SIST EN 13130-1:2004

Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 1: Guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants

This part of this European Standard provides a guide to the selection of the appropriate conditions of contact of food simulants with the test article before the determination of specific migration of those substances subject to a migration limit.
NOTE   According to Directive 90/128/EEC[2] the determination of the migration of specified components in foodstuffs instead of the use of simulants is permitted.  However, in that situation there is no need to give guidance on the test conditions of time and temperature as contact conditions shall be equal to conditions applied in real.
Also general guidance is given for the determination of the amount of the substance in the final plastics material or article.

Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Substanzen in Kunststoffen, die Beschränkungen unterliegen - Teil 1: Leitfaden für die Prüfverfahren für die spezifische Migration von Substanzen aus Kunststoffen in Lebensmittel und Prüflebensmittel, die Bestimmung von Substanzen in Kunststoffen und die Auswahl von Kontaktbedingungen mit Prüflebensmitteln

Dieser Teil dieser Europäischen Norm stellt eine Anleitung für die geeigneten Bedingungen des Kontakts von Prüflebensmitteln mit dem zu prüfenden Kunststoff vor der Bestimmung der spezifischen Migration derjenigen Substanzen, die einem Migrationsgrenzwert unterliegen, dar.
ANMERKUNG   Nach der Richtlinie 2002/72/EG [2] ist die Bestimmung der Migration festgelegter Kunststoffbestandteile in Lebensmittel anstelle der Verwendung von Prüflebensmitteln zulässig. Für diese Situation besteht jedoch keine Notwendigkeit, eine Anleitung zu den Prüfbedingungen Zeit und Temperatur zu geben, da die Expositionsbedingungen den tatsächlich angewendeten Bedingungen gleich sein müssen.
Es wird auch eine allgemeine Anleitung für die Bestimmung der Substanzmenge im endgültigen Kunststoffmaterial oder  bedarfsgegenstand gegeben.

Matériaux et objets en contact avec des denrées alimentaires - Substances dans les matieres plastiques soumises a des limitations - Partie 1 : Guide des méthodes d'essai pour la migration spécifique dans les denrées alimentaires et les simulants d'aliments de substances contenues dans les matieres plastiques, détermination des substances dans les matieres plastiques et choix des conditions d'exposition aux simulants d'aliments

La présente partie de cette Norme européenne constitue un guide pour le choix des conditions appropriées de contact de denrées alimentaires avec l'objet d'essai avant la détermination de la migration spécifique des substances soumises a des limitations de migration.
NOTE   Conformément a la Directive 2002/72/CE [2], la détermination de la migration de composants spécifiés dans les denrées alimentaires a la place de l'utilisation de simulants est autorisée. Dans ce cas, il n'est toutefois pas nécessaire de fournir des conseils sur les conditions d'essai quant a la durée et aux températures, car les conditions de contact doivent etre identiques a celles appliquées en réalité.
Des conseils généraux sont également fournis pour déterminer la teneur de la substance dans le matériau ou l'objet fini en matiere plastique.

Materiali in predmeti v stiku z živili - Snovi v polimernih materialih, katerih koncentracija je omejena - 1. del: Vodilo za preskusne metode za specifično migracijo snovi iz polimernih materialov v živila in njihove modelne raztopine ter določevanje snovi v polimernih materialih in izbiranje pogojev izpostavljanja modelnim raztopinam za živila

General Information

• Status: Published
• Publication Date: 31-Aug-2004
• ICS: 67.250 - Materials and articles in contact with foodstuffs
• Technical Committee: EPO - Packaging - sales and grouped
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2004
• Due Date: 01-Sep-2004
• Completion Date: 01-Sep-2004
• Directive: 89/109/EEC - Materials and articles intended to come into contact with foodstuffs
• Mandate: M/052 - Standardization mandate to CEN concerning methods of analysis for materials and articles intended to come into contact with foodstuffs
• Ref Project: EN 13130-1:2004 - Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 1: Guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants

Relations

• Replaces: SIST ENV 13130-1:2000 - Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 1: Guide to the test methods for the specific migration of substances from plastics into foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants
• Effective Date: 01-Sep-2004

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.VSHFLILþQRSRVWDYOMDQMDWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Substanzen in Kunststoffen, die Beschränkungen unterliegen - Teil 1: Leitfaden für die Prüfverfahren für die spezifische Migration von Substanzen aus Kunststoffen in Lebensmittel und Prüflebensmittel, die Bestimmung von Substanzen in Kunststoffen und die Auswahl von Kontaktbedingungen mit PrüflebensmittelnMatériaux et objets en contact avec des denrées alimentaires - Substances dans les matieres plastiques soumises a des limitations - Partie 1 : Guide des méthodes d'essai pour la migration spécifique dans les denrées alimentaires et les simulants d'aliments de substances contenues dans les matieres plastiques, détermination des substances dans les matieres plastiques et choix des conditions d'exposition aux simulants d'alimentsMaterials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 1: Guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 13130-1:2004SIST EN 13130-1:2004en,fr,de01-september-2004SIST EN 13130-1:2004SLOVENSKI
STANDARDSIST ENV 13130-1:20001DGRPHãþD



