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BIS ISI Certification for Follow-Up Formula

UMSPCS - BIS ISI Certification for Follow-Up Formula

BIS ISI Certification for Follow-Up Formula

Looking for BIS Certification for Follow-up Formula – Complimentary Foods under IS 15757? UMSPCS ensure safety, compliance, and market credibility for your brand.

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BIS ISI Certification for Follow-Up Formula IS 15757:2022: Current Requirements & FSSAI Compliance Guide

Follow up formula is a special formula designed for children over six months old, which is used during the complementary feeding phase. The control of nutritional composition, microbiological quality, contaminants, ingredients, packaging and labelling is therefore critical for the manufacturers of these products as they belong to a sensitive consumer group.

For manufacturers looking to get BIS ISI Certification for Follow-Up Formula as per IS 15757, it is important to note that BIS certification of the product is no longer mandatory.

The current list of products available in Scheme-I of BIS, in particular, the IS 15757 Follow-up Formula Complimentary Foods is marked as “De-notified from compulsory BIS certification.” The change comes after the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2024, were made, which did not include provisions regarding mandatory BIS/Agmark certification for specified food products.

The product is still subject to the Indian Standard, IS 15757:2022 – Infant Food – Follow-Up Formula – Specification (First Revision), and government Laboratories are still able to provide testing capacity against the standard.

UMSPCS can inform manufacturers about the status of the regulations, evaluate product needs, arrange for the appropriate food testing, and support paperwork required for compliance with the relevant food regulations.

What Is IS 15757:2022 for Follow-Up Formula?

IS 15757:2022 is the Indian Standard for Infant Food Follow-Up Formula  Specification, which is the first revision of the earlier IS 15757 standard.          

The standard is for follow-on infant formula after six months of age for quality/safety. These include specifications on the nutritional value, microbiological properties, contamination, and other features of the product.

Additionally, the BIS guidance for IS 15757:2022 regarding products also considers testing and inspection requirements, pointing out that the standard is still technically relevant in spite of the compulsory BIS certification being withdrawn.

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What Is the Current Compliance Route for Follow-Up Formula?

When the compulsory BIS ISI Certification for Follow-Up Formula is removed, there is no requirement to manufacture or sell follow-up formula without meeting the requirements for food safety compliance.

Manufacturers should continue to consider the relevant Food Safety and Standards (FSS) regulations such as food standards, composition, contaminants, microbiological safety, labelling and licensing.

It has been noted in the FSSAI notification for 2024 that mandatory BIS/Agmark certification provisions have been removed from the notification, thereby shifting the regulatory responsibility from required BIS/Agmark certification of the affected food categories.

Who Should Assess Compliance for Follow-Up Formula?

Compliance assistance may be applicable for:

  • Indian follow up formula producers
  • Infant-food producers
  • Food operation companies
  • Contract manufacturers/OEM producers
  • Private label infant food brands
  • Importers
  • International food producers operating in India
  • New product follow up formula manufacturers

The licensing requirements vary based on the type of product, manufacturing system, formula, and market.

What Does IS 15757:2022 Cover?

IS 15757:2022 provides the specifications for follow-up formula as an infant food product.

The standard contains provisions on the following aspects:

  • Product description
  • Nutritional composition
  • The protein and fat needs of a person.
  • Vitamins and minerals
  • Essential fatty acids
  • Amino acids and other specified nutrients
  • Microbiological quality
  • Contaminants
  • Product hygiene
  • Packaging and marking

What Testing Is Required for Follow-Up Formula?

Testing is still relevant and useful for the purpose of demonstrating the conformity of the product or food safety even if the certification is not required.

Testing under IS 15757:2022 can cover:

  • Protein
  • Fat
  • Vitamins
  • Minerals
  • Linoleic acid
  • Taurine
  • Essential amino acids
  • Inositol
  • Microbiological parameters
  • Lead
  • Arsenic
  • Tin
  • Cadmium
  • Melamine
  • Solubility index

Other nutritional and safety parameters that can be applied are also mentioned.

BIS LIMS currently displays laboratories with testing scope for IS 15757:2022, which include nutritional, microbiological and contaminant testing.

The selection of the proper test panel should be based on product formulation and relevant regulations.

Process BIS ISI Certification for Follow-Up Formula

Step 1: Identification of Applicable Indian Standard (IS) code

Identification of the IS code for the particular product.
The step includes:
  • Analysis of Product Type
  • Identify the IS code.
  • Compliance requirements review.
  • Gap analysis of the manufacturing process.
  • Quality compliance with BIS information.

    • Step 2: Laboratory Testing and Documentation of Product

    The product needs to be tested in a laboratory testing facility approved by BIS and accredited by NABL Testing in order to be sure that it complies with the applicable standards.
    The steps include:
  • Testing of Product Samples.
  • Technical Documents Preparation.
  • Technical Documents Preparation.
  • Manufacturing Information Gathering.
  • Quality Documentation.
  • Application form preparation.

    • Step 3: Submission of Application to BIS

    When the testing and documentation are completed,
    The step includes:
  • Filing of the BIS Application.
  • Submission of Lab Test Reports.
  • Submission of Factory Information.
  • Payment of government fees.
  • Initial checking by BIS officers.

    • Step 4: BIS Factory Inspection

    The BIS officials come to inspect the manufacturing unit for its suitability for the certification.
    In the factory inspection process, BIS will evaluate:
  • Manufacturing process
  • Production facilities
  • Quality assurance systems
  • Testing facility at the manufacturing unit
  • Consistency of the product

    • Step 5: Sample Testing and Laboratory Evaluation

    The BIS can test the samples of products at an independent laboratory during this process.
    This step consists of:
  • Collection of samples by BIS officials.
  • Laboratory testing
  • Technical evaluation of the test results
  • Laboratory Test Report (LTR) is to be submitted.

