ANNEX IIIFood simulants
1.Food simulants
For demonstration of compliance for plastic materials and articles not yet in contact with food the food simulants listed in Table 1 below are assigned.
Food simulant | Abbreviation |
---|---|
Ethanol 10 % (v/v) | Food simulant A |
Acetic acid 3 % (w/v) | Food simulant B |
Ethanol 20 % (v/v) | Food simulant C |
Ethanol 50 % (v/v) | Food simulant D1 |
Any vegetable oil containing less than 1 % unsaponifiable matter | Food simulant D2 |
poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm | Food simulant E |
2.General assignment of food simulants to foods
Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract hydrophilic substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.
Food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.
Food simulant E is assigned for testing specific migration into dry foods.
F13.Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food
For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according to Table 2 below.
For testing migration from materials and articles intended to come into contact with foods not listed in Table 2 below, or a combination of foods, the general food simulant assignments in point 2 shall be used for specific migration testing, and for overall migration testing the food simulant assignments in point 4 shall be applicable.
Table 2 contains the following information:
Column 1 (Reference number): contains the reference number of the food category
Column 2 (Description of food): contains a description of the foods covered by the food category
Column 3 (Food simulants): contains sub-columns for each of the food simulants
The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing migration of materials and articles not yet in contact with food.
For food categories where in sub-column D2 or E the cross is followed by an oblique stroke and a figure, the migration test result shall be corrected by dividing the result by this figure. The corrected test result shall then be compared to the migration limit to establish compliance. The test results for substances that shall not migrate in detectable quantities shall not be corrected in this way.
For food category 01.04 food simulant D2 shall be replaced by 95 % ethanol.
For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4,5.
For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted if it can be demonstrated that there is no ‘fatty contact’ with the plastic food contact material.
(1) | (2) | (3) | |||||
---|---|---|---|---|---|---|---|
Reference number | Description of food | Food simulants | |||||
A | B | C | D1 | D2 | E | ||
01 | Beverages | ||||||
01.01 | Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than or equal to 6 % vol.: | ||||||
| X(*) | X | |||||
| X(*) | X | |||||
01.02 | Alcoholic beverages of an alcoholic strength of between 6 %vol and 20 %. | X | |||||
01.03 | Alcoholic beverages of an alcoholic strength above 20 % and all cream liquors | X | |||||
01.04 | Miscellaneous: undenaturated ethyl alcohol | X(*) | Substitute 95 % ethanol | ||||
02 | Cereals, cereal products, pastry, biscuits, cakes and other bakers’ wares | ||||||
02.01 | Starches | X | |||||
02.02 | Cereals, unprocessed, puffed, in flakes (including popcorn, corn flakes and the like) | X | |||||
02.03 | Cereal flour and meal | X | |||||
02.04 | Dry pasta e.g. macaroni, spaghetti and similar products and fresh pasta | X | |||||
02.05 | Pastry, biscuits, cakes, bread, and other bakers’ wares, dry: | ||||||
| X/3 | ||||||
| X | ||||||
02.06 | Pastry, cakes, bread, dough and other bakers’ wares, fresh: | ||||||
| X/3 | ||||||
| X | ||||||
03 | Chocolate, sugar and products thereof Confectionery products | ||||||
03.01 | Chocolate, chocolate-coated products, substitutes and products coated with substitutes | X/3 | |||||
03.02 | Confectionery products: | ||||||
| |||||||
| X/3 | ||||||
| X | ||||||
| |||||||
| X/2 | ||||||
| X | ||||||
03.03 | Sugar and sugar products | ||||||
| X | ||||||
| X | ||||||
04 | Fruit, vegetables and products thereof | ||||||
F104.01 | Fruit, fresh or chilled: | ||||||
| X/10 | ||||||
| X | X (*) | |||||
04.02 | Processed fruit: | ||||||
| X | ||||||
| X(*) | X | |||||
| |||||||
| X | ||||||
