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 III of Schedule 4 adds dairy-specific rules on top of Part II for food businesses that manufacture, process, store and sell milk and milk products. It has four headings: sanitary requirements, personal hygiene, sanitary requirements for storage, and wrapping and packaging. 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 dairy manufacturers seeking a licence, see our FSSAI registration for food manufacturers service.
Part III applies in addition to Part II to the dairy establishment. Raw milk brought by a producer must arrive within four hours of milking and be cooled to 4 degrees C or lower (III.3). Pasteurised milk is cooled immediately to 4 degrees C or lower and stored at no more than 5 degrees C until it leaves the treatment establishment (III.5, III.8). Mild steel and plastic cans or containers are not allowed for storing and transporting milk and milk products (III.2). Sealing must show evidence of opening (IV.5). Workers need a medical certificate on recruitment (II.1). As per the 2017 compendium.
Four headings, one table
| Heading | Main subject | Headline points |
|---|---|---|
| I. Sanitary requirements | Establishment facilities and cleaning | Hygienic handling, watertight containers, waste water, cleaning of tanks; separated working areas; documented cleaning programme |
| II. Personal hygiene | Workers | Medical certificate on recruitment; clean clothing; hand washing; wounds covered |
| III. Sanitary requirements for storage | Raw milk, pasteurised milk and dairy products | Four-hour rule; 4 degrees C; no mild steel or plastic cans; temperature records |
| IV. Wrapping and packaging | Packaging rooms, filling and sealing | Hygienic rooms; limited reuse; sealing with evidence of opening |
I. Sanitary requirements
A dairy establishment shall have (paragraph 1):
- (a) facilities for hygienic handling and protection of raw materials and unpacked dairy products during loading, unloading, transport and storing, including bulk milk cooling facilities;
- (b) special watertight, non-corrodible containers for raw materials or products for human consumption, with conduits built so as to avoid contamination;
- (c) a hygienic and approved waste water disposal system;
- (d) facilities for cleaning and disinfecting tanks used for transporting dairy products and raw milk, cleaned after every use.
Other paragraphs in this heading:
- 2. The occupier takes measures to avoid cross-contamination in line with the cleaning programme in point 9.1 of Part II (see management, testing, audit and sanitation).
- 3. Dairy products and ingredients that have not undergone heat treatment or an equivalent treatment, used in foods made with other ingredients, are stored separately.
- 4. Heat-treated milk production, or manufacture of milk-based products that might contaminate other dairy products, takes place in a clearly separated working area.
- 5. Equipment and containers in contact with dairy products or perishable raw materials are cleaned, and if necessary disinfected, under a verified and documented cleaning programme.
- 6. Equipment, instruments and rooms for microbiologically stable dairy products are cleaned and disinfected under a verified and documented Food Safety management programme drawn up by the owner or occupier.
- 7. Disinfectants do not harm machinery or products, are in clearly labelled containers with instructions, and their use is followed by thorough rinsing with potable water, unless the supplier's instructions say otherwise.
II. Personal hygiene requirements
- The FBO employs persons to work directly with raw materials or dairy products only if they have proved by a medical certificate, on recruitment, that there is no medical impediment.
- Such persons keep the highest standard of cleanliness: suitable, clean working clothes and headgear that completely encloses the hair; hand washing each time work resumes and after contamination (coughing, sneezing, toilet, telephone, smoking); skin wounds covered with a suitable waterproof dressing, and no person with an injury on the hand, even with dressing, in a product making or handling section; and avoiding hand habits such as scratching the nose or hair.
III. Sanitary requirements for storage
| Para | Requirement |
|---|---|
| 1 | Raw milk is placed in a clean place, suitably equipped to prevent contamination, immediately after procurement |
| 2 | Mild steel and plastic cans or containers for storage and transport of milk and milk products are not allowed |
| 3 | Raw milk brought by a producer or farmer arrives within four hours of milking, is cooled as soon as practicable to 4 degrees C or lower, and kept there until processed |
| 4 | Raw milk collected daily from a producer is cooled immediately to 4 to 6 degrees C or lower and kept there until processed |
| 5 | After pasteurisation, pasteurised milk is cooled immediately to 4 degrees C or lower |
| 6 | Dairy products not meant for ambient storage are cooled as quickly as possible to the temperature set by the manufacturer for durability and stored at it |
| 7 | For dairy products other than raw milk stored cooled, storage temperatures are registered, and cooling is as quick as possible |
| 8 | Pasteurised milk is stored at a maximum of 5 degrees C until it leaves the treatment establishment |
Note that paragraph 3 says "4 degrees C or lower" while paragraph 4 says "4 to 6 degrees C or lower". Both appear in the compendium as printed, so follow the stricter reading where they overlap, and ask the authority if unsure. The product standards for milk and milk products are in separate regulations; for background on the dairy business, see FSSAI compliance for dairy business.
IV. Wrapping and packaging
- Wrapping and packaging takes place under satisfactory hygienic conditions, in rooms provided for that purpose.
- Manufacture and packaging may share a room only if: the room is large and equipped enough; packaging arrives in protective cover and is stored hygienically in a room meant for it; storage rooms are kept clear of vermin and dust, separated from contaminating substances, and packaging is not placed directly on the floor; packaging is assembled hygienically before entering the room (except automatic assembly with no contamination risk); packaging is done without delay by a separate group of experienced staff; and products go immediately to designated storage rooms at the required temperature.
- Bottling or filling of containers with heat-treated milk and milk products is carried out hygienically.
- Wrapping or packaging is not reused for dairy products, unless containers are of a type that may be reused after thorough cleaning and disinfecting.
- Sealing is done in the establishment where the last heat treatment took place, immediately after filling, by a sealing device that protects the milk, and designed so that once opened the evidence of opening remains clear and easy to check.
Returns for dairy licensees
Milk and milk product manufacturers file half-yearly Form D-2 returns under Regulation 2.1.13; see Regulations 2.1.12 and 2.1.13.
Practical examples
Example 1. A village producer delivers milk to a processing plant five hours after milking. Part III.3 asks for delivery within four hours and cooling to 4 degrees C or lower, so the plant should reject or treat the lot under its procedure and record it.
Example 2. A plant stores pasteurised milk at 7 degrees C before dispatch. Paragraph III.8 sets a maximum of 5 degrees C.
Example 3. A dairy uses mild steel cans for milk transport. Paragraph III.2 does not allow them.
Need help with a dairy or milk product licence?
Dairy units are watched closely on temperature records, cleaning programmes and packing rooms. TaxClue can review your plant against Part III and prepare the licence file through FSSAI registration for food manufacturers. We will check the current licence category and rules first, as the 2017 text may have been revised.
Key takeaways
- Part III applies on top of Part II for dairy establishments.
- Raw milk from producers must arrive within four hours of milking and be cooled to 4 degrees C or lower.
- Pasteurised milk is cooled to 4 degrees C or lower and stored at no more than 5 degrees C.
- Mild steel and plastic cans are not allowed for milk storage and transport.
- Workers need a recruitment medical certificate; wounded hands mean no product handling.
- Sealing must show clear evidence of opening.
Read next
- Schedule 4 Part II: personal hygiene, consumer information and training
- Schedule 4 Part IV: slaughter house and transport of animals
- FSSAI compliance for dairy business
- FSSAI licence for dairy processing unit
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.