FOOD SAFETY AND STANDARDS (PACKAGING)
REGULATIONS, 2018
PREAMBLE
Whereas the draft of
certain regulations, namely, the Food Safety and Standards (Packaging)
Regulations, 2018 vide notification number F. No.
1-95/Stds/Packaging/SP(L&C/A)/FSSAI-2017, dated the 19th March, 2018 was
published as required under Sub-section (1) of section 92 of Food Safety and
Standards Act, 2006 (34 of 2006) in Gazette of India, Extraordinary, Part III,
section 4, inviting objections and suggestions from the person likely to be
affected thereby, before the expiry of a period of thirty days from date on
which the copies of Gazette containing the said notification was made available
to the public;
And whereas, the Food
Safety and Standards Authority of India made the Food Safety and Standards
(Packaging and Labelling) Regulations, 2011, but now the Food Authority has
decided to divide these regulations into two regulations,
(i) the Food Safety and
Standards (Packaging) Regulations, 2018; and
(ii) the Food Safety and
Standards (Labelling and Display) Regulations, 2018,
And accordingly
published the aforesaid draft regulations;
And whereas copies of
the said Gazette were made available to the public on the 2nd April, 2018;
And whereas
objections and suggestions received on the said draft regulations have been
considered by the Food Safety and Standards Authority of India;
Now, therefore, in
exercise of the powers conferred by clause (k) of sub-section (2) of section
92, read with section 23 of the Food Safety and Standards Act, 2006 (34 of 2006)
and in supersession of the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011, in so far as they relate to the packaging regulations,
except as respects things done or omitted to be done before such supersession,
the Food Safety and Standards Authority of India hereby makes the following
regulations, namely:
Regulation - 1. Short Title and Commencement.
(1) These regulations may
be called the Food Safety and Standards (Packaging) Regulations, 2018.
(2) They shall come into
force on the date of their publication in the Official Gazette and Food
Business Operator shall comply with all the provisions of these regulations by
1st July, 2019.
Regulation - 2. Definitions.
(1) In these regulations
unless the context otherwise requires:
(a) "Act" means
the Food Safety and Standards Act, 2006 (Act 34 of 2006);
(b) "food
grade" means material made of substances which are safe and suitable for
their intended use, and shall not endanger human health or result in
unacceptable change in the composition of the food or organoleptic
characteristics;
(c) "multilayer/composite
food packaging" means a food packaging material composed of two or more
layers of same or different types of packaging materials specified under these
regulations;
(d) "overall
migration limit" means the maximum permitted amount of non-volatile
substances released from a material or article into food simulants;
(e) "package or
container" means a pre-packaged box, bottle, casket, tin, barrel, case,
pouch, receptacle, sack, bag, wrapper or such other things in which an article
of food is packed;
(f) "packaging
material" means materials such as cardboard, paper, glass, metal, plastic,
multi-layer packaging material used for packaging of food products;
(g) "primary food
packaging" means packaging material in direct contact with food products;
(h) "secondary food
packaging" means packaging material which encloses the primary food
packaging and does not come in direct contact with food products;
(i) "specific
migration limit" means the maximum permitted amount of a given substance
released from a material or article into food or food simulants.
(2) All other words and
expressions used herein and not defined, but defined in the Act, rules or
regulations made thereunder, shall have the meanings assigned to them in the
Act, rules or regulations, respectively.
Regulation - 3. General Requirements.
(1) Every food business
operator shall ensure that the packaging material used shall be in accordance
with these regulations:
Provided where Indian
Standards are not available, then relevant International Standards may be
complied with.
(2) Any material which
comes in direct contact with food or likely to come in contact with food used
for packaging, preparation, storing, wrapping, transportation and sale or
service of food shall be of food grade quality.
(3) Packaging materials
shall be suitable for the type of product, the conditions provided for storage
and the equipment for filling, sealing and packaging of food as well as
transportation conditions.
(4) Packaging materials
shall be able to withstand mechanical, chemical or thermal stresses encountered
during normal transportation. In case of flexible or semi-rigid containers, an
overwrap packaging may be necessary.
(5) Food products shall
be packed in clean, hygienic and tamper-proof package or container.
(6) The sealing material
shall be compatible with the product and the containers as well as the closure
systems used for the containers.
