Study on the Chemical Contamination of Pre-Packaged

Food (Retail) through Packaging Material

Revised Project Proposal (Amendment 2)

Submitted to

Food Safety and Standards Authority of India

FDA Bhawan, Near Bal Bhavan, Kotla Road, New Delhi – 110 002

by

Indian Institute of Packaging

E-2, MIDC Area, Andheri (E), Mumbai – 400 093

Tel.: 91-22-2821 9803 / 6751 / 9469, 28391506, 28329623, 2825 4631

Fax: 91-22- 28328178 / 2837 5302; Email: iip@iip-in.com

Website: www.iip-in.com

October 2016

2

Contents

Sr. No. Description Page No.

1. Background 4

2. Objective 7

3. Scope 7

3.1. Types of Packaging Materials 7

3.2. Sampling Plan 11

3.3. Testing of Samples 15

3.4. Analysis & Interpretation of Results 18

4. Budget 18

5. Payment Terms & Conditions 18

6. Timeline of the Study 19

7. References 20

Annexure – A: Template Format of Report to Submit the

Results on FSSAI Portal 21

3

List of Tables

Table No. Title Page No.

Table 1 List of Chemical Contaminants Migrating from FPMs 5

Table 2 Identification of Food Packaging Materials (FPMs) for

Testing 7

Table 3 Zone-wise Distribution of States 11

Table 4 No. of Probable FPMs Covering 28 Food Types 12

Table 5 Number of Samples of FPMs to be Tested and their

Segregation according to their type 12

Table 6 Locations of IIP Centers for Collecting Samples of FPMs

(Zone-wise) 14

Table 7 Simulants for Determination of Overall Migration 16

Table 8 Limit of Heavy Element Contents in Plastics for use in

contact with Food, Pharmaceuticals and Drinking Water 17

Table 9 Timeline of the Study 19

Table 10 Bar-Chart for Timeline of the Study 19

4

1. Background

India is a fast developing large democratic country with more than 1.3 billion people with

multitude of culture, language, lifestyle and food habits. The culture in urban India has

started modernizing with respect to life style and food habits, i.e., food preparation, inclusion

of new food menu with effect to the modern and imported culture. However, the issue of

assessment of health risks of food packaging materials (FPMs) represents an ongoing

challenge. This is due to the fact that FPMs have the potential to release and subsequent

transfer of components into the food. This transfer then can lead to an exposure of the

consumer to those components and/or their reaction products.

Food is packed into a large variety of containers made from four materials, e.g. paper &

cardboard, plastics, metals, glass and combinations thereof. These have to fulfill several

criteria mainly in order to preserve the food, extend its shelve-life and maintain its quality

with respect to freshness, taste, flavor, color etc. A major role of FPMs is the avoidance of

risks related to microbial or chemical contamination of the food, i.e. unwanted events, which

may imply serious health risks.

The transfer of chemical contaminants from food contact materials into food is called

migration. In fact, food contact materials are an underestimated source of chemical food

contamination. The extent to which migration occurs depends on various factors like physico-

chemical properties of the migrant, of the packaging material, and the food (e.g. fat content);

temperature; storage time; and size of the packaging in proportion to the foodstuff volume

(smaller size packaging has a larger surface to volume ratio). The types of chemicals that can

migrate from packaging into food are highly diverse and depend on the type of packaging

material.

From plastic FPMs, the additives added to guarantee certain properties required for

their function, like plasticizers, antioxidants, UV stabilizers, colors, printing inks, etc.

can migrate into the packaged food. Furthermore, the residues of mono- and

oligomers of the starting material(s) as well as additives required for the

polymerization may also be migrated into the food.

In case of paper and paper board, printing inks and chemicals used in the pulp and

paper production may migrate through paper board into dry foods.

Iron-based metal bodies are also used as FPM but usually these are coated inside with

polymers to avoid direct contact with the food. Corrosion by high-salt or acidic food

5

items is a major issue, which precludes direct contact between food and metals to be

feasible. Aluminum cans have to be covered with polymers as well since aluminum

also is a quite corrosion-prone metal being rather unstable when coming into contact

with many foods.

