SIST EN 1186-5:2002

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Materiali in predmeti v stiku z živili - Polimerni materiali - 5. del: Preskusne metode za celotno migracijo v vodne modelne raztopine z migracijsko celicoWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 5: Prüfverfahren für die Gesamtmigration in wässrigen Prüflebensmitteln mittels ZellenMatériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie 5: Méthodes d'essai pour la migration globale dans les liquides simulateurs aqueux en celluleMaterials and articles in contact with foodstuffs - Plastics - Part 5: Test methods for overall migration into aqueous food simulants by cell67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 1186-5:2002SIST EN 1186-5:2002en01-september-2002SIST EN 1186-5:2002SLOVENSKI
STANDARDSIST ENV 1186-5:19971DGRPHãþD



SIST EN 1186-5:2002



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1186-5April 2002ICS 67.250Supersedes ENV 1186-5:1994English versionMaterials and articles in contact with foodstuffs - Plastics - Part5: Test methods for overall migration into aqueous foodsimulants by cellMatériaux et objets en contact avec les denréesalimentaires - Matière plastique - Partie 5: Méthodesd'essai pour la migration globale dans les liquidessimulateurs aqueux en celluleWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Kunststoffe - Teil 5: Prüfverfahren für dieGesamtmigration in wässrigen Prüflebensmitteln mittelsZellenThis European Standard was approved by CEN on 4 January 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1186-5:2002 ESIST EN 1186-5:2002



EN 1186-5:2002 (E)2ContentspageForeword.31Scope.52Normative references.53Principle.54Reagents.55Apparatus.66Preparation of test specimens.77Number of test specimens.78Procedure.79Expression of results.910Test report.9Annex A (informative)
Precision data.10Annex ZA (informative)
Relationship of this European Standard with Council Directive 89/109/EECand Commission Directive 90/128/EEC and associated Directives.11Bibliography.13SIST EN 1186-5:2002



EN 1186-5:2002 (E)3ForewordThis document EN 1186-5:2002 has been prepared by Technical Committee CEN/TC 194 "Utensils in contact withfood”, the secretariat of which is held by BSI.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by October 2002, and conflicting national standards shall be withdrawn at the latestby October 2002.This document supersedes ENV 1186-5:1994.This European Standard is one of a series of methods of test for plastics materials and articles in contact withfoodstuffs.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EC Directive(s).For relationship with EC Directive(s), see informative annex ZA, which is an integral part of this document.At the time of preparation and publication of this standard the European Union legislation relating to plasticsmaterials and articles intended to come into contact with foodstuffs is incomplete.
Further Directives andamendments to existing Directives are expected which could change the legislative requirements which thisstandard supports.
It is therefore strongly recommended that users of this standard refer to the latest relevantpublished Directive(s) before commencement of any of the test or tests described in this standard.EN 1186-5 should be read in conjunction with EN 1186-1.Further Parts of this standard have been prepared concerned with the determination of overall migration fromplastics materials into food simulants.
Their titles are as follows:EN 1186 - Materials and articles in contact with foodstuffs – PlasticsPart 1Guide to the selection of conditions and test methods for overall migrationPart 2Test methods for overall migration into olive oil by total immersionPart 3Test methods for overall migration into aqueous food simulants by total immersionPart 4Test methods for overall migration into olive oil by cellPart 6Test methods for overall migration into olive oil using a pouchPart 7Test methods for overall migration into aqueous food simulants using a pouchPart 8Test methods for overall migration into olive oil by article fillingPart 9Test methods for overall migration into aqueous food simulants by article fillingPart 10Test methods for overall migration into olive oil modified method for use in cases whereincomplete extraction of olive oil occurs)Part 11Test methods for overall migration into mixtures of 14C-labelled synthetic triglyceridePart 12Test methods for overall migration at low temperaturesSIST EN 1186-5:2002



EN 1186-5:2002 (E)4Part 13Test methods for overall migration at high temperaturesPart 14Test methods for 'substitute tests' for overall migration from plastics intended to come intocontact with fatty foodstuffs using test media iso-octane and 95 % ethanolPart 15Alternative test methods to migration into fatty food simulants by rapid extraction into iso-octane and/or 95 % ethanolAnnex A is informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SIST EN 1186-5:2002



EN 1186-5:2002 (E)51 ScopeThis Part of this European Standard specifies test methods for the determination of the overall migration intoaqueous based food simulants from one surface only of plastics, which are intended to come into contact withfoodstuffs, by exposing the food contact surface, using a cell, to the selected food simulant at temperatures up toand including 70 °C for selected test times.This method is most suitable for plastics in the form of films and sheets, but is particularly applicable to thosematerials consisting of more than one layer or of surfaces that differ in their migration characteristics, which shouldbe tested with the food simulant in contact only with the surface which is intended to come into contact withfoodstuffs.2 Normative referencesThis European Standard incorporates by dated and undated reference, provisions from other publications.
Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to and revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision.
For undated references the latest edition of thepublication referred to applies (including amendments).EN 1186-1:2002, Materials and articles in contact with foodstuffs – Plastics – Part 1: Guide to the selection ofconditions and test methods for overall migration.ISO 648, Laboratory glassware - One mark pipettes.ISO 4788, Laboratory glassware - Graduated measuring cylinders.3 PrincipleThe overall migration of non-volatile substances from a sample of the plastics is determined as the mass of non-volatile residue after evaporation of the food simulant.The selection of the conditions of test and the food simulant(s) will be determined by the conditions of use, seeclauses 4, 5 and 6 of EN 1186-1:2002.Test specimens of approximately 2,5 dm² are exposed in a cell to the food simulant for the exposure time attemperatures up to and including 70 °C.
At the end of the test period, each test specimen is removed from the cell.The food simulant from each test specimen is evaporated to dryness, the mass of the non-volatile residue isdetermined gravimetrically and expressed as milligrams per square decimetre of surface area of test specimen.NOTEIn some circumstances the procedure described in this standard can be used for exposure at temperatures above70 °C.Overall migration is reported as the mean of three determinations on separate test specimens.4 ReagentsNOTEFor details of the preparation and purity of these reagents see clause 4 of EN 1186-1:2002.4.1Distilled water or water of equivalent quality (simulant A)4.2Acetic acid 3 % (w/v) in aqueous solution (simulant B)SIST EN 1186-5:2002



