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BIS No Longer Mandatory for Packaged Drinking Water: FSSAI's High-Risk Category Rules Explained (2026)

BIS (ISI mark) is now voluntary for packaged drinking water and mineral water, but FSSAI treats them as a High-Risk Food Category with annual inspections, third-party audits and monthly testing from 2026.

Glass of clear drinking water
Photo: KOBU Agency / Unsplash

Update, 17 October 2026: Uttar Pradesh is an exception. Under the UP FSDA order of 14 October 2026, new packaged drinking or mineral water units in UP will not get a food licence without BIS certification, and existing units must certify by 31 March 2027. Read what the UP order means.

For more than a decade, a packaged drinking water plant in India could not get an FSSAI licence without first getting a BIS certification (ISI mark). That rule has gone. FSSAI has made BIS certification voluntary for packaged drinking water and mineral water, but it has not loosened control. Instead, it has placed these products in its "High-Risk Food Category" and added a compulsory testing scheme.

If you run a water plant, or are planning one, here is exactly what changed, which category your product now sits in, and what you must do every year.

The short answer

  • BIS (ISI mark) is no longer mandatory for packaged drinking water (IS 14543) or natural mineral water (IS 13428). FSSAI notified the change on 17 October 2024.
  • Packaged drinking water and mineral water are now treated under FSSAI's "High-Risk Food Categories" (FSSAI order dated 29 November 2024).
  • From 1 January 2026, a compulsory FSSAI Scheme of Testing applies, with monthly microbiological testing and source-water testing (FSSAI order dated 17 December 2025).
  • In FSSAI's food category system, these products fall under Food Category 14.1.1 – Waters, within 14.1 Non-alcoholic ("soft") beverages. Natural mineral waters are sub-category 14.1.1.1.

What the rule was before

Until 2024, packaged drinking water and natural mineral water were among the few foods that needed two approvals before sale: a product licence from the Bureau of Indian Standards (BIS) and an FSSAI licence. The FSSAI licence was granted only after the BIS licence. Plants had to maintain an in-house laboratory, a qualified chemist and microbiologist, and face BIS surveillance visits and market sampling.

The industry had long argued that this "dual certification" was duplicate regulation for the same product. In October 2024, FSSAI agreed.

What changed in October 2024

By an amendment notified on 17 October 2024, FSSAI omitted the requirement of mandatory BIS certification for packaged drinking water and mineral water. A plant no longer needs a BIS licence to obtain or keep its FSSAI licence.

This did not mean the product became lightly regulated. Within six weeks, FSSAI moved it into its strictest inspection bracket.

The exact category: "High-Risk Food Category"

By an order dated 29 November 2024, FSSAI decided that "Packaged Drinking Water and Mineral Water" will be treated under "High-Risk Food Categories". This is a classification under FSSAI's risk-based inspection framework, and it brings three direct consequences:

  1. Inspection before licence. The premises must be inspected before an FSSAI licence or registration is granted.
  2. Annual risk-based inspection. Every manufacturer of packaged drinking water and mineral water must undergo a risk-based inspection once every year.
  3. Annual third-party audit. Centrally licensed manufacturers in high-risk categories must have their business audited every year by an FSSAI-recognised third-party food safety auditing agency. A good audit score can affect how inspections are scheduled.

In short, the oversight that BIS used to provide through surveillance has moved to FSSAI, through inspections and audits.

Don't confuse the two "categories"

Plant owners often mix up two different things FSSAI calls a category:

What it is Packaged drinking water / mineral water
Risk category (decides inspection and audit) High-Risk Food Category
Food category (FSSAI food category system) 14.1.1 – Waters, under 14.1 Non-alcoholic beverages
Licence category (State or Central) Depends on turnover and Kind of Business on FoSCoS

The licence category is decided separately. From 1 April 2026, State licences cover turnover from ₹1.5 crore to ₹50 crore and Central licences cover turnover above ₹50 crore, subject to Kind of Business rules. See our FSSAI 2026 guide.

The 2026 Scheme of Testing

By an order dated 17 December 2025, FSSAI introduced a compulsory Scheme of Testing for packaged drinking water and mineral water, effective 1 January 2026. The main requirements are:

  • Monthly microbiological testing of the finished product, covering coliform bacteria, faecal streptococci, Staphylococcus aureus, Pseudomonas aeruginosa, yeast and mould, Salmonella, Shigella and Vibrio species
  • Source (raw) water testing for all prescribed parameters at an FSSAI-notified NABL-accredited laboratory before use, and fresh testing whenever the source changes
  • Action on failure: investigate, retest stock, and show satisfactory results across five consecutive batches before resuming production and dispatch
  • Records of tests and incidents kept for at least five years
  • Packaging: containers must meet the packaging regulations; reused containers of 5 litres and above are allowed only if durable, hygienic and undamaged
  • If radioactive residues are found in the source, the source must be abandoned, the water recalled and the food authority informed

Should you still get BIS certification?

BIS certification is now a business decision, not a legal requirement. Consider keeping or getting it if:

  • A brand owner or co-packing client requires ISI-marked product in its contract
  • You supply institutions or tenders that specify ISI-marked water
  • You want the ISI mark on the label as a trust signal in a crowded market

If none of these apply, you can rely on your FSSAI licence and the Scheme of Testing. Either way, the in-house laboratory and quality records you kept for BIS remain useful: they are exactly what FSSAI inspectors and third-party auditors will ask to see.

What a water plant should do now

If you are running a plant:

  1. Check that your FSSAI licence correctly reflects your product and capacity
  2. Set up a monthly testing calendar and tie up with an FSSAI-notified NABL laboratory
  3. Get your source water tested for all prescribed parameters and keep the report on file
  4. Prepare for the annual FSSAI inspection and, if centrally licensed, the third-party audit
  5. Decide whether to renew your BIS licence, based on your customers' requirements

If you are setting up a new plant:

The approvals list is now shorter by one, but every other approval still applies: Pollution Control Board consents, groundwater NOC, factory licence, fire NOC, FSSAI licence, Legal Metrology and Plastic EPR. See the complete approval checklist for a new packaged drinking water plant.

How ClearPath Compliance India can help

We have run packaged drinking water plants and handled these approvals first-hand. We can review your FSSAI licence, set up your testing calendar and records, prepare you for the annual inspection and third-party audit, and handle your BIS certification if your customers still require it.

Frequently asked questions

Is BIS certification mandatory for packaged drinking water in 2026?

No. FSSAI removed the mandatory BIS (ISI mark) requirement for packaged drinking water and mineral water by an amendment notified on 17 October 2024. BIS certification is now voluntary.

Which FSSAI category does packaged drinking water fall under?

For inspection purposes, FSSAI treats packaged drinking water and mineral water under its High-Risk Food Categories (order dated 29 November 2024). In FSSAI's food category system, they fall under food category 14.1.1, Waters.

What does the High-Risk Food Category mean for a water plant?

Inspection before the FSSAI licence is granted, a risk-based inspection once every year, and for centrally licensed manufacturers an annual audit by an FSSAI-recognised third-party food safety auditing agency.

What is the FSSAI Scheme of Testing for packaged drinking water?

From 1 January 2026, manufacturers must carry out monthly microbiological testing, test source water at FSSAI-notified NABL-accredited laboratories, keep records for at least five years, and pass five consecutive batches after any failure before resuming dispatch.

This article is for general information. FSSAI and BIS revise their requirements from time to time; please confirm the current position on the FSSAI website or speak to us before acting.

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