ANNEXLIST OF SIMULANTS

Council Directive of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (85/572/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs OJ No L 297, 23. 10. 1982, p. 26. , and in particular Article 2 (3) thereof, Having regard to the proposal from the Commission OJ No C 102, 14. 4. 1984, p. 4. , Having regard to the opinion of the European Parliament OJ No C 175, 15. 7. 1985, p. 299. , Having regard to the opinion of the Economic and Social Committee OJ No C 25, 28. 1. 1985, p. 6. , Whereas, by virtue of Article 2 (3) of, together with the first indent of Chapter 1 (2) of the Annex to Directive 82/71 I/EEC, appropriate simulants to carry out migration tests should be indicated for plastic materials and articles intended to come into contact with a single foodstuff or a specific group of foodstuffs; Whereas the possibility should not be excluded, where necessary, of making use of methods for testing migration other than those laid down in this Directive; Whereas, in determining appropriate simulants, account must be taken in particular of the chemical composition of the foodstuff and its physical properties; Whereas, for some foodstuffs containing fat, the result obtained in migration tests with the simulant is higher than that obtained in migration tests with the foodstuff itself and whereas therefore the result should be corrected by applying a reduction factor appropriate to the particular situation; whereas in certain specific cases, particularly that of materials and objects in contact with foodstuffs with fatty substances on the surface, the existence of appropriate methods of analysis is essential for implementation of this Directive; Whereas the adaptation of this Directive to technical progress constitutes an implementing measure, the adoption of which, in order to simplify and accelerate the procedure, should in principle be the responsibility of the Commission; Whereas in all cases in which the Council confers on the Commission authority to implement the provisions relating to plastic materials and articles intended to come into contact with foodstuffs, a procedure should be laid down establishing close cooperation between Member States and the Commission within the Standing Committee for Foodstuffs, set up under Decision 69/414/EEC OJ No L 291, 19. 11. 1969, p. 9. , HAS ADOPTED THIS DIRECTIVE:

Article 1

Pursuant to Article 2 (3) of Directive 82/71 I/EEC, the simulants to be used for testing migration of the constituents of plastic materials and articles intended to come into contact with a single foodstuff or specific group of foodstuffs and the concentration of these simulants shall be those indicated in the Annex.

Article 2

Notwithstanding Article 1, the list of substances or materials whose use is authorized to the exclusion of all others may lay down procedures testing migration of particular constituents of plastic materials and articles which differ from those laid down in the Annex where this is appropriate.

Article 3

Adaptations to be made to the Annex to this Directive in the light of progress in scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC OJ No L 340, 9. 12. 1976, p. 19. .

Article 4

Member States shall take all measures necessary to comply with this Directive not later than such time as they take the measures to implement Directive 82/711/EEC

Article 5

This Directive is addressed to the Member States. Done at Brussels, 19 December 1985. For the Council The President M. Fischbach

Annex

ANNEX LIST OF SIMULANTS

1. In the following tables, which make up a non-exhaustive list of foodstuffs, the simulants to be used in migration tests with a particular foodstuff or group of foodstuffs are identified by the letters shown: Simulant Adistilled water or water of equivalent quality;Simulant B3 % acetic acid (w/v) in aqueous solution;Simulant C15 % ethanol (v/v) in aqueous solution;Simulant Drectified olive oil Characteristics of rectified olive oil Iodine value (Wijs)= 80 to 88Refractive index at 25 oC= 1,4665 to 1,4679Acidity (expressed as % oleic acid)= 0,5 % maximumPeroxide number (expressed as oxygen milliequivalents per kg of oil)= 10 maximum; if for technical reasons connected with the method of analysis it is necessary to use different simulants, olive oil must be replaced by a mixture of synthetic triglycerides Composition of the synthetic triglycerides mixture Fatty acid distribution Number of C-atoms in fatty acid residue681012141618othersGLC area [%]~ 16 to 98 to 1145 to 5212 to 158 to 108 to 12≤ 1 Purity Content of monoglycerides (enzymatically)≤ 0,2 %Content of diglycerides (enzymatically)≤ 2,0 %Unsaponifiable matter≤ 0,2 %Iodine value (Wijs)≤ 0,1 %Acid value≤ 0,1 %Water content (K. Fischer)≤ 0,1 %Melting point28 ± 2oC Typical absorption spectrum (thickness of layer: d = 1 cm; reference: water = 35 oC) Wavelength (nm)290310330350370390430470510Transmittance (%)~ 2~ 15~ 37~ 64~ 80~ 88~ 95~ 97~ 98 At least 10 % light transmittance at 310 nm (cell of 1 cm, reference: water 35 oC) , or by sunflower oil Characteristics of sunflower oil Iodine value (Wijs)= 120 to 145Refractive index at 20 oC= 1,474 to 1,476Saponification number= 188 to 193Relative density at 20 oC= 0,918 to 0,925Unsaponifiable matter= 0,5 % to 1,5 %.
2. For each foodstuff or group of foodstuffs, only the simulant(s) indicated by an X is (are) to be used, using for each simulant, a new sample of the materials and subject concerned. Where no X appears, no migration test is required for the heading or subheading concerned.
3. When X is followed by an oblique stroke and a figure, the result of the migration tests should be divided by the number indicated. In the case of certain types of fatty foodstuffs this figure, known as the reduction factor, is conventionally used to take account of the greater extractive capacity of the simulant for such foodstuffs.