    • Step 6: Closing of Observations

    If any observation is noted during the inspection and/or testing process, the manufacturer needs to rectify these observations before approval.
    It may consist of:
  • Observations by BIS
  • Corrective actions
  • Updating of technical documents
  • Evidence of conformity
  • Closure of observations

    • Step 7: Payment of License & Marking Fees

    Once compliance is confirmed successfully, the fee for BIS should be paid.
    These fees include:
  • Annual licence fee
  • ISI marking fee
  • BIS License compliance conditions.

    • Step 8: Grant of BIS Licence

    On completion of all the above processes, BIS issues the ISI license. With the issue of the license:
    Once the licence is issued:
  • An ISI mark can be applied for certified products.
  • The products can be legally manufactured and sold in India.
  • The manufacturers need to have continuous BIS compliance.

    • Documents Required for IS 15757

    Some of the documents required would include:

    • Basic information of the manufacturing unit and the product range
    • Proof of address of the manufacturing unit
    • Trademark certificate for the brand name
    • Manufacturing licence/certifications
    • Design drawings of the product
    • Total installed manufacturing capacity
    • List of materials and their specifications
    • Details of manufacturing machinery and equipment
    • Factory floor plan
    • Process flow in detail
    • Testing facilities with calibration details
    • Laboratory personnel details
    • Organogram of the factory

    Cost for IS 15757

    Many manufacturers ask how much certification will cost.

    The final price would be determined by:

    • Type of product
    • Indian standards that apply to the product
    • The quantity of models
    • Testing specifications
    • Requirements for factory audits
    • BIS fees from the government
    • Conditions for consulting services

    To determine the certification cost, an analysis would be necessary because every product type is unique.

    Particulars Estimated Cost (INR)
    Application Fees (BIS)
    ₹1,000
    Testing Charges (Lab Fees)
    15000- ₹2,50,000
    Factory Inspection Charges
    ₹7000
    Annual License Fees
    ₹1,000
    Marking Fees (ISI Mark Usage)
    As per BIS norms (based on production)
    Consultancy Charges (UMSPCS)
    ₹ 50000
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    BIS Certification Timeline for IS 15757

    The approval period depends on the following:

    • Complexity of the product
    • Duration of testing
    • Preparation of documentation
    • BIS approval process
    • Inspection of the factory

    In general, the whole process takes about 30-40 days, although with proper planning and consultation by experts, the process can be expedited considerably.

    What Are the Common Compliance Mistakes?

    When manufacturers use out-of-date BIS information, there will be unnecessary complications.

    Common issues include:

    • It is assumed that BIS certification will remain a requirement.
    • The present standard adopts the requirements of the old standard IS 15757:2007.
    • Ignoring the revised IS 15757:2022
    • Incomplete nutritional documentation
    • Incorrect formulation information
    • Inadequate microbiological testing
    • Missing contaminant testing
    • Labelling inconsistencies
    • Mixing BIS with FSSAI requirements.

    The current BIS regulatory position should be confirmed before starting a project as evidenced by competitor pages which continue to promote compulsory BIS certification and fixed BIS certification timelines for IS 15757.

    Why Choose UMSPCS for Follow-Up Formula Compliance?

    UMSPCS Provides Full Support to Manufacturers for BIS ISI Certification for Follow-Up Formula

    The following services will be provided by us

    • BIS Applicability Study
    • Identification of existing standards
    • Review of classification and grouping of the product
    • Documentation
    • Coordination of testing laboratory
    • Plan out for sampling and testing.
    • Test Report Review
    • BIS Application Help
    • Preparation for factory inspection
    • Assistance in answering BIS queries/observations
    • Scope of license assistance
    • Assistance after certification

    We have been helping thousands of manufacturers & importers in their BIS needs for the last 6+ years and have delivered more than 600+ certifications.

    Conclusion

    IS 15757 is an important Indian Standard for Follow-Up Formula Complimentary Foods, and the current revised Indian Standard is IS 15757:2022. But it should not be considered a compulsory requirement for BIS ISI certification for manufacturers.

    As per the regulatory changes notified by FSSAI in October 2024, BIS has mentioned IS 15757 in its present list of Schemes, where it has been de-notified from compulsory BIS certification.

    This implies that the compliance focus for follow-up formula manufacturers should now switch to the applicable food-safety requirements, product standards, testing, product composition, contaminants, microbiological food-safety, and labelling under the FSSAI.

    The Indian Standard continues to be a useful technology reference, and BIS LIMS continues to list laboratories capable of testing IS 15757:2022.

    Need Compliance Support for Follow-Up Formula?

    UMSPCS can assist with the evaluation of your follow-up formula product, the current regulatory pathway, testing needs, and compliance documentation.

    To know the current compliance requirements of your follow-up formula product in India, please contact UMSPCS. Also, get to know more about BIS Certification for Multipurpose Dry Batteries.

    Frequently Asked Questions (FAQs)

    IS 15757 is NOT compulsory for BIS certification.

     

    The latest standard is IS 15757:2022 Infant Food Follow-Up Formula  Specification.

     

    No, appropriate FSSAI food-safety, composition, testing, and labelling requirements still have to be observed.

    Relevant amendment of FSSAI was notified on 17 October 2024.

     

    Yes, BIS LIMS currently displays laboratories that have a testing scope for IS 15757:2022.

    Yes, UMSPCS can help you with regulatory assessment, testing coordination, documentation, and applicable food-compliance support.

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