Section 3 of the Food Safety and Standards Act, 2006: definitions of sale, sub-standard food and unsafe food (clauses (zg) to (zz) and sub-section (2))

Section 3 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.

This article completes section 3 of the Food Safety and Standards Act, 2006. It covers clauses (zg) to (zz) of section 3(1) and sub-section (2): notification, package, premises, prescribed, primary food, prohibition order, the risk-analysis terms, sale, sample, specified by regulations, standard, State Government, substance, sub-standard, Tribunal and unsafe food. The last definition, with its twelve limbs, is the key to the Act's strictest penalties.

"Sale" is very wide: it includes an offer, exposing for sale, possession for sale and even an attempt to sell, and it covers sale for analysis. "Sub-standard" food fails the specified standards but is not unsafe. "Unsafe food" is food whose nature, substance or quality is so affected as to be injurious to health in one of twelve ways, from poisonous substances to pesticide residues above the limit. The difference decides whether you face a civil penalty or criminal punishment under section 59.

Clauses (zg) to (zz) at a glance

Premises, package and sale: where and what you are regulated for

Premises is deliberately broad. It includes any shop, stall, hotel, restaurant, airline services and food canteens, and any place, vehicle or vessel where food is sold, manufactured or stored for sale. A delivery van or a stall on wheels is therefore "premises". Licences under section 31 attach to premises, and our page on basic FSSAI registration covers the smallest operators who still need one.

Sale covers the sale of any article of food, whether for cash or on credit or by way of exchange, whether wholesale or retail, for human consumption or use or for analysis. It includes an agreement for sale, an offer for sale, exposing for sale or having in possession for sale, and an attempt to sell. Because of this, stock kept in a godown for sale is already "sale" for the purposes of the Act. An inspector does not have to prove that a consumer bought the product.

Package covers pre-packed boxes, bottles, caskets, tins, barrels, cases, pouches, receptacles, sacks, bags, wrappers and other things in which food is packed.

FSSAI Licence✓FSSAI LicenceGet FSSAI Licence for Your Food BusinessNew Licence · Renewal · ModificationNew LicenceRenewalModificationGet FSSAI Licence →

Primary food, standard and sample

"Primary food" in clause (zk) is produce of agriculture, horticulture, animal husbandry and dairying or aquaculture in its natural form, resulting from growing, raising, cultivating, picking, harvesting, collecting or catching, in the hands of a person other than a farmer or fisherman. On this wording, produce in a farmer's own hands is not "primary food", while produce in the hands of a trader or wholesaler is.

"Standard" means the standards notified by the Food Authority. Whether a product meets the standard is what separates compliant from sub-standard food. "Sample" means a sample of food taken under the Act or its rules and regulations; see section 47 and the Rules on sampling for how it must be taken.

The risk vocabulary (clauses (zm) to (zq))

The Act defines risk as the probability of an adverse effect on the health of consumers and the severity of that effect, consequential to a food hazard. Risk analysis has three components: risk assessment, risk management and risk communication.

• Risk assessment has four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.
• Risk communication is the interactive exchange of information and opinions among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of findings and the basis of risk management decisions.
• Risk management is the process, distinct from risk assessment, of evaluating policy alternatives in consultation with interested parties and selecting prevention and control options.

These are mostly of interest to the Food Authority, which must base its decisions on them (see section 16 on its duties). For a business they explain why standards are set on scientific grounds and why the Authority publishes information on risk.

Sub-standard food: fails the standard, but not unsafe

Clause (zx) says food is sub-standard if it does not meet the specified standards but not so as to render it unsafe. The test has two parts: a standard exists, and the food falls short of it without becoming injurious to health. The penalty is in section 51. Note that clause (zz)(xi) treats mis-branded or sub-standard food, or food containing extraneous matter, as one of the ways food can be "unsafe", so the line between the categories is fact-specific. A product that is merely below the standard is sub-standard; a product whose defect makes it injurious to health is unsafe.

