BS-EN-1186-1-2002.pdf

BRITISH STANDARD BS EN 1186-1:2002 Materials and articles in contact with foodstuffs Plastics Part 1: Guide to the selection of conditions and test methods for overall migration The European Standard EN 1186-1:2002 has the status of a British Standard ICS 67.250 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 1186-1:2002 This British Standard, having been prepared under the direction of the Consumer Products and Services Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 21 May 2002 © BSI 21 May 2002 ISBN 0 580 39746 7 National foreword This British Standard is the official English language version of EN 1186-1:2002. It supersedes DD ENV 1186-1:1994 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materials in contact with food, 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 Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their 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 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 49 and a back cover. The BSI copyright date 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 1186-1 April 2002 ICS 67.250Supersedes ENV 1186-1:1994 English version Materials and articles in contact with foodstuffs - Plastics - Part 1: Guide to the selection of conditions and test methods for overall migration Matériaux et objets en contact avec les denrées alimentaires - Matière plastique - Partie 1: Guide pour le choix des conditions et des méthodes d'essai en matière de migration globale Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 1: Leitfaden für die Auswahl der Prüfbedingungen und Prüfverfahren für die Gesamtmigration This European Standard was approved by CEN on 5 January 2002. 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 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 translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. 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 STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1186-1:2002 E EN 1186-1:2002 (E) 2 Contents page Foreword3 Introduction.5 1Scope 6 2Normative references 6 3Terms and definitions6 4Types of test.8 5Food simulants, test media and reagents9 6Selection of food simulants10 7Migration test, substitute test and alternative test conditions .17 8Apparatus .22 9Samples and sample geometry23 10Overall migration test methods with fatty food simulants 27 11Precision.31 12Test reports 32 Annex A (normative) Characteristics of fatty food simulants and test media.35 Annex B (normative) Tolerances on contact times and contact temperatures applicable to all Parts of this standard.37 Annex C (informative) Supports and cells.39 Annex ZA (informative) Relationship of this European Standard with Council Directive 89/109/EEC and Commission Directive 90/128/EEC and associated Directives47 Bibliography49 EN 1186-1:2002 (E) 3 Foreword This document EN 1186-1:2002 has been prepared by Technical Committee CEN/TC 194 'Utensils in contact with food, 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 or by endorsement, at the latest by October 2002, and conflicting national standards shall be withdrawn at the latest by October 2002. This document supersedes ENV 1186-1:1994. This document is one of a series of methods of test for plastics materials and articles in contact with foodstuffs. This document has been prepared under a mandate given to CEN by the European Commission and the European Free 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 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 any of the test or tests described in this standard. The titles of other parts of this European Standard are as follows: EN 1186 Materials and articles in contact with foodstuffs - Plastics : Part 2Test methods for overall migration into olive oil by total immersion Part 3Test methods for overall migration into aqueous food simulants by total immersion Part 4Test methods for overall migration into olive oil by cell Part 5Test methods for overall migration into aqueous food simulants by cell Part 6Test methods for overall migration into olive oil using a pouch Part 7Test methods for overall migration into aqueous food simulants using a pouch Part 8Test methods for overall migration into olive oil by article filling Part 9Test methods for overall migration into aqueous food simulants by article filling Part 10Test methods for overall migration into olive oil (modified method for use in cases where incomplete extraction of olive oil occurs) Part 11Test methods for overall migration into mixtures of 14C-labelled synthetic triglycerides Part 12Test methods for overall migration at low temperatures Part 13Test methods for overall migration at high temperatures Part 14Test method for substitute tests for overall migration into iso-octane and 95 % aqueous ethanol EN 1186-1:2002 (E) 4 Part 15Alternative test methods to migration into fatty food simulants by rapid extraction into iso- octane and/or 95 % ethanol Annexes A and B form normative parts of this standard. Annex C is for information only According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries 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. EN 1186-1:2002 (E) 5 Introduction No single test method has been devised which can be used to determine overall migration, at all temperatures, in all food simulants. Indeed, owing to the practical difficulties inherent in testing with involatile extractants such as fats and the multitude of applications in which plastics articles come into contact with food, there are many methods and permitted variations to methods in this standard. EN 1186-1 is intended to give advice on the selection of the most appropriate type of test, test conditions and test method for a given application of a plastics article and is intended to be read in its entirety before testing protocols are finalized. For most plastics articles methods in EN 1186-2 to EN 1186-9 are suitable, according to the form in which the article is