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1、DRAFT FOR DEVELOPMENT DD CEN/TS 14234:2002 Materials and articles in contact with foodstuffs Polymeric coatings on paper and board Guide to the selection of conditions and test methods for overall migration ICS 67.250 ? DD CEN/TS 14234:2002 This Draft for Development was published under the authorit
2、y of the Standards Policy and Strategy Committee on 30 January 2003 BSI 30 January 2003 ISBN 0 580 41152 4 National foreword This Draft for Development is the English language version of CEN/TS 14234:2002. This publication is not to be regarded as a British Standard. It is being issued in the Draft
3、for Development series of publications and is of a provisional nature because of the need to develop a method of test dealing with the coatings of materials and articles in contact with food, in order to satisfy the proposed European legislation. It should be applied on this provisional basis, so th
4、at information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion to a European standard. A review of this publication
5、 will be initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the rep
6、lies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent in writing to the Secretary of BSI Subcommittee CW/47/1, M
7、igration from plastics, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The B
8、ritish 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
9、Online. Summary of pages This document comprises a front cover, an inside front cover, the CEN/TS title page, pages 2 to 26, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd.
10、No. DateComments TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 14234 October 2002 ICS 67.250 English version Materials and articles in contact with foodstuffs Polymeric coatings on paper and board Guide to the selection of conditions and test methods for overall migr
11、ation Matriaux et objets en contact avec les denres alimentaires Revtements polymres sur papier et carton Guide pour le choix des conditions et des mthodes dessai en matire de migration globale Werkstoffe und Gegenstnde in Kontakt mit Lebensmitteln - Polymere Beschichtungen auf Papier und Pappe Leif
12、taden fr die Auswahl von Prfbedingungen und Prfverfahren fr die Gesamtmigration This Technical Specification (CEN/TS) was approved by CEN on 28 July 2002 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be
13、 requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available. It is permissible to keep conflicting natio
14、nal standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxemb
15、ourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by
16、 any means reserved worldwide for CEN national Members. Ref. No. CEN/TS 14234:2002 E CEN/TS 14234:2002 (E) 2 Contents Foreword3 1Scope 4 2Normative references 5 3Test conditions 5 4Total immersion method.6 5Cell method.9 6Expression of results 12 7Test report 13 Annex A (normative) Proposed test sch
17、eme for papers with polymeric coatings intended for fatty food contact. .14 Annex B (informative) Guidance for migration testing of polymeric coatings on cellulosic substrates (paper and board) 15 Annex ZA (informative) Relationship of this Technical Specification with Council Directive 89/109/EEC a
18、nd associated EU Directive(s) 23 Bibliography25 CEN/TS 14234:2002 (E) 3 Foreword This document (CEN/TS 14234:2002) has been prepared by Technical Committee CEN/TC 194, “Utensils in contact with food“, the secretariat of which is held by BSI. This document has been prepared under a mandate given to C
19、EN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document. In this standard the Annex A is normative and Annex B is informa
20、tive. Guidance for migration testing of polymeric coatings on cellulosic substrates (paper and board) is given in the informative annex B. At the time of preparation and publication of this Technical Specification the European Union legislation relating to resinous and polymeric coatings on paper an
21、d board has not been formulated. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy
22、, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. CEN/TS 14234:2002 (E) 4 1 Scope This Technical Specification specifies test methods for alternative tests and substitute tests performed with volatile test media, iso-octane and a volume fraction o
23、f 95 % aqueous ethanol, for the determination of overall migration from polymeric coatings on paper and board intended to come into contact with fatty foodstuffs. NOTE 1It also includes guidance for the application of Council Directive 82/711/EEC 1, as last amended by Commission Directives 93/8/EC a
24、nd 97/48/EC 2 3 as regards the determination of the specific and overall migration into fatty food simulants (fat test) and includes a glossary to clarify the terminology used, see annex B. NOTE 2The iso-octane and a volume fraction of 95 % aqueous ethanol volatile test media used in these test meth
25、ods are those specified for substitute tests in Council Directive 82/711/EEC and its subsequent amendments. In addition to the use of iso-octane and 95 % v/v aqueous ethanol as test media for substitute tests, Council Directive 82/711/EEC and its subsequent amendments specifies the use of modified p
26、olyphenylene oxide as a test medium for use at temperatures of 100 ?C and above. A test method for overall migration from polymeric coatings intended to come into contact with fatty foodstuffs using modified polyphenylene oxide (MPPO) is in preparation. NOTE 3These test methods can also be used for
27、the alternative tests described in Council Directive 82/711/EEC and its subsequent amendments, when the chosen volatile test media are iso-octane and a volume fraction of 95 % aqueous ethanol, see ENV 1186-1. A suggested test scheme is given in Figure A.1. If the test result obtained by the total im
28、mersion method, described in clause 4 of this Technical Specification, exceeds the allowed overall migration limit the single-sided migration test using a cell, see clause 5, if technically feasible; may be used. If it is not possible to use the single sided cell method, e.g. because of pinholes, us
29、e adsorption by modified polyphenylene oxide, (MPPO). Iso-octane is used as a test medium for test samples coated with non polar food contact layers, such as polyolefins. For test samples coated with polar food contact polymers such as polyamide and polyethylene terephthalate, a volume fraction of 9
30、5 % aqueous ethanol is used. For polystyrenes, plasticised polyvinyl chloride and other polymers where the identification or polarity of the polymer is not clear, two parallel tests shall be conducted using both of the proposed test media and taking the higher value obtained as the relevant result.
