SIST EN 1186-7:2002
(Main)Materials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch
Materials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch
This part of this European Prestandard describes a method of test for the determination of the overall migration from one surface only of plastics in the form of sheet and film, which are intended to come into contact with foodstuffs, by forming the plastics film or sheet into standard pouches and exposure to the aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. A standard pouch is a pouch with the dimensions as described in 6.2. This method is most suitable for plastics in the form of films and sheets which are sealable by heat or pressure.
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 7: Prüfverfahren der Gesamtmigration in wässrige Prüflebensmittel mit einem Beutel
1 Anwendungsbereich
Dieser Teil dieser Europäischen Norm beschreibt Prüfverfahren zur Bestimmung der Gesamtmigration in wässrige Prüflebensmittel aus Kunststoffen, die dafür vorgesehen sind, mit Lebensmitteln in Berührung zu kommen, durch Herstellen eines Standardbeutels aus dem Kunststofffilm oder -bogen und Befüllen mit ausgewählten Prüflebensmitteln bei Prüftemperaturen bis zu und einschließlich 70 °C für ausgewählte Prüfzeiten.
Dieses Verfahren ist am besten geeignet für Kunststoffe in Form von Folien und Bögen, die durch Hitze oder Druck verschweißt werden können. Die Prüfung ist jedoch speziell anwendbar bei solchen Materialien, die aus mehr als einer Schicht bestehen, die im Kontakt mit Prüflebensmitteln nur mit der Oberfläche geprüft werden, welche vorgesehen ist, mit Lebensmitteln in Kontakt zu kommen.
Ein Standardbeutel ist ein Beutel mit Abmessungen, wie in 6.3 definiert.
ANMERKUNG Beutel mit anderen Abmessungen als 10 cm x 10 cm können zur Prüfung verwendet werden. Diese Beutel sollten wenn möglich so hergestellt werden, dass die gesamte benetzte Oberfläche nicht weniger als 1 dm2 beträgt.
Matériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie 7: Méthodes d'essai pour la migration globale dans les simulants aqueux a l'aide d'un sachet
La présente partie de la norme européenne spécifie une méthode d'essai permettant de déterminer la migration globale dans des simulants aqueux de plastiques sous forme de film ou de feuille, dont seule une face est destinée a entrer en contact avec des denrées alimentaires, en transformant le film ou la feuille plastique en sachets de référence et en les maintenant remplis du simulant choisi pendant les durées spécifiées a une température d'essai inférieure ou égale a 70 °C.
Cette méthode est généralement applicable aux plastiques sous forme de films et de feuilles scellables par chauffage ou par pression, mais plus particulierement aux matériaux composés de plusieurs couches, qui doivent etre essayés avec des simulants uniquement sur la surface destinée a entrer en contact avec les denrées alimentaires.
Un sachet de référence est un sachet dont les dimensions sont celles décrites en 6.3.
NOTE Des sachets de dimensions autres que 10 cm x 10 cm peuvent etre utilisés pour les essais. Il convient de les préparer de telle maniere que la surface totale exposée ne soit pas inférieure a 1 dm2.
Materiali in predmeti v stiku z živili - Polimerni materiali - 7. del: Preskusne metode za celotno migracijo v vodne modelne raztopine z vrečko
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 7: Prüfverfahren der Gesamtmigration in wässrige Prüflebensmittel mit einem BeutelMatériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie 7: Méthodes d'essai pour la migration globale dans les simulants aqueux a l'aide d'un sachetMaterials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 1186-7:2002SIST EN 1186-7:2002en01-september-2002SIST EN 1186-7:2002SLOVENSKI
STANDARDSIST ENV 1186-7:19971DGRPHãþD
SIST EN 1186-7:2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1186-7April 2002ICS 67.250Supersedes ENV 1186-7:1994English versionMaterials and articles in contact with foodstuffs - Plastics - Part7: Test methods for overall migration into aqueous foodsimulants using a pouchMatériaux et objets en contact avec les denréesalimentaires - Matière plastique - Partie 7: Méthodesd'essai pour la migration globale dans les liquidessimulateurs aqueux à l'aide d'un sachetWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Kunststoffe - Teil 7: Prüfverfahren der Gesamtmigration inwässrige Prüflebensmittel mit einem BeutelThis 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 1186-7:2002 ESIST EN 1186-7:2002
EN 1186-7:2002 (E)2ContentspageForeword.31Scope.52Normative references.53Principle.54Reagents.55Apparatus.66Preparation of test specimens.67Procedure.78Expression of results.99Test report.10Annex A (informative)
Example of a pouch holder.11Annex B (informative)
Precision data.12Annex ZA (informative)
Relationship of this European Standard with Council Directive 89/109/EECand Commission Directive 90/128/EEC and associated Directives.13Bibliography.15SIST EN 1186-7:2002
