Introduction about Food Safety & Standards Authority of India (FSSAI)

1. Introduction

Pre 2006, there were several acts and orders in force to ensure safety of food in our
country such as PFA-1954, Milk and Milk Products Order, 1992 etc. In order to bring
clarity in food legislations and authorities, a single Act i.e. Food Safety & Standards
Act, 2006 was enacted on 23rd August, 2006. Subsequently, Food Safety and
Standards Authority of India (FSSAI), a statutory body, established under the Ministry
of Health & Family Welfare in September 2008. The rules and regulations made
thereunder came into force with effect from 5th August, 2011.

Duties and functions of Food Authority.

(1) to regulate and monitor the manufacture, processing, distribution, sale and
import of food so as to ensure safe and wholesome food.

(2) the Food Authority may by regulations specify –

(a) the standards and guidelines in relation to articles of food;

(b) the limits for use of food additives, crop contaminants, pesticide residues,
residues of veterinary drugs, heavy metals, processing aids, myco-toxins,
antibiotics and pharmacological active substances and irradiation of food;

(c) the mechanisms and guidelines for accreditation of certification bodies

engaged in certification of food safety management systems for food businesses;

(d) the procedure and the enforcement of quality control in relation to any article
of food imported into India;

(e) the procedure and guidelines for accreditation of laboratories and notification
of the accredited laboratories;

(f) the method of sampling, analysis and exchange of information among

enforcement authorities;

(g) conduct survey of enforcement and administration of this Act in the country;

(h) food labelling standards including claims on health, nutrition, special dietary
uses and food category systems for foods; and

(i) the manner in which and the procedure subject to which risk analysis, risk
assessment, risk communication and risk management shall be undertaken.
Definition of Food u/s 3(j) of FSS Act 2006 –

3(j). “Food” means any substance, whether processed, partially processed or

unprocessed, which is intended for human consumption and includes primary food
to the extent defined in clause (zk), genetically modified or engineered food or food
containing such ingredients, infant food, packaged drinking water, alcoholic drink,
chewing gum, and any substance, including water used into the food during its
manufacture, preparation or treatment but does not include any animal feed, live
animals unless they are prepared or processed for placing on the market for human
consumption, plants, prior to harvesting, drugs and medicinal products, cosmetics,
narcotic or psychotropic substances :

Provided that the Central Government may declare, by notification in the Official
Gazette, any other article as food for the purposes of this Act having regards to its
use, nature, substance or quality;

Who is a Food Business Operator (FBO)?

As per section 3(n) and 3 (o) of FSS Act 2006, a person who is carrying out a food
business whether for profit or not, whether public or private, involved in the
activities related to any stage of manufacture, processing, packaging, storage,
transportation, distribution and import of food. This also includes food services,
catering services, sale of food or food ingredients (even through e-Commerce
platforms).

What is the need of FSSAI License/Registration?

As per section 31 of FSS Act 2006, No person shall commence or carry any food
business except under a License or Registration. There can be a penalty upto Rs 5
Lakhs or imprisonment of six months for carrying out food business without License
under section 63.

Who are petty food business operators?

A petty Food business operators means a person who himself manufactures or sells
any article of food or a petty retailer, hawker, itinerant vendor or a temporary stall
holder or small scale or cottage industries whose turnover is less than Rs 12 Lakhs
per annum or production capacity doesn’t exceed 100 Kg/Day or handling milk upto
500 ltr/day or having slaughtering capacity upto 2 Large Animals, 10 Small Animals
and 50 Poultry Birds.

Who is Eligible for FSSAI License?

All FBOs who are not fitting in petty FBO category are required to obtain FSSAI
License. There are two categories of FSSAI License i.e State License and Central
License, depending on the annual turnover or production capacity of Food
businesses.