Chemical contaminants (or substances) migrating from FPMs can be subdivided into

intentionally added substances (IAS) or migrants and non-intentionally added substances

(NIAS). IAS often are directly derived from FPMs, i.e., they are identical to the FPM (metals

etc.) or represent minor constituents used or are derived from the production process of the

FPM such as plastic monomers, plasticizers, dyes, antioxidants etc. NIAS in most cases are

compounds, which have not been added intentionally to the FPM during the manufacturing

process of the FPM or have been added to a portion of the FPM not thought to come into

contact with the food. Migration of components into foods has been identified as a major

route of human exposure to FPMs and/or their components. Table 1 provides a non-

comprehensive list of chemical contaminants (IAS and NIAS) migrating from FPMs.

Table 1: List of Chemical Contaminants Migrating from FPMs

Type Class of Substance Contaminant Source (FPM)

Intentionally added

substances (IAS)

Plastic monomers Vinyl chloride PVCs

Acrylamide Polyacrylamides

Caprolactum Polyamides

6-aminohexanoic acid Polyamides

p-hydroxybenzoic acid Polyesters

2-hydroxy-6-naphthoic acid Polyesters

Metals Aluminium Aluminium Foil

Dyes Azo-amines Paper / Cardboard

Antioxidants Butylated hydroxyanisole

(BHA), butylated

hydroxytoluene (BHT)

Plastics

Intermediates /

Plasticizers

Bisphenol-A (BPA) Plastics

Photo-initiators 2-isopropylthioxanthone Paper / Cardboard

Water/Fat repellents Perfluorinated acids Paper / Cardboard

Non-intentionally

added substances

(NIAS)

Mineral oils Mineral oil saturated

hydrocarbons (MOSH) /

Mineral oil aromatic

hydrocarbons (MOAH)

Recycled Paper /

Cardboard

6

The food packaging materials are also a source of heavy metals, which may be migrated

into the packaged food product. Heavy metals are individual metals and metal compounds

that can impact human health. Eight common heavy metals are discussed in this brief:

arsenic, barium, cadmium, chromium, lead, mercury, selenium, and silver. These are all

naturally occurring substances which are often already present in the packaging materials in

trace amounts. In higher amounts, however, they can be dangerous. Heavy metals may

disrupt our metabolic functions in two ways:

1. They accumulate and thereby disrupt function in vital organs and glands such as the

heart, brain, kidneys, bone, liver, etc.

2. They displace the vital nutritional minerals from their original place, thereby,

hindering their biological function. It is, however, impossible to live in an

environment free of heavy metals. There are many ways by which these toxins can be

introduced into the body such as consumption of foods, beverages, skin exposure, and

the inhaled air.

Keeping in view the chemical contamination of pre-packaged food through packaging

material; a meeting was held on 08th March, 2016 at FDA Bhawan, FSSAI under the

chairmanship of CEO of FSSAI to address the issue. It was decided, in the meeting, to

execute a Surveillance drive/study on Packaging of Food Products for which Indian Institute

of Packaging (IIP) shall prepare a proposal stating the scope, sampling methodology,

estimated cost and timeline of the study.

7

2. Objective

The objective of this Proposal is to study the migration of chemical contaminants like

vinyl chloride monomer (VCM), acrylamide monomer (AAM), dyes, harmful antioxidants,

plasticizers, pigments, heavy elements, etc. into food through various packaging materials,

e.g. plastics, paper and paper board, metals and glass. It will include the testing of

packaging materials for quantitative analysis of the global migration of chemical

contaminants and heavy metals from packaging into food.

3. Scope

3.1. Types of Packaging Materials

The scope of the Proposal includes all packaging materials from which contaminants

could migrate into food through direct contact. However, in the initial phase, numerous

packaging materials have been identified, according to the type of food material and listed

in Table 2.

Table 2: Identification of Food Packaging Materials (FPMs) for Testing

Sr.

No. Type Description

Food

Product Packaging Material

1. I

Aqueous, non

acidic foods

(pH > 5)

without fat

Honey Glass bottle with Metal Caps

Plastic based Thermoformed container

Blister Pack with foil/polyethylene lid

Polyethylene Terephthalate (PET) container with Plastic

Caps

Plastic laminated Tube

Mineral

water Plastic bottles made of either PET or Polycarbonate (PC)

with Plastic (Polypropylene -PP) caps

Heat sealed Plastic pouches made of Polyethylene (PE)

Glass bottles with metal caps

Plastic pouches made up of Polyethylene (PE) in CFB

Boxes

Liquid Milk

(Skimmed

Milk)

Glass bottle with Metal caps

Rigid Plastic container made of PET with plastic (PP) caps

Rigid Plastic container made up of High density

polyethylene(HDPE) with Plastic (PP) caps

Flexible plastic pouch made of polyethylene (PE) based co-

extruded multilayered material.

