CELEX: 51984PC0152
Language: en
Date: 1984-03-23
Title: PROPOSAL FOR A COUNCIL DIRECTIVE 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

N o C 102/4                            Official Journal of the European Communities                               14.4.84
                                                              II
                                                      (Preparatory Acts)
                                                COMMISSION
              Proposal for a Council Directive 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
                                                     COM(84) 152 final
                              (Submitted by the Commission to the Council on 2 April 1984)
                                                       (84/C 102/05)
T H E COUNCIL OF T H E EUROPEAN                                   the procedure, should in principle be the respon­
COMMUNITIES                                                       sibility of the Commission;
Having regard to the Treaty              establishing the         Whereas in all cases in which the Council confers on
European Economic Community,                                      the Commission authority to implement the
Having regard to Council Directive 82/711/EEC of                  provisions relating to plastic materials and articles
18 October 1982 laying down the basic rules                       intended to come into contact with foodstuffs, a
necessary for testing migration of the constituents of            procedure should be laid down establishing close
plastic materials and articles intended to come into              cooperation between Member States and the
contact with foodstufs ('), and in particular Article             Commission within the Standing Committee for
2 (3) thereof,                                                    Foodstuffs,
Having regard to the proposal from the Commission, ,              HAS ADOPTED THIS DIRECTIVE:
Having regard to the opinion of the European
Parliament,                                                                                 Article 1
Having regard to the opinion of the Economic and                  Pursuant to Article 2 (3) of Directive 82/711/EEC,
Social Commitee,                                                  the simulants to be used for testing migration of the
                                                                  constituents of plastic materials and articles intended
Whereas, by virtue of Article 2 (3) of, together with             to come into contact with a single foodstuff or
the first indent of Chapter I (2) of the Annex to                 specific group of foodstuffs and the concentration of
Directive 82/711/EEC, appropriate simulants to                    these simulants shall be those indicated in the Annex.
carry out migration tests should be indicated for
plastic materials and articles intended to come into                                        Article 2
contact with a single foodstuff or a specific group of
foodstuffs,                                                       Adaptations to be made to the Annex to this Directive
                                                                  in the light of progress in scientific and technical
Whereas, in determining appropriate simulants,                    knowledge shall be adopted in accordance with the
account must be taken in particular of the chemical               procedure laid down in Article 10 of Council
composition of the foodstuff and its physical prop­               Directive 76/893/EEC (2).
erties,
Whereas, for some foodstuffs containing fat, the                                            Article 3
result obtained in migration tests with the simulant is           Member States shall take all measures necessary to
higher than that obtained in migration tests with the
                                                                  comply with this Directive not later than such time as
foodstuff itself; whereas, therefore, the result should
                                                                  they take the measures to implement Directive
be corrected by applying a 'reduction factor' appro­
                                                                  82/711/EEC.
priate to the particular situation;
Whereas the adaptation of this Directive to technical                                       Article 4
progress constitutes an implementing measure, the
                                                                  This Directive is addressed to the Member States.
adoption of which, in order to simplify and accelerate
(') OJ N o L 297, 23. 10. 1982, p. 26.                            o   OJ N o L 340, 9. 12. 1976, p. 19.
 ---pagebreak--- 14. 4. 84                                 Official Journal of the European Communities                                         N o C 102/5
                                                                 ANNEX
                                                          LIST O F SIMULANTS
          1. In the following tables the simulants t o be used in migration tests with a particular foodstuff o r
              group of foodstuffs are identified b y the letters shown:
              Simulant A : distilled water o r the equivalent,
              Simulant B:- 3 % (w/v) acetic acid in aqueous solution,
              Simulant C : 15 % (v/v) ethanol in aqueous solution,
              Simulant D : rectified olive oil ('): if f o r technical reasons it proves impossible t o determine
                               migration in olive oil, the latter is replaced by sunflower oil o r by a standard
                               mixture of synthetic triglycerides ( 2 ).
          2. O n l y the simulant(s) indicated by an ' X ' is(are) t o be used f o r each heading o r subheading; a
              new sample should be used f o r each liquid. W h e r e n o ' X ' appears, n o migration test is required
              f o r the heading o r subheading concerned.
          3. W h e n ' X ' is followed by a stroke and a figure, the result of the migration tests should be divided
              b y the number indicated. In the case of certain types of fatty foodstuffs this, figure, known as the
              'reduction factor', is used t o take account of the greater extractive capacity of the simulating
              liquid f o r such foodstuffs.