Regulations made under Food Safety and Standards Act, 2006

1. Food Safety and Standards (Licensing and Registration of Food Businesses)

Regulation, 2011
2. Food Safety and Standards (Food Products Standards and Food Additives)
Regulation, 2011
3. Food Safety and Standards (Prohibition and Restriction of Sales) Regulation,
2011
4. Food Safety and Standards (Packaging and Labelling) Regulation, 2011
5. Food Safety and Standards (Contaminants, Toxins and Residues) Regulation,
2011
6. Food Safety and Standards (Laboratory and Sampling Analysis) Regulation,
2011
7. Food Safety and Standards (Food or Health Supplements, Nutraceuticals,
Food for Special Dietary Purpose, Functional Food and Novel Food) Regulation,
2016
8. Food Safety and Standards (Food Recall Procedure) Regulation, 2017
9. Food Safety and Standards (Import) Regulation, 2017
10. Food Safety and Standards (Approval for Non-Specific Food and Food
Ingredients) Regulation, 2017
11. Food Safety and Standards (Organic Food) Regulation, 2017
12. Food Safety and Standards (Alcoholic Beverages) Regulation, 2018
13. Food Safety and Standards (Fortification of Food) Regulation, 2018
14. Food Safety and Standards (Food Safety Auditing) Regulation, 2018
15. Food Safety and Standards (Recognition and Notification of Laboratories)
Regulation, 2018
16. Food Safety and Standards (Advertising and Claims) Regulation, 2018
17. Food Safety and Standards (Packaging) Regulation, 2018
18. Food Safety and Standards (Recovery and Distribution of Surplus food)
Regulation, 2019
Section 26. Responsibilities of the Food business operator.

(1) Every food business operator shall ensure that the articles of food satisfy the
requirements of this Act and the rules and regulations made thereunder at all stages of
production, processing, import, distribution and sale within the businesses under his
control.

(2) No food business operator shall himself or by any person on his behalf manufacture,
store, sell or distribute any article of food –

(i) which is unsafe; or

(ii) which is misbranded or sub-standard or contains extraneous matter; or

(iii) for which a licence is required, except in accordance with the conditions of the

licence; or

(iv) which is for the time being prohibited by the Food Authority or the Central
Government or the State Government in the interest of public health; or

(v) in contravention of any other provision of this Act or of any rule or regulation made
thereunder.

(3) No food business operator shall employ any person who is suffering from infectious,
contagious or loathsome disease.

(4) No food business operator shall sell or offer for sale any article of food to any vendor
unless he also gives a guarantee in writing in the form specified by regulations about the
nature and quality of such article to the vendor:

Provided that a bill, cash memo, or invoice in respect of the sale of any article of food
given by a food business operator to the vendor shall be deemed to be a guarantee
under this section, even if a guarantee in the specified form is not included in the bill,
cash memo or invoice.

(5) Where any food which is unsafe is part of a batch, lot or consignment of food of the
same class or description, it shall be presumed that all the food in that batch, lot or
consignment is also unsafe, unless following a detailed assessment within a specified
time, it is found that there is no evidence that the rest of the batch, lot or consignment
is unsafe:

Provided that any conformity of a food with specific provisions applicable to that food
shall be without prejudice to the competent authorities taking appropriate measures to
impose restrictions on that food being placed on the market or to require its withdrawal
from the market for the reasons to be recorded in writing where such authorities
suspect that, despite the conformity, the food is unsafe.
Section 27. Liability of the manufacturers, packers, wholesalers, distributors and
sellers

(1) The manufacturer or packer of an article of food shall be liable for such article of
food if it does not meet the requirements of this Act and the rules and regulations made
thereunder.

(2) The wholesaler or distributor shall be liable under this Act for any article of food
which is–

(a) Supplied after the date of its expiry; or

(b) Stored or supplied in violation of the safety instructions of the manufacturer; or

(c) Unsafe or misbranded; or

(d) Unidentifiable of manufacturer from whom the article of food have been received;
or

(e) Stored or handled or kept in violation of the provisions of this Act, the rules and
regulations made thereunder; or

(f) received by him with knowledge of being unsafe.

