TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021  
 
 
 
DRAFT TANZANIA STANDARD  
 
 
 
 
 
 
 
Determination of overall migration of constituents of plastics 
materials and articles intended to come in contact with foodstuffs - 
Method of analysis  
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 
 
 
 
 
 
                                    TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021 0. Foreword  
The ingred ients in the plastics packaging materials may cause toxicity as a result of their migration to the 
foodstuffs in which the later are packed. Prior to categorizing such plastics as toxic, evidence regarding 
degree of migration of their constituents has to b e ascertained . 
Since it is not always possible to analyze  actual foodstuffs for nature and quantity of migrants from the 
plastics , food simulants/extractants have to be substituted for the actual foodstuffs  in order to simplify 
such assessment .  
Due to dif ficultness of estimating all the migr ants individually, overall migration of all the migrants put 
together is considered for safe use, unless they are especially toxic and their limits fixed.   
In the preparation of this standard assistance has been derive d from: IS 9845:1998 Determination of 
overall migration of constituents of plastics materials and articles intended to come in contact with 
foodstuffs - Method of analysis published by Bureau of Indian Standards (BIS)  
In reporting the result of a test or analysis made in accordance with this standard, if the final values 
observed or calculated, is to be rounded off it shall be done in accordance with TZS 4 Rounding off 
numerical values.  
1.  Scope  
This standard prescribes the metho ds of analysis for determ ination of overall migration of constituents of 
single or multi -layered heat -sealable  films, single homogenous non -sealable films, finished containers 
and closures for sealing as lids, in the finished form, preformed or converted f orm.  
2. Normative Refere nces  
The following standard, in whole or in part, are normatively referenced in this document and are 
indispensable for its application. For dated references, only the edition cited applies. For undated 
references, the latest edit ion of the referenced doc ument (including any amendments) applies  
AFDC 2  (231) CD2: Specification for plastic materials for food contact applications part 3:  Colorants    
AFDC 2 (227) CD2: Guide on suitability of plastics for food packaging  
3. Terms and De finitions  
3.1 food Simul ants  
a test medium imitating food; in its behavior the food simulant mimics migration from food contact 
materials   
 3.2 Multi -Layered   
a material or article composed of two or more layers of plastic   
4.0 requirements                                     TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021 4.1 Simulants   
The determination of m igration in simulants is to be carried out using the simulants laid down in Table 1 : 
Table 1: Types of simulants used in determination of migrants   
Types of Simulants  Examples  
Simulant ‘A’  distilled water or w ater of equivalent quality  
Simulant ‘B’  3 percent acetic acid (w/v) in aqueous solution (using the simulant ‘A’)  
Simulant ‘C1’  10 percent ‘ethanol (v/v) in aqueous solution for foodstuffs having alcohol 
less than 10 percent (v/v) (using the simulant ‘A’).  
Simulant ‘C2’ 50 percent ethanol (v/v ) in aqueous solution for foodstuffs. having alcohol 
more than 10 percent and less than 50 percent ( v/v) (using the simulant ‘A’).  
Simulant ‘D’  n-heptane - shall be freshly distilled before use.  
    
4.2 selection of standard test conditions and simula nts for different foods  
4.2.1 The choice of simulating solvents and test conditions (time -temperature) depends on the type of 
food and condition of use of food products. Food products have been now classified i nto seven major 
groups as per Table 2.  
Table  2: Classification of Foods and Selection of simulant  
(Clause 4.1)  
 
Food 
type  Description  Example  Simulants  
I Aqueous, non acidic foods pH > 
5) without fat  Honey, mineral water, sugar syrups molasses, 
skimm ed milk, rasgulla, infusions, murabba, 
yeast paste etc.  A  
II Aqueous , acidic foods (pH 5.5) 
without fat  Fruit juices, squashes, fruit chunks or puree or 
paste, vinegar, jams, jellies, carbonated 
beverages. lemonade, processed vegetables, 
rennet, prepara tions of soups, broths, sauces, 
RTS beverages  etc. B 
 