          4. W h e r e the letter ' a ' is shown in brackets after the ' X ' , only one of the two simulants given
              should be used:
              — if the p H value of the foodstuff is higher than 5, simulant A should be used,
              — if the p H value of the foodstuff is 5 o r less, simulant B should be used.
          5. W h e r e a foodstuff is listed under both a specific and a general heading, only the simulant(s)
               indicated under the specific heading is(are) t o be used.
           ('). Characteristics o f rectified olive oil,:
                — iodine number (Wijs numbers) = 80 t o 88,
                — refractive index at 25° C = 1,4665 t o 1,4679,
                — acidity (expressed as % oleic acid) = 0,5 maximum,
                — number of peroxides (expressed as oxygen milli-equivalents per kilogram of oil) = 10 maximum.
            2
           ( ) Characteristics of the H B 307 standard mixture of synthetic triglycerides: see K. Figge, Fd. Cosmet. Toxicol.,
                10, 1972, p. 815.
 ---pagebreak--- N o C 102/6                         Official Journal of the European Communities                             14. 4. 84
                                                            TABLE
            Reference                                                             Simulants to be used
                No                    Description of foodstuffs
                                                                               A      B          C      D
               01      Beverages
               01.01   Beverages of an alcoholic strength lower than
                       5 % (v/v):
                       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, camomile,
                       beers and other                                       X(a)   X(a)
               01.02   Beverages of an alcoholic strength equal to or
                       exceeding 5 % (v/v):
                       Beverages shown under heading 01.01 but with
                       an alcoholic strength exceeding 5 % , wines, un-
                       denatured     ethyl    alcohol, potable      spirits,
                       concentrated extracts; liqueurs and other             X(a)   X(a)        X
               02     Cereals, cereal products, baker's and pastrycook's
                      wares
               02.01  Starches
               02.02  Cereals, unprocessed, puffed, in flakes (including
                      popcorn, corn flakes and the like)
              02.03   Cereal flours and meals
              02.04   Pasta products
              02.05   Baker's and pastrycook's wares, dry:
                      A. With fatty substances on the surface                                          X/5 •
                      B. Other
              02.06   Pastrycook's 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
                      B. In paste form:
                           I. With fatty substances on the surface                                     X/3
                          II. Semi-solid                                     X
              03.03.  Sugar and sugar products:
                      A. In solid form
                      B. Honey and the like                                  X
                      C. Molasses and sugar syrups                           X
 ---pagebreak--- 14. 4. 8 4                                     O f f i c i a l Journal o f t h e E u r o p e a n C o m m u n i t i e s                                            N o C 102/7
              Reference                                                                                                        Simulants t o b e us e d
                                                   Description o f f o o d s t u f f s
                  N o
                                                                                                                        A           B           C            D
                 04              Fruit, vegetables and products thereof
                 04.01          Whole fruit, fresh o r chilled
                 04.02           Processed fruit:
                                A. Dried o r dehydrated fruit whole o r in the
                                     form of flour o r powder
                                B. Fruit in the form of chunks, puree o r paste                                       X(a)        X(a)
                                C . Fruit preserves (jams and similar products —
                                     whole fruit o r chunks o r in the form of flour
                                     o r powder preserved in a liquid):
                                       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 % (v/v)
                                          alcohol)                                                                   X(a)         X(a)         X
                04.03           N u t s (peanuts, chestnuts, almonds, hazelnuts,
                                walnuts, pine kernels and other):
                                A. Shelled, dried
                                B. Shelled and roasted                                                                                                    X/5
                                C . In paste o r cream form                                                            X                                  X/3
                04.04           Whole vegetables, fresh o r chilled
                04.05           Processed vegetables:
                                A. Dried o r dehydrated vegetables whole o r in
                                    the f o r m of flour o r 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 % (v/v)
                                          alcohol)                                                                   X(a)        X(a)         X
                05              Fats and oils
                05.01          Animal and vegetable fats and oils, whether
                                natural o r treated (including cocoa butter, lard,
                                melted butter)                                                                                                             X
                05.02          Margarine, butter               and    other          fats and              oils
                               emulsified in water                                                                   X(a)        X(a)                    X/2
               06              Animal products and eggs
               06.01           Fish:
                               A. Fresh, chilled, salted, smoked                                                      X                                 X / 3 (')
                               B. In the form of paste                                                                X                                 X / 3 (>)
               06.02           Crustaceans and molluscs (including oysters,
                               mussels, snails) n o t naturally protected by their
                               shells                                                                                 X
           (') T h e test w i t h simulant D is t o b e use d o n l y f o r f o o d s t u f f s w i t h fatty substances o n the surface.