Tetra Brick cartons (Paper board/ Al foil/polyethylene)

based multilayered structure.

Tetrahedron made of multilayered laminated structure

(paper/Al foil/Polyethylene)

Tin plate container (Condensed Milk)

8

2. II Aqueous,

acidic foods

(pH ≤ 5)

without fat

Fruit Juices

Glass bottle with metal caps

Metal cans with easy open end.

Tinplate container (3 piece can)

Paper boat made up of multilayered structure (paper/Al

foil/plastic)

Tetra Brick cartons( Aseptic package)

Plastic rigid container (jar) made of either HDPE or Co-

extruded structure with Plastic (PP) caps.

Stand Up Pouch made up of Plastic based structure with

plastic spout

Flexible Plastic pouch(Pillow pouch) made of either PE or

Laminated structure

Leak proof composite can made up of laminated structure

with metal ends

Squashes

Glass bottle with metal caps

Plastic bottle made up of PET with plastic (PP) caps.

Plastic bottle made of HDPE with plastic caps

Jams Glass bottle with metal caps

Thermoformed Plastic container (blister Pack) with

aluminium foil / PE based lid.

Plastic jar (Co-extruded) with metal caps

Plastic jar made of PET with Plastic cap

Plastic Pouch made up of multilayered Laminate structure

Carbonated

Beverages Glass bottle with metal caps

Plastic jar made of PET with Plastic (PP) caps

Two Piece Aluminium Can With Easy Open Ends

Ready to

Serve (RTS)

Beverages

Plastic Pouch made of laminated structure(pillow pouch)

Paper board made plastic based laminated structure.

Tetra Brick

Aluminium can with easy open ends.

Glass bottles with plastic caps

Tin Plate Container (3-piece can)

Plastic bottle made of PET with Plastic caps.

Plastic pouch made of laminated structure (stand up pouch)

with Spout or without spout.

3. III (i) Alcoholic

beverages

(Alcohol

conc. < 10 %)

Beer Glass bottles with metal crown caps.

Glass bottles with V seal Caps.

Aluminium cans with easy open ends.

4. III (ii)

Alcoholic

beverages

(Alcohol

conc. > 10 %)

Wine

Glass bottles with metal caps

Glass bottles with plastic caps

Plastic bottle (PET) with plastic (PP) caps.

Plastic laminated pouch.

Tetra Brick

Whiskey Glass bottle with plastic based guala caps.

Glass bottle with plastic based caps other than guala caps.

Glass bottle with metal caps

Plastic bottle (PET) with plastic (PP) caps.

Tetra Brick

Plastic Laminated pouch (single layer)

Plastic Laminated pouch (multi layer)

9

5. IV

Oils, fats and

processed dry

foods with

surface fat or

volatile oil

Vegetable

Oils 3-piece tin plate container

Glass bottle with metal caps

Plastic rigid container (jar) made of HDPE

Plastic bottle (PET) with plastic caps.

Plastic Pouch made of Multi layered laminated structure.

Tetra brick.

Plastic laminated pouch in duplex board box (Bag in Box)

Ghee,

Vanaspati

Tin Plate Container (3-piece)

Glass bottle with metal caps

Rigid Plastic Laminated Plastic Pouch.

Plastic Co-extruded Pouches.

Plastic jar (Pet) with plastic caps.

Plastic bottles (Pet) with plastic caps.

Thermoformed plastic based wide mouth jar with plastic

caps.

Paper based lined cartons with liner made of aluminium foil

based laminated structure.

Biscuits

Three piece tin container with decorated printing.

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.

Spice

Powder

Glass bottle with metal lid

Glass bottle with plastic cap (PP Cap)

Plastic based rigid container with Plastic cap (PET &

HDPE Containers)

Paper & Paper board /foil/Plastic Film based Composite

Container

Printed Folding cartons with Plastic based flexible

laminated structure (heat sealed) pouch placed inside.

Snacks and

Savoury

Plastic based multilayered laminated structured heat sealed

pouch

Plastic based multilayered laminated structured Zipper

pouch

Thermoform trays with plastic lids.

