prEN 1186-14

SLOVENSKI STANDARD
oSIST prEN 1186-14:2006
01-december-2006
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Materials and articles in contact with foodstuffs - Plastics - 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
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 14:
Prüfverfahren für 'Ersatzprüfungen' für die Gesamtmigration aus Kunststoffen, die für
den Kontakt mit fettigen Lebensmitteln bestimmt sind, unter Verwendung der Prüfmedien
Iso-Octan und 95 %igem Ethanol
Matériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie
14 : Méthodes de replacement pour la vérification de la migration globale des matieres
plastiques en contact avec des denrées alimentaires grasses dans l'iso-octane et
l'éthanol a 95 %
Ta slovenski standard je istoveten z: prEN 1186-14
ICS:
67.250 Materiali in predmeti v stiku z Materials and articles in
živili contact with foodstuffs
oSIST prEN 1186-14:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
DRAFT
prEN 1186-14
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 67.250 Will supersede EN 1186-14:2002
English Version
Materials and articles in contact with foodstuffs - Plastics - 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
Matériaux et objets en contact avec les denrées Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln
alimentaires - Matière plastique - Partie 14 : Méthodes - Kunststoffe - Teil 14: Prüfverfahren für 'Ersatzprüfungen'
d'essai pour 'des tests de substitution' pour la migration für die Gesamtmigration aus Kunststoffen, die für den
globale des matières destinées au contact avec les Kontakt mit fettigen Lebensmitteln bestimmt sind, unter
denrées alimentaires gras en utilisant les 'test media' tels Verwendung der Prüfmedien Iso-Octan und 95 %igem
que l'isoctane et l'éthanol à 95 % Ethanol
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 1186-14:2006: E
worldwide for CEN national Members.

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prEN 1186-14:2006 (E)
Contents Page
Foreword.3
1 Scope.5
2 Normative references.5
3 Total immersion method .5
3.1 Principle.5
3.2 Reagents.6
3.3 Apparatus.6
3.4 Preparation of test specimens .7
3.5 Procedure.7
3.6 Expression of results.8
3.7 Precision.8
3.8 Test report.8
4 Cell method.9
4.1 Principle.9
4.2 Reagents.9
4.3 Apparatus.9
4.4 Preparation of test specimens .10
4.5 Procedure.10
4.6 Expression of results.11
4.7 Precision.11
4.8 Test report.11
5 Pouch method.12
5.1 Principle.12
5.2 Reagents.12
5.3 Apparatus.12
5.4 Preparation of test specimens .13
5.5 Procedure.13
5.6 Expression of results.14
5.7 Precision.14
5.8 Test report.15
6 Article filling method .15
6.1 Principle.15
6.2 Reagents.15
6.3 Apparatus.15
6.4 Preparation of test specimens .16
6.5 Procedure.16
6.6 Expression of results.17
6.7 Precision.17
6.8 Test report.17
Annex A (informative) Precision data.19
Annex B (informative)  Example of a pouch holder .20
Annex ZA (informative)  Relationship of this European Standard with Regulation 1935/2004 and
Commission Directive 2002/72/EC and associated Directives .21
Bibliography .23

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prEN 1186-14:2006 (E)
Foreword
This document (prEN 1186-14:2006) 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 supersedes EN 1186-14:2002.
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.
EN 1186-14 should be read in conjunction with EN 1186-1, EN 1186-3, EN 1186-5, EN 1886-7, and EN 1186-
9.
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 case where
incomplete extraction of olive oil occurs)
14
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 methods for overall migration at high temperatures
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prEN 1186-14:2006 (E)
Part 15 Alternative test methods to migration into fatty food simulants by rapid extraction into iso-octane
and/or 95 % ethanol
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prEN 1186-14:2006 (E)
1 Scope
This European Standard specifies test methods for 'substitute tests' performed with volatile test media, iso-
octane and 95 % v/v aqueous ethanol, for the determination of overall migration from plastics intended to
come into contact with fatty foodstuffs at all temperatures and for any period of time.
These test methods are suitable for plastics samples in a wide variety of forms.
