The Food Safety and Standards (Packaging) Regulations, 2018

The Food Safety and Standards Act, 2006

Official text

MINISTRY OF HEALTH AND FAMILY WELFARE

(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)

NOTIFICATION

New Delhi, the 24th December , 2018

F.No. 1-95/Stds/Packaging/SP(L&C/A)/FSSAI-2017 .—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;

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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:-

Regulations

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.

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;

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.

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.

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.

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.

(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;

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(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:

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

SI. 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

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.

Schedule – I

Paper and board materials intended to come in contact with food products

SI. 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

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.

Schedule – II

Metal and Metal Alloys intended to come in contact with food products

SI. No List of Standards

1. Cold - reduced Electrolytic Tinp late – 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)

Schedule – III

Plastic Materials intended to come in contact with food products

SI. 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

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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 Polyalkylene Terephathalates (PET & PBT) for their safe use in contact with foodst uffs,

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. Specifi cation 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

Schedule – IV

List of suggestive packaging materials

SI.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).

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• 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