31、NOTE 4The nature of the food contact layer determines the selection of the test medium(a). NOTE 5The overall migration limit for materials and articles of an all polymeric construction is specified in Commission Directive 90/128/EEC 4 and the conditions of test in Council Directive 82/711/EEC 1 and
32、its subsequent amendments, 2,3. There is an expectation that the scope of this directive will be extended to cover polymeric coatings on paper and board. The substitute tests described in this Technical Specification are by total immersion, see clause 4 and in a migration cell, see clause 5. NOTE 6T
33、he test conditions are those described in Council Directive 82/711/EEC 1 and its subsequent amendments, 2,3. The alternative test methods described here specifies a rapid extraction test with a more severe test character, for the assessment of the overall migration into fatty food simulants. The met
34、hod differs from the substitute test methods only in the combination of test time and test temperature. The method is based on the determination of the extraction of migrateable substances from polymeric coated paper or board, which are intended to come into contact with foodstuffs, by total immersi
35、on in non-polar, iso-octane, and/or polar, ethanol, solvents depending on the polarity of the polymeric coating. According to the results obtained by this method, see 5,6,7,8,9 and taking physio-chemical considerations into account, the obtained extraction efficiency has, generally, been found to be
36、 equivalent to or higher than overall migration results obtained using fat simulant D,under the test conditions, 10 days at 40 C, 2 h at 70 C, 1 h at 100 C, 30 min at 121 C and 30 min at 130 C. NOTE 7This method is not applicable to test materials intended for applications over 130 C. Test materials
37、 intended for applications over 70 C have to be checked for their physical suitability at the intended time and temperature of use. The test method should be applied to polymer coated packagings where the polymer layer is less than 300 m in thickness. However, if this extraction test is applied to m
38、aterials with coatings with higher thickness than 300 m and the result does not exceed any allowed overall migration limit then the method is considered to be suitable for those materials. CEN/TS 14234:2002 (E) 5 In those cases where the rapid extraction test by total immersion, yields total extract
39、ion values that exceed the overall migration limit or may be technically unsuitable a cell test method using the same time and temperature conditions is applicable. This cell test method should primarily only be applied to packagings with a physical barrier layer (for instance of aluminium or other
40、material to prevent penetrative loss of test medium) and which have a thinner food contact layer than 300 m. This test method can not be applied if the polymeric coating is shown to have pinholes. 2 Normative references This Technical Specification incorporates by dated and undated reference, provis
41、ions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to and revisions of any of these publications apply to this Technical Specification only when incorporated i
42、n it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). ENV 1186-1:1994Materials and articles in contact with foodstuffs Plastics - Guide to the selection of conditions and test methods for overall migration ISO 648Labor
43、atory glassware One-mark pipettes ISO 4788Laboratory glassware - Graduated measuring cylinders 3 Test conditions 3.1 Substitute test methods For substitute tests, the conditions of test will be determined by the conditions of use, see clauses 4, 5 and 6 of ENV 1186-1:1994. 3.2 Alternative test metho
44、ds For alternative tests, the test medium (a) and test conditions are to be selected according to the nature of the polymeric coating as given by Table 1. CEN/TS 14234:2002 (E) 6 Table 1 Use of test media and test conditions for alternative tests Polymer type of food contact layerTest medium to be a
45、ppliedTest conditions to be applied Polyolefins and copolymers Polyamides Polystyrene Polyethylene terephthalate Polyvinyl chloride (plasticised) Polyvinyl chloride (rigid) In case of doubt or unknown iso-octane 95 % ethanol iso-octane and 95 % ethanol 95 % ethanol iso-octane and 95 % ethanol 95 % e
46、thanol iso-octane and 95 % ethanol 24 h at 40 C 24 h at 40 C 24 h at 40 C 24 h at 50 C 24 h at 40 C 24 h at 50 C 24 h at 50 C 4 Total immersion method 4.1 Principle The migrateable substances extracted from a sample of the polymer coated paper or board is determined as the mass of non-volatile resid
47、ue after evaporation of the solvent following immersion. Test specimens of at least 1 dm (single side considered) are immersed in the test medium for set periods of time and at set temperatures and then removed. The test medium is evaporated to dryness, the mass of the non- volatile residue is deter
48、mined and expressed as milligrams per square decimetre of surface area of the test specimen. CEN/TS 14234:2002 (E) 7 4.2 Apparatus 4.2.1 Cutting slab, clean smooth glass, metal or plastics slab of suitable area to prepare test specimens, 250 mm x 250 mm is suitable. 4.2.2 Tweezers, stainless steel,
49、blunt nosed. 4.2.3 Cutting implement, scalpel, scissors or sharp knife or other suitable device. 4.2.4 Metal template, 100 mm 0,2 mm x 100 mm 0,2 mm (square). 4.2.5 Rule, graduated in mm, and readable to the nearest 0,1 mm. 4.2.6 Analytical balance, capable of determining a change in mass of 0,1 mg. 4.2.7 Extraction containers; glass weighing jars with ground joints, tall form, of a capacity of approximately 60 ml