Schedule 4 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.
Part II of Schedule 4 sets the general hygiene and sanitary requirements for every food business operator applying for a licence. Its first four paragraphs cover location and surroundings, layout and design of premises, equipment and containers, and facilities such as water, drainage, toilets, ventilation and lighting. This article is based on the 2017 compendium (Version II, 09.11.2017); later amendments may have changed it, verify on fssai.gov.in. For help preparing your premises for a licence, see our FSSAI compliance support service.
Part II applies to all FBOs applying for a licence. On top of the listed requirements, the FBO must identify steps critical to food safety and ensure safety procedures are identified, implemented, maintained and reviewed periodically. Paragraphs 1 to 4 cover location (1), layout and design (2), equipment and containers (3) and facilities (4): water, cleaning, raw-material washing, ice and steam, drainage and waste, personnel facilities and toilets, ventilation and lighting. Premises must be effectively separated from any privy, urinal, sullage, drain or foul matter storage to the satisfaction of the licensing authority. As per the 2017 compendium.
The scope of Part II
The preamble says the establishment in which food is handled, processed, manufactured, packed, stored and distributed, and the persons handling it, must conform to the sanitary and hygienic requirements, food safety measures and other standards in Part II. It is "deemed to be the responsibility of the food business operator to ensure adherence". The heading in the 2017 text points to Regulation 2.1.1(4), although the licence requirement is in Regulation 2.1.2(5); the schedule heading itself cites Regulation 2.1.2. Either way, licence applicants meet Part II. Petty registrants use Part I.
Paragraph 1: location and surroundings
| Para | Requirement |
|---|---|
| 1.1 | The establishment should ideally be away from environmental pollution and industrial activities that produce odour, fumes, soot, dust, smoke, chemical or biological emissions, pest-prone areas, or places where solid or liquid waste cannot be removed effectively |
| 1.2 | If polluting industry is nearby, appropriate protective measures for the manufacturing area |
| 1.3 | The manufacturing premise should not have direct access to any residential area |
Paragraph 2: layout and design
The layout should, as far as possible, prevent cross-contamination between operations such as goods receiving, pre-processing (for example, washing or portioning) and post-manufacturing work.
- 2.1 Floors, ceilings and walls in sound condition, impervious, smooth and easy to clean, with no flaking paint or plaster.
- 2.2 Doors smooth and non-absorbent.
- 2.3 Floors with adequate drainage and slope, so that drainage flows opposite to the direction of the process flow.
- 2.4 Control measures against insects and rodents entering from drains.
- 2.5 Windows, doors and openings screened with wire mesh or insect-proof screens, with doors fitted with automatic closing springs; screens removable for cleaning.
- 2.6 No one may manufacture, store, expose or permit the sale of food in premises not effectively separated, to the licensing authority's satisfaction, from any privy, urinal, sullage, drain or place of storage of foul and waste matter.
Paragraph 3: equipment and containers
| Para | Requirement |
|---|---|
| 3.1 | Food-contact equipment and containers of non-corroding materials that impart no toxicity and are easy to clean or disinfect (other than disposable single-use types) |
| 3.2 | Kept in good order, repair and clean condition; a utensil used for food is not used for any other purpose |
| 3.3 | Every utensil or container with food for sale has a properly fitted cover or lid, or a clean gauze net fine enough to protect from dust, dirt, flies and insects |
| 3.4 | Not kept where impure air, dust or noxious gases may contaminate them |
| 3.5 | Equipment located, designed and fabricated so that it allows maintenance, cleaning, monitoring and audit |
| 3.6 | Facilities for cleaning and disinfecting equipment; cleaning in place (CIP) where possible |
| 3.7, 3.8 | Containers for waste, by-products, inedible or dangerous substances identifiable and suitably constructed; containers for cleaning chemicals identified and stored separately |
| 3.9 | A waste water disposal system or effluent treatment plant if required |
| 3.10 | Items touching food kept in good condition; no chipped enamelled containers; stainless steel, aluminium or glass suitable for cooking and storing; brass utensils frequently lined |
Paragraph 4: facilities
Water (4.1)
Only potable water, with storage and distribution facilities, is used as an ingredient in processing and cooking (4.1.1). Water for handling and washing must not introduce hazard or contamination (4.1.2). Water storage tanks are cleaned periodically and records kept in a register (4.1.3). Non-potable water may be used only for cleaning equipment not in contact with food, steam production, firefighting and refrigeration equipment, provided pipes preclude other use (4.1.4), and non-potable water pipes must be clearly distinguished from potable ones (4.1.5).
Cleaning, washing, ice and steam (4.2 to 4.4)
Adequate facilities for cleaning and disinfecting utensils and equipment, with hot and cold water if required (4.2). Facilities for washing raw food, with each sink having hot and/or cold water; sinks for raw food should preferably be kept separate from those for utensils (4.3). Ice and steam in direct contact with food are made from potable water and handled so as to avoid contamination (4.4).
Drainage and waste (4.5)
Food and other waste removed periodically; a covered refuse bin of adequate size, preferably no-touch, emptied and washed daily with a disinfectant (4.5.1). Sewage and effluent disposal conforming to Factory / Environment Pollution Control Board requirements (4.5.2). Waste stored so that it does not contaminate food, storage areas or the environment, in covered containers removed at regular intervals (4.5.3). Periodic disposal is compulsory, and no waste is kept open inside the premises, with disposal per local rules including those for plastics (4.5.4).
Personnel facilities and toilets (4.6)
Hand washing and drying facilities; separate lavatories for males and females; changing facilities, none opening directly into food processing, handling or storage areas (4.6.1). Toilets adequate for the number of employees (4.6.2). Rest and refreshment rooms separate from food process and service areas (4.6.3). A display board of do's and don'ts for workers, in English or the local language, at a prominent place (4.6.4).
Air quality and lighting (4.7, 4.8)
Ventilation, natural or mechanical, so that air does not flow from contaminated to clean areas (4.7). Natural or artificial lighting so that workers can operate hygienically, with fittings protected against breakage over food (4.8).
Why it matters
A gap in these requirements is a ground for an improvement notice under section 32. Processing under unhygienic or unsanitary conditions is penalised under section 56, up to one lakh rupees. For the wider licence conditions see conditions for FSSAI licence: general and specific.
Practical examples
Example 1. A new sweet factory places its raw-material store beside its packing area with no partition. Paragraph 2 asks for a layout that avoids cross-contamination between receiving and post-manufacturing operations.
Example 2. A licensee uses borewell water for cooking without checking it. Paragraph 4.1.1 requires potable water, so a laboratory test of the water is a sensible step.
Example 3. A kitchen has one toilet that opens into the preparation area. Paragraph 4.6.1 requires separate lavatories that do not open directly into food areas.
Need help getting your premises licence-ready?
Most licence delays trace back to the premises. TaxClue can check your layout, water, waste and toilet arrangements against the Part II paragraphs before an inspection, as part of FSSAI compliance support. We confirm the current requirements first, since the 2017 text may have been amended.
Key takeaways
- Part II applies to all licence applicants and adds a duty to identify critical food safety steps.
- Locate away from pollution; no direct access to a residential area.
- Layout must avoid cross-contamination; drains flow against the process direction.
- Premises must be effectively separated from privies, urinals and drains.
- Only potable water in food; tank cleaning recorded in a register.
- Separate toilets, rest rooms away from food areas and a do's and don'ts board.
Read next
- Schedule 4 Part I: hygiene requirements for petty food business
- Schedule 4 Part II: food operations and controls
- Regulation 2.1.2: licence for food business
- Conditions for FSSAI licence: general and specific
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 Schedule 4 of 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.