In December 2025, the Food Safety and Standards Authority of India issued a new Scheme of Testing for Packaged Drinking Water and Mineral Water. This scheme makes testing and compliance mandatory for manufacturers from 01 January 2026.
Earlier, packaged drinking water and mineral water required mandatory BIS certification. However, FSSAI removed this requirement in October 2024. As a result, the authority introduced a structured testing framework to ensure product safety and regulatory control. This shift moves compliance away from logo based approval and towards continuous laboratory backed verification.
Therefore, all Food Business Operators manufacturing Packaged Drinking Water or Mineral Water must now follow this Scheme of Testing without exception.
Regulatory Background and Applicability
FSSAI issued this direction under File No. RCD 15001 19 2025 Regulatory FSSAI dated 17 December 2025. The scheme operationalizes Regulation 2.10.8 for Packaged Drinking Water and Regulation 2.10.7 for Mineral Water under the Food Products Standards and Food Additives Regulations, 2011.
In addition, the scheme links product testing with Schedule IV requirements of the Licensing and Registration Regulations, 2011. Consequently, compliance now covers product safety, hygiene, source control, and documentation.
This scheme applies to all licensed manufacturers of Packaged Drinking Water other than packaged natural mineral water and Mineral Water, irrespective of plant size, production volume, or packaging format.
Compliance Philosophy of the Scheme
The Scheme of Testing follows a preventive and risk based compliance model. Instead of relying on one time approvals, FSSAI now requires continuous monitoring.
First, manufacturers must conduct testing at defined frequencies. Second, they must maintain inspection ready records. Third, they must control risks related to source water and packaging materials. Finally, repeated non compliance triggers regulatory escalation.
As a result, testing becomes an operational control rather than a post production formality.
Testing Requirements for Packaged Drinking Water
Manufacturers of Packaged Drinking Water must test finished products as per Regulation 2.10.8. These tests cover microbiological parameters, chemical contaminants, undesirable substances, and pesticide residues.
Microbiological parameters must be tested once every month. These include coliform bacteria, faecal streptococci, staphylococcus aureus, sulphite reducing anaerobes, pseudomonas aeruginosa, yeast and mould, salmonella, shigella, and vibrio species.
If any microbiological parameter fails, the manufacturer must stop release of the affected stock. The manufacturer may release the product only after achieving compliant results.
Chemical and general parameters such as heavy metals, nitrates, nitrites, mineral oil, phenolic compounds, anionic surface active agents, calcium, magnesium, aluminium, and borates must be tested once every three months.
Pesticide residues, both individual and total, must be tested once every six months. In addition, all parameters prescribed under the regulation must undergo comprehensive six monthly testing as a licensing condition.
If any parameter fails during six monthly testing, FSSAI increases the testing frequency to once every month. This continues until three consecutive batches show compliance.
Testing Requirements for Mineral Water
Mineral Water manufacturers must comply with Regulation 2.10.7. Due to the nature of the product, FSSAI applies stricter controls.
Microbiological testing must take place every month. This includes testing for escherichia coli, coliform bacteria, faecal streptococci, sulphite reducing anaerobes, pseudomonas aeruginosa, yeast and mould, salmonella, shigella, and vibrio species.
Manufacturers must test chemical parameters such as nitrates, nitrites, sulphides, manganese, copper, barium, antimony, borates, zinc, magnesium, calcium, mineral oil, phenolic compounds, and anionic surface active agents once every three months.
Pesticide residue testing remains mandatory once every six months.
However, permitted treatments for Mineral Water must not alter the original mineral composition. If the mineral profile changes, the product becomes non compliant.
Source Water Control and Change Management
Source water acts as a critical control point under this scheme. Before use, manufacturers must test source water for all prescribed parameters from an FSSAI notified NABL accredited laboratory.
Whenever a manufacturer changes the source of water or adds a new source, full testing becomes mandatory before commercial use. Only compliant results allow production to begin.
If testing detects radioactive residues, the manufacturer must abandon the source immediately. In addition, the manufacturer must recall affected products and inform the Food Authority without delay.
Packaging Material Compliance
FSSAI brings packaging materials firmly within the compliance scope. All containers must comply with the Food Safety and Standards Packaging Regulations, 2018. Manufacturers must test plastic bottles, jars, pouches, glass bottles, laminated cartons, and aluminium cans at defined frequencies. These tests include overall migration, colour migration, specific migration, mechanical integrity, and water potability.
Manufacturers must conduct these tests through FSSAI notified NABL accredited laboratories. Moreover, any change in packaging supplier automatically requires fresh testing. Reused containers are permitted only for specified capacities and materials. However, manufacturers must reject deformed, soiled, or damaged containers.
Hygiene and GMP Requirements
Manufacturers must follow Schedule IV GMP requirements at all stages of operation. These stages include source water collection, processing, storage, packing, and dispatch. Manufacturers must document hygiene schedules and display them prominently within the facility. In addition, hygiene controls must extend to the water source location. Therefore, compliance applies not only inside the plant but also across the supply chain.
Non Compliance and Corrective Action
Any microbiological non compliance requires immediate corrective action. The manufacturer must investigate the root cause and stop production if required. The manufacturer may restart production only after obtaining satisfactory results for five consecutive batches. In addition, the manufacturer must retain records of such incidents for at least five years. If six monthly test reports show repeated non compliance, FSSAI may initiate risk based inspections. At this stage, enforcement action becomes more likely.
Documentation and Record Keeping
The Scheme of Testing prescribes specific formats for monthly testing, six monthly testing, source water testing, packaging material testing, and pouch testing.
Manufacturers must maintain these records in real time. Incomplete records or reports from non notified laboratories will result in non compliance. Therefore, documentation acts as both a compliance tool and an inspection defense mechanism.
Impact on Food Business Operators
This Scheme of Testing changes how water manufacturing businesses operate in India. Compliance now depends on systems, data, and discipline.
Manufacturers must invest in laboratory partnerships, internal quality controls, and compliance governance. Those who treat this as a paperwork exercise face higher regulatory risk. On the other hand, manufacturers who integrate testing into daily operations reduce enforcement exposure and improve market credibility.
The FSSAI Scheme of Testing for Packaged Drinking Water and Mineral Water marks a clear shift towards outcome based regulation. From January 2026, manufacturers must demonstrate safety through continuous testing and documented compliance.
In summary, compliance under this scheme is binary. Either the data exists and supports safety, or the product does not belong in the market.
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