PP containers with hinge type closures.

Thermoform trays wrapped with plastic based three layered

laminated structure Heat sealed pouch.

Thermoform trays with over wraps

Chocolate

Foil wrapped chocolates packed in paper Board cartons

Foil with lacquer coated wrappings for home made

chocolates

Metal container with metal lid

Plastic based multilayered laminated Heat sealed pouches

Composite containers made up of Paper Board/foil/plastic

base films with plastic / metal lids.

Plastic based rigid containers

Tea

Plastic based multi layered structure heat sealed pouches

Plastic based multi layered structure heat sealed Zipper

pouches / stand up pouches

Metal Container with metal / plastic lids

Rigid Plastic container with plastic caps (PP Caps)

Paper bags for dip tea

Paper& paper Board Lined cartons.

Paper board cartons inside with plastic container with

plastic lid

10

Coffee Powder Plastic based multi layered structure heat sealed pouches

Plastic based multi layered structure heat sealed Zipper

pouches/ stand up pouches

Metal Container with metal / plastic lids

Rigid Plastic container with plastic caps (PP Caps)

Glass bottle with plastic caps (PP)

Confectionery Plastic film based twist wraps (PP/ CPP)

Plastic based multilayered laminated heat sealed pouch

Plastic based tube with plastic lids

Metal container with plastic lid (PP cap)

Plastic Rigid Jars with plastic caps (PET/PP)

Composite containers (paper & paper Board /plastic film)

with plastic lid.

6. V Nonacidic

foods (pH >

5) or high fat

and having

high

moisture

content

Butter Plastic based PP cups with Peel-off lid

Wax coated paper butter wrappers

Rigid Plastic - PP containers with plastic lid

Paper & Paper Board based folding carton inside butter

wrapped with butter paper.

Metal Containers with plastic (PP) caps

Glass bottle with Plastic (PP) caps

Milk based

Sweets Plastic pet container with plastic lid.

Thermoform cup with peel-off lids

Paper & Paper Board setup boxes with or without

lamination –plastic film inside

Paper & Paper Board setup boxes with or without grease

proof paper placed inside

Glass Bottle with metal cap or with plastic caps

Metal container with metal Lid

Paper & Paper Board (outer Packaging with metal container

placed inside

Ice-cream Plastic pet containers (PP/PS) with plastic lid.

Paper & Paper Board setup boxes with or without grease

proof paper placed inside

Plastic Based multi layered flexible laminated heat sealed

pouch.

Edible cone wafers wrapped with paper laminate.

7. VI

Acidic foods

(pH <5) or

high fat and

having high

moisture

content

Pickles

Rigid plastic pet bottles with Plastic lid (PP) caps

Glass Bottles with Plastic PP caps

Glass bottle with Metal caps

HDPE containers with PP caps & handle

Plastic based multilayered laminated flexible heat sealed

pouch

Ketchup

Glass bottle with Plastic PP caps

Glass bottle with Metal crown caps

Plastic based Coextruded tubes With plastic caps

Plastic based multilayered flexible laminated with plastic

spout type closure (dispensing facility)

Plastic based multilayered structure with easy pour out and

reclosing stand up pouches.

Plastic based( PET/PP) squeeze bottles with dispensing

facilities

Cheese

Wrapped with butter Paper

Thermoform tray with Peal Off lid

paper & paper Board cartons

Plastic based multilayered flexible laminates heat sealed

pouches.

Metal container with plastic lids.

11

Fresh and

Processed

Food Products

Plastic Trays with peelable lids for ready-to-cook

Plastic based multilayered flexible laminated structure heat

sealed pouches (Nylon-Polyester, PA-PE)

Thermoform Plastic trays wrapped with plastic based

multilayered flexible laminates

Glass bottles with plastic caps for Fish sauces, pickles etc.

Metal Containers with metal lid for processed Meat & Fish

products

Plastic based multilayered flexible laminates heat sealed

pouches

plastic based flexible pouches in paper & paper Board

carton for ready to cook meat & fish products

Frozen Foods Plastic based Multilayered flexible laminates heat sealed

pouches

Thermoform trays with Flexible laminated peelable lid

Paper & paper Board laminated cartons

Plastic rigid containers

Plastic based PVDC/PVC /PE shrink films

3.2. Sampling Plan

The sampling of FPMs has been revised as per the Minutes of Meeting held on 30-09-

2016 at 11:00 hrs at Committee Room, CHEB Building, FSSAI, New Delhi under the

Chairmanship of Sh. Kumar Anil, Advisor (Standards), FSSAI (F. No. 1/ Standards/ PLC

Team/ FSSAI-2016).