III 
  Alcoholic beverages:  
i)  Alcohol concentration 
less than 10 percent   
Beer   
C1 
ii)   Alcohol concentration 
above 10 percent  Wine, brandy, whiskey, arrack and other 
alcoholic drinks  C2 
IV Oils. fa ts and processed dry 
foods with surface fat o r volatile 
oil  Vegetable oils, Ghee, Vanaspati, cocoa butter, 
lard, biscuits, spice powder, snacks and 
savoury, chocolate, caramels, malted foods, 
egg powder, tea, coffee powder , confectionery, 
fried and roaste d nuts etc.  D 
V Non-acidic foods (pH > 5) o r 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                                     TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021 VI Acidic foods (pH <5) or high fat 
and having high moisture content  Pickles, ketc hup, cheese, with low curd, fresh 
and processed meat and fish products, sauces 
having fat, frozen foods, mayonnaise etc.  B and D  
VII Dry processed foods without fat  Cereals and pulses, dehydrated vegetable and  
fruits, dried yeast , corn flakes, salt, suga r, 
milled products, barley powder, oats, vermicelli, 
spaghetti etc.  No end 
test  
  
The food products listed in AFDC  2 (227) CD2 have been fully covered in this table (further additions shall 
be made whenever n ecessary). This table has been prepared on th e lines of accepted classification of 
foodstuffs for such purposes in developed countries. Table 1 also gives suitable simulants to be used for 
different types of foods.   
4.2.2 Table 3 lists the simulants and te st conditions (time -temperature) for extracta bility studies to be 
carried out as above depending on the type of food and conditions of use.  
Table 3: Simulating solvents for different types of food and temperature - time conditions  
(Clause 4.2 ) 
 
 
  NOTES  
  1. Heptane simulant not to be used on wax lined  containers.  
  2. Heptane extractivity results m ust be divided by a factor of five in arriving at the extractivity of a  
  food product . 
 
5. Methods I:  
For finished containe r (within two liters capacity ) or sealable single/multi -layered flexible films 
(one  side exposure ) 
5.1 apparatus  
5.1.1 electric ov en/water bath equipped with thermostat to maintain the desired temperature up to ±1օC 
accuracy.  Conditions  of Use  Type of 
Food  Water 
(Time -
Temp)  3% 
Acetic 
Acid 
(Time -
Temp)  10% 
Alcohol 
(Time -
Temp)  50% 
Alcohol 
(Time -
Temp)  n-Heptane 
(Time -
Temp)  
High temperature heat sterilized 
(retorting)  I, II, IV, 
V and VI  121օC, 
2h 121օC, 2h  - - 66օC, 2h  
Hot filled or pas teurized above 
66օC, below 100 օC  I, II, IV, 
V and  VI  100օC, 
2h 100օC, 2h  - - 49օC for 
30 minutes  
Hot filled or pasteurized below 
60օC  I to VI  70օC, 
2h 70օC, 2h  70օC, 
2h 70օC 38օC for 
30minutes  
Room t emperature filled and 
stored (no thermal treatme nt in 
container) and also in 
refrigerated and frozen 
condition  I to VI  40օC, 
10 
days  40օC, 10 
days  40օC, 
10 days  40օC, 
10 days  38օC for 
30minutes                                     TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021 5.1.2 electric hot plate with temperature control regulator.  
5.1.3 analytical balance with a sensitivity of 0.1mg.  
5.1.4 glass beakers, pyrex of 1000mL capacity or equivalent  
5.1.5 stainless steel evaporating dish of 100mL capacity  
5.1.6 Stai nless steel tongs.  
5.2 Selection of Samples  
Minimum triplicate samples representing the lot/batch have to be selected. Samples in each replicate 
shall not consist of a number of containers (preformed or converted products)  with nearest exposed area 
of 100 0cm2 in the  case of films representative sample shall be of sufficient size to convert into 2 pouches 
of size 125mm width and 200mm length (inner dimension excluding seal area) with 1000cm3 surface area 
coming in contact.  
 5.3 Preparation of Test Specimen  
The containers/pouches used shall be ca refully rinsed with water (25 -30օC) to remove extraneous 
materials prior to actual migration test.   
5.4 Simulant Quantity  
Equal to nominal filli ng capacity or at least 1 m L/cm2 of contact 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 .  
5.5 Procedure  
Fill the container/pouch to their filled capacity with preheated simulant at test temperatu re 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 time. After exposure fo r 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 q uantity of 
the fresh simulant.  
5.6 Determination of Amount of Extractive  
Evaporate/ distill 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 a t 100±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.  
 
