Regulation 2 explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulation 2.1.2 is the core licensing rule. Subject to the petty-business registration in Regulation 2.1.1, no person may commence a food business without a valid licence. The Central Licensing Authority grants licences for the businesses listed in Schedule 1, and the State or UT Licensing Authority grants all others. This article is based on the 2017 compendium (Version II, 09.11.2017); later amendments may have changed it, verify on fssai.gov.in. If you are unsure which licence you need, see our State FSSAI licence service.
No person shall commence any food business unless he possesses a valid licence (sub-regulation (1)), subject to Regulation 2.1.1. Businesses in Schedule 1 are licensed by the Central Licensing Authority; all others by the State/UT Licensing Authority. The operator must comply at all times with the licence conditions (Annexure 3 of Form B) and the Schedule 4 hygiene requirements. Non-compliance with the conversion provisions attracts a penalty under section 55 of the Act. All of this is as per the 2017 compendium; later amendments may have changed it.
What each sub-regulation says
| Sub-reg. | What it says |
|---|---|
| (1) | No one commences any food business without a valid licence, subject to Regulation 2.1.1. Provisos deal with existing licences under the Acts and Orders in the Second Schedule of the Act |
| (2) | Despite existing certificates, the Licensing Authority may direct the operator to comply if it has reason to believe that conditions of the existing registration or licence, or the Schedule 4 safety requirements, are not being met |
| (3) | Licences for businesses in Schedule 1 are granted by the Central Licensing Authority; the Food Authority may by notification change or modify the Schedule 1 list |
| (4) | Licences for businesses not covered by Schedule 1 are granted by the State/UT Licensing Authority |
| (5) | The operator ensures at all times that the licence conditions (Annexure 3 of Form B, Schedule 2) and the Schedule 4 requirements are complied with. Provisos add periodic audit and inspection, and an irradiation bar |
The basic rule and how it fits with the Act
Sub-regulation (1) restates the rule in section 31(1) of the Act ("No person shall commence or carry on any food business except under a licence"). Section 31(2) exempts petty manufacturers, petty retailers, hawkers and similar small operators from a licence; they register under Regulation 2.1.1 instead (see Regulation 2.1.1). For the Act's own text, see section 31.
Carrying on a business that needs a licence without one is punishable under section 63. As amended by the Jan Vishwas (Amendment of Provisions) Act, 2023, the person is now "liable to penalty which may extend to ten lakh rupees", in place of the earlier imprisonment of up to six months and fine of up to five lakh rupees. The section 63 heading now reads "Penalty". See our existing post Operating without an FSSAI licence: section 63 for the background, which predates the 2023 change.
Central or State licence
The dividing line is Schedule 1 of the Regulations. In the 2017 compendium, Schedule 1 lists categories such as large dairy units, vegetable oil processing units above a stated capacity, and large slaughter houses, each with its own threshold. This article does not reproduce the list. Read it in full, because the Food Authority may change it by notification. Everything outside Schedule 1 goes to the State/UT Licensing Authority. For a comparison of the two, see State licence vs Central licence.
Existing licences under the older food laws
The first proviso to sub-regulation (1) deals with a person who, on the date these Regulations were notified, was carrying on business under a licence, registration or permission under the Acts or Orders listed in the Second Schedule of the Act. That person had to convert the existing licence into a licence or registration under these Regulations by applying to the Licensing or Registering Authority after complying with Schedule 4. The 2017 compendium shows the conversion period as "sixty months from the date of commencement of these regulations", as an amended figure. No licence fee was payable for the remaining validity of the earlier licence. Non-compliance attracts a penalty under section 55 of the Act, which provides for a penalty which may extend to two lakh rupees for failing, without reasonable ground, to comply as directed by the Food Safety Officer.
A second proviso covers a holder of a licence under those older laws with no specific validity or expiry date. Such a holder, if otherwise entitled to a licence under these Regulations, must apply and obtain one within the same period by paying the applicable fees. These conversion deadlines were written for the early years of the Act, so they are mainly of historical interest today. In case of difficulty, the Licensing Authority with the approval of the Food Safety Commissioner may decide whether to apply a specific condition, keeping in view food safety and public interest.
Conditions and audits
Sub-regulation (5) makes compliance continuing. The operator must meet the licence conditions in Annexure 3 of Form B and the Schedule 4 hygiene requirements, which vary with the nature of business, "at all times". The proviso says the Licensing Authority shall ensure periodical food safety audit and inspection of licensed establishments, through its own staff or agencies authorised by the FSSAI. For what Schedule 4 requires, start with Schedule 4, Part II premises and facilities.
The irradiation bar
A further proviso says no person shall manufacture, import, sell, stock, or exhibit for distribution or sale any article of food that has been subjected to irradiation, except under a licence from the Department of Atomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996. An FSSAI licence alone does not cover irradiated food.
Practical examples
Example 1. A packaged snack manufacturer not in Schedule 1 applies to the State/UT Licensing Authority. The licence issues only after the steps in Regulation 2.1.3 and 2.1.4.
Example 2. An operator with a licence stops maintaining drains and pest control. The Licensing Authority can direct compliance under sub-regulation (2) or audit under (5), and, if an improvement notice is ignored, suspension can follow under Regulation 2.1.8.
Example 3. A spice exporter plans to irradiate a consignment. It needs the separate Department of Atomic Energy licence as well.
Need help with choosing and obtaining the right licence?
If you are not sure whether your business falls in Schedule 1 or outside it, TaxClue can check the category against the current notified list and prepare the application for a State FSSAI licence. We will confirm the present fee and form position first, since the 2017 text may have changed.
Key takeaways
- No food business may start without a valid licence, except petty businesses that register under Regulation 2.1.1.
- Schedule 1 businesses get a Central licence; all others get a State/UT licence.
- Licence conditions (Annexure 3 of Form B) and Schedule 4 hygiene rules apply at all times.
- The authority must arrange periodic audit and inspection.
- Irradiated food needs a separate Department of Atomic Energy licence.
- Section 63, as amended in 2023, now carries a penalty up to ten lakh rupees for trading without a required licence.
Read next
- Regulation 2.1.1: registration of petty food business
- Regulation 2.1.3: application for licence
- FSSAI licence eligibility criteria
- FSSAI registration vs licence: key differences
Disclaimer: Based on the Food Safety and Standards Act, 2006 as enacted, read with the Jan Vishwas (Amendment of Provisions) Act, 2023 where it applies (ss.59, 61 and 63 only), and the FSS (Licensing and Registration of Food Businesses) Regulations, 2011 as per the 2017 compendium (Version II, 09.11.2017). Later amendments may have changed the Regulations (fees, forms, validity, portal steps and thresholds); verify on fssai.gov.in. Verify current notifications, regulations and FSSAI orders before acting.