ICS 13.030.50; 83.080.20  
 
Reference number  
DRS 499 -1:2022 
© RSB 202 2 
  
 RWANDA 
STANDARD  DRS 
499-1  
 
First edition  
2022 -mm-dd 
 
Post -consumer polyethylene terephthalate 
(PET) containers — Specification — Part 1: 
Food grade PET recyclates, preforms and 
containers  
   
DRS 499 -1: 2022  
©RSB 2022  - All rights  reserved                  ii 
 In order to match with technological development and to keep continuous progress in industries, 
standards are subject to periodic review. Users shall ascertain that they are in possession of the latest 
edition  
 
 
 
 
 
 
 
 
© RSB 2022  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized 
in any form or by any means, electronic or mechanical, including photocopying and microfilm, without 
prior written permission from R SB. 
Requests for permission to reproduce this document should be addressed to : 
Rwanda Standards  Board  
P.O Box 7099 Kigali -Rwanda  
KK 15 Rd, 49  
Tel. +250 788303492  
Toll Free: 3250  
E-mail: info@rsb.gov.rw  
Website: www.rsb.gov.rw  
ePortal: www.portal.rsb.gov.rw   DRS 49 9-1: 2022  
iii                ©RSB 2022  - All rights reserved  
 Contents  Page 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  2 
4 Requirem ents ................................ ................................ ................................ ................................ .........  4 
5 Packaging  ................................ ................................ ................................ ................................ ...............  8 
6 Marking  ................................ ................................ ................................ ................................ ...................  8 
7 Sampling  ................................ ................................ ................................ ................................ ................  9 
Annex  A (normative) Determination of overall migration of constituents of plastics materials and 
articles intended to come in contact with foodstuffs - Methods of analysis  ................................  11 
 DRS 499 -1: 2022  
©RSB 2022  - All rights  reserved                  iv 
 Foreword   
Rwanda Standard s are prepared  by Technical Committees and approved by Rwanda Standards Board (RSB) 
Board  of Directors in  accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT 
agreement on the preparation, adoption and application of standards.  
The main task of technical committees is to prepare national standards.  Final Draft Rwanda S tandards 
adopted by Technical committ ees are ratifie d by me mbers of RSB Board of Director s for publication and 
gazettment as Rwanda Standards.  
DRS 499 -1 was prepared by Technical Committee RSB/TC 020, Packaging and packaging materials . 
In the preparation of this standard, reference was made to the following  standard s:  
1) MS 250:2021 Plastics – Post-consumer polyethylene terephthalate (PET) bottle – Specifications for food 
grade PET recyclates and preforms  
The assistance de rived from the above source is hereby acknowledged with thanks.  
DRS 499  consists of the following parts, under the general title Post-consumer polyethylene terephthalate 
(PET) containers — Specification  
⎯ Part 1: Food grade PET recyclates, preforms and containers  
⎯ Part 2:  Non-food grade PET recyclates, preforms and containers   
Committee membership  
The following organizations were represented on the Technical Committee on Packaging and packaging 
materials. (RSB/TC 020) in the preparation of this standard.  
BRALIRWA Plc  
Cleaner Production and Innovation and C limate Innovation Centre (CPCIC/NIRDA)  
Horizon Sopyrwa  
Rwanda Forensic Laboratory  
Rwanda Harambee  
Rwanda Inspectorate, Competition and Consumer Protection Authority (RICA)  
Rwanda Investigation Bureau (RIB)  DRS 49 9-1: 2022  
v                ©RSB 2022  - All rights reserved  
 The Coca -Cola Company  
University of Rwanda -College of Education (UR -CE) 
University of Rwanda -College of Science and Technology (UR -CST)  
Rwanda  Standards Board  (RSB) – Secretariat  DRS 499 -1: 2022  
©RSB 2022  - All rights  reserved                  vi 
 Introduction   
Polyethylene tere phthalate (PET) has become the preferred packaging material worldwi de over glass and 
metal for water and soft drinks bottles. With the increasing demand for packaged and processed food, the risk 
of the amount of plastic waste accumulated will be too large for landfilling. To prevent degradation of the 
environment, manufac turers are encouraged to dispose post -consumer plastic bottles and containers  properly 
for ease of recycling.   
Recycling of PET waste is one type of material recovery process intended to save resources while minimizing 
harmful emissions into air, water and  soil as well as human health.  
 The environmental impact of recycling has to be assessed over the whole life cycle of the recycling system 
(from the waste generation point to the disposal of final residues). To ensure that recycling constitutes the 
best en vironmental option for treating the available waste, some prerequisites should preferably be met:  
⎯ recycling scheme being contemplated should generate lower environmental impacts than alternative 
recovery options;  
⎯ existing potential market outlets should be  identified that would secure a sustainable industrial 
recycling operation;  
⎯ collection and sorting schemes should be properly designed to deliver recyclable plastics waste 
fractions fitting reasonably well with the available recycling technologies and with  needs of the 
identified market outlets.  
Plastics packaging waste may contain residues from previous use, contaminants from misuse and 
contaminants from non -authorised substances which could migrate into the food the material contacts. 
Manufacturers of foo d contact articles made from recycled PET are responsible for ensuring that, like virgin 
material, recycled PET material is of suitable purity for its intended use and will meet all existing specifications 
for the virgin material.  DRS 499 -1: 2022  
1                ©RSB 2022  - All rights reserved  
 Post -consumer polyethylene terephthalate (PET) containers — 
Specification — Part 1: Food grade PET recyclates, preforms and 
containers  
1 Scope  
1.1 This Working Draft specifies requirements , sampling  and test methods for post -consumer polyethylene 
terephthalate (PET) recyclates (flakes and pellets) for use  in PET preforms and PET containers  intended for 
food pac kaging excluding alcoholic beverages.  
1.2 The standard also specifies requirements for the PET preform and container material that characterize it 
as safe for direct food contact.  
2  Normative references  
The following documents are referred to in the text in such a way that some or all of their content constitutes 
requirements of this document. For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
ASTM E1347 -06, Standard test method for color and color -difference measurement by tristimulus co lorimetry  
ASTM F1877 -16, Standard practice for characterization of particles  
ASTM F2013 -10, Standard Test Method for Determination of Residual Acetaldehyde in Polyethylene 
Terephthalate Bottle Polymer Using an Automated Static Head -Space Sampling Device an d a Capillary GC 
with a Flame Ionization Detector  
ASTM D4532 -15, Standard Test Method for Respirable Dust in Workplace Atmospheres Using Cyclone 
Samplers  
ASTM D4754 -98, Standard Test Method for Two -Sided Liquid Extraction of Plastic Materials Using FDA 
Migration Cell  
ASTM D6290, Standard test method for colour determination of plastic pellets  
ASTM D7486 , Standard Test Method for Measurement of Fines and Dust Particles on Plastic Pellets by Wet 
Analysis  