 Amount  of extractive  (𝐸𝑥)=𝑀
𝐴   𝑥100  𝑚𝑔𝑑𝑚2  
                                    TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021      
      and  
 
                                                     
   or ppm  
Where:   
M = mass of residue in mg minus blank value,  
A = total surfa ce area in cm2 exposed in each replicate, and  
V = total volume in m L of simulant used in each replicate.  
  NOTES  
1. for irregular shaped containers, nearest surface area is obtained by superimp osing the graph 
sheet on the container and getting the surface a rea by increments in each segment.  
2.  In case of heptane as solvent divide EX by a factor of five in arriving at the extractivity for a 
food product.  
6. Method I I:  
For larger containers made of single homogenous material above 2 litre capacity  
6.1 Select ion of Sample  
Minimum 3 c ontainers representing the lot/batch are to be selected.  
6.2 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 cor responding to thickness of 
the sample shall also be included.  
6.3 Procedure  
Immerse 5 thoroughly cleaned pieces cut from each container into a clean glass container (2 litre capacity 
beaker) containing preconditioned simulant at  test temperature such tha t no two pieces touch each other 
by placing a 2 to 3mm dia glass rod in between the specimens and cover the beaker with glass 
plate/watch glass and keep the set at specified temperature maintained in oven/water bath/pressure 
cooke r for the specified durati on of time. After exposure for the specified time, remove the test specimen 
from the extracted simulant with the help of clean tongs and wash the pieces with small amount of fresh 
simulant and combine with the extracted simulant. Blank shall also be carrie d out without the sample.  
6.4 Determination of amount of extractive  
Calculate the extractive in mg/dm2 and mg/kg or mg/L or ppm with respect to capacity of the container in 
accordance with the procedure specified in 5.6.                                     TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021  
  
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, and  
V = to tal volume of the container ( cm3).  
  NOTE -- Hept ane extractive to be divided by factor o f five.  
7.0 METHOD III: Both side exposure for single homogenous film, which cannot be heat sealed  
7.1 Apparatus  
7.1.1 Cylindrical Glass Jar, inner dimension of 10cm diameter and 14cm height with 1  000 mL capacity 
(or 1 litre beaker).  
7.1.2 Water Bath/ Electrical Oven, equipped with thermostat to maintain the desired temperature up to  
1°C.  
7.1.3 Glass/Stain less Steel Pins, of 7.5 -8.00 cm working length with extra bends ‘at both the ends.  
7.1.4 Electric Hot Plate, with temperature regulator.  
7.2 Specim en Size  
A film sample of 1 000cm2 surface area both sides with width not more than 10 cm and an appropriate 
length to g et the required area (10cm x 50 cm x 2 sides = 1  000cm2).  
7.3 Simulant Quantity  
Not less than 1 000 mL to immerse the sample completely .  
7.4 Preparation of Spec imen  
The film sample is rolled in the form of a coil in different concentric rings such that no two layers shall 
touch each other, and held in shape with the help of glass or stainless steel (SS) pin (see Fig. 1).                                     TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021 
 
