BIS ISI Certification for Food & Related Products: Understanding the Latest De-notification

Business firms that manufacture items like milk powder, baby food, and bottled water have been relating food safety compliance to the famous mark known as the BIS ISI Mark for years, but the regulatory landscape has changed significantly in October 2024.

The Food Safety and Standards Authority of India (FSSAI) has relaxed the obligatory certification protocol of BIS for a few food items in the First Amendment Regulations, 2024, which makes these foods a part of the list of “de-notified items of compulsory BIS certification” as provided by BIS.

The fact that de-notification does not mean that these products can be manufactured or sold without fulfilling regulatory requirements is that the responsibility for compliance with regard to the relevant food categories has mostly been transferred to the FSSAI food safety framework.

Anyone who is a manufacturer, importer, or considering entering the Indian market should understand this difference.

What has been changed in the most recent BIS food product de-notification?

On 17 October 2024, the FSSAI issued the first amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2024, omitting the specific provisions that had required mandatory BIS certification for certain food products.

BIS’s current Scheme-I product list identifies the following food and related products as de-notified from compulsory BIS certification:

The BIS is still listing these products in the Scheme-I information as having been withdrawn from compulsory certification.

What Implication Does this Have for Indian Manufacturers?

The first thing that an Indian manufacturer should do is to check if the product is actually on the de-notified list.

Then the manufacturer should look into the FSSAI licence in question, the food safety standards, the labelling requirements, the testing requirements, the hygiene controls and the inspection obligations.

For products which stay subject to compulsory BIS certification via a QCO or some other legal instrument, the usual BIS certification requirements remain in force.

As a result, the BIS ISI Certification for Indian manufacturers becomes a compliance issue that is specific to the product rather than a general requirement for the entire food sector.

Basic Compliance Requirements for Food Businesses

Depending on the product and regulatory pathway, businesses may need to maintain:

• Product specifications and formulation details
• Manufacturing process information
• Raw-material details
• Product and packaging specifications
• Laboratory test reports
• Food safety and hygiene records
• Manufacturing premises details
• FSSAI registration or licence documentation, where applicable
• Product labels and artwork
• Authorised representative details for applicable imported products
• Declarations, undertakings and supporting regulatory documents

The specific requirements vary according to the product category and the relevant regulations.

What is the Procedure Concerned with Compliance After De-notification?

A practical compliance assessment can be approached in the following sequence:

Step 1: Identify the Product & Standard

Find the product, the relevant IS code, and the present BIS/QCO status, and determine if it is included in the de-notified list.

Step 2: Review Requirements

Work out the BIS and FSSAI requirements that apply, covering the aspects of product, testing, labelling, and manufacturing standards.

Step 3: Prepare Documents

Put together the product specifications, the formulation details, the factory information, the test reports, the labels, the packaging, and all the other documents that are required.

Step 4: Product Testing

Carry out the necessary product testing at the relevant laboratory and get the reports that are required.

Step 5: Submit Application

Together with the required supporting documents and the prescribed fees, submit the appropriate BIS and/or FSSAI application.

Step 6: Inspection & Review

The authority concerned will look at the application and has the right to inspect the manufacturing facility and the quality-control systems.

Step 7: Resolve Queries

Handle any non-conformities, extra document requests, or regulatory questions that come up during the process.

Step 8: Obtain Approval

When all the requirements have been met, get the relevant licence or approval and then keep up ongoing compliance.

Key Documents Businesses Should Keep Ready

A compliance file may include:

• Basic data of the manufacturing unit and the product segment
• Evidence of the manufacturing unit’s address (for example, a title 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
• 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 given
• In-house test equipment and calibration information
• Information about the quality control personnel
• Factory organisational chart

The number of documents that may be needed will depend on the product and the regulatory authority.

BIS Certification vs FSSAI Compliance: Know the Difference

It is especially important to make this distinction when businesses are looking for BIS Certification in India and take into account only the fact that an Indian Standard exists.

Legal Framework and Regulatory Guidelines

The BIS Act of 2016 determines the requirements of the BIS structure, along with the relevant provisions concerning conformity assessment; furthermore, the BIS emphasizes that the Central Government has the right to enforce mandatory certification for some goods via QCOs.