ISO 472, Plastics — Vocabulary  
ISO 1133 -2, Plastics – Determination of the melt mass -flow rate (MFV) and melt volume flow rate (MVF) of 
thermoplastics - Part 2: Methods for materials sensitive to time -temperature history and/or moisture   
©RSB 2022  - All rights  reserved                  2 
 ISO 1628 -5, Plastics — Determination of the viscosity of polymers in dilut e solution using capillary 
viscometers — Part 5: Thermoplastic polyester (TP) homopolymers and copolymers  
ISO 1628 -1, Plastics — Determination of the viscosity of polymers in dilute solution using capillary 
viscometers — Part 1: General principles  
RS ISO 2859 -1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
RS ISO 9001 , Quality management systems — Requirements  
ISO 12418 -2, Plastics – Post-consumer poly(ethylene terephthalate) (PET) bottle recyclates – Part 2: 
Preparation of test specimens and determination of properties  
ISO 12418 -1, Plastics – Post-consumer poly(ethylene terephthalate) (PET) bottle recyclates – Part 1: 
Designation system and basis for specifications  
ISO 13106, Plastics — Blow -moulded polypropylene containers for packaging of liquid foodstuffs  
ISO 14001, Environmental management systems — Requirements with guidance for use  
ISO 14782 , Plastics — Determination of haze for transparent materials  
ISO 15270 , Plastics — Guidelines for the recovery and recycling of plastics waste  
ISO 15512, Plastics — Determination of water content  
ISO 22000 , Food safety management systems — Requirements for any organization in the food chain  
3 Terms and definitions  
For the purpose of this document, the terms and definitions given in ISO 472, ISO 15270 and the following 
apply:  
3.1 
challenge test  
demonstration of the effectiveness of a recycling process to remove chemical contamination from input  
3.2 
Flake  
plate -like regrind  
NOTE  The shape of regrind depends both on the plastics being processed and the manner of processing.  DRS 499 -1: 2022  
3                ©RSB 2022  - All rights reserved  
 3.3 
regrind  
regrind  
shredded and/or granulated recovered plastics material in the form of free -flowing material  
3.3 
pellet 
small mass of preformed moulding material, having relatively uniform dimensions in a given lot, used as 
feedstock in moulding  and extrusion  operations  
3.4 
recycled PET (rPET)  
recovered materials resulting from industrial packagings and post -consumer PET materials that have been 
cleaned, prepared and processed into new recyclates  
3.5 
bulk density  
weight per unit volume of plastic flakes or pellets.  
3.6 
recyclate  
plastics material resulting from the recycling of food grade PET waste  
3.7 
post -consumer  
descriptive term covering material, generated by the end -users of products, that has fulfilled its intended 
purpose or can no longer be used (including material returned from within the distribution chain)  
3.8 
intrinsic viscosity  
limiting val ue of the reduced viscosity or the inherent viscosity at infinite dilution of the polymer is a common 
descriptor of PET flow ability   
©RSB 2022  - All rights  reserved                  4 
 3.9 
food  
any substance, whether processed, semi -processed or raw, which is intended for human consumption, and 
includes dri nks, chewing gum and any substance which has been used in the manufacture, preparation or 
treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs.  
4 Requirements  
4.1  General requirements  
4.1.1  The resins shall be made from food grade flakes, pellets  or chips  which may be natural or coloured . 
4.1.2  The recycling process shall be done in accordance with ISO 15270. The input to the recycling process 
shall originate from a product loop which is in a closed and controlled ch ain ensuring that only PET materials 
are used and any contamination can be ruled out.  
NOTE   Management system s including ISO 9001, ISO 22000 and ISO 14001  is a suitable guarantee to consistent 
recyclate quality. Records of the quality control carried out, including incoming materials, processes and finished products 
are maintained in order that the purchaser of the recyclate can have confidence in the quality of the product.  
4.1.3  The recyclates, preform and container shall be manufactured in accordance wit h good manufacturing 
practice (GMP) so that, under normal or foreseeable conditions of use, they do not transfer their constituents 
to food in quantities which could endanger human health; bring about an unacceptable change in the 
composition of the food; bring about deterioration in the organoleptic characteristics (taste, odour and texture) 
thereof.  
4.1.4  The designation system and sizes for the post -consumer PET recyclates shall be done as described 
in ISO 12418 -1. 
4.1.5  Recyclates may be in various shap es/forms namely flakes or pellets.  
4.2 Specific requirements for recycled PET recyclates (pellets or flakes), preforms and 
containers  
4.2.1  Physical and chemical requirements  
4.2.1.1  Recycled PET flakes   
Recycled PET flakes shall comply with the physical and chemical requirements of Table 1 when tested in 
accordance with the test methods specified therein.    
Table 1 — Specific requirements for recycled PET flakes  
S/No.  Parameters  Requirement  Test  methods b 
Mandatory    DRS 499 -1: 2022  
5                ©RSB 2022  - All rights reserved  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2.1.2  Recycled PET pellets    
Recycled PET pellets shall comply with the physical and chemical requirements of Table 2 when tested in 
accordance with the test methods specified therein.    
Table 2 — Parameters of rPET pellets  i.  Fine particle content, %  ≤ 0.1  ASTM D7486  
ii.  Intrinsic viscosity (IV), dl/g  0.74 – 0.84  ISO 1628 -5 in combination with 
ISO 1628 - 1  
iii.  Contamination due to label and 
other visible contaminants, 
mg/kg, max  ≤ 300  ISO 12418 -2  
iv.  Contamination due to Polyvinyl 
Chloride (PVC), mg/kg  < 5  ISO 12418 -2  
v.  Contamination due to Polyolefins 
(including adhesives), mg/kg, 
max 50  ISO 12418 -2  
vi.  Metal (aluminium, steel),  mg/kg  < 5  Spectroscopic analysis:  FTIR or 
XRF 
vii.  Water content, %  ≤0.5  ISO 15512, Method B  
viii.  Bulk density, kg/m3 As specified 
by 
manufacturer  ISO 12418 -2,  
Optional    
ix.  Alkalinity  7 - 8  ISO 12418 -2  
x.  Melt volume -flow rate ( MVR), 
cm3/10min  As specified 
by 
manufacturer  ISO 1133 -2 
xi.  Filterability, 10 MPa/h/cm2 As specified 
by 
manufacturer  ASTM D4532 -15 
S/No.  Parameters  Requirements  Test methods b 
i.  Mandatory  
ii.  Fine particle content, % (max)  
(percentage of particles passing 
through the sieve  1mm)  0.05  ASTM D7486  
iii.  Intrinsic viscosity (IV) a, dl/g, min  0.78  ISO 1628 -5 and ISO 1628 -1  
iv.  Metal (aluminium, steel), mg/kg, 
max  < 5 Spectroscopic analysis: FTIR 
or XRF   
©RSB 2022  - All rights  reserved                  6 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2.1.3  Recycled PET preforms or containers    
Recycled PET preforms and containers shall comply with the physical and chemical requirements of Table 3 
when tested in accordance with the test methods specified therein.    v.  Haze 3mm thick plaques, %, max 
at 550nm  13 ISO 14782  
vi.  Acetaldehyde content, ppm (max)  1.0 ASTM F2013 10  
vii.  Limonene,  μg/kg  (max)  < 20  GC/MS  
viii.  Water content, %  < 0.5  ISO 15512  
ix.  Optional   
x.  Melt volume flow rate, cm3/10min  As specified by 
manufacturer  ISO 1133 -2  
xi.  Filterability, 10 MPa/h/cm2 As specified by 
manufacturer  ASTM D4532 -15 
xii.  Colour  ASTM D6290  
 Coloured 3mm thick plaques   
 Colour L*, min  70 
Colour a*, min  -3 
Colour b*, max  +10 
Coloured amorphous pellets (indicative values only - interim 
processing step in processes  
 