7.5 Procedur e  
Fill the cylindrical ja r of 1000 mL capacity with the required quantity of preheated simulant at the test 
temperature. Immerse the test specimen in the simulant completely. Cover with a glass plate and place 
the jar with sample immersed in simulant at th e prescribed temperature f or the prescribed length of time. 
At the end of the test period remove the sample with the help of glass rod and wash the sample with 
small quantity of fresh simulant and combine with the extractants. Concentrate th e extracted sim ulant to 
50-60mL , by evapo rating on a hot plate under low heat (n -heptane shall be concentrated by distillation). 
Transfer the concentrate into a clean tared stainless -steel  dish along with three washings with small 
amount of fresh simulant and further eva porate the concentrate to dryness in an oven at 100± 5°C. Cool 
this in a desiccator for 30 minutes and weigh to nearest 0.1mg till constant weight of residue is obtained. 
Calculate the extractive in mg/dm2. Blank shall also be carried out without the sample .  
 Where:   
M= mass of re sidue in mg minus blank value, and  
A= total surface area in cm2 exposed in each replicate.  
  NOTE -. Heptane extractive value to be divided by factor of five .  
8. Method IV: for closures, sealing gaskets, liners and  like material s  
8.1 Selection of Sample   
At least triplicate samples each consisting of a number of closures/sealing gaskets/liners with the lids 
exposing about 100 cm2 contact area (or ten lids) per replicate in each representing a lot or batch shall be 
selected.  
8.2 Procedure  
Smallest size glass bottles/jars actually being intended for use with closures can be used as containers to 
contain the simulant. Fill the glass container to their nominal capacity or 100 mL, whichever is lower with 
simulant preheated to test t emperature and closed tigh t with the closures/lids lined with the test 
specimen. Place the closed containers upside down (to ensure the contact of the closures with the 
simulant) in an oven maintained at test temperature. After the exposure to the stipulat ed time, the closure                                    TBS/AFDC 2(229 ) CD2 
                                                  ICS 67:250  
  
 
©TBS -2021 from the containers is opened and the contents from each replicate is pooled together in a glass beaker 
along with the washings of the exposed closures with small amount of fresh simulant. Blank shall also be 
carried out without the sa mple.   
8.3 Determination o f Amount of Extractive  
Proceed with the determination amount of extractive by method described at 5.6.  
Calculate the amount of extractive in ppm for the particular size of contain.er being tested.   
 
  
Where:    
M = mass of resid ue in mg minus blank value , and V = volume of the container in m L in a replicate in 
actual use.  
NOTES  
  1. If the e xtractive values for a smaller  size container are  within the prescribed limits, it may  
                    be taken that extractive  values  for a larger size contain er of the same material and     
       same  shape will definitely be less than the smaller container used.  
  2. Heptane extractive to be divided by factor of five.  
9. METHOD V: Materials of articles intended to come into repeate d contact with 
foodstuffs  
The migration test(s) shall be carried out three times on a same sample one after the other in accordance 
with the conditions laid down already using fresh simulant(s) in each occasion, following any one of the  
method applicable to it described earlier. I ts compliance shall be checked on the basis of the level of the 
migration found in the third test. However, if there is conclusive proof that the level of the migration does 
not increase  in the second and third tests and if the migration limit(s) is/are not exceeded on the first test, 
no further test is necessary.  
10.  Evaluation of results  
The materials and articles are regarded as confirming to the specifications if in the migration t ests for 
each simulant used, the average of at least three results does not exceed the value of overall migration 
limit specified in the relevant standards.  
NOTE - Before carrying out the test, make sure that sample is free from all traces of dust, fats a nd other 
impurities. If necessary, it shall be thoroughly wiped with filter paper (Whatman No. I). The sample shall 
be handled carefully -to avoid any contamination.  
11.  Colour  migration   
In the case of coloured plastic materials, colour migrated to simul ant or decolorized  coconut oil or food 
packed shall not be apparent to naked eye. If the colour migrated is clearly visible, such materials are not 
suitable for food contact applications, even though the extractive value is within the limit ( see AFDC  
2(231) CD2).