UNIT 8

FSSAI ACT AND RULES

SUB: PHARMACY LAW AND
ETHICS
COURSE : [Link] II YEAR

ANANTHARAJ V
ASSISTANT PROFESSOR,
DEPT OF PHARMACOGNOSY
FOP,DR MGR ERI
Contents:-

• Brief Overview and aspects related to

manufacture, storage, sale and
labelling of Food Supplements
 INTRODUCTION

•Food Safety and Standards Authority of India (FSSAI) is

a statutory body established under the Ministry of Health
& Family Welfare, Government of India.
•The FSSAI has been established under the Food Safety
and Standards Act 2006, which is a consolidating statute
related to food safety and regulation in India.
 INTRODUCTION
•FSSAI is responsible for protecting and promoting public
health through the regulation and supervision of food safety.
•FSSAI License or FSSAI Registration is mandatory before
starting any food business.
•The FSSAI has its headquarters at New Delhi.
•The FSSAI consists of a chairperson and 22 members.
•The authority also has 6 regional offices located in Delhi,
Guwahati, Mumbai, Kolkata, Cochin, and Chennai.
•14 referral laboratories notified by FSSAI, 72 State/UT
laboratories located throughout India and 112 laboratories are
NABL accredited private laboratories notified by FSSAI.
 DEFINITIONS

(a) “Adulterant" means any material which is or could be

employed for making the food unsafe or sub-standard
or mis-branded or containing extraneous matter.
(b) “Advertisement" means any audio or visual publicity,
representation or pronouncement made by means of
any light, sound, smoke, gas, print, electronic media,
internet or website and includes through any notice,
circular, label, wrapper, invoice or other documents.
(c) “Food safety" means assurance that food is acceptable
for human consumption according to its intended use;
 FUNCTIONS OF FSSAI
1. Framing of regulations to laydown food safety standards.
2. Laying down guidelines for accreditation of laboratories
for food testing.
3. Providing scientific advice and technical support to the
central government.
4. Collecting and collating data regarding food consumption,
contamination, emerging risks etc.,
5. Training programs are provided to the persons who are
involved and proposed to get involved in food business in
India.
6. Disseminating information and promoting awareness
about food safety and standards in India.
 RULES AND REGULATIONS UNDER
FSSAI ACT
•Section 91 in The Food Safety and Standards Act, 2006 provides
Power of Central Government to make rules. The Central
Government may, by notification in the Official Gazette, make rules
for carrying out the provisions of this Act.
•Section 92 in The Food Safety and Standards Act, 2006- provides
Power of Food Authority to make regulations. The Food Authority
make regulations consistent with this Act and the rules made there
under to carry out the provisions of this Act.
•Food Safety and Standards Rules, 2011 notified on 05-05-2011.
•Food Safety and Standards (Amendment) Rules, 2014 notified on
18-07-2014.
• Food Safety and Standards (Amendment) Rules, 2017 notified on
13-01-2017
MANUFACTURING OF FOOD SUPPLEMENTS
•The Food supplements facility shall be situated away from
environmentally polluted areas to avoid risk of contamination from
external environment. In case it is already existing, appropriate
control measures shall be taken.
•The manufacturing premise should not have direct access to any
residential area and should be free from floods and stagnant water
surrounding the facility.
•Floors should be non-slippery, sloped appropriately, to allow
adequate drainage and the floors and the walls should not be damp
or moist.
•Food processing operations, flow diagram and standard operating
procedures should be documented, implemented and displayed at
particular operations site and critical parameters like temperature /
vacuum etc. records shall be maintained with appropriate coding
for traceability.
•Personnel should wear clean protective clothing including
footwear and wash their hands before entering and cleaning
schedule for equipment should be maintained to ensure
entire operations are carried out in hygienic conditions.
•Systems should be in place to prevent contamination of
foods by foreign bodies such as glass, metal shards from
machinery and dust. In manufacturing and processing,
suitable detection or screening devices should be used where
necessary. Access to processing area by outsiders should be
restricted or controlled.
•When presence of any allergens identified in food
ingredients and products, controls should be made to prevent
the allergens.
•In case steam is used directly on food during processing, the
steam to be prepared from potable water.
•All manufacturing operations shall be carried out under the
supervision of authorised technical person. Each critical step
in the process relating to the selection, weighing and
measuring of raw material, addition during various stages
shall be performed by trained personnel under the direct
personal supervision of authorised technical person.
•Adequate space, preferably separated from processing areas,
should be provided for cleaning and storing equipment and
utensils including the storage of cleaning materials.
•Food supplements should be free from restricted food
additive or processing aid.
 STORAGE
•Appropriate arrangement for storage of food & food
ingredients provided and adequately segregated and
labelled.
•Systems to adequately maintain time- temperature
control at the time of storage.
•Containers used for storage are made of non toxic
material.
•Cold Storage facility, wherever necessary/provided. The
Regulations specify limits of metal contaminants, crop
contaminants and naturally occurring toxins and as well
as pesticide residue in various food items
 PACKAGING
•The packaging materials used should be able to provide protection
to all food products to prevent contamination, damage.
•Packaging materials like aluminum & its alloy, tinned copper &
brass and plastic should be compile with standards
(1) IS: 10146 (Specification for Polyethylene in contact with foodstuffs)
(2) IS: 10142 (Specification for Styrene Polymers in contact with
foodstuffs)
(3) IS: 10151 (Specification for Polyvinyl Chloride (PVC), in contact with
foodstuffs);
(4) IS: 10910 (Specification for Polypropylene in contact with foodstuffs)
(5) IS: 11434 (Specification for Ionomer Resins in contact with foodstuffs)
(6) IS:12252 (Specification for Poly ethylene terephthalates (PET))
 7. IS: 11704 Specification for Ethylene Acrylic Acid (EAA)
copolymer.
8. IS:12247-Specification for Nylon 6 Polymer
9. IS: 13601 - Ethylene Vinyl Acetate (EVA)
10. IS: 13576-Ethylene Metha Acrylic Acid (EMAA)
11. Tin and plastic containers once used, shall not be re-used for
packaging of edible oils and fats;
•Packaging materials should be robust, secure, easily scalable and
enough to prevent spoilage and contamination.
•The packaging materials or gases where used, should be non-toxic
and highly safety and suitability of food under the storage and use.
•The packaging materials should be inspected before use to prevent
use of damaged, defective or contaminated packaging materials.
•Packaging section should always be considered high care zone
and access to packaging section should be restricted and
controlled and personnel should wear clean protective clothing
and footwear before entry.
•All packaging equipment like weighing scale should be
calibrated on daily basis against certified standards & their
records should be maintained.
•Filling and packaging should be done under hygienic
environment in a separate designated area that should be closed
from all sides to restrict entry of flies, rodents, birds and pests.
 LABELLING
•All products should carry a label containing information about the
name of ingredients present.
•Contents on the label should be clear, prominent, indelible and
readily legible by the consumer under normal conditions of
purchase and use.
•If container is covered by a wrapper, the wrapper should carry the
necessary information.
•Nutritional Information or nutritional facts per 100 gm or 100 ml
or per serving of the product should be given on the label
containing the following:
i. energy value in kcal
ii. the amounts of protein, carbohydrate (specify quantity of
sugar) and fat in gram (g) or ml;
iii. the amount of any other nutrient for which a nutrition or health
claim like vitamin, minerals, enzymes or other raw agricultural
commodities.
• If the nature of food is non-veg, then the symbol of a brown colour filled
box should be printed, if the nature of food is veg, then the symbol of
green colour filled in the box.