Colour L*, min  45 
Colour a*, min  -10 
Colour b*, max  +1 
Coloured crystallized pellets  
 Colour L*, min  67 
Colour a*, min  -3 
Colour b*, max  +3 
a Solvent shall be a mixture of phenol and 1,1,2,2 -tetrachloroethane (6:4)  
b A certificate of analysis, including the test results for each batch of recyclate, the sampling method and the number of 
replicates, shall be provided by the supplier to the purchas er on request.  The sampling method and the number of 
replicates are important in determining the quality of the material. Quality levels can vary within the batch and from batch to 
batch, depending on the source of the recyclate.  DRS 499 -1: 2022  
7                ©RSB 2022  - All rights reserved  
 Table 3 — Physical and chemical requirements of recycled PET preforms or containers  
S/No.  Parameter  Requirements  Test Method  
i.  Acetaldehyde , ppm, max  4 ASTM F2013 -10  
ii.  Intrinsic Viscosity , dL/g  0.76 - 0.86 ISO 1628 ‑5 
iii.  Colour L* (CIE ), min   70 ASTM E1347 -06 
 iv.  Colour a* (CIE ), min  - 4 
v.  Colour b* (CIE), max  1.4 
vi.  Bulk density, kg/m3  820 ± 30  ASTM D4602  
vii.  Water content, %  < 0.2  ISO 15512  
 
