1、BRITISH STANDARD Materials and articles in contact with foodstuffs Plastics Part 3: Test methods for overall migration into aqueous food simulants by total immersion The European Standard EN 1186-3:2002 has the status of a British Standard ICs 67.250 BS EN 1 186-3 12002 WkNb A%“ U- rn% E rn NO COPYI
2、NG WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW $ 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. - A
3、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 “Inter
4、national 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
5、British Standard does not ofitself confer immunity from legal obligations. This British Standard. having - been prepared under the direction of the Consumer Products and Services Sector Summary of pages This document comprises a front cover, an inside front cover, the EN title page, PolicyandStrateg
6、yCommittee, was published under the authoritv of the Standards pages 2 to 17 and a back cover. The BSI copyright date displayed in this document indicates when the Policy aid Strategy Committee on 21 May 2002 document was last issued. OBSI 21 May 2002 ISBN O 580 39748 3 EUROPEAN STANDARD NORME EUROP
7、ENNE EUROPISCHE NORM EN 1186-3 April 2002 ICs 67.250 Supersedes ENV 11 86-3:1994 English version Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration into aqueous food simulants by total immersion Matriaux et objets en contact avec les denres alim
8、entaires - Matire plastique - Partie 3: Mthodes dessai pour la migration globale dans lhuile dolive par immersion totale Werkstoffe und Gegenstnde in Kontakt mit Lebensmitteln - Kunststoffe -Teil 3: Prfverfahren fr die Gesamtmigration in wssrige Prflebensmittel durch vlliges Eintauchen This European
9、 Standard was approved by CEN on 4 January 2002. CEN members are bound to comply with the CENKENELEC 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 concern
10、ing 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 lang
11、uage 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, Swe
12、den, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION EUROPISCHES KOMITEE FR NORMUNG COMIT EUROPEN DE NORMALISATION Management Centre: rue de Stassart, 36 B-1050 Brussels O 2002 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Memb
13、ers. Ref. No. EN 1186-3:2002 E EN 1186-312002 (E) Contents Foreword 3 1 Scope 5 2 Normative references 5 3 Method A . overall migration into aqueous food simulants by total immersion in an oven or incubator or refrigerator 5 4 Method B . overall migration into aqueous food simulants by total immersi
14、on at reflux . 11 Annex A (informative) Precision data . 14 Annex ZA (informative) Relationship of this European Standard with Council Directive 89/109/EEC and Commission Directive 90/128/EEC and associated Directives 15 Bibliography 17 2 EN 1186-312002 (E) Foreword This document EN 1186-3:2002 has
15、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 conflict
16、ing national standards shall be withdrawn at the latest by October 2002. This document supersedes ENV 1186-3:1994. This European Standard 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
17、 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 Eu
18、ropean 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 strong
19、ly 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. EN 11 86-3 should be read in conjunction with EN 11 86-1. Further Parts of this standard have been prepared concerned with the de
20、termination of overall migration from plastics materials into food simulants. Their titles are as follows: EN 1 186 - Materials and articles in contact with foodstuffs - Plastics - Part 1 Guide to the selection of conditions and test methods for overall migration Part 2 Test methods for overall migr
21、ation into olive oil simulants by total immersion Part 4 Test methods for overall migration into olive oil by cell Part 5 Test methods for overall migration into aqueous food simulants by cell Part 6 Test methods for overall migration into olive oil using a pouch Part 7 Test methods for overall migr
22、ation into aqueous food simulants using a pouch Part 8 Test methods for overall migration into olive oil by article filling Part 9 Test methods for overall migration into aqueous food simulants by article filling Part 10 Part 11 Test methods for overall migration into olive oil (modified method for
23、use in cases where incomplete extraction of olive oil occurs) Test methods for overall migration into mixtures of 14C-labelled synthetic triglyceride 3 EN 1186-312002 (E) Part 12 Test methods for overall migration at low temperatures Part 13 Test methods for overall migration at high temperatures Pa
24、rt 14 Part 15 Test methods for substitute tests for overall migration from plastics intended to come into contact with fatty foodstuffs using test media iso-octane and 95 % ethanol Alternative test methods to migration into fatty food simulants by rapid extraction into iso- octane and/or 95 % ethano
25、l Annex A is informative. According to the CENKENELEC 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,
26、 Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. 4 EN 1186-312002 (E) 1 Scope This Part of this European Standard specifies test methods for the determination of the overall migration into aqueous based food simulants from plastics which are intended to come
27、into contact with foodstuffs, by total immersion of test specimens in a selected food simulant at test temperatures up to reflux for selected test times. This method is most suitable for plastics in the form of films and sheets, but can be applied to a wide range of articles or containers from which
28、 test pieces of suitable size can be cut. 2 Normative references This European Standard incorporates by dated and undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated re
29、ferences, subsequent amendments to and revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 1186-1:2002, Materials and
30、articles in contact with foodstuffs - Plastics - Part I: Guide to the selection of conditions and test methods for overall migration. EN 10088-1 :I 995, Stainless steels - Part I: List of stainless steels. EN IS0 8442-2:1997, Materials and articles in contact with foodstuffs - Cutlery and table holl