SIST EN 13130-1:2004



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13130-1May 2004ICS 67.250English versionMaterials and articles in contact with foodstuffs - Plasticssubstances subject to limitation - Part 1: Guide to test methodsfor the specific migration of substances from plastics to foodsand food simulants and the determination of substances inplastics and the selection of conditions of exposure to foodsimulantsMatériaux et objets en contact avec des denréesalimentaires - Substances dans les matières plastiquessoumises à des limitations - Partie 1 : Guide des méthodesd'essai pour la migration spécifique dans les denréesalimentaires et les simulants d'aliments de substancescontenues dans les matières plastiques, détermination dessubstances dans les matières plastiques et choix desconditions d'exposition aux simulants d'alimentsWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Substanzen in Kunststoffen, die Beschränkungenunterliegen - Teil 1: Anleitung für Testmethoden für diespezifische Migration von Substanzen aus Kunststoffen inLebensmitteln und Lebensmitteln-Simulantien, Bestimmungder Substanzen in Kunststoffen und Auswahl vonExpositions bedingungen für Lebensmitteln-Simulantien.This European Standard was approved by CEN on 24 March 2004.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 Central Secretariat 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 Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13130-1:2004: ESIST EN 13130-1:2004



EN 13130-1:2004 (E) 2 Contents
page Foreword.6 1 Scope.9 2 Normative references.9 3 Terms and definitions.9 4 General.12 4.1 Summary.12 4.2 Precautions in handling and testing.12 4.3 Analysis of a substance in a food simulant - migration test.12 4.4 Analysis of substance in a foodstuff.13 4.5 Analysis of a substance in a test medium - substitute fat tests.13 4.6 Analysis of a substance in a ‘volatile’ test medium - alternative fat tests.13 4.7 Analysis of a substance in a plastics material or article.13 4.8 Multi-analyte analyses.13 4.9 Multilayer materials and articles.13 5 Types of test.14 5.1 Substitute tests.14 5.2 Substitute tests.14 5.3 Alternative fat tests.14 5.3.1 General.14 5.3.2 Alternative tests with volatile media.14 5.3.3 Extraction tests.14 5.4 Residual content determination.15 5.4.1 “QM” test.15 5.4.2 “QMA” test.15 6 Food simulants, test media and reagents.15 6.1 Aqueous food simulants.15 6.2 Fatty food simulants.16 6.3 Test media.16 6.3.1 Test media for substitute tests.16 6.3.2 Test media for alternative tests.16 6.4 Reagents.16 7 Selection of food simulants.17 7.1 General.17 7.2 Simulating contact with all food types.17 7.3 Simulating contact with specific food types.17 7.4 Simulating contact with dry foods and frozen food.23 7.5 Testing for fatty contact.23 8 Migration test, substitute test and alternative test conditions and conditions of residual content determination.24 8.1 Test conditions for migration tests.24 8.1.1 General.24 8.1.2 Introduction.24 8.1.3 Contact conditions generally recognized as ‘more severe’.24 8.1.4 Contact for less than 15 min at temperatures between 70 °°°°C and 100 °°°°C.25 8.1.5 Contact in a microwave oven.26 8.1.6 Contact conditions causing changes in physical or other properties.26 8.1.7 Contact not covered by the conventional condition for migration tests.26 8.1.8 Testing at low temperatures.26 SIST EN 13130-1:2004



EN 13130-1:2004 (E) 3 8.1.9 Testing at high temperature.27 8.1.10 Caps, gaskets, stoppers or similar sealing devices and lids.27 8.1.11 Tubing, taps, valves, filters.27 8.2 Test conditions for substitute fat tests.27 8.3 Test conditions for alternative fat tests.28 8.3.1 Alternative fat test with volatile media.28 8.3.2 Extraction tests.28 9 Apparatus.28 9.1 Specimen supports.28 9.2 Tubes, glass rods and glass beads.28 9.3 Cells.29 9.4 Thermostatically controlled ovens or incubators.29 10 Samples and sample geometry.29 10.1 Samples.29 10.2 Surface-to-volume ratio.30 10.3 Single surface versus double surface testing (by total immersion).30 10.4 Single surface testing using a cell type A Mark 2.31 10.5 Single surface testing using a pouch.31 10.6 Single surface testing using a reverse pouch.31 10.7 Single surface testing by filling.32 10.8 Articles intended for repeated use.32 10.9 Caps, closures and other sealing devices.32 10.10 Large containers.33 10.11 Tubing, taps, valves and filters.33 10.12 Fibres and cloths.33 10.13 Articles of irregular shape.33 11 Sampling.33 11.1 Sampling of test articles.33 11.2 Sampling of foodstuffs.34 12 Precision.34 13 Expression of results.34 13.1 General - specific migration test results.34 13.1.1 Introduction.34 13.1.2 For unknown surface-to-volume ratios.34 13.1.3 For known surface-to-volume ratios and tested under these conditions.35 13.1.4 For known surface-to-volume ratios and not tested under these conditions.35 13.1.5 Conversion recalculation.35 13.2 Reduction factors with the fat simulant.35 13.3 Calculation of QA for compliance with QMA.36 13.4 Validity of results.37 13.5 Confirmation of results.37 13.6 Group limits.37 14 Test reports and statements of compliance.38 14.1 Test reports.38 15 Exposure by total immersion in a thermostatically controlled oven, incubator or refrigerator.38 15.1 Introduction.38 15.2 Principle.38 15.3 Reagents.39 15.3.1 Distilled water or water of equivalent quality (simulant A).39 15.3.2 Acetic acid 3 % (w/v) in aqueous solution (simulant B).39 15.3.3 Ethanol 10 % (v/v) in aqueous solution (simulant C).39 15.3.4 Alcoholic simulants for liquids or beverages of an alcoholic strength exceeding 10% (v/v)….39 15.3.5 Olive oil, simulant D as specified in clause 8.39 15.3.6 Dewaxed sunflower oil for determinations at low temperatures.39 15.3.7 Test media for substitute tests.39 15.4 Apparatus.39 SIST EN 13130-1:2004