4.2.2  Overall migration  of constituents  
When tested in accordance with Annex A  the rPET recyclates and preform material shall not transfer their 
constituents to food and beverage simulants in quantities exceeding an overall migration limit of 10 milligrams 
of total constituents (non -volatile substances) released per square decimetre  (10 mg/dm2) of food or beverage 
contact surface, equivalent to 60 mg of total constituents  released  per kg (60 mg/kg) of food simulants.   
4.2.3  Specific migration of chemicals  
4.2.3.1  Specific migration of compound  
The specific migration limit of compound from the recyclates or preform material shall not exceed the limit 
specified in Table 4 when determined in accordance with The test method specified therein.  
Table 4 — Specific migration limits for compounds used in the manufacture of recyclates and preform  
 
S/No.  Compound  Specific Migration Limit,  
mg/kg of food , max.  Test method  
i.  Mono - and diethylene glycol  
(including the ester of stearic acid with 
ethylene glycol)  30 ASTM D4754 -98 
ii.  Terephthalic acid  7.5 
iii.  Isophthalic acid  5 
iv.  Antimony trioxide(calculated as antimony)  0.04 
 
v.  2-Aminobenzamide (anthranilamide)  0.05 
 
4.2.3.2  Restrictions on release of inorganic  substances  
The preform and container material shall not release contaminants in quantities exceeding their 
migration limits given in Table 5 when determined in accordance with spectroscopic analysis such as 
FTIR or  
XRF or any other equivalent method.   
©RSB 2022  - All rights  reserved                  8 
 Table 5 — Specific migration limit of inorganic substances  
 
