FSSAI License for Packaged Drinking Water in India

The Food Safety and Standards Authority of India (FSSAI) has classified packaged drinking water as a “high-risk food” category. This classification mandates stricter compliance measures for manufacturers and sellers.

In India, FSSAI is the highest authority that guarantees the safety and quality of food products, like Packaged Drinking Water (PDW). Due to growing demand and to keep on maintaining the safety standards, the makers of packaged drinking water are compelled to enlist with the FSSAI. 

This article outlines the essentials for obtaining an FSSAI registration for packaged drinking water, including requirements, licensing process, and compliance standards.

Why is it Important to get an FSSAI License for Packaged Drinking Water?

Water is essential for human survival, accounting for approximately 60% of the human body. It plays a crucial role in ensuring the body functions properly. Pure drinking water is vital for maintaining excellent health, whereas dirty or polluted water can lead to serious health issues.

Therefore, FSSAI has ordered stricter regulation of packaged drinking water. This registration process ensures that the water is clean, pure, and safe for consumption. An FSSAI license gives customers confidence in the product’s safety and adherence to government standards following a thorough inspection.

Packaged Drinking Water: A High-Risk Food Category

In November 2024, the FSSAI reclassified packaged drinking water and mineral water as “high-risk food categories.” This decision was made to enhance safety protocols and compliance within the industry. As a result, manufacturers are now subject to:

• Annual Inspections: Mandatory risk-based inspections once every year.
  
• Third-Party Audits: Annual audits by FSSAI-recognized third-party food safety auditing agencies.
  
• Pre-License Inspections: Inspections before the grant of a license or registration.

These measures aim to mitigate potential health risks associated with the production and consumption of packaged drinking water.

pH of Packaged Drinking Water: FSSAI Standards

The FSSAI mandates that the pH level of packaged drinking water should be between 6.5 to 8.5. Maintaining this pH range is crucial to ensure the water is neither too acidic nor too alkaline, thereby safeguarding consumer health.

Source of Packaged Drinking Water

FSSAI permits packaged drinking water to be sourced from various origins, provided it undergoes appropriate treatment to ensure safety and quality. According to FSSAI guidelines, acceptable sources include:

• Local Water Supply: Municipal or community water systems.
  
• Underground Water: Extracted via wells or boreholes.
  
• Surface Water: From rivers, lakes, or reservoirs.
  
• Sea Water: Subject to desalination processes.
  
• Other Consistent Sources: Any reliable and safe water source.

Regardless of the source, the water must undergo a series of treatments to meet safety standards. These treatments include decantation, filtration, reverse osmosis, demineralization, remineralization, and disinfection. For seawater, desalination is mandatory before any other treatment. Post-treatment, the water should be packaged in clean, hygienic, and tamper-proof containers suitable for direct consumption.

Mandatory BIS Certification for Packaged Water

FSSAI mandates that all Food Business Operators (FBOs) involved in the manufacturing, processing, or sale of packaged drinking water and mineral water must obtain BIS certification. This requirement is stipulated under the Food Safety and Standards (Prohibition and Restriction on Sales) Regulations, 2011. The regulation states that no person shall manufacture, sell, or exhibit for sale packaged drinking water and mineral water except under the Bureau of Indian Standards (BIS) certification mark.

The relevant Indian Standards for BIS certification are:

• IS 14543: For Packaged Drinking Water (other than natural mineral water).
  
• IS 13428: For Packaged Natural Mineral Water.

These standards outline the specifications for water quality, treatment processes, packaging, and labeling requirements to ensure the safety and purity of the water intended for human consumption.

Types of FSSAI Licences for Packaged Drinking Water

FSSAI offers three types of licenses based on annual income and operational location. FSSAI instruction for package drinking water plant surrounds around these types of licenses:

1. FSSAI Basic License:

This is for small operators or retailers who make less than Rs. 12 lakh a year. This licence is good for local businesses that don’t operate on a large scale.

2. FSSAI State License:

For medium-level firms between Rs. 12 lakh and Rs. 20 crores annually, the FSSAI State License is applied. It is for a firm-specific, state-level packaged water business.

3. FSSAI Central License:

This is for big operations or manufacturers that make more than Rs. 20 crore each year, or those that work in several states. Any national-level manufacturer requires an FSSAI Central license.

Which Category Applies to Packaged Drinking Water: FSSAI Registration vs. License

The type of license required depends on the scale and nature of the business operations.

Importantly, both ‘Packaged Drinking Water’ (as per IS 14543) and ‘Mineral Water’ (as per IS 13428) units are mandatorily required to obtain an FSSAI State or Central License, depending on their production capacity and operational scope. In this case, basic registration is not sufficient for these categories.

• FSSAI Registration: This is a basic registration intended for small-scale food businesses with an annual turnover of up to ₹12 lakh. It is suitable for petty food manufacturers, small retailers, and hawkers. 
• FSSAI License: This is mandatory for larger food businesses and is categorized into:
  
  • State License: For businesses with an annual turnover between ₹12 lakh and ₹20 crore.
    
  • Central License: For businesses with an annual turnover exceeding ₹20 crore or those operating in multiple states.

Procedure for FSSAI License for Packaged Drinking Water

The process for obtaining an FSSAI license involves several steps:

Determine the Type of License:

• Basic Registration: 

For businesses with an annual turnover up to ₹12 lakh. Typically suitable for small-scale food businesses such as petty retailers, hawkers, and small manufacturers.