| X | ||||||
04.03 | Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others): | ||||||
| X | ||||||
| X | ||||||
| X | X | |||||
F104.04 | Vegetables, fresh or chilled: | ||||||
| X/10 | ||||||
| X | X (*) | |||||
F104.05 | Processed vegetables:
| X | |||||
| |||||||
| X (*) | X | |||||
| |||||||
| X | X | |||||
| X | ||||||
05 | Fats and oils | ||||||
05.01 | Animals and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter) | X | |||||
05.02 | Margarine, butter and other fats and oils made from water emulsions in oil | X/2 | |||||
06 | Animal products and eggs | ||||||
06.01 | Fish: | ||||||
| X | X/3(**) | |||||
| |||||||
| X | X | |||||
| X(*) | X | |||||
06.02 | Crustaceans and molluscs (including oysters, mussels, snails) | ||||||
| |||||||
| |||||||
| X | X | |||||
| X(*) | X | |||||
06.03 | Meat of all zoological species (including poultry and game): | ||||||
| X | X/4(**) | |||||
| X | X/4(**) | |||||
| X | X | |||||
06.04 | Preserved meat: | ||||||
| X | X/3 | |||||
| X(*) | X | |||||
06.05 | Whole eggs, egg yolk, egg white | ||||||
| X | ||||||
| X | ||||||
07 | Milk products | ||||||
07.01 | Milk | ||||||
| X | ||||||
| X | ||||||
07.02 | Fermented milk such as yoghurt, buttermilk and similar products | X(*) | X | ||||
07.03 | Cream and sour cream | X(*) | X | ||||
07.04 | Cheeses: | ||||||
| X | ||||||
| X/3(**) | ||||||
| X(*) | X | |||||
| |||||||
| X | X | |||||
| X(*) | X | |||||
08 | Miscellaneous products | ||||||
08.01 | Vinegar | X | |||||
08.02 | Fried or roasted foods: | ||||||
| X | X/5 | |||||
| X | X/4 | |||||
08.03 | Preparations for soups, broths, sauces, in liquid, solid or powder form (extracts, concentrates); homogenised composite food preparations, prepared dishes including yeast and raising agents | ||||||
| |||||||
| X/5 | ||||||
| X | ||||||
| |||||||
| X | X(*) | X/3 | ||||
| X(*) | X | |||||
08.04 | Sauces: | ||||||
| X(*) | X | |||||
| X | X(*) | X | ||||
08.05 | Mustard (except powdered mustard under heading 08.14) | X | X(*) | X/3(**) | |||
08.06 | Sandwiches, toasted bread pizza and the like containing any kind of foodstuff | ||||||
| X | X/5 | |||||
| X | ||||||
08.07 | Ice-creams | X | |||||
08.08 | Dried foods: | ||||||
| X/5 | ||||||
| X | ||||||
08.09 | Frozen or deep-frozen foods | X | |||||
08.10 | Concentrated extracts of an alcoholic strength equal to or exceeding 6 % vol. | X(*) | X | ||||
08.11 | Cocoa: | ||||||
| X | ||||||
| X/3 | ||||||
08.12 | Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered | X | |||||
08.13 | Aromatic herbs and other herbs such as camomile, mallow, mint, tea, lime blossom and others | X | |||||
08.14 | Spices and seasonings in the natural state such as cinnamon, cloves, powdered mustard, pepper, vanilla, saffron, salt and other | X | |||||
08.15 | Spices and seasoning in oily medium such as pesto, curry paste | X |
F44.Food simulant assignment for testing overall migration
For tests to demonstrate compliance with the overall migration limit food simulants shall be chosen as set out in Table 3:
Foods covered | Food simulants in which testing shall be performed |
---|---|
all types of food |
|
all types of food except for acidic foods |
|
F3all aqueous and alcoholic foods and milk products with a pH ≥ 4,5 | food simulant D1 |
all aqueous and alcoholic foods and milk products with a pH < 4,5 | food simulant D1 and food simulant B |
all aqueous foods and alcoholic foods up to an alcohol content of 20 % | food simulant C |
all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % |
|
F25.General derogation to the assignment of food simulants
By derogation from the assignments of food simulants in points 2 to 4 of this Annex, where testing with several food simulants is required, a single food simulant shall be sufficient if on the basis of evidence acquired using generally recognised scientific methods this food simulant is shown to be the most severe food simulant for the particular material or article being tested under the applicable time and temperature conditions selected in accordance with Chapters 2 and 3 of Annex V.
The scientific basis on which this derogation is used shall in such cases form part of the documentation required under Article 16 of this Regulation.