CELEX: 31985L0572
Language: en
Date: 1985-12-19 00:00:00
Title: Council Directive 85/572/EEC 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

Avis juridique important

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31985L0572

Council Directive 85/572/EEC 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  

Official Journal L 372 , 31/12/1985 P. 0014 - 0021 Finnish special edition: Chapter 13 Volume 15 P. 0003  Spanish special edition: Chapter 13 Volume 19 P. 0041  Swedish special edition: Chapter 13 Volume 15 P. 0003  Portuguese special edition Chapter 13 Volume 19 P. 0041 

 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 (1) , and in particular Article 2 ( 3 )   thereof ,    Having regard to the proposal from the Commission (2) ,    Having regard to the opinion of the European   Parliament (3) ,    Having regard to the opinion of the Economic and   Social Committee (4) ,    Whereas , by virtue of Article 2 ( 3 ) of , together with   the first indent of Chapter 1 ( 2 ) of the Annex to   Directive 82/711/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 (5) ,    HAS ADOPTED THIS DIRECTIVE :    Article 1    Pursuant to Article 2 ( 3 ) of Directive 82/711/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 (6) .    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    (1) OJ No L 297 , 23 . 10 . 1982 , p. 26 .    (2) OJ No C 102 , 14 . 4 . 1984 , p. 4 .    (3) OJ No C 175 , 15 . 7 . 1985 , p. 299 .    (4) OJ No C 25 , 28 . 1 . 1985 , p. 6 .    (5) OJ No L 291 , 19 . 11 . 1969 , p. 9 .    (6) OJ No L 340 , 9 . 12 . 1976 , p. 19 .    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 A :    distilled water or water of equivalent quality ;    Simulant B :    3 % acetic acid ( w/v ) in aqueous solution ;    Simulant C :    15 % ethanol ( v/v ) in aqueous solution ;    Simulant D :    rectified olive oil (1) ; 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 (2) , or   by sunflower oil (3) .    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 .    4 . 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 .    5 . 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 .    (1) Characteristics of rectified olive oil    Iodine value ( Wijs ) = 80 to 88    Refractive index at 25 ° C = 1,4665 to 1,4679    Acidity ( expressed as % oleic acid ) = 0,5 % maximum    Peroxide number ( expressed as oxygen milliequivalents   per kg of oil ) = 10 maximum    (2) Composition of the synthetic triglycerides mixture    Fatty acid distribution    Number of C-atoms in fatty acid residue * 6 * 8 * 10 *   12 * 14 * 16 * 18 * others *    GLC area [ % ] * ~ 1 * 6 to 9 * 8 to 11 *   45 to 52 * 12 to 15 * 8 to 10 * 8 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 point 28 ± 2 ° C    Typical absorption spectrum ( thickness of layer :   d = 1 cm ; reference : water = 35 ° C )    Wavelength ( nm ) * 290 * 310 * 330 * 350 * 370 *   390 * 430 * 470 * 510 *    Transmittance ( % ) * ~ 2 * ~ 15 * ~ 37 * ~ 64 *   ~ 80 * ~ 88 * ~ 95 * ~ 97 * ~ 98 *    At least 10 % light transmittance at 310 nm   ( cell of 1 cm , reference : water 35 ° C )    (3) Characteristics of sunflower oil    Iodine value ( Wijs ) = 120 to 145    Refractive index at 20 ° C = 1,474 to 1,476    Saponification number = 188 to 193    Relative density at 20 ° C = 0,918 to 0,925    Unsaponifiable matter = 0,5 % to 1,5 %    TABLE    Reference number * Description of foodstuffs *   Simulants to be used *     * * A * B * C * D *    01 * Beverages * * * * *    01.01 * 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) * * *    01.02 * 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) * *    01.03 * Miscellaneous : undenatured ethyl   aclcohol * * X (1) * X (2) * *    02 * Cereals , cereal products , pastry , biscuits ,   cakes and other bakers' wares * * * * *    02.01 * Starches * * * * *    02.02 * Cereals , unprocessed , puffed , in flakes ,   ( including popcorn , corn flakes and the like ) * * * * *    02.03 * Cereal flour and meal * * * * *    02.04 * Macaroni , spaghetti and similar   products * * * * *    02.05 * Pastry , biscuits , cakes and , other bakers'   wares , dry : * * * * *     * A . With fatty substances on the surface * * * * X/5 *     * B . Other * * * * *    02.06 * Pastry , cakes and other bakers' wares ,   fresh : * * * * *     * A . With fatty substances on the surface * * * * X/5 *     * B . Other * X * * * *    03 * Chocolate , sugar and products thereof Confectionery   products * * * * *    03.01 * Chocolate , chocolate-coated products ,   substitutes and products coated with substitutes * * *   * X/5 *    03.02 * Confectionery products : * * * * *     * A . In solid form : * * * * *     * I . With fatty substances on the surface * * * * X/5 *     * II . Other * * * * *    Reference number * Description of foodstuffs *   Simulants to be used *     * * A * B * C * D *    03.02 ( continued ) * B . In paste form : * * * * *     * I . With fatty substances on the surface * * * * X/3 *     * II . Moist * X * * * *    03.03 * Sugar and sugar products : * * * * *     * A . In solid form *  * * *     * B . Honey and the like * X * * * *     * C . Molasses and sugar syrups * X * * * *    04 * Fruit , vegetables and products thereof * * * * *    04.01 * Whole fruit , fresh or chilled * * * * *    04.02 * 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 * *    04.03 * 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) *    04.04 * Whole vegetables , fresh or chilled * * * * *    04.05 * 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 * *    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 *    Reference number * Description of foodstuffs *   Simulants to be used *     * * A * B * C * D *    06 * Animal products and eggs * * * * *    06.01 * Fish : * * * * *     * A . Fresh , chilled , salted , smoked * X * * *   X/3 (5) *     * B . In the form of paste * X * * * X/3 (5) *    06.02 * Crustaceans and molluscs ( including oysters ,   mussels , snails ) not naturally protected by their   shells * X * * * *    06.03 * 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 *    06.04 * Processed meat products ( ham , salami ,   bacon and other ) * X * * * X/4 *    06.05 * 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 *    06.06 * Eggs not in shell : * * * * *     * A . Powdered or dried * * * * *     * B . Other * X * * * *    06.07 * Egg yolks : * * * * *     * A . Liquid * X * * * *     * B . Powdered or frozen * * * * *    06.08 * Dried white of egg * * * * *    07 * Milk products * * * * *    07.01 * Milk : * * * * *     * A . Whole * X * * * *     * B . Partly dried * X * * * *     * C . Skimmed or partly skimmed * X * * * *     * D . Dried * * * * *    07.02 * Fermented milk such as yoghourt , buttermilk   and such products in association with fruit and fruit   products * * X * * *    07.03 * Cream and sour cream * X (a) * X (a) * * *    07.04 * Cheeses : * * * * *     * A . Whole , with rind * * * * *     * B . Processed cheeses * X (a) * X (a) * * *     * C . All others * X (a) * X (a) * * X/3 (5) *    Reference number * Description of foodstuffs *   Simulants to be used *     * * A * B * C * D *    07.05 * Rennet : * * * * *     * A . In liquid or viscous form * X (a) * X (a) * * *     * B . Powdered or dried * * * * *    08 * Miscellaneous products * * * * *    08.01 * Vinegar * * X * * *    08.02 * Fried or roasted foods : * * * * *     * A . Fried potatoes , fritters and the like * * * *   X/5 *     * B . Of animal origin * * * * X/4 *    08.03 * 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) * * *    08.04 * Yeasts and raising agents : * * * * *     * A . In paste form * X (a) * X (a) * * *     * B . Dried * * * * *    08.05 * Salt * * * * *    08.06 * 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 *    08.07 * Mustard ( except powdered mustard under heading   08.17 ) * X (a) * X (a) * * X/3 (6) *    08.08 * Sandwiches , toasted bread and the like   containing any kind of foodstuff : * * * * *     * A . With fatty substances on the surface * * * * X/5 *     * B . Other * * * * *    08.09 * Ice-creams * X * * * *    08.10 * Dried foods : * * * * *     * A . With fatty substances on the surface * * * * X/5 *     * B . Other * * * * *    Reference number * Description of foodstuffs *   Simulants to be used *     * * A * B * C * D *    08.11 * Frozen or deep-frozen foods * * * * *    08.12 * Concentrated extracts of an alcoholic   strength equal to or exceeding 5 % vol * * X (8) * X * *    08.13 * Cocoa : * * * * *     * A . Cocoa powder * * * * X/5 (7) *     * B . Cocoa paste * * * * X/3 (7) *    08.14 * Coffee , whether or not roasted , decaffeinated   or soluble , coffee substitutes , granulated or   powdered * * * * *    08.15 * Liquid coffee extracts * X * * * *    08.16 * Aromatic herbs and other herbs : * * * * *     * camomile , mallow , mint , tea , lime blossom and   others * * * * *    08.17 * 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 .