tested. Subsequent Parts of this standard are intended to be used in conjunction with the methods in EN 1186-2 to EN 1186-9 for more difficult samples and at other temperatures. The general criteria for the operation and assessment of testing laboratories as well as the general criteria for laboratory accreditation bodies are set out in EN 45001, EN 45002 and EN 45003. It is recommended that laboratories using this standard validate their procedures by testing certified reference samples and by taking part in a proficiency scheme. Reference plastics samples with well characterized values for overall migration into the fatty food simulant olive oil have been prepared as part of a programme sponsored by the Standards, Measurement b) the migration in the alternative test does not exceed the overall migration limit, after application of appropriate reduction factors. If either or both conditions are not fulfilled, then the migration tests (4.1) have to be performed. 4.3.2 Extraction tests Other tests are permitted which use other test media having very strong extractive power under severe test conditions, if it is generally recognized, on the basis of scientific evidence, that the results obtained using these extraction tests are equal to or higher than those obtained with simulant D. EN 1186-1:2002 (E) 9 4.4 Criteria for the use of substitute tests The use of substitute tests is justified, when the migration test carried out with each of the possible simulants D is found to be inapplicable due to technical reasons connected with the migration test, e.g. interferences, incomplete extraction of oil, absence of stability of the mass of the plastics, excessive absorption of fatty food simulant, reaction of components with the fat. 5 Food simulants, test media and reagents 5.1 Aqueous food simulants The aqueous food simulants shall be of the following quality: - distilled water or water of equivalent quality, simulant A; - 3 % acetic acid (w/v) in aqueous solution, simulant B; For the purposes of this standard this means a solution prepared by diluting 30 g of acetic acid with distilled water to a volume of 1 l; - 10 % ethanol (v/v) in aqueous solution, simulant C. For liquids or beverages with an ethanol content greater than 10 % (v/v) the test is carried out with aqueous solutions of ethanol of a similar strength. Each of the above food simulants shall give a non-volatile residue of less than 5 mg/l, when evaporated to dryness and dried to constant mass at 105 °C to 110 °C. 5.2 Fatty food simulants The fatty food simulants are as follows: - rectified olive oil, “reference simulant D“. This “reference simulant D“ may be replaced by a synthetic mixture of triglycerides or sunflower oil or corn oil with standardized specifications. These are known as “other fatty food simulants“ and called “simulant D“. For the characteristics of olive oil, a synthetic mixture of triglycerides, sunflower oil and corn oil, see annex A. NOTEWhen these fatty food simulants are used to simulate some classes of food, reduction factors can be used, see 6.2 and Table 2. 5.3 Test media 5.3.1 Test media for substitute tests The test media to be used in substitute tests are iso-octane, 95 % ethanol in aqueous solution and a modified polyphenylene oxide (MPPO). The characteristics of modified polyphenylene oxide are to be found in annex A. 5.3.2 Test media for alternative tests These are volatile media such as iso-octane and 95 % ethanol in aqueous solution or other volatile solvents or mixtures of solvents. 5.4 Reagents Unless otherwise required, reagents shall be of analytical quality. EN 1186-1:2002 (E) 10 NOTESpecifications for solid reagents, used as such in discrete quantities, may not address suitability for use in methods of analysis in this standard. Solid reagents meight not be homogeneous with respect to contaminants not addressed by specifications, therefore it may be necessary to demonstrate that such reagents are suitable for use. 6 Selection of food simulants NOTECommission Directive 85/572/EEC 6 specifies the use of 15 % ethanol (v/v) in aqueous solution as simulant C. This has been superseded by Commission Directive 97/48/EC 5 the second amendment to Council Directive 82/711/EEC 3 that specifies 10 % ethanol (v/v) in aqueous solution. 6.1 Simulating contact with all food types Where a plastics article is intended for use in contact with all types of food it shall be tested with 3 % acetic acid (w/v) in aqueous solution, simulant B, 10 % ethanol (v/v) in aqueous solution, simulant C and a fatty food simulant, simulant D, without reduction factors. If when using any of the other fatty food simulants, see 5.2, the migration limit is exceeded, for the judgement of non compliance with the overall migration limit a confirmation of the result by using olive oil is obligatory, when technically feasible. If this confirmation is not technically feasible and the migration from the material or article exceeds the limit it shall be deemed not in compliance with the overall migration limit. 6.2 Simulating contact with specific food types Provision for materials and articles intended to come into contact with specific food types has been made in the following situations: a) when the material or article is already in contact with a known foodstuff; b) when the material or article is accompanied, by a specific indication stating with which food types it may or may not be used, for example “only for aqueous foods“; c) when the material or article is accompanied by a specific indication stating with which foodstuff(s) or group(s) of foodstuffs they may or may not be used. This indication shall be expressed: 1) at the marketing stage other than retail stage, by using the “ reference number“ or “description of foodstuffs“; 2) at the retail stage using an indication which shall refer to only a few foods or groups of food, preferably with examples which are easy to understand. In situation b) the simulants to be used in the ov