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BIS ISI Certification for Milk Powder

UMSPCS - BIS ISI Certification for Milk Powder

BIS ISI Certification for Milk Powder

BIS Certificate is Mandatory to Manufacture, Import & Sell Milk Powder Under IS 1165:2022. Get to check the Complete Procedure, Documents Required with UMSPCS

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BIS ISI Certification for Milk Powder (IS 1165): De-notification & Latest Compliance Update

Milk powder is a shelf-stable product, but the requirements relating to its compliance are by no means simple. A manufacturer might still come across references to BIS ISI Certification for Milk Powder under IS 1165, to older BIS licences, or to testing requirements based on the former compulsory certification system. Nevertheless, the regulatory position has changed.

IS 1165 - Milk Powder is currently included in the list maintained by the Bureau of Indian Standards (BIS) of products which have been withdrawn from the requirement of compulsory BIS certification. Accordingly, companies should not regard the BIS ISI certification for IS 1165 as currently mandatory just because the Indian Standard is still in existence.

At the same time, the Indian Standard IS 1165:2022 is still a significant standard for whole milk powder and includes detailed requirements concerning product quality, microbiological safety, contaminants, packaging and testing.

This means that for manufacturers, importers, and companies intending to enter a market, there is a significant distinction in that the withdrawal of compulsory BIS certification does not imply that the product can be manufactured or sold without adhering to the relevant food-safety requirements.

The reason behind the most recent position, the changes that have taken place, the scope of 1165:2022, and the way in which businesses should deal with compliance today.

What Does BIS ISI Certification Mean for Milk Powder?

In the past, the BIS ISI Certification for milk powder was linked to the mandatory certification system whereby manufacturers had to obtain a BIS licence in order to use the Standard Mark on products that complied with the relevant Indian Standard.

The standard in question was IS 1165, which originally included specifications for milk powder.

The BIS later amended the standard from IS 1165:2002 to IS 1165:2022, the 2002 edition being withdrawn on 4 January 2023. The updated standard was called "Whole Milk Powder - Specification".

The current listing of IS 1165 - Milk powder under the BIS Scheme-I clearly states that it has been "denotified from compulsory BIS certification."

Hence, any business in India looking to obtain BIS Certification for milk powder should first decide whether or not it actually needs a BIS licence or whether its compliance obligation is now mainly based on the relevant food regulations.

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IS 1165 Has Been De-notified from Compulsory BIS Certification

The most important aspect for manufacturers is that, under the present BIS Scheme-I product listing, the standard IS 1165 - milk powder - has been withdrawn from the requirement for compulsory BIS certification.

What de-notification entails is that the product is withdrawn from the requirement of having to be certified by BIS under the previous mandatory certification system.

In practical terms:

  • It would be wrong for a manufacturer to suppose that a mandatory BIS ISI licence is currently required just because the product is covered by IS 1165.
  • References that are currently made to mandatory BIS certification might be connected with the previous regulatory system.
  • The Indian Standard may still exist even if compulsory BIS certification is abolished.
  • Before manufacturing, importing, distributing, or selling milk powder, businesses have to look into the relevant FSSAI and other regulatory requirements.

This point is particularly important when companies are preparing regulatory documents, product labels, or market-entry plans.

BIS Certification vs Indian Standard: Why the Difference Matters

A frequently made mistake when it comes to compliance is to regard an Indian Standard and compulsory BIS certification as being identical.

That is not the case; the IS 1165:2022 standard still includes the technical specifications for whole milk powder. The documentation from BIS sets out the requirements relating to production, quality, packaging, hygiene and testing.

The present listing of IS 1165 under the BIS Scheme-I states that it has been withdrawn from compulsory BIS certification.

For example, let us consider an Indian manufacturer of whole milk powder.

Although the company can use IS 1165:2022 as a technical benchmark for product quality, it should not simply claim that the product is "BIS certified" nor should it assume that a BIS licence is required without first determining the relevant legal requirement.

A proper BIS Compliance Assessment for milk powder is something that proves valuable 

What Was the Reason for the Revision of IS 1165?

The update to IS 1165:2002 to become IS 1165:2022 involved more than just altering the year displayed on the standard. BIS had introduced several technical changes.