Unsafe food: the twelve limbs of clause (zz)

"Unsafe food" means an article whose nature, substance or quality is so affected as to render it injurious to health:

1. by the article itself, or its package, being composed wholly or partly of a poisonous or deleterious substance; or
2. by the article consisting wholly or partly of any filthy, putrid, rotten, decomposed or diseased animal or vegetable substance; or
3. by virtue of unhygienic processing or the presence of any harmful substance; or
4. by substitution of any inferior or cheaper substance, wholly or partly; or
5. by addition of a substance, directly or as an ingredient, which is not permitted; or
6. by abstraction, wholly or partly, of any of its constituents; or
7. by the article being so coloured, flavoured, coated, powdered or polished as to damage or conceal it or make it appear better or of greater value than it is; or
8. by the presence of any colouring matter or preservatives other than that specified; or
9. by infection or infestation with worms, weevils or insects; or
10. by being prepared, packed or kept under insanitary conditions; or
11. by virtue of being mis-branded or sub-standard or food containing extraneous matter; or
12. by containing pesticides and other contaminants in excess of quantities specified by regulations.

The phrase "so affected as to render it injurious to health" governs the whole list. On this wording the limbs describe how food may become injurious; the defect must also be of a kind that affects health, so a document or report should show both the cause and the effect.

Why it matters: section 59. A person who, by himself or through another, manufactures for sale, stores, sells, distributes or imports unsafe food is punishable under section 59. The punishment rises with the harm: where there is no injury, imprisonment and fine (clause (i)); non-grievous injury (ii); grievous injury (iii); and death (iv), where imprisonment is not less than seven years and may extend to life, with fine not less than ten lakh rupees. Clause (i) was amended by the Jan Vishwas (Amendment of Provisions) Act, 2023: the no-injury punishment is now imprisonment up to three months and fine up to three lakh rupees, in place of imprisonment up to six months and fine up to one lakh rupees. Clauses (ii) to (iv) are as enacted: imprisonment up to one year and fine up to three lakh rupees for non-grievous injury, up to six years and five lakh rupees for grievous injury.

For penalty for selling food that is not in compliance with the Act or not of the nature, substance or quality demanded, see section 50. For advice if you have received a notice, see our FSSAI penalty and adjudication service.

Sub-section (2): laws not in force in Jammu and Kashmir

Section 3(2) says that any reference in the Act to a law which is not in force in the State of Jammu and Kashmir shall, in relation to that State, be read as a reference to the corresponding law, if any, in force there. This is printed as enacted in 2006, and readers should check how the provision is read now.

Need help with a penalty or notice?

If your product has been sampled, or you have received a notice alleging sub-standard or unsafe food, TaxClue can review the report and help you plan the response. Our FSSAI penalty and adjudication page explains how the process works and what we need from you.

Key takeaways

• "Sale" includes offering, exposing, possessing for sale and attempting to sell, even for analysis.
• "Premises" includes vehicles, vessels and stalls, not only buildings.
• Sub-standard food fails the notified standard but is not unsafe; unsafe food is injurious to health by one of the twelve limbs of clause (zz).
• Section 59(i), as amended by the Jan Vishwas Act, 2023, now provides imprisonment up to three months and fine up to three lakh rupees where unsafe food causes no injury.
• Pesticides and contaminants above the specified limits make food unsafe under limb (xii).

Read next

• Section 51: penalty for sub-standard food
• What constitutes unsafe food under the FSS Act
• Food causing injury or death: severe penalties
• Section 3 definitions: food safety, label and misbranded food
• Section 3 definitions: food business and FBO

Disclaimer: Based on the Food Safety and Standards Act, 2006 as enacted, read with the Jan Vishwas (Amendment of Provisions) Act, 2023 (which amended section 59(i), section 61 and section 63). Verify current notifications, regulations and FSSAI orders before acting.