 ---pagebreak--- N o C 102/8                              O f f i c i a l J o u r n a l of t h e E u r o p e a n C o m m u n i t i e s                             14. 4. 84
                                                                                                                  Simulants t o be used
            Reference                       Description of foodstuffs
                No                                                                                                                C
                                                                                                        A               B                  D
               06.03        Meat of all zoological species (including poultry
                            and game):
                            A. Fresh, chilled, salted, smoked                                           X                               X / 3 (')
                            B. In the form of paste, creams                                             X                               X / 3 0)
               06.04        Processed meat products (ham, salami, bacon and
                            other)                                                                      X                               X / 3 (>)
               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                                X/3
                            B. Powdered or deep-frozen
               66.08       -Dried white of egg
                                                                                                                                  '
               07           Grocery products
               07.01        Vinegar                                                                                     X
                07.02       Cocoa:
                            A. Cocoa powder                                                                                               X/5
                            B. Cocoa paste                                                                                                X/3
             . 07.03        Coffee, whether roasted or not, decaffeinated or
                            soluble, coffee substitutes, granulated or pow­
                            dered
                07.04        Liquid coffee extracts                                                      X
                07:05       Aromatic herbs and medical herbs:
                             Chamomile, mallow, mint, tea, lime blossom tea
                             and other
                07.06        Yeasts and raising agents:
                             A. In paste form                                                          X(a)           X(a)
                             B. Dried
                07.07        Edible salt                                                                               -
                07.08        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. N o t emulsified water/oil sauces                                      X(a)           X(a)                  X
                07.09        Spices and seasonings in the natural state:
                             Cinnamon, cloves, powdered mustard, pepper,
                             vanilla, saffron and other
            (') T h e test with simulant D is to be used only for foodstuffs with fatty substances o n the surface.
 ---pagebreak--- 14. 4. 84                              Official Journal o f the European Communities                                              N o C 102/9
            Reference                                                                             Simulants to be used
                No                        Description of foodstuffs
                                                                                           A           B         C           D
              08          Milk products
              08.01       Milk:
                          A. Whole                                                       X(a)       X(a)
                          B. Dried or partly dried                                      • X(a)      X(a)
                          C. Skimmed or partly skimmed                                   X(a)       X(a)
              08.02       Fermented milk such as yoghourt, buttermilk and
                          such products in association with fruit and fruit
                          products                                                       X(a)       X(a)
              08.03       Cream                                                          X(a)       X(a)
              08.04       Cheeses:
                          A. Whole, with rind
                          B. Soft cheeses                                                X(a)       X(a)
                          C. All others                                                  X(a)       X(a)                X / 3 (')
              08.05       Rennet:
                          A. In liquid or viscous form                                   X(a)       X(a)
                          B. Powdered or dried
              09          Food preparations
              09.01       Fried o r roasted foods:
                          A. Fried potatoes, fritters and the like                                                        X/5
                          B. Of animal origin                                                                             X/3
              09.02       Preparations for soups, stews and broths; pre­
                          pared soups, stews and broths (extracts,
                          concentrates); homogenized composite food prep­
                          arations, prepared dishes:
                          A. Powdered or dried:
                               I. With fatty substances on the surface                                                    X/5
                              II. Other                                                                     •
                          B. Liquid or thick:
                               I. With fatty substances on the surface                   X(a)       X(a)                  X/3
                              II. Other                                                  X(a)       X(a)
              09.03       Mustard (except        powdered      mustard      under
                          heading 07.09)                                                 X(a)       X(a)                  X/3
              09.04       Spread bread, sandwiches, toasted bread and the
                          like containing any kind of foodstuff:
                          A. With fatty substances on the surface                                                         X/5
                          B. Other
              10          Miscellaneous products
              10.01       Ice-creams
              10.02       Dried foods:
                          A. With fatty substances on the surface                                                         X/5
                          B. Other
              10.03       Deep-frozen or quick-frozen foods
          (') If it can be demonstrated by means o f an appropriate test that there is n o 'fatty contact' with the plastic, the
              test with simulant D may be dispensed with.