S/No.  Substance  Specific migration limit  
mg/kg of food, beverage or food stim ulant , 
max.  
i.  Aluminium  1 
ii.  Barium  1 
iii.  Cobalt  0.05 
iv.  Copper  5 
v.  Iron 48 
vi.  Lithium  0.6 
vii.  Manganese  0.6 
viii.  Zinc 5 
4.2.4  The dimensional and mechanical properties of the PET containers  
The dimensional and mechanical properties of the PET containers shall be as specified in ISO 13106.  
5 Packaging  
The recyclates, preforms and containers shall be packaged in suitable packaging materials that maintain their 
integrity prevent the ingress of dust, moisture and other foreign matters during transportation and storage.  
6 Marking   
The following information shall be legibly and indelibly marked on the packaging, container or in 
accompanying documents:  
a) name, trade mark or other means of identification of the  manufacturer;  
b) batch number  
c) date of  manufacture;  
d) words “ for food contact ” or symbol for food contact material  DRS 499 -1: 2022  
9                ©RSB 2022  - All rights reserved  
  
 
e) symb ol indicating that it is made  from recycled PET material;  
 
f) if necessary, special instructions to be observed for safe and appropriate  use; and 
g) recycled content, %  
7 Sampling  
The sampling criteria shall be in accordance with ISO 2859 -1 
 
 
 
 
 
 
 
 
 
©RSB 2022  - All rights  reserved                  10 
  
 
 
 
 
 
 
 
 DRS 499 -1: 2022  
11                ©RSB 2022  - All rights reserved  
 Annex  A 
(normative ) 
Determination of overall migration of constituents of plastics materials 
and articles intended to come in contact with foodstuffs - Method s of 
analysis  
A.1 Types of simulants  
The determination of migration in simulants is to be carried ou t using the simulants laid down:  
a) Simulant ‘A’ - distilled water or water of equivalent quality.  
b) Simulant ‘B’ - 3 percent acetic acid (w/v) in aqueous solution (using the simulant ‘A’)  
c) Simulant ‘C1 - 10 percent ‘ethanol (v/v) in aqueous solution for foodstuffs aqueous solution for 
foodstuffs having alcohol less than 10 percent (v/r)) (using the simulant ‘A’).  
d) Simulant ‘C2’ - - 50 percent ethanol (v/v) in aqueous solution for foodstuffs having alcoho l more 
than 10 percent and less than 50 percent (r/v) (using the simulant ‘A’).  
e) Simulant ‘D’ -n-heptane - shall be freshly distilled before use.  
f) Simulant ‘E’ -Rectified olive oil or mixture of synthetic triglycerides or sunflower oil.  
NOTE  This simulant ‘E’  suggested by EEC for fatty foods need not be considered at present as the methodology of 
estimation is not yet developed.  
A.2 Selection of standard test conditions and simulants for different foods tuffs  
A.2.1 The choice of simulating solvents and test  conditions (time -temperature) depends on the type of  
foodtuff and its condition of use. Food  products have been classified into seven major  groups suitable 
simulants to be used for different types of foods as per Table A.1.  
Table A.1 — Classification of foods and selection of simulant  
S/N Type 
of 
food   Description  Examples  Simulant  
i.  I Aqueous, non -acidic foods 
without fat (pH > 5)  Honey, mineral water, sugar syrups molasses, 
skimmed milk, rusgulla, infusions, murabba, yeast, 
paste etc yeast paste etc  ‘A’ 
 