NOTE 1 The iso-octane and 95 % v/v aqueous ethanol volatile test media used in these test methods are those
specified for 'substitute tests' in Commission Directive 82/711/EEC [3] and its subsequent amendments [4], [5]. In addition
to the use of iso-octane and 95 % v/v aqueous ethanol as test media for 'substitute tests', Commission Directive
82/711/EEC and its subsequent amendments specifies the use of modified polyphenylene oxide as a test medium for use
at temperatures of 100 °C and above. For a test method for overall migration from plastics intended to come into contact
with fatty foodstuffs using modified polyphenylene oxide as a test medium, see EN 1186-13.
NOTE 2 These test methods can also be used for the 'alternative tests' described in Council Directive 82/711/EEC and
its subsequent amendments, when the chosen volatile test media are iso-octane and 95 % aqueous ethanol, provided
equivalence is shown with olive oil, see EN 1186-1:2002.
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.
EN 1186-3:2002, Materials and articles in contact with foodstuffs – Plastics – Part 3: Test methods for overall
migration into aqueous food simulants by total immersion.
EN 1186-5:2002, Materials and articles in contact with foodstuffs – Plastics – Part 5: Test methods for overall
migration into aqueous food simulants by cell.
EN 1186-7:2002, Materials and articles in contact with foodstuffs – Plastics – Part 7: Test methods for overall
migration into aqueous food simulants using a pouch.
EN 1186-9:2002, Materials and articles in contact with foodstuffs – Plastics – Part 9: Test methods for overall
migration into aqueous food simulants by article filling.
EN 10088-1:1995, Stainless steels - Part 1: List of stainless steels.
ISO 648, Laboratory glassware - One mark pipettes.
ISO 4788, Laboratory glassware - Graduated measuring cylinders.
3 Total immersion method
3.1 Principle
The overall migration of non-volatile substances from a sample of the plastics material or article into the test
medium is determined as the mass of non-volatile residue after evaporation of the test medium following
immersion.
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prEN 1186-14:2006 (E)
The selection of the conditions of test will be determined by the conditions of use, see clauses 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 a test medium for
set periods of time and at set temperatures. At the end of the test period, each test specimen is removed from
the test medium. The test medium from each test 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 separate test specimens.
3.2 Reagents
1
3.2.1 Iso-octane, (2,2,4-trimethyl pentane), purity 98,5 % (v/v) or greater, CAS No. 540-84-1 .
3.2.2 Ethanol, purity 96 % (v/v) or greater, 95 % (v/v) in aqueous solution.
WARNING — Both these solvents are flammable. Take care at all times when handling these solvents
to prevent contact with sources of ignition.
3.3 Apparatus
3.3.1 Cutting slab, clean smooth glass, metal or plastics slab of suitable area to prepare test specimens,
250 mm x 250 mm is suitable.
3.3.2 Tweezers, stainless steel, blunt nosed.
3.3.3 Cutting implement, scalpel, scissors or sharp knife or other suitable device.
3.3.4 Metal template, 100 mm ± 0,2 mm x 100 mm ± 0,2 mm (square).
3.3.5 Rule or template, 25 mm ± 1 mm wide.
3.3.6 Rule, graduated in mm, and with an accuracy of 0,1 mm.
3.3.7 Analytical balance capable determining a change in mass of 0,1 mg.
3.3.8 Specimen 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 steel
supports. The use of a degreasing solvent and then with dilute nitric acid has been found to be suitable.
NOTE The method has been written for the supports shown in Figure C.1 of prEN 1186-1:2002 which have been
found to be suitable for holding thin film and sheet test pieces. However other supports may be used providing they are
capable of holding and keeping the test pieces apart and at the same time ensuring complete contact with the test medium.
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 suitable,
approximately 25 mm x 100 mm or, glass rods, 2 mm to 3 mm in diameter and approximately 100 mm long for
insertion between the test pieces. Before initial use thoroughly clean the gauze, first with a degreasing
solvent and then with dilute nitric acid.

1
The source of this is the Chemical Abstracts published by the American Chemical Society
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prEN 1186-14:2006 (E)
3.3.10 Glass tubes, ground neck with stoppers, for retaining the test medium and test specimens. Tubes
with an internal diameter of approximately 35 mm and length in the range of 100 mm to 200 mm, excluding
the ground neck, see 7.2 of EN 1186-1:2002, have been found to be satisfactory.