EN 13130-1:2004 (E) 4 15.5 Preparation of test specimens.40 15.5.1 Number of test specimens.40 15.5.2 Thin films and sheet materials.40 15.5.3 Containers and other articles.40 15.5.4 Articles of irregular shape.40 15.5.5 General.41 15.6 Procedure.41 16 Exposure by total immersion at reflux temperatures.41 16.1 Introduction.41 16.2 Principle.41 16.3 Reagents.42 16.4 Apparatus.42 16.5 Preparation of test specimens.42 16.6 Procedure.42 17 Single-side exposure in a cell in a thermostatically controlled oven, incubator or refrigerator.42 17.1 Introduction.42 17.2 Principle.42 17.3 Reagents.43 17.4 Apparatus.43 17.5 Preparation of the test specimens.43 17.5.1 Number of test specimens.43 17.5.2 Cutting test specimens.43 17.6 Procedure.43 18 Single-side exposure with a pouch in a thermostatically controlled oven, incubator or refrigerator.44 18.1 Introduction.44 18.2 Principle.44 18.3 Reagents.45 18.4 Apparatus.45 18.5 Preparation of test specimens.45 18.5.1 Number of test specimens.45 18.5.2 Cutting and preparation of specimens.45 18.6 Procedure.46 19 Single-side exposure by article fill in a thermostatically controlled oven, incubator or refrigerator.46 19.1 Introduction.46 19.2 Principle.46 19.3 Reagents.47 19.4 Apparatus.47 19.5 Preparation of the test specimens.47 19.5.1 Number of test specimens.47 19.5.2 Articles with a capacity of less than 500 ml or more than 10 l.47 19.6 Procedure.47 Annex A (normative)
Criteria for classification of non-volatility.49 A.1 Volatile substances.49 A.2 Criteria for conventional classification of non-volatility.49 Annex B (normative)
Characteristics of fatty food simulants and test media.50 Characteristics of rectified olive oil, reference simulant D.50 Composition of the mixture of synthetic triglycerides, simulant D.50 Characteristics of sunflower oil, simulant D.51 Characteristics of corn oil, simulant D.51 Characteristics of modified polyphenylene oxide (MPPO).51 Annex C (normative)
Tolerances on contact times and contact temperatures applicable to all parts of this standard.52 Annex D (informative)
Supports and cells.54 SIST EN 13130-1:2004



EN 13130-1:2004 (E) 5 Annex E (informative)
Relationship of this European Standard with Council Directive 89/109/EEC and Commission Directive 2002/72/EC and associated Directives.63 Bibliography.65 SIST EN 13130-1:2004



EN 13130-1:2004 (E) 6 Foreword This document (EN 13130-1:2004) has been prepared by Technical Committee CEN/TC 194 “Utensils in contact with food”, the secretariat of which is held by BSI. This document was prepared by Subcommittee SC1 of TC 194 to provide guidance in the preparation of samples for testing in a series of test methods contained in other parts of this standard. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2004, and conflicting national standards shall be withdrawn at the latest by November 2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. Informative annex E details the relationship of this standard with the European Union Directives. At the time of preparation and publication of this standard the European Union legislation relating to plastics materials and articles intended to come into contact with foodstuffs is incomplete.
Further Directives and amendments to existing Directives are expected which could change the legislative requirements which this standard supports.
It is therefore strongly recommended that users of this standard refer to the latest relevant published Directive(s) before commencement of a test or tests described in this standard. Further parts of EN 13130, under the general title Materials and articles in contact with foodstuffs - Plastics substances subject to limitation, have been prepared, and others are in preparation, concerned with the determination of specific migration from plastics materials into foodstuffs and food simulants and the determination of specific monomers and additives in plastics. The other parts of
EN 13130 are as follows.
Part 2: Determination of terephthalic acid in food simulants Part 3: Determination of acrylonitrile in food and food simulants Part 4: Determination of 1,3-butadiene in plastics
Part 5: Determination of vinylidene chloride in f
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