EN 1186-5:2002 (E)64.3Ethanol 10 % (v/v) in aqueous solution (simulant C)4.4Alcoholic simulants for liquids or beverages of an alcoholic strength exceeding 10 % (v/v).NOTEIn the case of materials and articles intended to come into contact with liquids or beverages of an alcoholic strengthexceeding 10 % (v/v) the test is carried out with aqueous solutions of ethanol of a similar strength.5 Apparatus5.1Cutting slab, clean smooth glass, metal or plastics slab of suitable area to prepare test specimens,250 mm ´ 250 mm is suitable.5.2Tweezers, stainless steel, blunt nosed.5.3Cutting implement, scalpel, scissors or sharp knife or other suitable device.5.4Rule, graduated in millimetres, and with an accuracy of 0,1 mm.5.5Analytical balance capable of determining a change in mass of 0,1 mg.5.6Cells, type A as shown in Figure C.3 of EN 1186-1:2002, either the all aluminium (anodized) cells or the cellswith the stainless steel (316 grade) lids and rings, are suitable for the water and aqueous ethanol food simulants.For the aqueous acetic acid food simulant the cells with the stainless steel lids and rings are used.
The internaldiameter of the rim of the sealing ring shall be 178,4 mm ± 0,1 mm, to give an area of the test specimen exposed tothe food simulant of 2,5 dm².NOTEThe cells, type A, are constructed with a rubber mat in the base plate.
When using the cells with either the water oraqueous ethanol food simulants it is advised that a disc of aluminium foil is placed on the mat before inserting the testspecimen.
For the aqueous acetic acid food simulant a disc of polytetrafluoroethylene or other suitable material which is inert toacetic acid can be used.
The use of these discs will prevent any substances from the mat influencing the migration result.For details of equivalent cells see 7.3 of EN 1186-1:2002.5.7Pipettes, complying with the minimum requirements of ISO 648, 50 ml and 100 ml.5.8Glass tubes, ground neck, and stoppers, for retaining the food simulant.
Tubes with an internal diameter ofapproximately 35 mm and length of approximately 100 mm to 200 mm, excluding the ground neck (see 7.2 of EN1186-1:2002), have been found to be satisfactory.5.9Thermostatically controlled oven or incubator or refrigerator capable of maintaining a set temperature withinthe tolerances specified in Table B.2 of EN 1186-1:2002.5.10Dishes, stainless steel, nickel, platinum, platinum alloy, gold, 50 mm to 90 mm diameter and maximum mass100 g, for evaporation of food simulants and weighing of residues.
Glass, glass ceramic or ceramic dishes may beused, provided that the surface characteristics are such that the masses of the dishes after evaporation of anyspecified food simulants followed by conditioning in the desiccator used achieves a constancy of ± 0,5 mg.Stainless steel and nickel dishes are suitable only for distilled water and ethanol solutions.
Glass, glass ceramic,glazed ceramic, platinum, platinum alloy or gold dishes are suitable for all three simulants.5.11Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of food simulant at the endof test period.5.12Desiccator with anhydrous calcium chloride or self indicating silica gel.5.13Measuring cylinders, 250 ml, complying with the minimum requirements of ISO 4788.SIST EN 1186-5:2002



EN 1186-5:2002 (E)76 Preparation of test specimens6.1 GeneralIt is essential that test specimens are clean and free from surface contamination (many plastics can readily attractdust due to static charges).
Before preparing test specimens, remove any surface contamination from the sampleby gently wiping it with a lint free cloth, or by brushing with a soft brush.
Under no circumstances wash the samplewith water or solvent.
If it is specified in the instructions for use of the article that it should be washed or cleanedbefore use, see 8.1 of EN 1186-1:2002.
Minimize handling of the samples and where necessary, wear cottongloves.7 Number of test specimensThree test specimens are required for samples, in the form of thin films, sheets, and flat sections cut fromcontainers or similar articles.7.1 Cutting test specimensLay the sample on the cutting slab (5.1) with the surface to be in contact with the food simulant uppermost.
Takethe ring from the standard cell (5.6) and place on the surface of the sample.
Cut out the test specimen by cuttinground the outer edge of the ring, using the cutting implement (5.3).8 Procedure8.1 Exposure to food simulantTake three cells (5.6), mark these for identification purposes.
Place in the thermostatically contr
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