oSIST prEN 1186-15:2006

SLOVENSKI STANDARD
01-december-2006
0DWHULDOLLQSUHGPHWLYVWLNX]åLYLOL3ROLPHUQLPDWHULDOLGHO$OWHUQDWLYQH
SUHVNXVQHPHWRGH]DPLJUDFLMRYPRGHOQHUD]WRSLQH]DPDãþREQDåLYLODVKLWUR
HNVWUDNFLMR]L]RRNWDQRPLQDOLRGVWRWQLPHWDQRORP
Materials and articles in contact with foodstuffs - Plastics - Part 15: Alternative test
methods to migration into fatty food simulants by rapid extraction into iso-octane and/or
95 % ethanol
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 15:
Alternative Prüfverfahren zur Migration in fettige Prüflebensmittel durch Schnellextraktion
in Iso-Octan und/oder 95%iges Ethanol
Matériaux et objets en contact avec les denrées alimentaires - Plastiques - Partie 15 :
Méthodes de remplacement pour la vérification de la migration dans les simulants gras
par extraction rapide dans l'iso-octane et/ou l'éthanol aqueux a 95 %
Ta slovenski standard je istoveten z: prEN 1186-15
ICS:
67.250 Materiali in predmeti v stiku z Materials and articles in
živili contact with foodstuffs
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
DRAFT
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 67.250 Will supersede EN 1186-15:2002
English Version
Materials and articles in contact with foodstuffs - Plastics - Part
15: Alternative test methods to migration into fatty food
simulants by rapid extraction into iso-octane and/or 95 %
ethanol
Matériaux et objets en contact avec les denrées Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln
alimentaires - Matière plastique - Partie 15 : Méthodes - Kunststoffe - Teil 15: Alternative Prüfverfahren zur
d'essai alternatives pour la migration dans les simulants Migration in fettige Prüflebensmittel durch Schnellextraktion
alimentaires gras par extraction rapide dans l'iso-octane in Iso-Octan und/oder 95%iges Ethanol
et/ou l'éthanol à 95 %
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 194.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1186-15:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
1 Scope.5
2 Normative references.5
3 Method A Alternative test method to migration into fatty food simulants by rapid
extraction into iso-octane and/or 95 % ethanol by total immersion.6
3.1 Principle.6
3.2 Reagents.6
3.3 Apparatus.7
3.4 Preparation of test specimens .7
3.5 Procedure.8
3.6 Expression of results.10
3.7 Test report.10
4 Method B Alternative test method to migration into fatty food simulants by rapid
extraction into iso-octane and/or 95 % ethanol in the single side mode by cell .11
4.1 Principle.11
4.2 Reagents.11
4.3 Apparatus.11
4.4 Preparation of test specimens .12
4.5 Procedure.12
4.6 Expression of results.15
4.7 Test report.15
Annex A (informative) Precision data.16
Annex ZA (informative)  Relationship of this European Standard with Regulation 1935/2004 and
Commission Directive 2002/72/EC and associated Directives .17
Bibliography .19

Foreword
This document (prEN 1186-15:2006) has been prepared by Technical Committee CEN/TC 194 “Utensils in
contact with food”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
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 EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
This document will supersede EN 1186-15:2002.
WARNING — Both iso-octane and ethanol are volatile flammable solvents. Take care to ensure that
the test specimens are well stoppered, closed and covered to prevent solvent volatilizing into the
interior of the oven, incubator or refrigerator and generating an explosive mixture. Care should be
taken at all times when handling these solvents to prevent contact with sources of ignition.
Read EN 1186-15 in conjunction with EN 1186-1.
Further Parts of this standard have been prepared concerned with the determination of overall migration from
plastics materials into food simulants. Their titles are as follows:
EN 1186 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 migration into olive oil by total immersion
Part 3 Test methods for overall migration into aqueous food 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 migration 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 simulants by article filling
Part 10 Test methods for overall migration into olive oil (modified method for use in cases where
incomplete extraction of olive oil occurs)
Part 11 Test methods for overall migration into mixtures of C-labelled synthetic triglyceride
Part 12 Test methods for overall migration at low temperatures
Part 13 Test method for overall migration at high temperatures
Part 14 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
1 Scope
This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more
severe' test character, for the assessment of the overall migration into fatty food simulants.
Method A is based on the determination of the extraction of migrateable substances from plastics which are
intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar,
ethanol, solvents depending on the polarity of the packaging material. According to results obtained by this
method (see [1], [2], [3], [4], [5]) and taking physio-chemical considerations into account, the obtained
extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results
obtained 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.
To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of
the sample by the extraction solvent is necessary. For this purpose, iso-octane is used as an extraction
solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins. For
test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 %
(v/v) aqueous ethanol is used. For polystyrenes, plasticized polyvinyl chloride and other polymers where the
identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using
both of the proposed extraction solvents and taking the higher value obtained as the relevant result.
NOTE 1 In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food
contact layer determines the selection of the extraction solvent(s).
This test method should only be applied to flexible packagings which are less than 300 µm in thickness. When
the result does not exceed the allowed overall migration limit then the material can be considered to be in
compliance with EC regulations. If the test result exceeds the allowed overall migration limit the following
options may be applied chronologically with respect to further migration testing:
1) single-sided extraction test using a cell, if technically feasible (see 15B of this standard);
2) conventional migration test using olive oil or other fatty food simulants;
NOTE 2 The overall migration limit is specified in Commission Directive 2002/72/EC [7] and the conditions of test in
Council Directive 82/711/EEC [8] and its subsequent amendments, [9], [10].
Method B is applicable in those cases where the total immersion test, EN 1186-15 Method 15A, yields total
extraction values that exceed the overall migration or may be technically unsuitable, i.e. in the case of
multilayer structures, such as plastics laminates and co-extruded films. This test method should primarily only
be applied to flexible packagings with a physical barrier layer (for instance of aluminium or other material to
prevent penetrative loss of extraction solvent) and which have a thinner food contact layer than 300 µm. If the
result does not exceed the allowed overall migration limit then the material can be considered to be in
compliance with EC regulations. If the test result exceeds the allowed overall migration limit then the following
option may be applied with respect to further migration testing:
- conventional migration test using olive oil or other fatty food simulants.
NOTE 3 Methods A and B are not applicable to test materials intended for applications over 130 °C.
NOTE 4 Test materials intended for applications over 70 °C should be checked for their physical suitability at the
intended time and temperature of use.
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 references, 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 articles in contact with foodstuffs – Plastics – Part 1: Guide to the selection of
conditions and test methods for overall migration
ISO 648, Laboratory glassware - One mark pipettes
ISO 4788, Laboratory glassware - Graduated measuring cylinders
3 Method A
Alternative test method to migration into fatty food simu
...