The sampling plan includes 14 States which have maximum number of licenses (as per

the data provided by FSSAI) and covering all four Zones is shown in Table 3.

Table 3: Zone-wise Distribution of States

Zone States

North 1. Haryana

2. Rajasthan

3. Uttar Pradesh

4. Uttarakhand

5. Delhi

East / North East 1. Assam

2. West Bengal

West 1. Maharashtra

2. Madhya Pradesh

3. Goa

4. Gujarat

South 1. Tamil Nadu

2. Kerala

3. Karnataka

12

The states and the numbers of samples of each type of FPM for a particular food type

were selected on the basis of the percentage of licenses issued for that food type by

FSSAI. The sampling may be conducted in two phases (if required) as per mutual

understanding with FSSAI.

A total of 160 different types of packaging materials will be collected covering 28 food

types (as mentioned in Table 2 above) and are mentioned in Table 4.

Table 4: No. of Probable Food Packaging Materials (FPMs) Covering 28 Food Types

Sr.

No. Packaging Material

No. of Packaging Materials Covering 28 Food Types

(as per the Previous Project Proposal)

1. Plastic 82

2. Paper 31

3. Others 47

TOTAL 160

Considering 28 types of food and their packaging materials, i.e., plastics, papers and other

types, are multiplied by the factor for the respective materials that in total maintains the

percentage distribution based on the guidelines provided by FSSAI (in the Minutes of

Meeting), i.e., 60%, 30%, and 10% for plastic-based, paper-based and other types of

packaging materials respectively. Accordingly, considering a total of 3000 samples of

FPMs, the segregation of each type of packaging material (plastic-based, paper-based and

other packaging materials) were divided as 1800, 900 and 300 respectively, as shown in

Table 5. However, as mentioned in the previous project proposal and the Minutes of

Meeting, the number of samples for testing/analysis will be restricted to 2500.

Table 5: No. FPM Samples to be Tested and their Segregation

Total No. of Samples to be Collected 3000

(i) Plastic-based Packaging Materials (60%) 1800

(ii) Paper-based Packaging Materials (30%) 900

(iii) Other Packaging Materials (10%) 300

13

In order to collect 1800 samples of plastic-based packaging materials,

Muliplication factor for plastic-based materials = 1800/82 = 21.951

Similarly,

Muliplication factor for paper-based materials = 900/31 = 29.03

Muliplication factor for other packaging materials = 300/47 = 6.383

The numbers of plastic-based, paper-based and other packaging materials were

distributed on the basis of the packaging material for particular food type, as mentioned in

Table 2.

As an example, Biscuit can be packed into 7 types of materials, i.e.

1. Three piece tin container with decorated printing.

2. Aluminium Foil Based laminated pouch in metal container.

3. Wrapper made of wax coated paper.

4. Wrapper made of three layered laminated structure.

5. Plastic based multilayered laminated pouch (heat sealed).

6. Plastic based thermoform container with plastic lid.

7. Lined carton with liner made of multi layered laminated structure.

Out of which 3 are plastic-based, 2 are paper-based and the remaining 2 are other

packaging materials.

So, for Biscuits,

Plastic-based packaging materials to be drawn = 3 x 21.951 ≈ 66

Paper-based packaging materials to be drawn = 2 x 29.03 ≈ 58

Other packaging materials to be drawn = 2 x 6.383 ≈ 13

3.2.1. Guidelines for Sampling:

Following are the guidelines for collecting the samples:

The sampling shall be done by the FSSAI executive along with a regional officer

of the Indian Institute of Packaging (IIP).

After collection, the samples should be sent to the regional centers of Indian IIP,

the complete address of which are given in Table 6.

The samples of FPMs will be drawn in duplicate, one set of sample will be used

for testing/analysis and another will be kept at IIP as reference/control sample.

For demonstration purpose, the process flow diagram for sampling is shown in

Figure 1.

