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.
Paragraphs 6 to 9 of Part II move from the building to the system that keeps it safe. They require written procedures and qualified supervisors, testing of food, periodic audit and records, and a cleaning, sanitation and pest control programme. 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 setting this up, see our FSSAI compliance support service.
Licensees must draw up a detailed SOP for processing, packing, despatch and storage (6.1) and ensure technical managers and supervisors have the qualifications and skills to judge food hazards (6.2). A laboratory for physical, microbiological and chemical testing should be in place inside the premises, or regular testing through an accredited lab notified by FSSAI (7). A periodic audit of the whole system is required (8.1) and records must be kept for one year or the shelf life of the product, whichever is more (8.2). Paragraph 9 requires a cleaning and sanitation programme and pest control with records. As per the 2017 compendium.
The four paragraphs at a glance
| Para | Topic | Headline requirement |
|---|---|---|
| 6 | Management and supervision | SOP for processing, packing, despatch, storage; qualified technical managers and supervisors |
| 7 | Food testing facilities | In-house laboratory, or testing through an accredited or FSSAI-notified laboratory |
| 8 | Audit, documentation and records | Periodic audit against the SOP; records kept one year or shelf life, whichever is more |
| 9 | Sanitation and maintenance | Cleaning and sanitation programme; pest control; chemicals stored separately |
Paragraph 6: management and supervision
6.1 A detailed Standard Operating Procedure for the processing of food as well as its packing, despatch and storage is developed. The text says this helps identify a problem and the exact point, so damage control is faster. 6.2 The business ensures that technical managers and supervisors have appropriate qualifications, knowledge and skills in food hygiene principles and practices, so that they can ensure safety and quality, judge food hazards, take preventive and corrective action, and monitor effectively. The regulation does not name a specific qualification, so describe your supervisors' training in your own records. For a model plan, see Food safety management plan template for FBOs.
Paragraph 7: food testing facilities
- 7.1 A well-equipped laboratory for testing food materials and food for physical, microbiological and chemical analysis, in accordance with the specifications and standards under the rules and regulations, should be in place inside the premises for regular or periodic testing and whenever required.
- 7.2 In case of suspicion or possible contamination, food materials or food are tested before dispatch from the factory.
- 7.3 If there is no in-house laboratory, regular testing is done through an accredited lab notified by FSSAI. In case of complaints, and if required, the company voluntarily tests either in-house or at an accredited or FSSAI-notified laboratory.
The tests and standards themselves come from other regulations that are not reproduced here; the text says "the specification/standards laid down under the rules and regulations". For the statutory laboratory framework, see Sections 43 and 44 on laboratories and audit agencies.
Paragraph 8: audit, documentation and records
- 8.1 A periodic audit of the whole system according to the SOP is done to find any fault or gap in the GMP/GHP system.
- 8.2 Appropriate records of food processing or preparation, production or cooking, storage, distribution, service, food quality, laboratory test results, cleaning and sanitation, pest control and product recall are kept and retained for one year or the shelf life of the product, whichever is more.
A product with an 18-month shelf life needs records for 18 months. A product with a 3-month shelf life needs them for a full year. The audit also ties to renewals: an operator with a valid certificate from an accredited food safety auditor will not normally be inspected before renewal under Regulation 2.1.7.
Paragraph 9: sanitation and maintenance
Cleaning and maintenance (9.1)
- 9.1.1 A cleaning and sanitation programme is drawn up and observed, and its record maintained, showing the areas to be cleaned, cleaning frequency and procedure, including equipment and materials. Manufacturing equipment is cleaned and sterilised at set frequencies.
- 9.1.2 Cleaning chemicals are used per the manufacturer's instructions and stored separately from food, in clearly identified containers.
Pest control (9.2)
- 9.2.1 Buildings and equipment kept in good repair to prevent pest access; holes, drains and other entry points sealed or fitted with mesh, grills or cladding; animals, birds and pets not allowed into the premises.
- 9.2.2 Food stored in pest-proof containers stacked above the ground and away from walls.
- 9.2.3 Infestations dealt with immediately without harming food safety. Treatment with permissible chemical, physical or biological agents within appropriate limits. Records of pesticides and insecticides used, with dates and frequency, are maintained.
Why it matters
The records in paragraph 8.2 are what you show an inspector. A gap can result in an improvement notice under section 32, and continued default can lead to suspension under Regulation 2.1.8. Section 56 of the Act separately provides a penalty which may extend to one lakh rupees for manufacturing or processing under unhygienic or unsanitary conditions.
Practical examples
Example 1. A namkeen manufacturer with no laboratory arranges regular tests with an accredited lab notified by FSSAI and files the reports with its records, as 7.3 allows.
Example 2. A dairy unit with a 6-month shelf life product keeps its cleaning, pest control and lab test records for at least one year, the longer of the two periods.
Example 3. A kitchen logs every pest control visit with the date, agent used and frequency, as 9.2.3 asks.
Need help with SOPs and records?
Written procedures and a clean record trail are what make inspections routine. TaxClue can draft SOPs, a cleaning and pest control log and a records calendar within FSSAI compliance support. We check the current requirements first, because the 2017 text may have been amended.
Key takeaways
- Write a detailed SOP for processing, packing, despatch and storage.
- Supervisors need relevant food hygiene qualifications and skills.
- Test in-house or through an accredited lab notified by FSSAI; test before dispatch if contamination is suspected.
- Audit the system periodically against the SOP.
- Keep records for one year or the shelf life, whichever is more.
- Run a written cleaning, sanitation and pest control programme, with records.
Read next
- Schedule 4 Part II: food operations and controls
- Schedule 4 Part II: personal hygiene, consumer information and training
- Sections 43 and 44: laboratories and food safety audit agencies
- FSSAI hygiene rating scheme
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.