ii.  II Aqueous. acidic foods without 
fat (pH ≤ 5 5) 
 Fruit juices, squashes, fruit chunks or puree or 
paste, vinegar, jams, jellies, carbonated beverages. 
lemonade, processed vegetables, rennet, 
preparations of soups, broths, sauces, RTS 
beverages etc  ‘B’  
©RSB 2022  - All rights  reserved                  12 
 iii.  III Alcoholic 
beverages:  i)Alcohol 
concentration 
less than 10 
percent  Beer and some pharmaceuticals syrups  ‘C1” 
 ii)Alcohol 
concentration 
above 10 percent  Wine, brandy, whiskey, arrack and other alcoholic 
drinks  ‘C2’ 
iv.  IV Oils. fats and processed dry 
foods with surface fat or 
volatile oil  Vegetable oils, ghee, cocoa butter, lard,  
biscuits, spice powder, snacks and savoury. 
chocolate,  
caramels, malted foods, egg powder, tea, coffee 
powder  
confectionery, fried and roasted nuts etc  ‘D’ 
v.  V Nonacidic foods (pH > 5) or 
high fat and having high 
moisture content  Butter, bread, pastry shreekand  with low cakes, 
milk based sweets, ice -cream, moist and fatty 
confectionery products  A and D’  
vi.  VI Acidic foods (pH ˂ 5) or high 
fat and having h igh moisture 
content  Pickles, ketchup, cheese, with low curd, fresh and 
processed meat and fish products, sauces having 
fat, frozen foods, mayonnaise etc  ‘B and D’  
vii.  VII Dry processed foods without 
fat Cereals and pulses, dehydrated vegetable and 
fruits, dried yeast. corn flakes, salt, sugar, milled 
products, barley powder, oats, vermicelli, spaghetti 
etc No end test  
 