14

Figure 1: Process Flow Chart (Example) for Sample Collection

Table 6: Locations of IIP Centers for Collecting Samples of FPMs (Zone-wise)

Zone Selected States for Sampling Regional IIP Center for Testing the Samples

North Zone Haryana, Delhi, Uttar Pradesh,

Uttarakhand and Rajasthan Indian Institute of Packaging

Plot No. 21, Patparganj Industrial Estate,

Delhi – 110 092

Tel : +91-11-2216 6703 / 4 / 5

Mobile : +91-93106 01300

Fax : +91-11-2216 9612

Email : iipdelhi@iip-in.com

East / North

East Zone

West Bengal, Assam Indian Institute of Packaging

Plot E-2, Road No. 8, MIDC Area,

Andheri (East), Mumbai – 400 093

Tel : 91-22-2821 9803 / 6751 / 9469

Fax : 91-22-28328178 / 28375302

Email : rdiip@iip-in.com

West Zone Gujarat, Maharashtra, Goa and

Madhya Pradesh Indian Institute of Packaging

Block C. P. – 10, Sector – V,

Salt Lake, Bidhan Nagar, Kolkata – 700091

Tel : 91 - 033-2367 0763 / 2367 6016,

Mobile : +91-801 721 9939

Fax : +91-33-2367 9561

Email : iipkolkata@iip-in.com

South Zone Kerala, Tamil Nadu and

Karnataka Indian Institute of Packaging

Plot No. 169, Industrial Estate, 2nd Main Road,

Burma Colony Perungudi,

Chennai – 600096

Tel : +91-44-2496 0730 / 2496 1560

Mobile : +91-938 219 9089

Fax : +91-44-2496 1077

Email : iipchennai@iip-in.com

15

Notes:

The Districts as well as Cities of the States mentioned in Table 3 will be

identified shortly and submitted to FSSAI accordingly.

The sampling of the FPMs and testing of the drawn samples will be done in

parallel.

At least 5 (five) samples of each type of packaging material should be drawn.

For example, if the sampling is to be done for packaging materials of “Dabur”

brand of honey, the following types (empty packages) from the manufacturer’s

site shall be collected:

Glass Bottle with Metal Cap – 5 Samples

Plastic, e.g. Polyethylene Terephthalate (PET) Container with Plastic Caps

– 5 Samples

Any other type of Packaging Available, e.g. Blister Pack – 5 Samples

The sampling of packaging material shall be done from the manufacturing site of

the food material. For example, if the samples of empty plastic pouches for milk

are to be collected from “Mother’s Diary” or “Amul”, the person should take the

samples from the raw materials storage area (godown / store room) of the

company where the empty pouches are kept in bulk.

Please note that NO packaging material containing the food item is required to be

collected.

3.3. Testing of the Samples

All the packaging materials and their individual components shall be tested for the

migration of chemical contaminants from the packaging material or heavy metal(s)

content. Hence, the scope also includes chemical migration from closures and lids,

integral to the packaging, into foods.

3.3.1. Test # 1: Extractive Value Method for Global Migration (or Overall

Migration)

a. Test Standard: IS 9845:1998 – Determination of Overall Migration of

Constituents of Plastics Materials and articles intended to come in contact with

foodstuffs.

This standard includes method for the determination of overall migration of single

or multilayer composites in the form of pouches or containers. The Committee,

16

while drafting the standard, had reviewed other international test methods and had

noted that the test conditions (time and temperature) and food stimulant

extractants stipulated by the European Union (EEC) directives and the Codes of

Federal Regulations (FDA), USA represent most closely the normal and actual

conditions of plastics in food contact. In view of this, the present standard is based

on methods prescribed by the EU Directives, FDA, USA and Deutsche

Lebensmittel Rundschau/88 Jahrg/Heft 5/1992.

b. Methodology

In general, migration and extraction studies need to be conducted on actual food

products under conditions, which are slightly more stringent than those

encountered in normal usage. It is, however, not always possible to analyze actual

food for nature and quantity of migrants from the plastics. In order to simplify

such assessment, food simulants / extractants are to be substituted for the actual

foodstuff. Moreover, it is very difficult to estimate all the migrants individually,

hence as a good measure, the overall migration of all the migrants put together is

considered for safe use, unless they are especially toxic and their limits fixed. The

simulants specified as per IS: 9845-1998 are given in Table 7.