• State License: 

For businesses with an annual turnover between ₹12 lakh and ₹20 crore. This license is applicable for medium-sized PDW units operating within a single state.

• Central License: 

For businesses with an annual turnover above ₹20 crore or those operating in multiple states. Suitable for large-scale PDW units, especially those involved in import-export activities or operating across multiple states.

Note: For PDW units, basic registration is generally not sufficient due to the high-risk classification of packaged drinking water.

2. Application Submission:

Step 1: Determine the Appropriate License Type

• Assess your business’s annual turnover and operational scope to identify whether a State or Central License is required.

Step 2: Prepare Necessary Documentation

• Common documents include:
  
  • Identity proof and address proof of the business owner.
    
  • Proof of business premises (e.g., rental agreement or property documents).
    
  • Water testing reports from a NABL-accredited laboratory.
    
  • Plant layout and equipment details.
    
  • Food Safety Management System (FSMS) plan.
    
  • BIS certification, if applicable

Learning more about the needed documentation for FSSAI registration is crucial for successfully complying with the government authorities.

Step 3: Online Application via FoSCoS Portal

• Visit the FSSAI FoSCoS portal.
  
• Register and fill out the application form corresponding to your license type.
  
• Upload the required documents.

Step 4: Fee Payment

• Pay the applicable fee online based on the license type and duration.

3. FSSAI Instructions for Packaged Drinking Water Plants

FSSAI officials will inspect your PDW unit to verify compliance with safety and hygiene standards. They will assess the water purification process, storage facilities, and overall operational practices.

• Water Source: Utilize water from a safe and reliable source, such as surface water, underground water, or seawater (after desalination).
• Treatment Processes: Implement treatments like decantation, filtration, reverse osmosis, demineralization, remineralization, and disinfection to ensure water safety.
• Packaging: Use clean, colorless, hygienic, transparent, and tamper-proof bottles made from food-grade plastic.
• Labeling: Ensure labels include the product name, manufacturer’s details, batch number, date of packaging, best before date, and the FSSAI logo with the license number.

Navigating the regulatory landscape for packaged drinking water in India requires a thorough understanding of FSSAI’s mandates. Compliance with these regulations not only ensures legal operation but also reinforces consumer trust in the safety and quality of the product. Manufacturers and sellers must stay updated with FSSAI guidelines to maintain compliance and contribute to public health safety.

Contact RegisterKaro to learn more about FSSAI registration for packaged drinking water and get the chance to enjoy a FREE consultation with an expert.

Frequently Asked Questions (FAQs)

1. Is FSSAI Mandatory for Packaged Drinking Water?

Yes, obtaining an FSSAI license is mandatory for all entities involved in the manufacturing, processing, distribution, or sale of packaged drinking water in India. This requirement ensures adherence to safety standards and quality control measures set by the FSSAI.

2. What are the criteria for obtaining a State or Central FSSAI License for packaged drinking water?

• State License: Required for businesses with an annual turnover between ₹12 lakh and ₹20 crore, operating within a single state.
  
• Central License: Mandatory for businesses with an annual turnover exceeding ₹20 crore or those operating in multiple states.

3. Is BIS certification still required for packaged drinking water units?

Yes. While the FSSAI license is mandatory, manufacturers of packaged drinking water and mineral water must also obtain BIS certification as per the relevant Indian Standards (IS 14543 for packaged drinking water and IS 13428 for mineral water).

4. What is the validity period of an FSSAI license for packaged drinking water?

An FSSAI license can be issued for a period ranging from 1 to 5 years, based on the fee paid by the Food Business Operator (FBO). It’s essential to renew the license before its expiry to continue operations without legal hindrance.

5. What are the labeling requirements for packaged drinking water as per FSSAI?

Labels on packaged drinking water must include:

• Product name (e.g., “Packaged Drinking Water”)
  
• Manufacturer’s name and address
  
• Batch or lot number
  
• Date of manufacture and “Best Before” date
  
• FSSAI logo and license number
  
• Instructions such as “Crush the bottle after use”

6. Are there specific water quality standards that packaged drinking water must meet?

Yes. The FSSAI mandates that packaged drinking water must:

• Be free from contaminants like E. coli, coliform bacteria, and other harmful microorganisms.
  
• Have a pH level between 6.5 and 8.5.
  
• Undergo treatments like filtration, reverse osmosis, and disinfection to ensure safety.
  

7. Is it mandatory to submit a BIS License or Application receipt while applying for an FSSAI License for Packaged Drinking Water or Mineral Water?

Yes, Food Business Operators (FBOs) must mandatorily upload a copy of the BIS license or a copy of the letter indicating the recording of the application for BIS license at the time of applying for a new FSSAI license for packaged drinking water and mineral water on the FoSCoS online system.

8. What are the consequences of non-compliance with FSSAI regulations for packaged drinking water?

 Non-compliance can lead to:

• Suspension or cancellation of the FSSAI license.
  
• Monetary penalties.
  
• Legal actions under the Food Safety and Standards Act, 2006.
  

9. How can consumers verify the authenticity of a packaged drinking water brand’s FSSAI license?

 Consumers can check the 14-digit FSSAI license number printed on the product label through the FSSAI’s Food Safety Connect app or the FoSCoS portal. This ensures the product is registered and complies with safety standards.