The implementation circular notes changes including:

  • Revised description of whole milk powder
  • Reference to applicable food-additive requirements
  • Introduction of a milk-protein requirement
  • Revised titratable-acidity requirements
  • Introduction of a scorched-particle requirement
  • Alignment of microbiological limits with food regulations
  • Addition of requirements for yeast and mould
  • Addition of Listeria monocytogenes
  • Addition of Bacillus cereus
  • Addition of sulphite-reducing clostridia
  • Addition of E. coli
  • Removal of the earlier Shigella requirement
  • Addition of heavy-metal and contaminant requirements
  • Inclusion of a microbiological sampling plan

This shows that manufacturers should stop relying on the earlier IS 1165:2002 compliance documents when assessing their current technical requirements.

Key Quality Requirements Under IS 1165:2022

The standard offers a structured framework for assessing whole milk powder.              

1. The physical and chemical properties

The product is assessed against parameters such as:

Parameter

Compliance focus

Moisture

Maximum permissible level

Total solids

Product composition

Milk fat

Minimum requirement

Milk protein in milk solids-not-fat

Minimum requirement

Insolubility index

Solubility/performance

Total ash

Composition

Titratable acidity

Acidity control

Scorched particles

Processing quality

They aid in telling the difference between whole milk powder that has been properly processed and one which may have problems with its composition, processing or storage.

2. Microbiological safety

The revised standard also addresses microbiological parameters such as:

  • Aerobic plate count
  • Coliform count
  • Staphylococcus aureus
  • Yeast and mould
  • Salmonella
  • Listeria monocytogenes
  • Bacillus cereus
  • Sulphite-reducing clostridia
  • coli
3. Contaminants and residues

The standard also addresses contaminants and food-safety parameters including:

  • Lead
  • Arsenic
  • Aflatoxin M1
  • Melamine
  • Pesticide residues
  • Antibiotic and veterinary-drug residues

Technical testing therefore becomes an important element of a manufacturer's overall compliance strategy even when compulsory BIS certification is no longer applicable.

What Concern is There Regarding BIS Certification for Foreign Manufacturers?

Before exporting food products to India, many foreign companies look for BIS Certification for Foreign Manufacturers.

The same principle holds in this case: the company must first check whether the specific product is currently covered by a compulsory BIS requirement.

The fact that IS 1165 is now listed by BIS as de-notified from compulsory BIS certification means that a foreign manufacturer cannot automatically conclude that it needs an FMCS licence just because its product is whole milk powder.

The importer and the foreign manufacturer should assess the entire Indian regulatory framework which applies to the product.

This is especially important since food imports may entail regulatory requirements in addition to those of BIS.

BIS ISI Certification for Milk Powder: What Businesses Should Do Now

Rather than approaching the issue as a conventional “apply for BIS licence” project, the current approach should be:

Step 1: Identify the exact product

Determine whether the product is:
  • Whole milk powder
  • Skimmed milk powder
  • Partly skimmed milk powder
  • Another dairy powder or milk-based preparation
    • This is important since different products may be covered by different standards and regulatory provisions.

    Step 2: Identify the applicable standard

    The appropriate Indian Standard for whole milk powder is IS 1165:2022.
    For example, the BIS documentation gives separate specifications for skimmed milk powder, covering IS 13334 Part 1 and Part 2.

    Step 3: Check compulsory certification status

    Don't use a previous licence, an old article, or an outdated consultancy page. It should be checked whether the product is still subject to compulsory certification under the present BIS Scheme-I listing. BIS at present indicates that IS 1165 has been de-notified from compulsory BIS certification.

    Step 4: Evaluate testing requirements

    In places where BIS certification is not mandatory, technical testing can still be important for showing that the product meets the relevant product and food-safety requirements.

    Step 5: Review FSSAI compliance

    Since milk powder is a food product, companies ought to consider the FSSAI regulations relevant to its composition, contaminants, additives, microbiological safety, packaging, and labelling.

    Step 6: Review labels and packaging

    The standard includes provisions regarding packaging and marking, although other regulations in India may require additional measures.

    Step 7: Maintain technical records

    Manufacturers should retain relevant:
  • Product specifications
  • Test reports
  • Raw-material records
  • Manufacturing records
  • Quality-control records
  • Packaging information
  • Label artwork
  • Supplier documentation
    • A stronger compliance trail is thus established, and this makes it easier for regulators to carry out their future assessments.

    Documents and Information Required for Compliance Assessment

    As the situation is now mainly concerned with a compliance assessment rather than being a simple mandatory application for BIS certification, the documentation can differ depending on the business.