• In case of food additives, the following class titles should be used

together with the specific names or recognized international numerical
identifications: Acidity Regulator, Antioxidant, Bulking Agent, Colour,
Emulsifier, Flavour Enhancer, Foaming Agent, Gelling Agent,
Humectant, Preservative, Stabilizer, Sweetener, Thickener.
• The date, month and year in which the commodity is manufactured,
packed or pre- packed, should be given on the label:
• Provided that the month and the year of manufacture, packing or
pre-packing should be given if the "Best Before Date" of the products is
more than three months.
• Provided further that in case any package contains commodity which has
a short shelf life of less than three months, the date, month and year in
which the commodity is manufactured or prepared or pre-packed shall be
mentioned on the label.
 SALES
•The sales of certain admixture contained cream which has not
prepared from milk & and its derivatives, edible oils and other
food materials are prohibited.
•It prohibit the sale of food supplements coated with mineral oil
above the limit.
•It restrict the sale of honey that it should be sold only in the sealed
container with the label of AGMARK and the food resembles
honey should not be marketed as honey by the word, marking or
other illustration that resembles honey.
•It prohibit the use of substances in the food products preparation
which are highly injurious to health like tobacco and other
nicotinic products.
•It prohibit the uses of gases for the ripening fruits which are used
the preparation of fruit juices.
•The oil which are obtained from white sesame should be sold in the
container with an AGMARK seal.
•The Tea and flavored tea should be only sold the manufacturer
registered with the tea board.
•It restrict the sale of common salt for the direct consumption unless
it is iodized and if the salt was fortified salt, animal use,
preservation and manufacturing etc., then it should properly
labelled.
•The usage of naturally dead animals and fowls are prohibited.
•It prohibit the foods which consists of direct addition of
insecticides.
•It prohibit the sale of any novel food, genetically modified food &
irradiated food.
•It prohibit advertisement shall be made of any food which is
misleading or deceiving or contravenes for improving the sales.