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Food simulants and migration testing conditions

Simulants

To avoid possible argument about what kind of food should be chosen to perform migration testing, EU legislators have agreed on 4 food simulants, which are able to mimic foods:

Choice of simulants

Not all five simulants need to be included in testing. Directive 85/572/EC as amended by 2007/19/EC defines which simulants need to be used to simulate certain foods. Alternatives for olive oil may be used if needed (like sunflower oil). In some cases it is not possible to use olive oil as food simulant because of technical reasons and alternative simulants may be used like isooctane and 95% ethanol.

Reference number  Description of foodstuffs  Simulants to be used
   A  B  C  D
1  Beverages        
1,01  Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5 % vol. :        
   Waters , ciders , fruit or vegetable juices of normal strength or concentrated , musts , fruit nectars , lemonades and mineral waters , syrups , bitters , infusions , coffee , tea , liquid chocolate , beers and other  X (a)  X (a)    
1,02  Alcoholic beverages of an alcoholic strength equal to or exceeding 5 % vol. :        
   Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5 % vol. :        
 Wines , spirits and liqueurs    X (1)  X (2)  
1,03  Miscellaneous : undenatured ethyl aclcohol    X (1)  X (2)  
2  Cereals , cereal products , pastry , biscuits , cakes and other bakers' wares        
2,01  Starches        
2,02  Cereals , unprocessed , puffed , in flakes , ( including popcorn , corn flakes and the like )        
2,03  Cereal flour and meal        
2,04  Macaroni , spaghetti and similar products        
2,05  Pastry , biscuits , cakes and , other bakers' wares , dry :        
 A . With fatty substances on the surface        X/5
 B . Other        
2,06  Pastry , cakes and other bakers' wares , fresh :        
 A . With fatty substances on the surface        X/5
 B . Other  X      
3  Chocolate , sugar and products thereof Confectionery products        
3,01  Chocolate , chocolate-coated products , substitutes and products coated with substitutes        X/5
3,02  Confectionery products :        
 A . In solid form :        
 I . With fatty substances on the surface        X/5
 II . Other        
 B . In paste form :        
 I . With fatty substances on the surface        X/3
 II . Moist  X      
3,03  Sugar and sugar products :        
 A . In solid form        
 B . Honey and the like  X      
 C . Molasses and sugar syrups  X      
4  Fruit , vegetables and products thereof        
4,01  Whole fruit , fresh or chilled        
4,02  Processed fruit :        
   A . Dried or dehydrated fruit , whole or in the form of flour or powder        
 B . Fruit in the form of chunks , purée or paste  X (a)  X (a)    
   C . Fruit preserves ( jams and similar products - whole fruit or chunks or in the form of flour or powder , preserved in a liquid medium ) :        
 I . In an aqueous medium  X (a)  X (a)    
 II . In an oily medium  X (a)  X (a)    X
 III . In an alcoholic medium (  5 % vol. )    X (3)  X
4,03  Nuts ( peanuts , chestnuts , almonds , hazelnuts , walnuts , pine kernels and other ) :        
 A . Shelled , dried        
 B . Shelled and roasted        X/5 (4)
 C . In paste or cream form X      X/3 (4)  
4,04  Whole vegetables , fresh or chilled        
4,05  Processed vegetables :        
   A . Dried or dehydrated vegetables whole or in the form of flour or powder        
 B . Vegetables , cut , in the form of purées  X (a)  X (a)    
 C . Preserved vegetables :        
 I . In an aqueous medium  X (a)  X (a)    
 II . In an oily medium  X (a)  X (a)    X
 III . In an alcoholic medium (  5 % vol. )    X (3)  X
5  Fats and oils        
5,01  Animals and vegetable fats and oils , whether natural or treated ( including cocoa butter , lard , resolidified butter )        X
5,02  Margarine , butter and other fats and oils made from water emulsions in oil        X/2
6  Animal products and eggs        
6,01  Fish :        
 A . Fresh , chilled , salted , smoked  X      X/3 (5)
 B . In the form of paste  X      X/3 (5)
6,02  Crustaceans and molluscs ( including oysters , mussels , snails ) not naturally protected by their shells  X      
6,03  Meat of all zoological species ( including poultry and game ) :        
 A . Fresh , chilled , salted , smoked  X      X/4
 B . In the form of paste , creams  X      X/4
6,04  Processed meat products ( ham , salami , bacon and other )  X      X/4
6,05  Preserved and part-preserved meat and fish :        
 A . In an aqueous medium  X (a)  X (a)    
 B . In an oily medium  X (a)  X (a)    X
6,06  Eggs not in shell :        
 A . Powdered or dried        
 B . Other  X      
6,07  Egg yolks :        
 A . Liquid  X      
 B . Powdered or frozen        
6,08  Dried white of egg        
7  Milk products        
7,01  Milk :        
 A . Whole  X     X(b)
 B . Partly dried  X     X(b)
 C . Skimmed or partly skimmed  X     X(b)
 D . Dried        
7,02  Fermented milk such as yoghourt , buttermilk and such products in association with fruit and fruit products    X   X(b)
7,03  Cream and sour cream  X (a)  X (a)   X(b)
7,04  Cheeses :        
 A . Whole , with rind        
 B . Processed cheeses  X (a)  X (a)    
 C . All others  X (a)  X (a)    X/3 (5)
7,05  Rennet :        
 A . In liquid or viscous form  X (a)  X (a)    
 B . Powdered or dried        
8  Miscellaneous products        
8,01  Vinegar    X    
8,02  Fried or roasted foods :        
 A . Fried potatoes , fritters and the like        X/5
 B . Of animal origin        X/4
8,03  Preparations for soups , broths , in liquid , solid or powder form ( extracts , concentrates ) ; homogenized composite food preparations , prepared dishes :        
 A . Powdered or dried :        
 I . With fatty substances on the surface        X/5
 II . Other        
 B . Liquid or paste :        
 I . With fatty substances on the surface  X (a)  X (a)    X/3
 II . Other  X (a)  X (a)    
8,04  Yeasts and raising agents :        
 A . In paste form  X (a)  X (a)    
 B . Dried        
8,05  Salt        
8,06  Sauces :        
 A . Without fatty substances on the surface  X (a)  X (a)    
   B . Mayonnaise , sauces derived from mayonnaise , salad creams and other oil in water emulsions  X (a)  X (a)    X/3
 C . Sauce containing oil and water forming two distinct layers  X (a)  X (a)    X
8,07  Mustard ( except powdered mustard under heading 08.17 )  X (a)  X (a)    X/3 (6)
8,08  Sandwiches , toasted bread and the like containing any kind of foodstuff :        
 A . With fatty substances on the surface        X/5
 B . Other        
8,09  Ice-creams  X      
8,1  Dried foods :        
 A . With fatty substances on the surface        X/5
 B . Other        
8,11  Frozen or deep-frozen foods        
8,12  Concentrated extracts of an alcoholic strength equal to or exceeding 5 % vol    X (8)  X  
8,13  Cocoa :        
 A . Cocoa powder        X/5 (7)
 B . Cocoa paste        X/3 (7)
8,14  Coffee , whether or not roasted , decaffeinated or soluble , coffee substitutes , granulated or powdered        
8,15  Liquid coffee extracts  X      
8,16  Aromatic herbs and other herbs :        
 camomile , mallow , mint , tea , lime blossom and others        
8,17  Spices and seasonings in the natural state :        
   cinnamon , cloves , powdered mustard , pepper , vanilla , saffron and other        
         