Table 7: Simulants for Determination of Overall Migration

Simulant Description

Simulant A Distilled water or water of equivalent quality

Simulant B 3% acetic acid (w/v) in aqueous solution (using the stimulant

A)

Simulant C1 10% ethanol (v/v) in aqueous solution for foodstuffs having

alcohol less than 10% (v/v) (using the stimulant A)

Simulant C2 10% ethanol (v/v) in aqueous solution for foodstuffs having

alcohol less than 10% (v/v) (using the stimulant A)

50% ethanol (v/v) in aqueous solution for foodstuffs having

alcohol more than 10% (v/v) (using the stimulant A)

Simulant D n-heptane – shall be freshly distilled before use

c. Limits

In general, the limits of overall migration are specified as 10 mg/dm² or/and 60

mg/L, in food simulants for different types of materials as per IS and EU. Apart

from the overall migration of plastic constituents in food simulants, there should

not be any colour migration into the simulant, apparent to the naked eye. If the

17

colour migrated is clearly visible, such materials are not suitable for food contact

applications, even though the extractive value is within the limit. Some of the

plastics like PVC, Polystyrene, Polyacrylonitrile, Nylon-6 whose monomers are

toxic should be tested separately for their monomer content in the plastic as well

as monomers migrated into foods. The limit of different monomers in the

respective polymers is 0.1 ppm, 0.2 ppm, 11 ppm and 10 ppm respectively.

d. As per Plastic regulation (EU) 10/2011, for multilayer films (e.g. 3-layer films), if

the layers do not contain aluinium foil (layer) in-between, then only the layer

which is in immediate contact with food needs to be tested for migration.

Otherwise, all the three layers should be tested separately after delaminating the

layers.

3.3.2. Test # 2: Energy Dispersive X-ray (EDX) Spectroscopy

a. Test Standard (Methodology): As per ASTM E1508 - 12a – Standard Guide for

Quantitative Analysis by Energy-Dispersive X-ray Spectroscopy (EDX).

b. Limits

As prescribed in IS 9833 : 1981 Standard, the quantity of the heavy elements in

plastics for use in contact with food, pharmaceuticals and drinking water which

may be regarded as safe shall not exceed the limit as specified in Table 8 below.

Table 8: Limit of Heavy Element Contents in Plastics for use in contact with

Food, Pharmaceuticals and Drinking Water (as per IS 9833 : 1981)

Sr.

No. Heavy Element Limit

Should be soluble

in N/10 HCl

1. Lead, % by mass, Max. 0.01 -

2. Arsenic, % by mass, Max. 0.005 -

3. Mercury, % by mass, Max. 0.005 Yes

4. Cadmium, % by mass, Max. 0.10 Yes

5. Zinc, % by mass, Max. 0.20 Yes

6. Selenium, % by mass, Max. 0.01 Yes

7. Barium, % by mass, Max. 0.01 Yes

8. Chromium, % by mass, Max. 0.025 Yes

9. Antimony, % by mass, Max. 0.025 Yes

10. Total aromatic amines, % by mass, Max. 0.05 Yes

18

3.4. Analysis and Interpretation of the Results

The tested samples should not exceed the value of global (or overall) migration and

heavy metals limit specified in the relevant National / International Standard.

However, the analysis of each and every sample will be reported along with the

interpretation of the results.

The template format of report to submit the results on FSSAI portal directly (Login

ID to be provided by FSSAI) is attached herewith as Annexure A.

4. Project Cost:

Particulars Amount, INR

Testing Charges (for both Global Migration and Heavy Metals)

per Sample

(as per Minutes of Meeting Document No. F. No. 1 / Standards

/ PLC Team / FSSAI-2016 F)

: 5,000/-

Travelling Allowance & Daily Allowance etc. per Sample : 1,500/-

Sub-Total : 6,500/-

Total Number of Samples to be Tested : 2,500

Total Amount : 1,62,50,000/-

5. Terms & Conditions of the Payment

50% of the Total Project Cost need to be released as grant-in-aid to IIP in advance and

rest, after submission of the Project Report to FSSAI. The bank account details of IIP for

making the payment are as follows:

Bank Account No. 10606567751

Account Type Current

MICR Code / Bank Key 400002057

Name of The Bank State Bank Of India

Bank Address Plot No. B-1, Near ESIS Hospital, M.I.D.C. Central Road,

Andheri (East), Mumbai – 400 093

Bank City Mumbai

Bank Branch MIDC, Andheri (East)

IFSC RTGS Number SBIN0007074

IFSC NEFT Number SBIN0007074

Branch Code 0007074

19

6. Timeline of the Study:

Keeping in view the estimated number of types of packaging materials for the selected food

items (approx. 160) and the number of materials to be tested for both the tests, the timeline is

prepared and shown in Table 9 below.

