FSSAI Proposes Amendments to Food Business Licensing Regulations

The draft FSSAI amendments to the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, signal a move toward stricter, outcome-based enforcement, with higher penalties and automatic suspension for delayed return filing. The changes have important compliance implications for food business operators.

The Food Safety and Standards Authority of India (FSSAI) has issued draft amendments to the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. As per the gazette notification F. No. REG-11013/1/2026, issued on January 20, 2026, the proposed changes primarily affect return filing obligations, penalty structures, record-keeping requirements, and stock management practices for licensed food business operators (FBOs).

These amendments are currently open for public consultation for 60 days from the date of publication in the Official Gazette. Stakeholders may submit objections or suggestions to FSSAI via post or email. The authority will review the feedback before finalizing the regulations.

Existing framework: Annual return filing requirements

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Under the prevailing regulatory framework, all licensed Food Business Operators (FBOs) in India are required to file an annual return specifying the categories of food products handled during the immediately preceding financial year.

Key requirements

Due date: The annual return must be filed no later than May 31 of each year. It is the statutory deadline for compliance; returns submitted after this date are treated as delayed.

Prescribed forms:

1. Form D-1: Applicable to most food business operators
2. Form D-2: Applicable to manufacturers of milk and milk products, to be filed on a half-yearly basis, covering the following periods:
   • April 1 to September 30
   • October 1 to March 31

Submission may be made electronically or in physical form, as specified by the relevant State Food Safety Commissioner. A separate return must be filed for each license, even where multiple licenses are held by the same food business operator

Penalty for late filing

Failure to submit the annual return by May 31 attracts a late fee of INR 100 per day (approximately US$1.09) for each day of delay beyond the prescribed due date.

Key proposed amendments

Revised penalty structure for delayed return filing

FSSAI has proposed a graduated and significantly stricter penalty framework to improve compliance with annual return filing requirements.

Consequences of license suspension

• The food business must cease all food-related operations during the suspension period
• The license will be reinstated only after payment of the applicable penalty
• Any food activity conducted during suspension will be treated as a statutory violation, potentially triggering further action under the Food Safety and Standards Act, 2006

Clarification on daily record-keeping obligations

The draft amendments clearly define the scope of daily operational record requirements.

• Applicable to food businesses engaged in manufacturing activities
• Requirement: Daily records of production volumes and raw material usage
• Exemptions: Non-manufacturing entities such as traders, distributors, and retailers are excluded from this obligation

This clarification aims to reduce unnecessary compliance burdens on non-manufacturing food businesses.

Stock management and rotation practices

The amendments reinforce food safety standards related to storage and inventory management. Food businesses must follow mandatory practices such as:

1. FIFO (first in, first out); and
2. FEFO (first expiry, first out) methods.

These apply to raw materials and ingredients, work-in-progress items and cooked, processed, and packaged food products

Retailers are expressly excluded from these stock rotation requirements, recognizing the operational differences in retail food handling.

Compliance takeaways for food businesses

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The FSSAI is moving toward stricter enforcement of annual return filing, introducing penalties linked to license fees and automatic suspension in cases of prolonged non-compliance. The proposed amendments also clarify operational obligations, with clearer distinctions between manufacturing and non-manufacturing food businesses.

At the same time, storage and hygiene standards are being strengthened, while retailers and smaller operators are protected from disproportionate compliance burdens.

Food businesses should track the finalization of these amendments and review their internal compliance frameworks, particularly with respect to return filing timelines and supporting documentation.

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