3.3.11 Glass beads, 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, incubator or refrigerator capable of maintaining a temperature within
the range of 5 °C to 60 °C and within the tolerances specified in Table B.2 of EN 1186-1:2002.
WARNING — The interior/sample space of the oven, incubator or refrigerator should not have any
exposed heating elements, to minimise safety hazards arising from any loss of the flammable test
media from the tubes during the test period.
3.3.13 Dishes, stainless steel, nickel, platinum, platinum alloy, gold 50 mm to 90 mm diameter and maximum
weight 100 g, for evaporation of test media and weighing of residues. Glass, glass ceramic or ceramic dishes
may be used provided that the surface characteristics are such that the weights of the dishes after
evaporation of any specified test media followed by conditioning in the desiccator used achieves a constancy
of ± 0,5 mg.
3.3.14 Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of test medium at the
end of test period.
3.3.15 Desiccator with anhydrous calcium chloride or self indicating silica gel.
3.3.16 Measuring cylinder, 100 ml, complying with the minimum requirements of ISO 4788.
3.3.17 Thermometer or electronic temperature measuring instrument with thermocouple, capable of
measuring temperature in the range 5 °C to 60 °C, with a precision of 0,1 °C.
3.4 Preparation of test specimens
Prepare the test specimens in accordance with 3.4 of EN 1186-3:2002.
3.5 Procedure
3.5.1 Exposure to test media
Take three of the glass tubes, for the test specimens and a further two to provide blanks, measure by
measuring cylinder 100 ml ± 2 ml of the test medium into each tube and stopper the tube. If the evaporation
method is to be used measure into a further two tubes, by measuring cylinder, 120 ml ± 2 ml of the test
medium, to provide blanks. If the distillation method is to be used measure into those further two tubes by
measuring cylinder 100 ml ± 2 ml of the test medium to provide blanks. Insert a thermometer or thermocouple
in one of the tubes containing 100 ml of test medium, then stopper all five tubes. Place the five tubes in the
thermostatically controlled oven, incubator or refrigerator, set at the test temperature, and leave until the test
medium has attained the test temperature.
Place a test specimen into each of the three tubes containing 100 ml of test medium, re-insert the
thermometer or thermocouple and re-stopper the tubes. Mark the tubes for identification. Ensure that the test
specimens are totally immersed in the test medium; if they are not then add either glass beads or rods to raise
the level of the test medium until total immersion is achieved. This part of the operation should be carried out
in the minimum time to prevent undue heat loss from the test medium.
Mark the liquid level on the outside of each tube with a suitable marker.
Replace all of the tubes in the thermostatically controlled oven, incubator or refrigerator, set at the test
temperature. Observe the temperature and leave the tubes for the selected test period, taking into account
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prEN 1186-14:2006 (E)
the tolerances specified in Table B.1 of EN 1186-1:2002, after the temperature in the tube has reached a
temperature within the tolerance specified in Table B.2 of EN 1186-1:2002.
WARNING 1 — Both iso-octane and ethanol are volatile flammable solvents. Take care to ensure that
the tubes are well stoppered to prevent solvent volatilizing into the interior of the oven, incubator or
refrigerator and generating an explosive mixture.
WARNING 2 — If possible place the tubes in a drip container capable of holding the total volume of
volatile simulant in case of accident.
WARNING 3 — To minimise hazards arising due to the volatile and flammable nature of the two test
media the maximum test temperature is 60 °°°°C. Do not conduct the tests at temperatures above 60 °°°°C.
Take the tubes from the oven, incubator or refrigerator and check the level of test medium in each, if this has
fallen to more than 10 mm below the mark, or has exposed any part of the test pieces, repeat the test using
fresh test specimens.
NOTE For exposure times of more than 24 h it is acceptable to monitor the temperature of the airbath of the
thermostatically controlled oven or incubator, instead of the temperature of the simulant.
If the level of test medium in a tube is less than 10 mm below the mark, remove the test specimen from the
tube, and allow the test medium adhering to the test specimen and support to drain back into the tube.
Recover at least 90 % of the original volume of test medium or repeat the test.