The most important change in terms of regulation of the goods included in the disliked list of 2024 is the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Rules, 2024, that were issued on October 17, 2024, under the rules of the Food Safety and Standards Act of 2006.

Therefore, prior to using the previously acquired data about compliance with BIS, it is their duty to check out the recent notification, QCO, and requirements of the goods.

Advantages of Performing Regulatory Applicability Assessment

A proper assessment can help businesses:

• Avoid applying for an unnecessary mandatory certification
• Identify the correct regulatory authority
• Prevent delays caused by incorrect documentation
• Understand whether BIS or FSSAI requirements apply
• Prepare products for Indian market entry
• Reduce the risk of non-compliance
• Maintain accurate product and labelling claims
• Plan testing and regulatory costs more effectively

BIS ISI Certification Cost for Food & Related Products in India

The price for BIS ISI Certification for Food and Related Products varies according to the product category, the testing requirements, the size of the factory, and the documentation.

The actual costs could differ depending on the relevant product and the BIS requirements.

Timeline & Validity for BIS ISI Certification for Food & Related Products

• The estimated time frame is 30 to 40 working days, depending on testing and inspection.
• Validity: As required by the relevant BIS scheme, with renewal having to take place before expiry.
• With regard to food products that have been de-notified, businesses should first check whether BIS certification is currently applicable before paying the certification fees.

How UMSPCS Can Help Manufacturers for Food & Related Products

At UMSPCS, we assist businesses in understanding the changing product regulations and in identifying the approvals that apply to their products.

With 6+ years of compliance experience and support across 600+ product compliance requirements, our team can assist with:

• BIS applicability assessment
• Indian Standard identification
• BIS ISI certification support where applicable
• FSSAI compliance assessment
• Product and document review
• Testing and laboratory coordination
• Application and documentation support
• Foreign manufacturer compliance assistance
• Regulatory query support
• Ongoing compliance guidance

What we are doing is to determine the right regulatory pathway before businesses spend their time and resources on an unnecessary application.

Conclusion

The most recent de-notification in the food sector marks a significant shift in the way India handles product compliance. Products relating to food and other similar products which had previously been required to obtain BIS certification are now officially listed by BIS as being de-notified from compulsory certification.

The regulatory responsibility is still there. The FSSAI requirements remain in force, and products like packaged drinking water and mineral water are covered by special high-risk food compliance measures.

The safest course of action for manufacturers, importers and foreign companies is to check the present regulatory stance specific to the product before they manufacture, import, or sell it in India.

Wanting to launch or import a food product into India? 

Have the compliance experts at UMSPCS check whether your product is covered by BIS and FSSAI.

Read more also: Get BIS Certification for Power Adaptors IT Equipment: IS 13252

FAQs

1. Is it still necessary to have BIS certification for foods that have been de-notified?

The specified products have not been notified by the BIS for compulsory BIS certification; nevertheless, the relevant FSSAI and other regulatory requirements remain in force.

2. What food products were removed from the requirement of obtaining BIS certification?

The products listed consist of specified milk powders, condensed milk products, infant foods, complementary foods, packaged natural mineral water, and packaged drinking water, and others.

3. Does de-notification imply that packaged drinking water requires no approval?

Packaged drinking water and mineral water have now been classified as high-risk food categories under FSSAI’s relevant order and are subject to compulsory inspection requirements.

4. Can I still apply for BIS certification on my own?

BIS certification is usually voluntary unless the Government makes it mandatory for a product. In order to find out if voluntary certification is available for a specific de-notified product, one should check the current BIS scheme and the status of the product.

5. Do products made by foreign manufacturers need to have BIS certification?

It is not necessarily required under the previous compulsory BIS regulations concerning the de-notified products; however, foreign manufacturers and importers have to assess the relevant FSSAI and Indian import requirements.

6. Does an Indian Standard remain relevant after de-notification?

Yes, an Indian Standard can remain in force even if compulsory certification has been withdrawn. The important point is now whether certification according to that standard is required, given voluntarily, or otherwise referred to in the relevant regulations.