ISI / BIS Certification for Follow-up Formula Complementary Foods

Follow-up formula complementary foods are carefully crafted, nutritionally sound meals that support a baby's diet during the shift from formula or exclusive breastfeeding to solid food consumption. As advised by medical experts and groups like the American Academy of Pediatrics and the World Health Organization (WHO), these supplemental foods are usually provided to infants at the age of six months. Supplementary foods for infants that boost their nutrition and foster healthy development are crucial. During a crucial stage of growth and development, their thoughtfully crafted nutritional profiles, suitable feeding techniques, and parental advice all contribute to the health and wellbeing of infants and toddlers.

A product made by spray-drying cow or buffalo milk, or a combination of the two, is considered a supplemental food for a follow-up formula. When this product is in liquid form, it can be taken as is or combined with water before feeding. It needs water to prepare in powder form, and it needs to be lump-free and homogeneous in appearance.

According to IS standard IS 15757: 2022, all Follow-up Formula Complementary Foods are now part of the required ISI Certification Scheme.

Without the ISI Mark, this product cannot be marketed, imported, or exported into the Indian consumer market.

This standard describes the requirements, testing protocols, and sampling techniques that apply to supplementary foods made with formula that are intended for infants who are weaning, or between the ages of six months and two years.

About ISI / BIS Certification

Indian Standards Institute, or ISI was renamed the Bureau of Indian Standards (BIS) in 1987. The official mark that the Bureau of Indian Standards provides for manufacturers of various goods is the ISI Mark. It is used to indicate compliance with Indian standards (IS) set by the Bureau of Indian Standards (BIS) and has been used as a conformity marking for industrial products. Manufacturers received permission from BIS to use the ISI Mark on items that comply with relevant Indian requirements through the product certification program. 

Only manufacturers (domestic or foreign) who produce the finished product will be awarded ISI Certification. This will not be given to any product importers, traders, dealers, or distributors.

Documents Required for ISI / BIS Certification

The following documentation is required to get an ISI certification:

• Main Application Form V
• Address Proof of Manufacturing Unit
• Details of Manufacturing Process
• Test Report of products

For more detailed information, please click here.

Process of ISI / BIS Certification

There are two approaches for Indian manufacturers to become certified with the ISI Mark:

• Regular Procedure
• Simplified Procedure 

Regular Procedure

With the possible exception of cases deemed "All India first," which might take up to 180 days, the licensing procedure is expected to be finished in 120 days. This timeline starts on the day the application is received, assuming that at different points in time the documentation, unit assessment, and product conformance are all deemed acceptable.

Step 1: Manufacturing Unit Customization in Compliance with Applicable Indian Standards

• Identifying the applicable Indian Standard
• Establishing in-house testing facilities as per the Standard's requirements

Step 2: Submission of the Application Form

• Preparing an Internal Test Report for the product by the relevant Indian Standard
• Compiling all necessary documents
• Completing the Online Application Form
• Online payment of application fees directly to BIS
• Submitting hard copies of the Application Form with all enclosures to the relevant Branch Office (BO) of BIS

For more detailed information, please click here.

Simplified Procedure

This is a much faster process than the standard procedure. After a factory inspection is deemed satisfactory and the initial evaluation establishes that the sample complies with the applicable Indian Standard(s), the license application process is expected to be finished in 30 days.

Step 1: Adapting the Manufacturing Unit to Comply with the Relevant Indian Standard

• Identifying the applicable Indian Standard
• Establishing in-house testing facilities to meet the Standard's requirements

Step 2: Sample Testing

• Obtaining the necessary certificate for raw materials (Material Test Certificate - MTC)
• Conducting product sample testing at a BIS-recognized testing laboratory

For more detailed information, please click here

ISI Mark Certification Process for Foreign Manufacturers

The process of obtaining ISI Mark Certification for Foreign Manufacturers typically includes the following steps:

Step 1: Application

• Compile all the required documents.
• Submit the documents along with the Application Fee.
• An Application Number will be allotted.
• Scrutiny of the Application will be conducted within a specified time frame.​

Step 2: Query Raised (If Any)

• If any documents are missing or there is non-compliance, you will be informed.
• You need to submit a reply within the given timeframe.

​For more detailed information, please click here.

Why choose Brand Liaison?

Brand Liaison provides helpful support for achieving ISI Mark Certification. Among our offerings are:

•  Expert guidance
•  Streamline process
• Comprehensive support
• Cost-effective solutions
• Time efficient

Please click here to get in contact with our team of specialists for a deeper explanation of the paperwork and steps needed to get ISI Mark Certification.