Table 9: Timeline of the Study

Sr.

No. Activity

Timeline

From To

1. Collection of Samples and Analysis 1st week of

Nov. 2016

1st week of

Feb. 2016

2. Compilation / Uploading of the Testing Results 1st week of

Dec. 2016 21st Feb. 2017

3. Final Report Preparation & Submission 21st Feb.

2017

28th Feb.

2017

Table 10: Bar Chart for Timeline of the Study

Sr. No. Activity Nov’16 Dec’16 Jan’17 Feb’17

Month No. 1 2 3 4

1. Collection & Testing of Samples

2. Compilation / Uploading of the Testing

Results

3. Final Report Preparation & Submission

20

7. References:

1. Senthil Kumar Kurunthachalam, “Possible Adverse Implications of Chemical

Migration from Food Pack Materials in India”. Hydrology Current Research; Vol. 4,

Issue 3 (2013), pp 1-5.

2. Kanishka Bhunia, Shyam S. Sablani, Juming Tang, and Barbara Rasco, “Migration

of Chemical Compounds from Packaging Polymers during Microwave, Conventional

Heat Treatment, and Storage”. Comprehensive Reviews in Food Science and Food

Safety; Vol. 12 (2013), pp 523-545.

3. IS 9845:1998 – Determination of Overall Migration of Constituents of Plastics

Materials and articles intended to come in contact with foodstuffs.

4. IS 9833 : 1981 – List of pigments and colourants for use in plastics in contact with

foodstuffs, pharmaceuticals and drinking water.

5. ASTM E1508 - 12a – Standard Guide for Quantitative Analysis by Energy-

Dispersive X-ray Spectroscopy (EDX).

6. Commission Regulation (EU) No 10/2011 on plastic materials and articles intended

to come into contact with food.

7. http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm

8. http://www.fda.gov/Food/FoodIngredientsPackaging/FoodContactSubstancesFCS/uc

m064161.htm

21

PROPOSED TEMPLATE FOR FSSAI REPORT Report No.: _____________ Dated: __________

Page 1 of 1 Particulars of Sample Submitted

Sample Received From : Food Safety Standards Authority of India

Address

Nature of Sample : Plastic pouch used for milk packaging

Sample drawn from : M/s. ABC Pvt. Ltd.

Address

Sampling done by : Mr. _________ from FSSAI & Mr. ________ from IIP

Sample Identification code : IIP/FSSAI/State/Dist./SampleType

/YYMMDD/Name code of FSSAI Official/

Name code of IIP Official

Batch No. & Date of Manufacture : Batch/Lot No. __ / __; DOM: _________

Quantity : 2 Nos.

Date of commencement of testing : ___________

Date of completion of testing : ___________

Tested by: Asst./Dy./Jt. Director HEAD

Laboratory Division

Sr. No.

Tests Cl. Ref. Specified

Requirements Units

Test Results / Observation

Tested as per Method

1. Overall Migration (Extraction value) with distilled water at 40°C for 10 days

- 60 mg/L or 10 mg/dm2

mg/L IS 9845 - 2010

2. Overall Migration (Extraction value) with 3% Acetic Acid at 40°C for 10 days

- 60 mg/L or 10 mg/dm2

mg/L IS 9845 - 2010

3. Overall Migration (Extraction value) with 10% ethanol at 40°C for 10 days

- 60 mg/L or 10 mg/dm2

mg/L IS 9845 - 2010

4. Overall Migration (Extraction value) with 50% ethanol at 40°C for 10 days

- 60 mg/L or 10 mg/dm2

mg/L IS 9845 - 2010

5. Overall Migration (Extraction value) with n-heptane at 38°C for 30 min.

- 60 mg/L or 10 mg/dm2

mg/L IS 9845 - 2010

6. Heavy Metal Analysis Lead (Pb) Arsenic (As) Mercury (Hg) Cadmium (Cd) Selenium (Se) Barium (Ba) Chromium (Cr) Antimony (Sb)

- 0.01 0.005 0.005 0.10 0.01 0.01 0.025 0.025

% EDX / ICP-OES Method

Annexure-A