3.5.2 Determination of migrating substances
Determine the migrating substances in accordance with 3.5 of EN 1186-3:2002.
WARNING — Both iso-octane and ethanol are volatile and flammable solvents. Take care when
evaporating these test media to prevent vapours contacting sources of ignition, particularly when
using a hot plate to carry out the evaporation. The evaporation should be carried out in a fume
cupboard.
3.6 Expression of results
Calculate the results in accordance with 3.6 of EN 1186-3:2002.
3.7 Precision
See Annex A.
3.8 Test report
The test report shall include the following, see clause 11 of EN 1186-1:2002:
a) reference to this European Standard and to the Part used for the test procedure;
b) all information necessary for complete identification of the sample such as chemical type, supplier, trade
mark, grade, batch number, thicknesses;
c) conditions of time and temperature of exposure to test media;
d) departures from the specified procedure, and reasons for these;
e) individual test results, and the mean of these, expressed as milligrams of residue per square decimetre of
sample;
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prEN 1186-14:2006 (E)
f) relevant comments on the test results.
4 Cell method
4.1 Principle
The overall migration of non-volatile substances from a sample of the plastics material or article into the test
medium, is determined as the mass of non-volatile residue after evaporation of the test medium.
The selection of the conditions of test will be determined by the conditions of use, see clauses 4, 5 and 6 of
EN 1186-1:2002.
One surface of the test specimen is exposed in a cell to a test medium for set periods of time and at set
temperatures. At the end of the test period, each test specimen is removed from contact with the test medium.
The test medium from each test 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, which had
been in contact with the test medium.
Overall migration is reported as the mean of three determinations on separate test specimens.
4.2 Reagents
4.2.1 Iso-octane (2,2,4-trimethyl pentane), purity 98,5 % (v/v) or greater, CAS No. 540-84-1.
4.2.2 Ethanol, purity 96 % (v/v) or greater, 95 % (v/v) in aqueous solution.
WARNING — Both these solvents are flammable. Take care at all times when handling these solvents
to prevent contact with sources of ignition.
4.3 Apparatus
4.3.1 Cutting slab, clean smooth glass, metal or plastics slab of suitable area to prepare test specimens,
250 mm x 250 mm is suitable.
4.3.2 Tweezers, stainless steel, blunt nosed.
4.3.3 Cutting implement, scalpel, scissors or sharp knife or other suitable device.
4.3.4 Rule, graduated in mm, and with an accuracy of 0,1 mm.
4.3.5 Analytical balance capable of determining a change in mass of 0,1 mg.
4.3.6 Cell type A, as shown in Figure C.3 of EN 1186-1:2002, either the all aluminium (anodised) cells or
the cells with the stainless steel (316 grade) lids and rings. The internal diameter of the rib of the sealing ring
shall be 178,4 mm ± 0,1 mm, to give an area of the test specimen exposed to the test medium of 2,5 dm². It
will be necessary to modify the filler plug on one of the cells to allow a thermometer or thermocouple to be
inserted into the test medium, whilst maintaining an effective seal to prevent loss of test medium during the
test period).
NOTE The cell type A is constructed with a rubber mat in the base plate. It is advised that a disc of aluminium foil is
placed on the mat before inserting the test specimen. The use of these discs will prevent any substances from the mat
influencing the migration result.
For details of equivalent cells see 7.3 of EN 1186-1:2002.
4.3.7 Pipettes, complying with the minimum requirements of ISO 648, 50 ml and 100 ml.
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prEN 1186-14:2006 (E)
4.3.8 Glass tubes, ground neck, and stoppers, for retaining the test medium. Tubes with an internal
diameter of approximately 35 mm and length of approximately 100 mm to 200 mm, excluding the ground neck,
see 7.2 of
EN 1186-1:2002, have been found to be satisfactory.
4.3.9 Thermostatically controlled oven, incubator or refrigerator capable of maintaining a temperature within
the range 5 °C to 60 °C and within the tolerances specified in Table B.1 of EN 1186-1:2002.
WARNING — The interior/sample space of the oven, incubator or refrigerator should not have any
exposed heating elements, to minimise safety hazards arising from any loss of the flammable test
media from the tubes and cells.
4.3.10 Dishes
...