(1) This test shall be carried out only in cases where the pH is 4,5 or less .
(2) This test may be carried out in the case of liquids or beverages of an alcoholic strength exceeding 15 % vol. with aqueous solutions of ethanol of a similar strength .
(3) This test is to be used only where the pH is 4,5 or less .
(4) If it can be demonstrated by means of an appropriate test that there is no " fatty contact " with the plastic , the test with simulant D may be dispensed with .
(5) If it can be demonstrated by means of an appropriate test that there is no " fatty contact " with the plastic , the test with simulant D may be dispensed with .
(6) If it can be demonstrated by means of an appropriate test that there is no " fatty contact " with the plastic , the test with simulant D may be dispensed with .
(7) If it can be demonstrated by means of an appropriate test that there is no " fatty contact " with the plastic , the test with simulant D may be dispensed with .
(8) This test is to be used only where the pH is 4,5 or less .
X(b) = 50% ethanol

 

 The time and temperature conditions that must be chosen to mimic the contact with the food are regulated for plastics in Directive 82/711/EEC as amended by 93/8/EEC and 97/48/EC93/8/EEC. Additional information can be found in CEN methods for overall migration (EN 1186-1:2002) and specific migrations (EN 13130-1:2005).

Contact time&temperature

The contact time and temperatures are selected using the table below.

Contact time Test time             Contact temperature Test temperature
t ≤5 min See below (**)   T ≤5 °C 5 °C
5 min <t ≤0,5 hours 0,5 hours   5 °C <T ≤20 °C 20 °C
0,5 h <t ≤1 hour 1 hours   20 °C <T ≤40 °C 40 °C
1h <t ≤2 hours 2 hours   40 °C <T ≤70 °C 70 °C
2h <t ≤4 hours 4 hours   70 °C <T ≤100 °C 100 °C or reflux temperature
4 hours <t ≤24 hours 24 hours   100 °C <T ≤121 °C 121 °C (*)
t >24 hours 10 days   121 °C <T ≤130 °C 130 °C (*)
      130 °C <T ≤150 °C 150 °C (*)
      T >150 °C 175 °C (*)
(*)This temperature shall be used only for simulant D.For simulants A,B or C the test may be replaced by a test at 100 °C or at reflux temperature for a duration of four times the time selected according to the general rules of paragraph 1.

(**) In those instances where the conventional conditions for migration testing are not adequately covered by the test contact conditions of Table 3 (for instance contact temperatures greater than 175 °C or contact time less than 5 minutes), other contact conditions may be used which are more appropriate to the case under examination, provided that the selected conditions may
represent the worst foreseeable conditions of contact for the plastic materials or articles being studied.

Example: if a packaging is used for sterilisation at 110°C for 15 minutes and subsequently storage at room temperature up to 3 months the test conditions would be 30 minutes at 121°C and subsequently for 10 days at 40°C.

In many cases national legislation also applies the use of such simulants, temperature and time conditions, to other, non-plastic, food contact materials.

 For ceramics a specific time/temperature/food simulant has been chosen: 22 °C for 24 hours using 4% acidic acid as food simulant regardless of the real-life application, as described in Directives 84/500/EEC and 2005/31/EC.

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