(7) Tin containers once
used, shall not be re-used for packaging of food.
(8) Plastic containers of
capacity 5 litre and above and Glass bottles, which are reused for packaging of
food, shall be suitably durable, easy to clean or disinfect.
(9) Printing inks for use
on food packages shall conform to IS: 15495.
(10) Printed surface of
packaging material shall not come into direct contact with food products.
(11) Newspaper or any such
material shall not be used for storing and wrapping of food.
(12) In case of multilayer
packaging the layer which comes in direct contact with food or layers likely to
come in contact with food shall meet the requirements of packaging materials
specified in Schedule I, II and III of these regulations.
(13) The materials listed
in Schedule I, II and III of these regulations shall be compatible with their
intended use as a packaging material so as not to alter the quality and safety
of the food product.
(14) Every food business
operator shall obtain the certificate of conformity issued by NABL accredited
laboratory against these regulations for the packaging material which comes in
direct contact with food or layers likely to come in contact with food to be
used.
Regulation - 4. Specific Requirements for Primary food packaging.
(1) Paper and board
materials intended to come in contact with food products.
(a) Paper and board
material shall be of uniform formation, thickness and substance.
(b) It shall be free from
visible specks, grease marks, cuts, pinholes and other blemishes.
(c) The paper used for
the manufacture of boxes, cartons, plates, cups and paper lids or paper which
are meant to be direct in contact with food shall be of food grade and shall be
free from contaminants.
(d) Paper and board
materials used for the manufacturing of containers for packing or storing the
food products shall conform to either of the Indian Standards specifications as
provided in Schedule-I.
(2) Glass containers intended
to come in contact with food products.
(a) As far as possible,
they shall be free from blisters, mould marks, stones and chippings and as far
as possible shall be free from cords, seeds and other visible defects.
(b) They shall have a
smooth surface without cracks, pinholes and sharp edges.
(c) The sealing surface
shall be free from hairline cracks and prominent seam marks.
(3) Metal and Metal
Alloys intended to come in contact with food products.
(a) A utensil or
container made of the following materials or metals, when used in the
preparation, packaging and storing of food shall be deemed to render it unfit
for human consumption:
(i) containers which are
rusty;
(ii) enamelled containers
which have become chipped and rusty;
(iii) copper or brass
containers which are not properly tinned.
(b) Appropriate grades of
metal and metal alloys where applicable shall be used for packing or storing of
food products.
(c) Metal and metal
alloys used for the manufacturing of containers for packing or storing the food
products shall conform to either of the Indian Standards specifications as
provided in Schedule-II.
(4) Plastic materials
intended to come in contact with food products.
(a) Plastic materials
used for the manufacturing of containers for packing or storing the food
products shall conform to either of the Indian Standards specifications as
provided in Schedule-III:
Provided that
Drinking Water (both Packaged and Mineral Water) shall be packed in colourless,
transparent and tamper-proof bottles or containers made of polyethylene (PE)
conforming to IS: 10146 or polyvinyl chloride (PVC) conforming to IS: 10151 or
polyalkylene terephthalate (PET and PBT) conforming to IS: 12252 or
polypropylene (PP) conforming to IS: 10910 or food grade polycarbonate
conforming to IS: 14971 or polystyrene conforming to IS: 10142 or sterile glass
bottles only. The transparency of a container shall not be less than 85 percent
in light transmittance:
[1][Provided further
that food grade packaging materials as specified in regulation 4(1) to (3),
which may or may not contain plastic as component compatible with the water to
be packaged may also be used. In such cases requirements of transparency would
not apply.]
Provided also that
all pigments or colorants as specified in Indian Standard IS: 9833 may be
allowed in plastic containers of five litre and above made of Polycarbonate and
Polyethylene Terephthalate (PET) used for packaging of mineral water and
packaged drinking water. The transparency of such containers shall not be less
than 85 percent in light transmittance.
(b) All packaging
materials of plastic origin shall pass the prescribed overall migration limit
of 60mg/kg or 10mg/dm2 when tested as per IS 9845 with no visible colour
migration.
(c) Plastic materials and
articles shall not release the substances in quantities exceeding the specific
migration limits listed under Table 1.
(d) Pigments or Colorants
for use in plastics in contact with food products and drinking water shall
conform to IS: 9833.
