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FSSAI Regulation of Infant Formula in India

Infant food plays a vital role in the early stages of a child’s life, providing essential nutrients needed for growth, development, and overall health. The precise composition of infant formula is therefore critical for supporting the health and development of babies. Ensuring the safety, quality, and appropriateness of these foods through proper regulation is a primary role of regulatory bodies. In this blog, we attempt to provide information on the key regulations involved in maintaining the quality, standard, and safety of infant’s food in India.

Food Safety and Standards Authority of India (FSSAI) Regulation of Infant Formula in India

Categories of Infant Food as per FSSAI Regulation of Infant Formula in India

  • “Food for infants based on traditional food ingredients” are products that are often made at home for feeding babies but are processed and packaged for infants between six months and twenty-four months of age.

  • “Food for special medical purposes intended for infants” is a human milk or formula replacement that is especially made to satisfy the unique nutritional needs of newborns to twenty-four months of age who have particular illnesses, diseases, or medical issues.

  • “Follow-up formula” is food that is meant to be used as a liquid component of an infant's supplemental diet after six months to twenty-four months of age, provided that it is prepared according to the usage instructions.

  • “Infant formula” means a breast milk substitute product based on milk of cow, buffalo, or other milch animals as specified under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 or a mixture of ingredients that have been proven to be suitable for infant feeding to meet the nutritional requirements of infants during the first six months;

  • “Milk cereal based complementary food” means food for infants after 6 months up to 24 months of age that is based on milk, cereals and/or legumes (pulses), millets, nuts, protein concentrates, protein isolates, and/or defatted edible oilseed extracts and so prepared as to permit dilution with water, milk, or other suitable medium;

  • “Processed cereal based complementary food” means food for infants after 6 months up to 24 months of age that is based on cereals and legumes (pulses), millets, nuts, protein isolates or protein concentrates, or de-fatted edible oil seed extracts and so prepared as to permit dilution with water or milk or other suitable medium;

Regulatory Authority in India and FSSAI Regulation of Infant Formula in India

The regulation of infant food in India is governed by the Food Safety and Standards Authority of India (FSSAI), which operates under the Ministry of Health and Family Welfare. FSSAI is a comprehensive legal framework aimed at ensuring the safety, quality, and nutritional adequacy of food products intended for infants.

The Infant Formulas to be manufactured, imported, distributed and sold in India are subjected to FSSAI Regulations :

  • The Food Safety and Standards Act, 2006

  • Infant Milk Substitutes, Feeding Bottles and Infant Foods (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 Labeling) Regulations, 2011

  • Food Safety and Standards (Foods 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

Regulatory Process in India

The Indian manufacturers must obtain FSSAI licnse as an essential pre-requisites for manufacturing Infant Formulas in India. FSSAI issues licenses under three categories, namely:

  • Basic FSSAI License for small-scale businesses with turnover less than 12 lakhs

  • State FSSAI for businesses with turnover between 12 lakhs and 20 crores

  • Central FSSAI registration for companies with turnover of more than 20 crores

FSSAI grants licenses for a period of 1-5 years, depending on the nature of the food product and the type of food business. The cost of registration varies from INR 3000 to INR 7500 per annum, depending on the type of license.

List of documents required for the application process

  • Form-B duly completed and signed (in duplicate) by the proprietor, partner, or authorized signatory

  • Photo identity proof of the proprietor or director of the food business issues by 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 products being produced, distributed, and sold

  • Details of food processing equipment and machinery

  • Details of the water source and treatment

  • Hygiene and sanitation 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.

FSSAI Regulations for Import of Infant Formulas into India

  • Registration Requirement: Importers of infant food must be registered with the FSSAI. This involves submitting an application along with the necessary documents to obtain an Importer Exporter Code (IEC). A valid FSSAI license specific to importing food products is mandatory, and it needs to be renewed periodically. Typically, a license is issued for a period of 1–5 years. In order to renew a license, the importer must apply within 30 days of its expiration. If the license is not renewed, it expires, and the food business operator must reapply for a new one.

  • Product Approval: All infant food products intended for import must receive approval from FSSAI. This process ensures that the products comply with Indian food safety standards and are safe for consumption. Importers must submit detailed documentation for product approval, including ingredient lists, nutritional information, manufacturing process details, and safety data.

  • Labeling Requirements: Mandatory Information: Labels on imported infant food products must provide essential information in English or Hindi, including:

1.     Product name

2.     List of ingredients

3.     Nutritional information

4.     Instructions for preparation and use

5.     Manufacturer’s name and address

6.     Importer’s name and address

7.     FSSAI logo and license number

8.     Batch number, date of manufacture, and expiry date

9.     Storage instructions and warnings, if any

10.  Non-Veg or Veg Logo

11.  Category or sub-category along with the generic name, nature, and composition of proprietary food

  • Compliance: Labels must comply with the Food Safety and Standards (Packaging and Labeling) Regulations, 2011, ensuring transparency and consumer safety.

  • Customs Clearance: Importers need to submit various documents to the customs authorities, including:

1.     Bill of entry

2.     Commercial invoice

3.     Packing list

4.     Certificate of origin

5.     Health certificates and certificates of analysis

6.     FSSAI license and product approval documents

  • Inspection and Sampling: Customs authorities, in coordination with FSSAI, conduct visual inspections of the imported products to ensure they meet the required standards. Non-compliant products may be rejected or subjected to further testing. The importer is liable to pay visual inspection charges of INR 2,000 and laboratory charges of INR 12,000 for testing food samples.

In cases of non-compliance, a rejection report is sent to the customs authorities, stating the reason(s) for the refusal of the sample from the imported food consignment. FSSAI provides provision for the importer to reapply for the test within 15 days if the sample is found to be non-conforming to FSS regulations by the primary laboratory.

  •  Storage and distribution : Imported infant food products must be stored under specified conditions to maintain their quality and safety. This includes proper temperature control and hygiene practices during storage and transportation.

  • Traceability: Importers must ensure traceability of products from the point of entry to the end consumer, enabling effective recall procedures if necessary.

  • Recall Procedures: Importers must have a robust recall plan in place to address any safety or quality issues that may arise. This plan should detail the steps for identifying, communicating, and resolving the issues, ensuring minimal risk to consumers.

The regulation of infant food in India is a multi-faceted approach that involves stringent standards, comprehensive labeling, strict advertising rules, and robust enforcement mechanisms. These measures ensure that infant foods available in the market are safe, nutritionally adequate, and support the health and development of infants. As FSSAI continues to refine its regulations, the focus remains on aligning with global best practices and addressing emerging nutritional needs.

Navigating the complex landscape of infant food regulations requires expert guidance and comprehensive understanding. Ensure your products meet the highest safety and quality standards with Atrixio's specialized regulatory consultation services. Make sure you take the lead in the baby food market and get in touch with Atrixio for a consultation. Together, we can ensure that your products provide the highest level of care and nutrition for infants. Contact Artixio today @ for expert consultation services.

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