(2) The seller shall be liable under this Act for any article of food which is –

(a) sold after the date of its expiry; or

(b) handled or kept in unhygienic conditions; or

(c) misbranded; or

(d) unidentifiable of the manufacturer or the distributors from whom such articles of
food were received; or

(e) received by him with knowledge of being unsafe.

Section 31. Licensing and registration of food business.

(1) No person shall commence or carry on any food business except under a licence.

(2) Nothing contained in sub-section (1) shall apply to a petty manufacturer who himself
manufactures or sells any article of food or a petty retailer, hawker, itinerant vendor or
a temporary stall holder or small scale or cottage or such other industries relating to
food business or tiny food business operator; but they shall register themselves with
such authority and in such manner as may be specified by regulations, without prejudice
to the availability of safe and wholesome food for human consumption or affecting the
interests of the consumers.
 License application can be made to Designated Officer
 Designated Officer has power to either grant the License or reject the License
application, if he is satisfied that it is necessary so to do in the interest of public
health and shall make available to the applicant a copy of the order
 A License shall be issued within two months from the date of making the
application
 If application is not rejected, the applicant may start his food business after
expiry of the said period and in such a case, the Designated Officer shall not
refuse to issue a licence but may, if he considers necessary, issue an
improvement notice, under section 32 and follow procedures in that regard.
 A single licence may be issued by the Designated Officer for one or more articles
of food and also for different establishments or premises in the same area.
 If the articles of food are manufactured, stored, sold or exhibited for sale at
different premises situated in more than one area, separate applications shall be
made and separate licence shall be issued in respect of such premises not falling
within the same area.
 An appeal against the order of rejection for the grant of licence shall lie to the
Commissioner of Food Safety.
 A licence unless suspended or cancelled earlier shall be in force for such period as
may be specified by regulations: Provided that if an application for a renewal of
licence is made before the expiry of the period of validity of the licence, the
licence shall continue to be in force until orders are passed on the application.

Penalty and Punishments under FSS Act, 2006

Section Maximum Penalty

50. Penalty for selling food not of the nature or substance Rs. 5 Lakhs
or quality demanded. Rs. 25000 for petty FBOs
51. Penalty for sub-standard food. Rs. 5 Lakhs
52. Penalty for misbranded food. Rs. 3 Lakhs
53. Penalty for misleading advertisement. Rs. 10 Lakhs
54. Penalty for food containing extraneous matter. Rs. 1 Lakh
55. Penalty for failure to comply with the directions of Rs. 2 Lakhs
Food Safety Officer.
56. Penalty for unhygienic or unsanitary processing or Rs. 1 Lakh
manufacturing of food.
57. Penalty for possessing adulterant. Rs. 10 Lakh
58. Penalty for contraventions for which no specific Rs. 2 Lakh
penalty is provided.
59. Punishment for unsafe food.
a) failure or contravention does not result in injury – Imprisonment upto Six months
with fine upto Rs. 1 Lakh
b) failure or contravention results in a non-grievous injury – Imprisonment upto One
year with fine upto Rs. 3 Lakhs

c) failure or contravention results in a grievous injury – Imprisonment upto Six years

with fine upto Rs. 5 Lakh
d) failure or contravention results in death – Imprisonment shall not be less than seven
years which may extend to imprisonment for life with fine not less than Rs. 10 Lakhs

60. Punishment for interfering with seized items. Imprisonment for the
term upto Six months
with fine upto Rs. 2 Lakhs
61. Punishment for false information. Imprisonment for the
term upto three months
with fine upto Rs. 2 Lakhs
62. Punishment for obstructing or impersonating a Food Imprisonment for the
Safety Officer. term upto three months
with fine upto Rs. 1 Lakh
63. Punishment for carrying out a business without Imprisonment for the
licence. term upto six months
with fine upto Rs. 5 Lakhs
64. Punishment for subsequent offences. Twice the punishment
earlier awarded.
Further, Rs. One Lakh fine
per day, if the offence is
continuing one and
subsequently,
cancellation of License.