(e) Products made of
recycled plastics including carry bags shall not be used for packaging,
storing, carrying or dispensing articles of food.
Table
1
Requirement for
specific migration limits of substances from plastic materials intended to be
in contact with articles of food
Sl. No. |
Substances |
Maximum Migration Limit (mg/Kg) |
1. |
Barium |
1.0 |
2. |
Cobalt |
0.05 |
3. |
Copper |
5.0 |
4. |
Iron |
48.0 |
5. |
Lithium |
0.6 |
6. |
Manganese |
0.6 |
7. |
Zinc |
25.0 |
[2][8. |
Antimony |
0.04 |
9. |
Phthalic acid, bis (2-ethylhexyl)
ester (DEHP) |
1.5] |
Regulation - 5.
A list of suggestive
packaging materials which may be used for packaging of food products falling
under the specified categories is provided in Schedule-IV:
Provided that this is
an indicative list not restricting the use of any other packaging material
complying with the specified standards.
Paper
and board materials intended to come in contact with food products
Sl. No |
List of Standards |
1. |
Grease proof paper-IS 6622 |
2. |
Vegetable parchment or Grease proof
paper or Aluminium Foil Laminate-IS 7161 |
3. |
Aluminium Foil Laminates for
Packaging-IS 8970 |
4. |
General purpose packing or wrapping
Paper-IS 6615 |
5. |
Folding Box Board, uncoated-IS 1776 |
6. |
Corrugated Fibre Board
Boxes-Specification (Part 1)-IS 2771 |
Note: The wax used
for coating the paper or board shall be paraffin wax conforming to Type I of IS
4654.
Metal
and Metal Alloys intended to come in contact with food products
Sl. No. |
List of Standards |
1. |
Cold-reduced Electrolytic Tinplate-IS
1993/ISO 11949 |
2. |
Cold reduced Electrolytic Chromium or
Chromium Oxide-Coated Steel-IS 12591/ISO 11950 |
3. |
Wrought Aluminium and Aluminium Alloy
Sheet and Strip for General Engineering-IS 737 |
4. |
Aluminium and Aluminium Alloy Bare
Foil for Food Packaging-IS 15392 |
5. |
Specification for Crown Closures-IS
1994 |
6. |
Specification for Round Open Top
Sanitary Cans for Foods and Drinks-IS 9396 (Part 1) |
7. |
Specification for Round Open Top
Sanitary cans for Foods and Drinks-IS 9396 (Part 2) |
Plastic
Materials intended to come in contact with food products
Sl. No. |
List of Standards |
1. |
Specification for Polyethylene for
its safe use in contact with foodstuffs, pharmaceuticals and drinking
water-IS 10146 |
2. |
Specification for Polystyrene for its
safe use in contact with foodstuffs, pharmaceuticals and drinking water-IS
10142 |
3. |
Specification for Polyvinyl Chloride
(PVC) and its copolymers for its safe use in contact with foodstuffs,
pharmaceuticals and drinking water-IS 10151 |
4. |
Specification for Polypropylene and
its copolymers for its safe use in contact with foodstuffs, pharmaceuticals
and drinking water-IS 10910 |
5. |
Specification for Ionomer Resins for
its safe use in contact with foodstuffs, pharmaceuticals and drinking
water-IS 11434 |
6. |
Specification for Ethylene Acrylic
Acid (EAA) copolymers for their safe use in contact with foodstuffs, pharmaceuticals
and drinking water-IS 11704 |
7. |
Specification for
PolyalkyleneTerephathalates (PET & PBT) for their safe use in contact
with foodstuffs, pharmaceuticals and drinking water-IS 12252 |
8. |
Specification for Nylon 6 Polymer for
its safe use in contact with foodstuffs, pharmaceuticals and drinking
water-IS 12247 |
9. |
Specification for Ethylene Vinyl
Acetate (EVA) copolymers for its safe use in contact with foodstuffs,
pharmaceuticals and drinking water-IS 13601 |
10. |
Specification for Ethylene Metha
Acrylic Acid (EMAA) copolymers and terpolymers for its safe use in contact
with foodstuffs, pharmaceuticals and drinking water-IS 13576 |
11. |
Specification for Polycarbonate
Resins for its safe use in contact with foodstuffs, pharmaceuticals and
drinking water-IS 14971 |
12. |
Specification for Flexible Packaging
Materials for packaging of Edible Oils, Ghee and Vanaspati-IS 14636 |
13. |
Specification for Polyalkylene
Terephthalates (PET & PBT) for Moulding and Extrusion-IS 13193 |
14. |
Specification for Polyethylene Films
and Sheets-IS 2508 |
15. |
Specification for Linear Low Density
Polyethylene (LLDPE) Films-IS 14500 |
16. |
Specification for High Density
Polyethylene Materials for Moulding and Extrusion-IS 7328 |
17. |
Specification for
Melamine-Formaldehyde Resins for its safe use in contact with foodstuffs,
pharmaceuticals and drinking water-IS 14999 |
18. |
Low Density Polyethylene Films-IS
2508 |
19. |
Blow Moulded Polyolefin
Containers-Part 2 : Over 5 Litres, Up to and Including 60 Litres Capacity-IS
7408 |
20. |
Stretch Cling Films-IS 14995 |
List of suggestive
packaging materials
Sl.
