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1、DRAFT FOR DEVELOPMENT DD CEN/TS 13130-28:2005 Materials and articles in contact with foodstuffs Plastics substances subject to limitation Part 28: Determination of 1,1,1-trimethylolpropane in food simulants ICS 67.250 ? Licensed Copy: London South Bank University, London South Bank University, Tue D
2、ec 12 05:31:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD CEN/TS 13130-28:2005 This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 16 September 2005 BSI 16 September 2005 ISBN 0 580 46056 8 National foreword This Draft for Development is
3、the official English language version of CEN/TS 13130-28:2005. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature because the method was not evaluated using recognized ring trial procedur
4、es. As a consequence there are no reproducibility data for the method. It should be applied on this provisional basis, so that 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
5、be reported to the European organization responsible for its conversion to a European standard. A review of this publication 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 s
6、tart of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies 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 T
7、echnical Specification or to withdraw it. Comments should be sent in writing to the Secretary of BSI Subcommittee CW/47/1, Migration from plastics, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an app
8、ropriate revision of the text. 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
9、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 applicatio
10、n. Summary of pages This document comprises a front cover, an inside front cover, the CEN/TS title page, pages 2 to 15 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 Licensed
11、 Copy: London South Bank University, London South Bank University, Tue Dec 12 05:31:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 13130-28 February 2005 ICS 67.250 English version Materials and articles in contact with fo
12、odstuffs - Plastics substances subject to limitation - Part 28: Determination of 1,1,1-trimethylolpropane in food simulants Matriaux et objets en contact avec les denres alimentaires - Substances dans les matires plastiques soumises des limitations - Partie 28 : Dtermination du 1,1,1,-trimthylolprop
13、ane dans les simulants daliments Werkstoffe und Gegenstnde in Kontakt mit Lebensmitteln - Substanzen in Kunststoffen, die Beschrnkungen unterliegen - Teil 28: Bestimmung von 1,1,1- Trimethylolpropan in Prflebensmitteln This Technical Specification (CEN/TS) was approved by CEN on 16 December 2004 for
14、 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 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 a
15、nnounce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion o
16、f the CEN/TS into an EN is reached. 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,
17、Slovenia, 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 2005 CENAll rights of exploitation in any form and by any means reserved worldwide for
18、CEN national Members. Ref. No. CEN/TS 13130-28:2005: E Licensed Copy: London South Bank University, London South Bank University, Tue Dec 12 05:31:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 Contents page Foreword. 3 Introduction 5 1Scope 6 2Normative references . 6 3Principle. 6 4Reagents 6 5Ap
19、paratus 8 6Samples . 9 7Procedure 10 8Expression of results 12 9Confirmation 13 10Test report . 14 Bibliography . 15 DD CEN/TS 13130-28:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Dec 12 05:31:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 Foreword This docum
20、ent (CEN/TS 13130-28:2005) has been prepared by Technical Committee CEN/TC 194 “Utensils in contact with food”, the secretariat of which is held by BSI. This part of EN 13130 has been prepared within the Standards, Measurement and Testing project, MAT1-CT92-0006, “Development of Methods of Analysis
21、for Monomers” and has been prepared by Subcommittee (SC 1) of TC 194 “Utensils in contact with food“ as one of a series of test methods for plastics materials and articles in contact with foodstuffs. Informative Annex A details the relationship of this standard with the European Union Directives. At
22、 the time of preparation and publication of this part of EN 13130 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 legis
23、lative 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. This standard is intended to support Directives 2002/72/EC 1, 89/1
24、09/EEC 2, 82/711/EEC 3 and its amendments 93/8/EEC 4 and 97/48/EC 5, and 85/572/EEC 6. 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 t
25、he determination of specific migration from plastics materials into foodstuffs and food simulants and the determination of specific monomers and additives in plastics. The parts of EN 13130 are as follows. Part 1: Guide to test methods for the specific migration of substances from plastics to foods
26、and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants 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 pl
27、astics 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, v
28、inyl 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 DD CEN/TS 13130-28:2005 Licensed Copy: London South Bank University, London Sou
