Section 48 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.
Section 48 of the Food Safety and Standards Act, 2006 opens the Chapter on offences and penalties. It lists four ways of making food injurious to health, sets out what must be considered in deciding whether food is unsafe or injurious, protects primary food that falls short solely because of natural causes, and defines "injury".
Food may be rendered injurious to health by adding a substance, using a substance as an ingredient, abstracting constituents, or subjecting it to any other process, with knowledge that it may be sold or offered for sale or distributed for human consumption (s.48(1)). In deciding whether food is unsafe or injurious, the authority must consider normal conditions of use, the label and consumer information, cumulative and long-term effects including on subsequent generations, and the sensitivities of a target group (s.48(2)(a)). Primary food that falls short solely due to natural causes beyond human control is not unsafe, sub-standard or food with extraneous matter (s.48(2)(b)).
Section 48 at a glance
| Provision | What it does |
|---|---|
| 48(1) | Four operations by which food may be rendered injurious to health: adding, using as ingredient, abstracting, other process or treatment |
| 48(2)(a) | Five considerations in deciding whether food is unsafe or injurious to health |
| 48(2)(b) | Natural-causes exception for primary food |
| Explanation | "Injury" includes any impairment, permanent or temporary; "injurious to health" is read accordingly |
Section 48(1): four ways to make food injurious
The sub-section says a person may render any article of food injurious to health by one or more of these operations:
- (a) adding any article or substance to the food;
- (b) using any article or substance as an ingredient in the preparation of the food;
- (c) abstracting any constituents from the food; or
- (d) subjecting the food to any other process or treatment,
"with the knowledge that it may be sold or offered for sale or distributed for human consumption".
The knowledge element is part of the description: the operation is done with the knowledge that the food may go to sale or distribution. This links directly to the definition of "unsafe food" in s.3(1)(zz), which includes unsafe-by-substitution, abstraction and non-permitted additions, among other things. See our article on definitions of sale, sub-standard and unsafe food. If a recipe change or a process change is being considered, our penalty and adjudication team can help you look at where the exposure lies.
Section 48(2)(a): what must be taken into account
In determining whether any food is unsafe or injurious to health, "regard shall be had to" five things.
| Factor | Plain meaning |
|---|---|
| (i) Normal conditions of use and handling | How the consumer normally uses the food and how it is handled at each stage of production, processing and distribution |
| (ii) Information to the consumer | Information on the label or otherwise generally available about avoiding specific adverse health effects, and the probable immediate, short-term or long-term effects on a consumer and on subsequent generations |
| (iii) Probable cumulative toxic effects | Effects that build up over time |
| (iv) Particular health sensitivities of a specific category of consumers | Where the food is intended for that category, for example a product marketed to a particular group |
| (v) Probable cumulative effect of food of substantially the same composition | The effect on a person consuming it in ordinary quantities |
Three observations help a food business operator.
- The label is evidence. Factor (ii) means a clear warning can change the assessment of a food. It does not cure a defect, but it is something the authority must consider.
- The test looks beyond the day of eating. Factor (ii) reaches long-term effects and effects on "subsequent generations". A food that seems harmless in one serving may be assessed on cumulative exposure.
- Target groups matter. If you market to infants, patients or other sensitive groups, factor (iv) holds you to a higher level of care than for a general-audience product. The Act does not set the level in this section.
Section 48(2)(b): the natural-causes protection
Clause (b) protects a category of case: where "the quality or purity of the article, being primary food, has fallen below the specified standard or its constituents are present in quantities not within the specified limits of variability, in either case, solely due to natural causes and beyond the control of human agency, then such article shall not be deemed to be unsafe or sub-standard or food containing extraneous matter."
Reading it word by word:
- "Primary food" is defined in s.3(1)(zk): a produce of agriculture, horticulture, animal husbandry and dairying or aquaculture in its natural form, in the hands of a person other than a farmer or fisherman. The definition speaks of produce "in its natural form", so processed products are outside it.
- "Solely due to natural causes": if human action contributed, even partly, the protection fails.
- "Beyond the control of human agency": the cause must have been outside what a person could control.
- The effect is that the article is not to be deemed unsafe, sub-standard or food containing extraneous matter.
Example. A wholesaler sells whole wheat whose natural moisture or protein is outside the specified variability because of a drought season. If the variation is solely due to natural causes and beyond human control, s.48(2)(b) removes the "sub-standard" label. If the same wheat was wetted or stored badly by the wholesaler, the protection is not available.
The Explanation: what "injury" means
"Injury" includes "any impairment, whether permanent or temporary", and "injurious to health" is construed accordingly. So a temporary illness, such as stomach upset, is an injury for the purposes of the Act. The grades of injury in s.59 (non-grievous injury, grievous injury, death) sit on top of this base definition; see our post on food causing injury or death.
How section 48 connects to the penalty sections
Section 48 has no penalty. It is used by the authorities and courts as the test applied in Chapter IX. The next sections set the penalties: s.49 gives the factors for fixing the amount (see the article on section 49), ss.50 to 58 provide penalties, and s.59 and onwards provide punishments. As amended by the Jan Vishwas (Amendment of Provisions) Act, 2023, s.59(i) carries imprisonment up to three months and fine up to three lakh rupees where unsafe food causes no injury.
Need help with a notice alleging unsafe food?
If you have a notice or a case that turns on whether your food is "unsafe" or "injurious to health", TaxClue can help you work through the section 48 factors against the facts. See our penalty and adjudication page.
Key takeaways
- Section 48(1) lists four operations by which food may be made injurious to health, done with knowledge that it may be sold or distributed.
- Section 48(2)(a) sets five factors for judging unsafe or injurious food, including cumulative and generational effects.
- Primary food is protected only where the shortfall is solely due to natural causes beyond human control.
- "Injury" covers any permanent or temporary impairment.
- The section sets the test; penalties and punishments are in other sections.
Read next
- Section 49: general provisions relating to penalty
- Section 3: definitions of sale, sub-standard and unsafe food
- Food causing injury or death: severe penalties
- Selling unsafe food: penalty under sections 50 and 51
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). Verify current notifications, regulations and FSSAI orders before acting.