    Typically, the assessment may require:

    • Basic data on the manufacturing unit and the product segment
    • Evidence of the manufacturing unit's address (for example, a deed showing ownership or a utility bill, etc.)
    • Trademark registration certificate (if brand name is used and registered)
    • Manufacturing licence / statutory approvals (where relevant - such as pollution
    • control and industry-specific approvals)
    • Product drawings/design schematics
    • Installed manufacturing capacity
    • List of materials used, and specification
    • Details of manufacturing machinery and equipment
    • The layout plan of the factory, including production and testing areas, and storage areas
    • A detailed manufacturing process flow is provided
    • In-house test equipment and calibration information
    • Information about the quality control personnel
    • Factory organisational chart

    It is also possible to discover how the product was previously evaluated by looking at the historical certification documents for a company which had earlier held a BIS licence under the old system.

    Cost of BIS Compliance for Milk Powder

    Since the compulsory BIS certification as per IS 1165 has been withdrawn, companies should be careful in giving a quoted price for 'BIS ISI Certification for Milk Powder'.

    There is no single universal fee that applies to all milk-powder compliance projects.

    The overall cost can depend on:

    • Product category
    • Testing requirements
    • Factory size
    • Documentation complexity
    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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    How Long Does it Take to Achieve Compliance with Milk Powder?

    There cannot be a single fixed timeline since the present procedure is not merely a standard compulsory application for a BIS ISI licence in accordance with IS 1165.

    For Indian manufacturers, the timeline is usually between 30 and 40 days, though businesses that have complete specifications and valid reports already in place are generally able to make progress more quickly than companies that are starting their compliance documentation from scratch.

    What Makes UMSPCS the Choice for Milk Powder Compliance?

    UMSPCS is a consultancy firm owned by BIS that helps businesses with product compliance and regulatory requirements.

    Because of its experience with more than 600 product compliance requirements and having more than 6 years of experience, UMSPCS is able to assist companies in distinguishing between a current mandatory requirement and an outdated certification assumption.

    Our support can include:

    • Product and standard identification
    • Current BIS status verification
    • IS 1165:2022 compliance assessment
    • Documentation review
    • Testing requirement identification
    • Laboratory coordination
    • Technical document review
    • Packaging and label compliance guidance
    • Regulatory roadmap preparation
    • Support for Indian manufacturers
    • Support for foreign manufacturers and importers

    Conclusion

    The regulatory stance concerning BIS ISI Certification for milk powder has changed considerably.

    Even though the IS 1165:2022 standard still includes detailed specifications for whole milk powder, BIS presently has IS 1165 - Milk powder listed as de-notified from mandatory BIS certification.

    Meanwhile, the technical requirements set out in IS 1165:2022 are still useful for evaluating product quality and safety, and food businesses must carry on taking into account the relevant FSSAI and other regulatory requirements.

    Thus, if you are an Indian manufacturer of dairy products, a dairy importer, a private-label brand or an overseas supplier, the appropriate first step is not simply to apply for a BIS licence; rather, it should be a current assessment of your product's regulatory requirements.

    If you are at all in doubt as to whether your milk powder needs to have BIS certification, testing or some other form of regulatory approval, UMSPCS can examine your product and assist you in determining the appropriate compliance route. Also get to know more information about BIS Certification for Electric Fence Energizers.

    Frequently Asked Questions (FAQs)

    BIS at the moment has listed IS 1165 - Milk powder as being de-notified from compulsory BIS certification; nevertheless, other food safety and regulatory requirements might still apply.

     

    Yes, the current revised standard for whole milk powder is IS 1165:2022; the previous standard, IS 1165:2002, was withdrawn on 4 January 2023.

     

    No, the de-notification applies only to the mandatory BIS certification, and manufacturers and importers must still meet the relevant food-safety, labelling, packaging and other regulatory requirements.

     

    Yes, the technical requirements and those concerning testing set out in IS 1165:2022 apply to whole milk powder and it still serves as an important reference for the assessment of product quality.

     

    It is not automatically covered by IS 1165. The product is at present listed as de-notified from compulsory BIS certification, so foreign manufacturers should carry out a product-specific regulatory assessment before applying for BIS certification.

     

    The tests carried out will depend on the relevant scope and may cover moisture, fat, protein, total solids, microbiological parameters, contaminants, aflatoxin M1, melamine, and any other requirements specified in the applicable standard and regulations.


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