29、th Bank University, Tue Dec 12 05:31:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 Part 13: Determination of 2,2-bis(4-hydroxyphenyl)propane (Bisphenol A) in food simulants Part 14: Determination of 3,3-bis(3-methyl-4-hydroxyphenyl)-2-indoline in food simulants Part 15: Determination of 1,3-butadi
30、ene 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
31、 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
32、: 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 tetrahydrofuran in food simulants Part 27: Det
33、ermination of 2,4,6-triamino-1,3,5-triazine in food simulants Part 28: Determination of 1,1,1-trimethylolpropane in food simulants Parts 1 to 8 are European Standards. Parts 9 to 28 are Technical Specifications. WARNING All chemicals are hazardous to health to a greater or lesser extent. It is beyon
34、d the scope of this Technical Specification to give instructions for the safe handling of all chemicals, that meet, in full, the legal obligations in all countries in which this Technical Specification may be followed. Therefore, specific warnings are not given and users of this Technical Specificat
35、ion should ensure that they meet all the necessary safety requirements in their own country. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this CEN Technical Specification: Austria, Belgium, Cyprus, Czech Repu
36、blic, 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. DD CEN/TS 13130-28:2005 Licensed Copy: London South Bank Univers
37、ity, London South Bank University, Tue Dec 12 05:31:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 5 Introduction 1,1,1-trimethylolpropane (TMP), C6H14O3, PM/Ref. No 25600, is a monomer used in the manufacture of certain plastics materials and articles intended to come into contact with foodstuffs. A
38、fter manufacture residual 1,1,1-trimethylolpropane can remain in the finished product and may migrate into foodstuffs coming into contact with that product. NOTE 1 The analytical method described in this part of EN 13130 is the result of a study on the determination of the migration of 1,1,1-trimeth
39、ylolpropane from plastics materials into food simulants. In the course of the study several problems were encountered and solutions for these problems were incorporated in the final method. The most suitable method is described in this part of EN 13130. The method was successfully pre-validated by t
40、he developing laboratory tests, using the four official EU food simulants, to establish the precision data at the restriction criterion. Also migration tests were performed with samples containing 1,1,1-trimethylolpropane as monomer in contact for 10 d at 40 C with 15 % v/v aqueous ethanol and olive
41、 oil. NOTE 2 During the testing of the method by a second laboratory it appeared that the testing laboratory was not able to reproduce the precision data as obtained by the developing laboratory. Based on the problems encountered by the testing laboratory the method description was modified to make
42、critical points more clear. Within the scope of the project “Development of Methods of Analysis for Monomers” it was not possible to re-test the method and therefore the method described should be considered as a useful analytical method, with limited validation data. Further testing is required to
43、demonstrate that the method can be applied with the required accuracy. The method has been pre-validated in a validation experiment only by one laboratory, the developing laboratory. DD CEN/TS 13130-28:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Dec 12 05:31:1
44、7 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD CEN/TS 13130-28:2005 6 1Scope This document, part of EN 13130, specifies an analytical procedure for the determination of 1,1,1- trimethylolpropane in food simulants distilled water, 3 % (w/v) acetic acid aqueous solution, 15 % (v/v) ethanol aqueous so
45、lution and rectified olive oil. The method is appropriate for the quantitative determination of 1,1,1-trimethylolpropane in approximate analyte concentration range of 0,6 mg/kg to 12 mg/kg food simulant. NOTE The method should also be applicable to other aqueous food simulants as well as to the othe
46、r fatty food simulants e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides. 2Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest editi
47、on of the referenced document (including any amendments) applies. 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 dete
48、rmination of substances in plastics and the selection of conditions of exposure to food simulants. 3Principle Aqueous food simulants are saturated with potassium carbonate and extracted with ethanol/ethyl acetate. After evaporation of the solvent, the extracted TMP is silylated with trimethylsilylim
49、idazole in pyridine. The amount of 1,1,1-trimethylolpropane silyl ethers are determined by gas chromatography with flame ionization detection. 1,4-butanediol is used as an internal standard. Fat simulant is extracted with water prior to derivatization. Confirmationoftheidentityof1,1,1-trimethylolpropaneisestablishedbycombinedgas chromatography/mass spectrometry. 4Reagents NOTE All reagents should be of recognized analytical quality unless otherwise stated. Licensed Copy: London