BS-EN-13130-1-2004.pdf

BRITISH STANDARD BS 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 The European Standard EN 13130-1:2004 has the status of a British Standard ICS 67.250 ? BS EN 13130-1:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 16 June 2004 © BSI 16 June 2004 ISBN 0 580 43931 3 National foreword This British Standard is the official English language version of EN 13130-1:2004. It supersedes DD ENV 13130-1:1999 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materials and articles in contact with foodstuffs, to Subcommittee CW/47/1, Migration from plastics, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 65 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 13130-1 May 2004 ICS 67.250 English version 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 Matériaux et objets en contact avec des denrées alimentaires - Substances dans les matières plastiques soumises à 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 matières plastiques, détermination des substances dans les matières plastiques et choix des conditions d'exposition aux simulants d'aliments Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Substanzen in Kunststoffen, die Beschränkungen unterliegen - Teil 1: Anleitung für Testmethoden für die spezifische Migration von Substanzen aus Kunststoffen in Lebensmitteln und Lebensmitteln-Simulantien, Bestimmung der Substanzen in Kunststoffen und Auswahl von Expositions 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. 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 STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2004 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13130-1:2004: E EN 13130-1:2004 (E) 2 Contents page Foreword6 1 Scope 9 2 Normative references9 3 Terms and definitions .9 4 General12 4.1 Summary.12 4.2 Precautions in handling and testing12 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 articles13 5 Types of test.14 5.1 Substitute tests14 5.2 Substitute tests14 5.3 Alternative fat tests14 5.3.1 General14 5.3.2 Alternative tests with volatile media14 5.3.3 Extraction tests14 5.4 Residual content determination.15 5.4.1 “QM” test15 5.4.2 “QMA” test15 6 Food simulants, test media and reagents.15 6.1 Aqueous food simulants.15 6.2 Fatty food simulants16 6.3 Test media16 6.3.1 Test media for substitute tests.16 6.3.2 Test media for alternative tests16 6.4 Reagents.16 7 Selection of food simulants17 7.1 General17 7.2 Simulating contact with all food types17 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 contact23 8 Migration test, substitute test and alternative test conditions and conditions of residual content determination.24 8.1 Test conditions for migration tests24 8.1.1 General24 8.1.2 Introduction24 8.1.3 Contact conditions generally recognized as more severe24 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 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 tests28 8.3.1 Alternative fat test with volatile media28 8.3.2 Extraction tests28 9 Apparatus.28 9.1 Specimen supports .28 9.2 Tubes, glass rods and glass beads.28 9.3 Cells29 9.4 Thermostatically controlled ovens or incubators29 10 Samples and sample geometry29 10.1 Samples29 10.2 Surface-to-volume ratio30 10.3 Single surface versus double surface testing (by total immersion)30 10.4 Single surface testing using a cell type A Mark 231 10.5 Single surface testing using a pouch31 10.6 Single surface testing using a reverse pouch31 10.7 Single surface testing by filling .32 10.8 Articles intended for repeated use 32 10.9 Caps, closures and other sealing devices32 10.10 Large containers33 10.11 Tubing, taps, valves and filters33 10.12 Fibres and cloths.33 10.13 Articles of irregular shape33 11 Sampling.33 11.1 Sampling of test articles.33 11.2 Sampling of foodstuffs .34 12 Precision.34 13 Expression of results34 13.1 General - specific migration test results.34 13.1.1 Introduction34 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 recalculation35 13.2 Reduction factors with the fat simulant35 13.3 Calculation of QA for compliance with QMA36 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 reports38 15 Exposure by total immersion in a thermostatically controlled oven, incubator or refrigerator .38 15.1 Introduction38 15.2 Principle38 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 temperatures39 15.3.7 Test media for substitute tests 39 15.4 Apparatus.39 EN 13130-1:2004 (E) 4 15.5 Preparation of test specimens .40 15.5.1 Number of test specimens40 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 General41 15.6 Procedure .41 16 Exposure by total immersion at reflux temperatures 41 16.1 Introduction41 16.2 Principle41 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 refrigerator42 17.1 Introduction42 17.2 Principle42 17.3 Reagents.43 17.4 Apparatus .43 17.5 Preparation of the test specimens.43 17.5.1 Number of test specimens43 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 refrigerator44 18.1 Introduction44 18.2 Principle44 18.3 Reagents.45 18.4 Apparatus .45 18.5 Preparation of test specimens .45 18.5.1 Number of test specimens45 18.5.2 Cutting and preparation of specimens45 18.6 Procedure .46 19 Single-side exposure by article fill in a thermostatically controlled oven, incubator or refrigerator46 19.1 Introduction46 19.2 Principle46 19.3 Reagents.47 19.4 Apparatus .47 19.5 Preparation of the test specimens.47 19.5.1 Number of test specimens47 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-volatility49 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 media50 Characteristics of rectified olive oil, reference simulant D50 Composition of the mixture of synthetic triglycerides, simulant D.50 Characteristics of sunflower oil, simulant D51 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 standard52 Annex D (informative) Supports and cells54 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 Directives63 Bibliography65 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 food simulants Part 6: Determination of vinylidene chloride in plastics Part 7: Determination of monoethylene glycol and diethylene glycol in food simulants Part 8: Determination of isocyanates in plastics Part 9: Determination of acetic acid, vinyl ester in food simulants Part 10: Determination of acrylamide in food simulants Part 11: Determination of 11-aminoundecanoic acid in food simulants Part 12: Determination of 1,3-benzenedimethanamine in food simulants Part 13: Determination of 2,2-bis(4-hydroxyphenyl)propane (Bisphenol A) in food simulants EN 13130-1:2004 (E) 7 Part 14: Determination of 3,3-bis(3-methyl-4-hydroxyphenyl)-2-indoline in food simulants Part 15: Determination of 1,3-butadiene in food simulants Part 16: Determination of caprolactam and caprolactam salt in food simulants Part 17: Determination of carbonyl chloride in plastics Part 18: Determination of 1,2-dihydroxybenzene, 1,3- dihydroxybenzene, 1,4- dihydroxybenzene, 4,4- dihydroxybenzophenone and 4,4dihydroxybiphenyl in food simulants Part 19: Determination of dimethylaminoethanol in food simulants Part 20: Determination of epichlorohydrin in plastics Part 21: Determination of ethylenediamine and hexamethylenediamine in food simulants Part 22: Determination of ethylene oxide and propylene oxide in plastics Part 23: Determination of formaldehyde and hexamethylenetetramine in food simulants Part 24: Determination of maleic acid and maleic anhydride in food simulants Part 25: Determination of 4-methyl-pentene in food simulants Part 26: Determination of 1-octene and tetrah