1. Where the letter a is shown in brackets after the X, only one of the two simulants given should be used: if the pH value of the foodstuff is higher than 4,5, simulant A should be used, if the pH value of the foodstuff is 4,5, or less, simulant B should be used.
2. Where a foodstuff is listed under both a specific and a general heading, only the simulant(s) indicated under the specific heading is (are) to be used. TABLE This test shall be carried out only in cases where the pH is 4,5 or less. 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. This test is to be used only where the pH is 4,5 or less. 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. Reference numberDescription of foodstuffsSimulants to be usedABCD01Beverages01.01Non-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 otherX(a)X(a)01.02Alcoholic 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 liqueursXX01.03Miscellaneous: undenatured ethyl aclcoholXX02Cereals, cereal products, pastry, biscuits, cakes and other bakers' wares02.01Starches02.02Cereals, unprocessed, puffed, in flakes, (including popcorn, corn flakes and the like)02.03Cereal flour and meal02.04Macaroni, spaghetti and similar products02.05Pastry, biscuits, cakes and, other bakers' wares, dry: A. With fatty substances on the surface X/5 B. Other 02.06Pastry, cakes and other bakers' wares, fresh: A. With fatty substances on the surface X/5 B. Other X03Chocolate, sugar and products thereof Confectionery products03.01Chocolate, chocolate-coated products, substitutes and products coated with substitutesX/503.02Confectionery 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 X03.03Sugar and sugar products: A. In solid form B. Honey and the like X C. Molasses and sugar syrups X04Fruit, vegetables and products thereof04.01Whole fruit, fresh or chilled04.02Processed fruit: A. Dried or dehydrated fruit, whole or in the form of flour or powder B. Fruit in the form of chunks, puree 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.) XX04.03Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and other): A. Shelled, dried B. Shelled and roasted

X/5 C. In paste or cream form XX/304.04Whole vegetables, fresh or chilled04.05Processed vegetables: A. Dried or dehydrated vegetables whole or in the form of flour or powder B. Vegetables, cut, in the form of purees 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.) XX05Fats and oils05.01Animals and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)X05.02Margarine, butter and other fats and oils made from water emulsions in oilX/2 06Animal products and eggs06.01Fish: A. Fresh, chilled, salted, smoked XX/3 B. In the form of paste XX/306.02Crustaceans and molluscs (including oysters, mussels, snails) not naturally protected by their shellsX06.03Meat of all zoological species (including poultry and game): A. Fresh, chilled, salted, smoked XX/4 B. In the form of paste, creams XX/406.04Processed meat products (ham, salami, bacon and other)XX/406.05Preserved and part-preserved meat and fish: A. In an aqueous medium X (a)X (a) B. In an oily medium X (a)X (a)X06.06Eggs not in shell: A. Powdered or dried B. Other X06.07Egg yolks: A. Liquid X B. Powdered or frozen 06.08Dried white of egg07Milk products07.01Milk: A. Whole X B. Partly dried X C. Skimmed or partly skimmed X D. Dried 07.02Fermented milk such as yoghourt, buttermilk and such products in association with fruit and fruit productsX07.03Cream and sour creamX (a)X (a)07.04Cheeses: A. Whole, with rind B. Processed cheeses X (a)X (a) C. All others X (a)X (a)X/3 07.05Rennet: A. In liquid or viscous form X (a)X (a) B. Powdered or dried 08Miscellaneous products08.01VinegarX08.02Fried or roasted foods: A. Fried potatoes, fritters and the like X/5 B. Of animal origin X/408.03Preparations 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)08.04Yeasts and raising agents: A. In paste form X (a)X (a) B. Dried 08.05Salt08.06Sauces: 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)X08.07Mustard (except powdered mustard under heading 08.17)X (a)X (a)X/308.08Sandwiches, toasted bread and the like containing any kind of foodstuff: A. With fatty substances on the surface X/5 B. Other 08.09Ice-creamsX08.10Dried foods: A. With fatty substances on the surface X/5 B. Other 08.11Frozen or deep-frozen foods08.12Concentrated extracts of an alcoholic strength equal to or exceeding 5 % volXX08.13Cocoa: A. Cocoa powder X/5 B. Cocoa paste X/308.14Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered08.15Liquid coffee extractsX08.16Aromatic herbs and other herbs:camomile, mallow, mint, tea, lime blossom and others08.17Spices and seasonings in the natural state:cinnamon, cloves, powdered mustard, pepper, vanilla, saffron and other