31、oware - Part 2: Requirements for stainless steel and silver- plated cutlery (IS0 8442-2: 1997). IS0 4788, Laboratory glassware - Graduated measuring cylinders. 3 Method A - overall migration into aqueous food simulants by total immersion in an oven or incubator or refrigerator 3.1 Principle The over
32、all migration of non-volatile substances from a sample of the plastics is determined as the mass of non- volatile residue after evaporation of the food simulant following immersion. The selection of the conditions of test and the food simulant(s) shall be determined by the conditions of use; see cla
33、uses 4, 5 and 6 of EN 1186-1 :2002. Test specimens of approximately 1 dm2, see clause 8 of EN 1186-1:2002, are immersed in the food simulant for the exposure time at temperatures up to and including the temperature of reflux. At the end of the test period, each test specimen is removed from the food
34、 simulant. The food simulant from each test specimen is evaporated to dryness, the mass of the non-volatile residue is determined gravimetrically and expressed as milligrams per square decimetre of surface area of test specimen. Overall migration is reported as the mean of three determinations on se
35、parate test specimens. 3.2 Reagents NOTE For details of preparation and quality of these reagents, see clause 4 of EN 1186-1 :2002. 3.2.1 Distilled water or water of equivalent quality (simulant A) 3.2.2 Acetic acid 3 % (w/v) in aqueous solution (simulant B) 3.2.3 Ethanol 10 % (v/v) in aqueous solut
36、ion (simulant C) 5 EN 1186-312002 (E) 3.2.4 Alcoholic simulants for liquids or beverages of an alcoholic strength exceeding 10 % (v/v). NOTE exceeding 10 % (v/v) the test is carried out with aqueous solutions of ethanol of a similar strength. In the case of materials and articles intended to come in
37、to contact with liquids or beverages of an alcoholic strength 3.3 Apparatus 3.3.1 250 mm x 250 mm is suitable. Cutting slab, clean smooth glass, metal or plastics slab of suitable area to prepare test specimens, 3.3.2 Tweezers, stainless steel, blunt nosed. 3.3.3 Cutting implement, scalpel, scissors
38、 or sharp knife or other suitable device. 3.3.4 Metal template, (100 mm I0,2 mm) x (100 mm I0,2 mm) (square). 3.3.5 Rule or template, 25 mm I 1 mm wide. 3.3.6 Rule, graduated in mm, and with an accuracy of 0,l mm. 3.3.7 Analytical balance capable determining a change in mass of 0,l mg. 3.3.8 Specime
39、n supports, constructed of stainless steel with cross arms attached by welding or silver soldering, or of glass. Stainless steel X4 CrNi 18 10 according to EN 10088-1: 1995 or of composition, chromium 17 %, nickel 9 %, carbon 0,04 %, is suitable. Before initial use thoroughly clean the stainless ste
40、el supports. The use of a degreasing solvent and then dilute nitric acid has been found to be suitable. For the aqueous acetic acid food simulant, use supports constructed out of glass, as there is a tendency for the acetic acid to corrode stainless steel supports, particularly if the joints are sil
41、ver soldered. NOTE 1 However stainless steel supports can be used for acetic acid if it can be demonstrated that when immersed on their own in simulant, for the test period, at the test temperature, the residue after evaporating the simulant to dryness and drying in an oven or incubator or refrigera
42、tor to constant mass at 105 OC to 110 OC is less than 5mg/l, see 4.1 of EN 11 86-1 :2002. NOTE 2 The method has been written for the supports shown in Figure C.l of EN 1186-1:2002 which have been found to be suitable for holding thin film and sheet test pieces. However other supports can be used pro
43、viding they are capable of holding and keeping the test pieces apart and at the same time ensuring complete contact with the simulant. For rigid samples, supports with a single cross arm may be used. 3.3.9 Gauze, pieces of fine stainless steel gauze, with a mesh size of 1 mm have been found to be su
44、itable, approximately 25 mm x 100 mm or, glass rods, 2 mm to 3 mm in diameter and approximately 100 mm long to be used with the acetic acid food simulant, for insertion between the test pieces. Before initial use thoroughly clean the gauze, first with a degreasing solvent and then with dilute nitric
45、 acid. 3.3.10 Glass tubes, ground neck, for retaining the food simulant and test specimens. Tubes with an internal diameter of approximately 35 mm and length of between 100 mm and 200 mm, excluding the ground neck (see 7.2 of EN 11 86-1 :2002) have been found to be satisfactory. 3.3.11 Glass beads,
46、2 mm to 3 mm diameter or glass rods, 2 mm to 3 mm in diameter and approximately 100 mm long (see 7.2 of EN 1186-1:2002). 3.3.12 Thermostatically controlled oven or incubator or refrigerator capable of maintaining the set temperature within the tolerances specified in Table B.2 of EN 11 86-1 :2002. 3
47、.3.13 Dishes, stainless steel, nickel, platinum, platinum alloy, gold 50 mm to 90 mm diameter and maximum mass 100 g, for evaporation of food simulants and weighing of residues. Glass, glass ceramic or ceramic dishes may be used provided that the surface characteristics are such that the masses of t
48、he dishes after evaporation of any specified food simulants followed by conditioning in the desiccator used achieves a constancy of I0,5 mg. Stainless steel and nickel dishes are suitable only for distilled water and ethanol solutions. Glass, glass ceramic, glazed ceramic, platinum or, platinum allo
49、y or gold dishes are suitable for all three simulants. 6 EN 1186-312002 (E) 3.3.14 Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of food simulant at the end of test period. 3.3.1 5 Desiccator with anhydrous calcium chloride or self indicating silica gel 3.3.16 Measuring cylinder, 100 ml, complying with the minimum requirements of IS0 4788. 3.4 Preparation of test specimens 3.4.1 General It is essential that test specimens are clean and free from surface contamination (many plastics can readily attract dust due to stati
