EN 1186-11:2002

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 11: Prüfverfahren für die Gesamtmigration in Mischungen aus 14C-markierten synthetischen TriglyceridenMatériaux et objets en contact avec les denrées alimentaires - Matieres plastiques - Partie 11: Méthodes d'essai pour la migration globale dans des mélanges de triglycérides synthétiques marqués au 14CMaterials and articles in contact with foodstuffs - Plastics - Part 11: Test methods for overall migration into mixtures of C-labelled synthetic triglycerides67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 1186-11:2002SIST EN 1186-11:2003en01-januar-2003SIST EN 1186-11:2003SLOVENSKI
STANDARDSIST ENV 1186-11:19971DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1186-11September 2002ICS 67.250English versionMaterials and articles in contact with foodstuffs - Plastics - Part11: Test methods for overall migration into mixtures of C-labelledsynthetic triglyceridesMatériaux et objets en contact avec les denréesalimentaires - Matière plastique - Partie 11: Méthodesd'essai pour la migration globale dans des mélanges detriglycérides synthétiques marqués au CWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Kunststoffe - Teil 11: Prüfverfahren für dieGesamtmigration in Mischungen aus 14C-markiertensynthetischen TriglyceridenThis European Standard was approved by CEN on 29 April 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 1186-11:2002 ESIST EN 1186-11:2003

Determination of the need for sample conditioning.48Annex B (normative)
Determination of the need for sample conditioning anddetermination of the mass of moisture sensitive test specimens, by vacuum drying.49Annex C (normative)
Determination of change in moisture content of test specimens bymeasurement of the transfer of water to, or from mixture of 14C-labelled synthetictriglycerides, by Karl Fischer titration.51Annex D (informative)
Example of a pouch holder.54Annex E (informative)
Precision data.55Annex ZA
(informative)
Relationship of this European Standard with Council Directive89/109/EEC and Commission Directive 90/128/EEC and associated Directives.56Bibliography.58SIST EN 1186-11:2003

FurtherDirectives and amendments to existing Directives are expected which could change the legislativerequirements which this standard supports.
It is therefore strongly recommended that users of thisstandard refer to the latest relevant published Directive(s) before commencement of any of the test ortests described in this standard.Further parts of this standard have been prepared, concerned with the determination of overallmigration 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 foroverall 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 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 12Test methods for overall migration at low temperaturesPart 13Test methods for overall migration at high temperaturesPart 14Test methods for 'substitute tests' for overall migration from plastics intended to comeinto contact 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 % ethanolSIST EN 1186-11:2003

These normative references are cited at the appropriate places in the text and thepublications are listed hereafter. For dated references, subsequent amendments to and revisions ofany of these publications apply to this European Standard only when incorporated in it by amendmentor revision.
For undated references the latest edition of the publication referred to applies (includingamendments).EN 1186-1:2002, Materials and articles in contact with foodstuffs – Plastics - Part 1: Guide to theselection of conditions and test methods for overall migration.EN 10088-1, Stainless steels – Part 1: List of stainless steels.ISO 648, Laboratory glassware - One mark pipettes.ISO 4788, Laboratory glassware - Graduated measuring cylinders.3 Method A Total immersion3.1 PrincipleWARNINGThe use and disposal of 14C labelled substances are subject to regulations which vary fromcountry to country.
Laboratories should ensure that they comply with local legislation requirements.NOTE 1This method is most suitable for plastics in the form of films and sheets, but can be applied to a widerange of articles or containers from which test pieces of a suitable size can be cut.The overall migration from a sample of the plastics is determined as the loss in mass per unit ofsurface area intended to come into contact with foodstuffs.The selection of the conditions of test will be determined by the conditions of use, see clauses 6 and 7of EN 1186-1:2002.SIST EN 1186-11:2003

In this method the mixture of 14C-labelled synthetictriglycerides that remains after soxhlet extraction is released by dissolution or combustion.
Thecombustion method is suitable for all plastics, the dissolution method is only suitable for polymers thatare soluble in a suitable solvent, e.g. tetrahydrofuran.NOTE 2Good sensitivity can only be achieved for samples of very low mass, e.g. for thin films.
The specificradioactivity of the mixture of 14C-labelled synthetic triglycerides routinely used is approximately 200 dpm/mg.
Inroutine tests the limit of determination in liquid scintillation counting is in the order of 20 dpm per sample, forcombustion, and 10 dpm per sample, for dissolution.
In combustion only aliquots up to approximately 50 mg canbe used.
Consequently the determination limit for retained simulant is in the order of 0,1 mg to 50 mg.
It isapparent that for heavy test specimens the method gives only an estimation of the retained simulant.
Thedissolution method, which is generally preferred, results in similar figures.
A higher specific radioactivity of thesimulant would improve the determination limit.Migration into the mixture of 14C-labelled synthetic triglycerides is calculated by subtracting the mass of14C-labelled synthetic triglycerides retained by the test specimen from the mass of the test specimenafter removal from the 14C-labelled synthetic triglycerides, and then subtracting this mass from theinitial mass of the specimen.The total loss in mass is expressed in milligrams per square decimetre of surface area of the specimenand the overall migration is reported as the mean of a minimum of three determinations on separatetest specimens.To allow for inaccuracies which may arise during the procedure and which may be difficult to detect,due for example to contamination or loss of the 14C-labelled synthetic triglycerides during the samplehandling stages, quadruplicate determinations are carried out on the sample allowing for the resultfrom one specimen to be discarded.This method includes variations which are applicable to certain plastics and to experiencedlaboratories.3.2 ReagentsNOTEAll reagents should be of recognized analytical quality, unless otherwise specified.3.2.1 Mixture of 14C-labelled synthetic triglycerides, simulant D as specified in 5.2 ofEN 1186-1:2002.NOTEDetails of suppliers can be obtained from CEN.3.2.2 Extraction solvent (see 10.1 of EN 1186-1:2002).3.2.2.1Pentane 98 % (mixed isomers) boiling point 36 °C.WARNINGPentane is a very volatile and highly flammable solvent.
Take care when using and handlingthis solvent to prevent contact with sources of ignition.
It is not recommended for extractions with thissolvent to be left unattended, particularly overnight.NOTEDue to low boiling point of the solvent, cooled condenser water can be used to prevent undue loss ofthe solvent from the condenser.SIST EN 1186-11:2003

For environmental reasons the use of this solventshould be avoided where possible, see 10.1 of EN 1186-1:2002.
Experience has shown that this solvent althougheffective for most plastics requires longer periods of extraction.3.2.3 Liquid scintillation cocktail, suitable for scintillation counting of the 14C-labelled synthetictriglycerides and in which the fat simulant is soluble.3.2.4 Diethyl ether.3.2.5 Karl Fischer solvent, commercially prepared, methanol and chloroform based, water capacityof 5 mg/ml.3.2.6 Karl Fischer titrant (for volumetric apparatus only), commercially prepared, water capacity of 2mg/ml.3.3 Apparatus3.3.1 Cutting slab, clean smooth glass, metal or plas
...