study on the chemical contamination of pre...
TRANSCRIPT
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: [email protected]
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
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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
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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
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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
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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.
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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)
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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
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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.
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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
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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
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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.
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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 : [email protected]
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 : [email protected]
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 : [email protected]
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 : [email protected]
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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
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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
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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