No. |
Product
Category |
Types
of Packaging materials |
1. |
Milk
and milk products |
Glass bottle with metal caps or plastic
(polypropylene (PP) or High-density polyethylene (HDPE)) caps. Rigid Plastic container made of PET with
plastic (polypropylene (PP) or High-density polyethylene (HDPE)) caps. Rigid Plastic container made up of High
density polyethylene (HDPE) or Polypropylene (PP) or Polystyrene (PS) with
Plastic (PP or High-density polyethylene (HDPE) caps. Flexible plastic pouch made of
polyethylene (PE) or Polypropylene (PP) based co-extruded multilayered
material. Aseptic and flexible packaging material
(Paper board or Aluminium foil or polyethylene) based multilayered structure. Tin plate container. Paper based lined cartons with liner made
of aluminium foil based laminated structure. Plastic based polypropylene (PP) or
polystyrene (PS) cups with paper or Peel-off lid. Wax coated paper butter wrappers. Paper and Paper Board based folding carton
inside butter wrapped with butter paper. Metal Containers with plastic
polypropylene (PP) caps or metal or plastic lid. Plastic pet container with plastic lid. Thermoform cup or tray with paper or
peel-off lids. Paper and Paper Board setup boxes with or
without lamination-plastic film inside. Paper and Paper Board setup boxes with or
without grease proof paper placed inside. Plastic Based multi layered flexible
laminated heat sealed pouch. Mud or clay pots. Thermoformed Plastic container (blister
pack) with aluminium foil or polyethylene (PE) based lid |
2. |
Fats,
oils and fat emulsions |
Tin plate container. Glass bottle with metal caps or plastic
polypropylene (PP) or High-density polyethylene (HDPE) caps. Plastic rigid container (jar) made of
High-density polyethylene (HDPE). Plastic bottle or Jar Polyethylene
terephthalate (PET) with plastic caps. Plastic Pouch made of Multi layered
laminated or co-extruded structure. Aseptic and flexible packaging material
(Paper board or Aluminium foil or polyethylene) based multilayered structure. Plastic laminated pouch in duplex board
box (Bag in Box). Thermoformed plastic based jar with
plastic caps. Paper based lined cartons with liner made
of aluminium foil based laminated structure. |
3. |
Fruit
& Vegetable products |
Glass bottle with metal caps or plastic
(polypropylene (PP) or High-density polyethylene (HDPE) caps. Aluminium can with easy open end. Tinplate container. Aseptic and flexible packaging material
(Paper board or Aluminium foil or polyethylene) based multilayered structure. Plastic rigid container (jar) made of
either High-density polyethylene (HDPE) or Co-extruded structure with Plastic
(polypropylene (PP) or High-density polyethylene (HDPE) caps. Stand up Pouch made up of Plastic based
structure with plastic spout. Flexible Plastic pouch made of either
polyethylene (PE) or Laminated structure. Thermoformed Plastic container (blister
Pack) with aluminium foil or polyethylene (PE) based lid. Plastic jar (Co-extruded) with metal caps. Plastic trays with overwrap. Polyethylene terephthalate (PET) or
polypropylene (PP) or Poly Vinyl Chloride (PVC) Punnets |
4. |
Sweets
and Confectionery |
Metal Containers with plastic
polypropylene (PP) caps or metal or plastic lid Plastic based multilayered laminated
Heat sealed pouches. Composite containers made up of Paper
Board or Aluminium foil or plastic base films with plastic or metal lids. Plastic based rigid containers. Foil wrap. Plastic film based twist wraps
(Polyethylene terephthalate (PET) or polypropylene (PP) or Poly Vinyl
Chloride (PVC)). Thermoformed tray and punnet with lid. Glass bottle with metal or plastic caps. Plastic cups with film lid. |