EN 1186-7:2002 (E)3ForewordThis Document EN 1186-7:2002 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 1186-7:1994.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 1186-7:2002 should be read in conjunction with EN 1186-1:2002.Further Parts of this standard have been prepared, and others are in preparation, concerned with the determinationof overall migration from plastics materials into food simulants.Their titles are as follows:EN 1186 - Materials and articles in contact with foodstuffs - Plastics –Part 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 5Test methods for overall migration into aqueous food simulants by cellPart 6Test methods for overall migration into olive oil 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 1186-7:2002
EN 1186-7:2002 (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 % ethanolAnnexes A and B are 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 1186-7:2002
EN 1186-7:2002 (E)51 ScopeThis Part of this European Standard specifies test methods for the determination of the overall migration intoaqueous based food simulants from plastics which are intended to come into contact with foodstuffs, by forming theplastics film or sheet into standard pouches and filling with a selected food simulant at test temperatures up to andincluding 70 °C for selected test times.This method is most suitable for plastics in the form of films and sheets which are sealable by heat or pressure.The test is particularly applicable to those materials consisting of more than one layer, which are tested with thefood simulant in contact only with the surface which is intended to be in contact with the foodstuffs.A standard pouch is a pouch with the dimensions as described in 6.3.NOTEPouches of dimensions other than 10 cm ´ 10 cm can be used for testing.
These pouches should be preparedwhere possible so that the total surface area exposed is not less than 1 dm².2 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 food – Plastics – Part 1: Guide to the selection of conditionsand 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, see clauses 4, 5 and 5 of EN 1186-1:2002.Test specimens in the form of pouches are filled with the aqueous food simulant for the exposure time attemperatures up to and including 70 °C.
At the end of the test period, the food simulant is removed from each testspecimen.
The food simulant from each test specimen is evaporated to dryness, the mass of the non-volatileresidue is determined 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 1186-7:2002
EN 1186-7:2002 (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 can be 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 mm, and with an accuracy of 0,1 mm.5.5Metal template (120 mm ± 1 mm) ´ (120 mm + 1 mm) (square).5.6Analytical balance capable of determining a change in mass of 0,1 mg.5.7Pouch holder, the example shown in Figure A.1 has been shown to be suitable, constructed from aluminiumor other suitable material or an equivalent holder, plus clips to secure corners of pouches.5.8Pipettes, complying with the minimum requirements of ISO 648, 50 ml and 100 ml.5.9Glass tubes, ground neck, and stoppers, for retaining the food simulant. Tubes with an internal diameter ofapproximately 35 mm and length in the range of 100 mm to 200 mm, excluding the ground neck, (see 7.2 ofEN 1186-1:2002) have been found to be satisfactory.5.10Thermostatically controlled oven or incubator or refrigerator capable of maintaining the set temperaturewithin the tolerances specified in Table B.2 of EN 1186-1:2002.5.11Dishes, 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.5.12Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of food simulant at the endof test period.5.13Desiccator with anhydrous calcium chloride or self indicating silica gel.5.14Heat or pressure sealing device, for use in forming pouches.5.15Measuring cylinders, 100 ml, complying with the minimum requirements of ISO 4788.6 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 sampleSIST EN 1186-7:2002
EN 1186-7:2002 (E)7with 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.6.2 Number of test specimensThree test specimens are required.6.3 Cutting and preparation of specimensLay the sample on the cutting slab (5.1) with the surface to be in contact with the food simulant uppermost and cutthe test specimens using the 120 mm ´ 120 mm template (5.5).Place pairs of the test pieces together with the surfaces to be in contact with the food simulant facing.
Using theheat or pressure sealer (5.14), join to form pouches with four seals parallel to all four edges, 10 mm from the edge.Measure the distances between the inner edges of the seals to the nearest 1 mm and calculate the total surfacearea of the test specimen which will be exposed to the food simulant, to the nearest 0,01 dm².
This shall beapproximately 2 dm2.
Using the cutting implement (5.3), remove excess film from the sealed area (to reduce areaof film not directly exposed to food simulant whilst leaving enough to withstand the test conditions without leaking.Measure and record the surface area of the pouch which will be in contact with the simulant and the total externalarea of the pouch after trimming excess material.Mark each pouch for identification.
Cut off one corner of the pouch to leave a hole sufficiently large to insert a100 ml pipette.7 Procedure7.1 Exposure to food simulantTake three glass tubes (5.9), for the simulant for filling the pouches and a further two to provide the blanks,measure by measuring cylinder 100 ml ± 2 ml of the food simulant into each tube. Insert a thermometer orthermocouple, if applicable, see NOTE 3, in one of the tubes and stopper the tubes.
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