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 10 to 12 of Part II cover the people in a food business. Paragraph 10 sets health and cleanliness rules for food handlers and visitors, paragraph 11 requires labelled, traceable product information, and paragraph 12 requires training. 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 building these into your operations, see our FSSAI compliance support service.
Persons known or believed to suffer from or carry a disease likely to be transmitted through food must not enter food handling areas, and must report illness to management (10.1.1). Food handlers are medically examined once in a year, with a record signed by a registered medical practitioner (10.1.2). Factory staff are to be inoculated against the enteric group of diseases (10.1.3). Handlers follow strict cleanliness and hand-washing rules (10.2), visitors are discouraged and must follow hygiene rules (10.3). Packaged food carries the label required by the Act and its regulations so lots can be traced and recalled (11). Handlers are trained and training is reviewed (12). As per the 2017 compendium.
The three paragraphs at a glance
| Para | Topic | Headline requirement |
|---|---|---|
| 10.1 | Health status | Ill persons kept out and self-reporting; annual medical; enteric vaccination; vaccination in an epidemic |
| 10.2 | Personal cleanliness | Clean protective clothing, hand washing, no smoking, spitting or chewing, trimmed nails and hair |
| 10.3 | Visitors | Discouraged; protective clothing and hygiene rules where appropriate |
| 11 | Product information | Label and information as per the Act and regulations, for safe handling and traceability |
| 12 | Training | Awareness, skills, instruction, periodic assessment and review |
10.1 Health status
- 10.1.1 Personnel known or believed to be suffering from, or a carrier of, a disease or illness likely to be transmitted through food shall not be allowed to enter any food handling area. The business develops a system so that anyone affected immediately reports illness or symptoms to management, and a medical examination is carried out apart from periodic check-ups if clinically or epidemiologically indicated.
- 10.1.2 Food handlers and employees are medically examined once in a year to ensure they do not have infectious, contagious or other communicable diseases. A record signed by a registered medical practitioner is kept for inspection.
- 10.1.3 Factory staff are compulsorily inoculated against the enteric group of diseases per the recommended vaccine schedule, with a record kept.
- 10.1.4 In an epidemic, all workers are vaccinated irrespective of the scheduled vaccination.
10.2 Personal cleanliness
- 10.2.1 Food handlers keep a high degree of personal cleanliness. The business provides adequate, suitable, clean protective clothing, head covering, face mask, gloves and footwear, and ensures handlers at work wear only clean protective clothes, head covering and footwear each day.
- 10.2.2 Handlers wash their hands with soap and clean potable water, disinfect, and dry with a hand drier, clean cloth towel or disposable paper: at the start of food handling, immediately after handling raw food or any contaminated material, tool, equipment or surface where this could contaminate other food, and after using the toilet.
- 10.2.3 Handlers refrain from smoking, spitting, chewing, sneezing or coughing over food, and from eating in preparation and service areas.
- 10.2.4 Nails and hair trimmed periodically; no unhygienic habits.
- 10.2.5 Persons working directly with raw materials or food products: no smoking, spitting, eating or drinking where raw materials and food are handled or stored; wash hands each time work resumes and after contamination (for example, after coughing, sneezing, visiting the toilet, using the telephone or smoking); avoid hand habits such as scratching nose or hair, rubbing eyes, ears or mouth, scratching the beard or body, and wash hands before resuming work if unavoidable.
10.3 Visitors
Visitors are generally discouraged from going inside food handling areas, and care is taken that hygiene is not compromised by visitors (10.3.1). Visitors to manufacturing, cooking, preparation, storage or handling areas, wherever appropriate, wear protective clothing and footwear and follow the personal hygiene provisions in the section (10.3.2).
Paragraph 11: product information and consumer awareness
All packaged food carries a label and the requisite information as per the Act and its regulations. The stated purpose is that adequate, accessible information reaches each person in the food chain to handle, store, process, prepare and display the food safely, and that the lot or batch can be easily traced and recalled if necessary. The content of labels is governed by separate labelling regulations that are not reproduced here. See FSSAI label compliance and FSSAI logo and licence number on labels.
Paragraph 12: training
- 12.1 All food handlers are aware of their role and responsibility in protecting food from contamination or deterioration and have the knowledge and skills relevant to processing, packing, storing and serving.
- 12.2 Handlers are instructed and trained in food hygiene, food safety and personal hygiene, matched to their work, the food and its handling.
- 12.3 Periodic assessments of training effectiveness, awareness of safety requirements and competency, with routine supervision and checks.
- 12.4 Training programmes are routinely reviewed and updated.
Why it matters
A health or hygiene lapse in a food handler is a common trigger for complaints and improvement notices. Food that causes harm can bring heavier consequences; see Food causing injury or death: severe penalties. Unhygienic processing also falls under section 56 of the Act, with a penalty which may extend to one lakh rupees.
Practical examples
Example 1. A bakery schedules yearly medical examinations for all handlers, and keeps each report signed by a registered medical practitioner with its licence records.
Example 2. A cook reports a stomach infection on the morning shift. Under 10.1.1, the cook stays out of the food handling area.
Example 3. A supplier visits the packing hall. Under 10.3, the visitor wears protective clothing and footwear and follows the hygiene rules.
Example 4. A new helper is shown hand-washing and cleaning steps on day one, and a supervisor checks competence a month later, as 12.2 and 12.3 suggest.
Need help with handler health records and training?
Medical records, vaccination certificates and training logs are simple to keep but easy to forget. TaxClue can set up a register and a yearly calendar for your team through FSSAI compliance support. We will check the current requirements first, because the 2017 text may have been amended.
Key takeaways
- Ill or carrier personnel stay out of food handling areas and report illness.
- Annual medical examination with a record signed by a registered medical practitioner.
- Enteric group vaccination for factory staff, and for all workers in an epidemic.
- Clean protective clothing and strict hand washing and behaviour rules.
- Visitors are discouraged and must follow hygiene rules.
- Packaged food carries its label so lots can be traced and recalled.
- Handlers are trained, assessed and retrained as needed.
Read next
- Schedule 4 Part II: management, testing, audit and sanitation
- Schedule 4 Part III: specific hygiene for milk and milk products
- FSSAI hygiene rating: how to apply and get rated
- Food causing injury or death: severe penalties
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.
