from start to finish.