5. |
Cereals
and cereal products |
Tin container. Aluminium Foil Based laminated pouch in
metal container. Wrapper made of wax coated paper. Wrapper made of three layered laminated
structure. Plastic based multilayered laminated pouch
(heat sealed). Plastic based thermoform container with
plastic lid. Lined carton with liner made of multi
layered laminated structure. Plastic based multilayered laminated
structured Zipper pouch. Thermoform trays with plastic lids or over
wraps. Glass bottle with metal caps. Polyethylene terephthalate (PET) or Plastic
based rigid containers with metal or plastic (polypropylene (PP) or
High-density polyethylene (HDPE) caps Plastic films or co-extruded film or
polypropylene (PP) or polyethylene (PE) |
6. |
Meat
and Meat Products or Poultry Products |
Glass jars with plastic (polypropylene
(PP) or High-density polyethylene (HDPE) caps. Metal Containers with metal lid (lacquered
tin containers). Plastic based flexible pouches in paper
& paper Board carton. Plastic based multilayered flexible
laminates heat sealed pouches. Plastic tray with overwrap. Aluminium foil wrap. Polyethylene terephthalate (PET) punnets
or containers with plastic caps |
7. |
Fish
and fish products or Seafood |
Glass jars with plastic (PP or
High-density polyethylene (HDPE) caps. Metal Containers with metal lid (lacquered
tin containers). Polyethylene terephthalate (PET) punnets
or containers with plastic caps. Plastic based multilayered flexible
laminates heat sealed pouches. Plastic tray with overwrap. |
8. |
Sweetening
agents including Honey |
Glass bottle with Metal Caps or Plastic
(polypropylene (PP) or High-density polyethylene (HDPE) Caps. Plastic based Thermoformed container. Blister Pack with foil or polyethylene
lid. Polyethylene Terephthalate (PET) container
with Plastic Caps. Plastic laminated Tube. |
9. |
Salt,
spices, Condiments and related products |
Glass bottle with metal lid or plastic
(polypropylene (PP) or High-density polyethylene (HDPE) caps. Plastic based rigid container with Plastic
cap (Polyethylene terephthalate (PET) and High-density polyethylene (HDPE)
Containers). Paper & Paper board or Aluminium foil
or Plastic Film based Composite Container. Folding cartons with Plastic based
flexible laminated structure (heat sealed) pouch placed inside. Plastic based multilayered layered
laminated pouch (heat sealed). |
10. |
Beverages
(other than Dairy and Fruits & vegetables based) |
Plastic bottles made of either
Polyethylene terephthalate (PET) or Polycarbonate (PC) with Plastic
(Polypropylene (PP) or High-density polyethylene (HDPE) or Aluminium caps. Heat sealed Plastic pouches made of
Polyethylene (PE). Glass bottles with metal caps or plastic
caps. Plastic pouches made up of Polyethylene
(PE) in Corrugated fibre board Boxes. Aluminium can with easy open end. Tin plate container. Plastic pouch made of laminated structure. Aseptic and flexible packaging material
(Paper board or Aluminium foil or polyethylene) based multilayered structure. Plastic based multi layered structure heat
sealed pouches. Plastic based multi layered structure heat
sealed Zipper pouches or stand up pouches. Metal Containers with plastic or
Polypropylene (PP) caps or metal or plastic lid, Rigid Plastic container with
plastic caps (Polypropylene (PP) Caps). Wooden cask (for wines). |
[1]Inserted by Food
Safety and Standards (Packaging) First Amendment Regulations, 2022
vide Notification No. Std/SP-08/A-1.2019/N-01 dated 25.01.2022.
[2]Inserted by Food
Safety and Standards (Packaging) Second Amendment Regulations, 2022
vide Notification No. Std/SP-20/T(Migration-N) dated 30.08.2022.