FSSAI Regulation of Infant Formula in India
- Induja Ratakonda
- Jun 11, 2024
- 8 min read
Updated: 8 hours ago
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.
Know more about what infant formula is and its types.
Types of Infant Formula Under FSSAI Guidelines
Here are the types of Infant Formula and Complementary Foods under FSSAI guidelines 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. Example: A simple lentil soup processed and packed for infants.
Traditional ragi finger millet dish processed and packaged for infants.
“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. Example: Soy-based infant formula for infants with cow milk allergy.
Lactose-free infant formula for infants with lactose intolerance.
“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. Example: Similac Follow-Up Formula, Nestlé Nan Pro 2- formula milk for 6-24 months infants.
“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; Example: Similac Stage 1 and Nestlé Nan 1- formula milk for infants from birth to 6 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; Example: Nestle Cerelac Rice Cereal- A ready-to-use rice cereal with milk that can be prepared by adding water or milk.
Farex Instant Cereal- Milk and grains instant cereal made by adding milk or water.
“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; Example: Farex Multigrain Cereal- Multigrain blend cereal to be mixed with water or milk. Nestle Cerelac Wheat Cereal-Processed wheat cereal to be used by adding water or milk.
Regulatory Authority in India and FSSAI Infant Food Regulation:
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 is 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
FSSAI Amendments For Foods For Infant Regulations 2020:
Recently on the 1st of October 2022, the FSSAI made amendments to the Food Safety and Standards Regulations 2020, known as the first amended regulations, 2022.
According to this amendment, some of the regulations are changed and some new points are being added which are as follows:
The labeling of infant food should be according to the Food Safety and Standards (Labelling and Display) Regulations, 2020.
Sub-regulation 3 has now been added under regulation 7 for infant food, where it states that the powdered formula should not use any vegetable oil, linoleate, vitamin E, starch, specified food additive, and optional ingredients so be categorized as “Infant Milk Food”.
Packaging gases such as Carbon dioxide and Nitrogen have now been added for use at GMP for Follow-up Formula.
Vitamin B12 limit has been increased from 0.25 - 0.70 mcg and 0.05 - 0.15 mcg to 0.25 – 4.0 mcg and 0.05 - 0.90 mcg per 100 g and per 100 kcal for both Infant Formula and Follow-up Formula.
Infant Formula Regulatory Process in India
The Indian manufacturers must obtain FSSAI license as an essential pre-requisites for manufacturing Infant food regulations 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.
Steps For Manufacturing And Marketing Infant Formula Product In India:
The process of marketing an infant food in India under the regulations of FSSAI includes a comprehensive process with the following steps:
Product Development: An infant formula milk or complementary food product is prepared after long research and studies.
FSSAI registration: For the sale of the infant food product the product is registered with the FSSAI, where its safety, efficacy, and quality are confirmed.
Compliance with FSSAI nutritional requirements: The product is analyzed to see if it complies with all the nutritional requirements of the FSSAI guidelines.
Infant formula product testing: The infant product is tested under the FSSAI labs to ensure its safety and quality standards.
Audits and inspections: The manufacturing units of these infant formula products are inspected and audited.
Marketing authorization: After surpassing all these steps, the infant formula product is authorized by the FSSAI for market sale.
Advertising compliance: There are some FSSAI guidelines for the advertisement of infant formula food that need to be complied with such as false claims, claims supporting scientific evidence, etc.
Post-marketing surveillance: Monitoring of the product should be done continuously after the sale of the product to encounter any adverse effect after the use of the product if any or any changes in the product required according to the consumers.
Product recall if required: If any serious adverse effect is reported against the product, the infant food product may be recalled by the FSSAI.
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 issued 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.
Importing Guidelines For Infant Food In India:
The importing of infant food in India should follow strict guidelines under the FSSAI regulations. The detailed process of bringing the imported infant milk and complementary infant food to India is as follows:
1. Registration with FSSAI:
Before the import of the infant food product, the manufacturer must register the product with the FSSAI and obtain an FSSAI license.
The documents required here are FSSAI license details, importer business details, and product details.
2. Product certifications review:
Then the certifications of the infant formula product are reviewed such as certificate of analysis, health certificate, objection certificate (NOC), etc.
3. Compliance with FSSAI standards:
The product should comply with all the guidelines mentioned under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.
General nutrient concentrations should be according to their allowed concentrations.
The product, if fortified, should meet the nutrient levels mentioned in the guidelines.
4. Compliance with labeling requirements:
The label should mention:
Product name
Nutritional information
Age group
Precautions
Warnings
Storage instructions
Manufacturing and expiry date
Importer details.
5. Meeting the packaging requirements:
The packaging should be tamper-proof, and child-resistant and should mention its expiry date.
6. Product testing under FSSAI labs:
The imported product is tested under FSSAI labs to ensure its safety and adulteration with contaminants.
7. Import clearance and Custom clearance:
On arrival of the product in India the product must show its FSSAI license and address the customs duties and import clearance it is applicable for.
8. Approval granted for sale In India:
After passing through all these steps, finally the infant formula milk or complementary food product enters the Indian market for sale.
After the imported infant formula has entered the Indian market for sale, the manufacturer should conduct post-marketing surveillance update its report to the FSSAI, and ensure that the product has no complaint or occurrence of adverse effect, or the product shall be recalled by FSSAI.
FAQs:
1. Can formula milk be marketed as a substitute for breast milk in India?
No, the marketing of formula milk as a substitute for breast milk is strictly prohibited in India. The label of the formula milk should clearly state that "Mother's milk is best for infants”
2. Does non-compliance with infant formula regulations by FSSAI cause penalties?
Yes, non-compliance with infant formula regulations causes penalties such as product recalls, fines, or suspension of the product.
3. What is the shelf life of formula milk as per FSSAI?
According to the FSSAI regulations, infant formula milk must have a shelf life mentioned on the package label which is usually 12-24 months.
4. Are there any FSSAI guidelines for fortified infant formula?
Yes, fortified infant formula should comply with the FSSAI nutrient requirements. The formula should be fortified with nutrients such as iron, calcium, vitamin A, etc.
References :
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