A.4.2 Table A.2 lists th e simulants and test conditions (time -temperature) for extractability studies to be  
carried out as above depending on the type of food and  conditions of use.  
Table A.2 — Simulating solvents for different types of food,  temperature  and time conditions  
S/N Conditions of use  Type 
of 
food  Water (time - 
temperature )  3 % Acetic 
acid  
(time-
temperature ) 10 % alcohol  
(time- 
temperature ) 50 % alcohol  
(time - 
temperature )  n-Heptane  
i.  High temperature  
heat sterilized 
(Retorting ) I, II, 
IV, V 
and VI 121 °C, 2 h 121 °C, 2 h - - 66 °C for 2 h  
ii.  Hot filled or 
pasteurized above 66  
°C, 100  °C I, II, 
IV, V 
and VI  100 °C, 2  h 100 °C, 2  h - - 49 °C for  30 
min 
iii.  Hot filled or 
pasteurized below 66  
°C I to VI  70 °C, 2 h 70 °C, 2 h 70 °C, 2 h 70 °C, 2 h 38 °C for 30 
min 
iv.  Room temperature 
filled and stored (no 
thermal treatment in 
container) and also in 
refrigerated and 
frozen condition  I to VI  40 °C, 10 days  40 °C, 10 
days  40 °C, 10 
days  40 °C, 10 days  38 °C for 30 
min 
 DRS 499 -1: 2022  
13                ©RSB 2022  - All rights reserved  
 NOTE 1  Heptane simulant not to be used on wax lined containers.  
NOTE 2  Heptane e xtractivity results must be divided by a factor of five in arriving at the extractivity of a food product  
A.3 Method I: For finished container (within two litres  capacity) or sealable 
single/multi -layered flexible films  (one side exposure ) 
A.3.1  Apparatus  
A.3.1.1  Electric oven/water bath, equipped with thermostat to maintain the desired temperature within ± 1 
ºC accuracy  
A.3.1.2  Electric hot plate, with temperature control regulator  
A.3.1.3  Analytical balance, with a sensitivity of 0.1 mg  
A.3.1.4  Glass beakers, Pyrex of 1 000 ml capacity or equivalent  
A.3.1.5  Stainless steel evaporating dish of 100 ml capacity  
A.3.1.6  Stainless steel tongs  
A.3.2  Selection of Sample  
Minimum triplicate sample s representing the lot/batch have to be selected . The films representative sample 
shall be of sufficient size to convert into two pouches of size 125 mm width and 200 mm length (inner 
dimension excluding seal area) with 1 000 cm² surface area coming in con tact. 
A.3.3  Preparation of the test specimen  
The containers/pouches used shall be carefully rinsed with water (25 -30օC) to remove extraneous materials 
prior to actual migration test.  
A.3.4  Simulant Quantity  
Equal to nominal filling capacity or at least 1 mL/cm2 of co ntact area.  
NOTE  Glassware, laboratory apparatus which come into contact with simulants and/or the sample  during the test 
shall be thoroughly washed and dried prior to test . 
A.3.5  Procedure  
Fill the container/pouch to their filled capacity with preheated simula nt at test temperature and close it. In case 
of pouches, exclude air as much as possible before sealing and expose the filled container/pouch to specified 
temperature maintained in oven/water bath/pressure cooker/autoclave for the specified duration of tim e. After  
©RSB 2022  - All rights  reserved                  14 
 exposure for the specified duration, remove the container/pouch and transfer the contents immediately into a 
clean Pyrex beaker along with three washings of the specimen with small quantity of the fresh simulant.  
A.3.6  Determination of Amount of Extract ive 
A.3.6.1  Evaporate/distil the contents in Pyrex beaker to about 50 -60mL and transfer into a clean tared 
stainless steel dish along with 3 washings of Pyrex beaker with small quantity of fresh simulant and further 
evaporate the concentrate in the dish to dryness in an oven at 100 °C ±  5 °C. Cool the dish with extractive in a 
desiccator for 30 minutes and weigh to nearest 0.1mg till constant weight of residue is obtained. Calculate the 
extractives in mg/dm2 and mg/kg or mg/L or ppm of the foodstuff with respect to the capacity of 
container/pouch to be used. Blank shall also be carried out without the sample.  
A.3.6.2  Calculate the amount of extractive in ppm for the  particular size of contain er being tested.  
Amount of extractive (Ex) = 𝑀
𝑉x1000 mg/kg  or mg/l    
                          or       Ex= 𝑀
𝐴x100 mg/dm2  
where  
M = mass of residue in mg minus blank value ; 
A= surface area in cm2 exposed in each replicate ; 
V = volume of the container in ml in a replicate in actual use.  
NOTE 1   For irregular shaped containers, nearest surface area is obtained by superimposing the graph  sheet on the 
container and getting the surface area by increments in each segment.  
NOTE 2  In case of heptane as solvent divide EX by a factor of five in arriving at th e extractivity for a  food product.  
A.4 Method II: For larger containers made of single homogenous material above 2 
litre capacity  
A.4.1  Selection of Sample  
Minimum 3 containers representing the lot/batch are to be selected.  
A.4.2  Test Specimen  
Cut 5 pieces each of size 10  cm x 10 cm from each container at different places (each piece exposing  about 
200 cm2 surface area both sides). In the case of thick material area corresponding to thickness of  the sample 
shall also be included.  DRS 499 -1: 2022  
15                ©RSB 2022  - All rights reserved  
 A.4.3   Procedure  
Immerse 5 thoroughly cleaned pie ces cut from each container into a clean glass container (2 litre capacity  
beaker) containing preconditioned simulant at test temperature such that no two pieces touch each other  by 
placing a 2 to 3mm dia glass rod in between the specimens and cover the be aker with glass  plate/watch glass 
and keep the set at specified temperature maintained in oven/water bath/pressure  cooker for the specified 
duration of time. After exposure for the specified time, remove the test specimen  from the extracted simulant 
with t he help of clean tongs and wash the pieces with small amount of fresh  simulant and combine with the 
extracted simulant. Blank shall also be carried out without the sample.  
A.4.4  Determination of amount of extractive  
Follow the procedure in A.3.6.1 and  calculate the amount of  extractive in mg/dm2 and mg/kg or mg/l  with 
respect to capacity of the container.  
Amount of extractive (Ex) = M x TSA x 1000
𝐴𝑥𝑉mg/kg or mg/l    
                          or       Ex= 𝑀
𝐴x100 mg/dm2  
where  
M = mass of residue in mg minus blank value;  
A= surface area in cm2 exposed in each replicate;  
TSA= total surface area of the container in cm2; 
V = total volume of the container in ml  or cm3 in 
 NOTE   Heptane extractive to be divided by factor of five  
 
  
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 Bibliography  
[1] US 1659:2016  Materials in Contact with Food — Requirements for Packaging materials  
[2] IS 9845 (1998): Determination of overall migration of constituents of plastics materials and articles 
intended to come in contact with foodstuffs – method of analysis  
[3] European Commission Regulation (EC) No. 2023/2006 of 22 December 2006 on good manufacturing 
practice for materials and articles intended to come into contact with food, Official Journal of the 
European Union, OJ L 384/75 -78 (29.12.2006  
[4] European Commission Regulatio n (EC) No. 282/2008 of 27 March 2008 on recycled plastic materials 
and articles intended to come into contact with foods and amending Regulation (EC) No. 2023/2006, 
Official Journal of the European Union, OJ L 86/9 -18 (28.3.2008)  
 
 
 
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