prEN 1186-2

Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for overall migration in vegetable oils

This document specifies methods for measuring overall migration of plastic materials and articles intended to come into contact with foodstuffs by contacting test specimens with vegetable oils at temperatures greater than or equal to 4 °C and up to 175 °C.
NOTE   Some vegetable oils are not suitable for use below 20 °C.
The overall migration from a sample of the plastics is determined as the loss in mass of non-volatile substances expressed:
-   per unit surface area, or
-   per kg of food simulant, or
-   per article;
after contact with a food simulant under defined conditions.
According to the type of materials or articles, contact with the food simulant is carried out on a single surface (pouch, cell, filling) or by immersion.
This document does not cover the interpretation of the results which is expected to account for regulatory requirements.

Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 2: Prüfverfahren für die Gesamtmigration in Pflanzenölen

Dieses Dokument legt Verfahren für die Messung der Gesamtmigration von für den Kontakt mit Lebensmitteln vorgesehenen Werkstoffen und Gegenständen aus Kunststoff fest, bei der die Prüfmuster mit Pflanzenölen in Kontakt gebracht werden, die auf einer Temperatur von größer oder gleich 4 °C und kleiner oder gleich 175 °C gehalten werden.
ANMERKUNG   Einige Pflanzenöle sind für den Gebrauch bei Temperaturen unterhalb von 20 °C ungeeignet.
Die Gesamtmigration aus einer Probe des Kunststoffes wird als der Massenverlust an nichtflüchtigen Substanzen, angegeben:
-   je Oberflächeneinheit; oder
-   je kg des Prüflebensmittels; oder
-   je Gegenstand;
nach Kontakt mit einem Prüflebensmittel unter festgelegten Bedingungen bestimmt.
Je nach der Art der Werkstoffe oder Gegenstände erfolgt der Kontakt mit dem Prüflebensmittel entweder an nur einer Oberfläche (Beutel, Zelle, Befüllen) oder durch Eintauchen.
Dieses Dokument deckt nicht die Auswertung der Ergebnisse ab, die wahrscheinlich behördliche Anforderungen bedingt.

Matériaux et objets en contact avec les denrées alimentaires - Matière plastique - Partie 2 : Méthodes d’essai pour la migration globale dans les huiles végétales

Le présent document spécifie des méthodes pour mesurer la migration globale des matériaux et objets en matière plastique destinés à entrer en contact avec des denrées alimentaires en mettant en contact des éprouvettes avec des huiles végétales à des températures supérieures ou égales à 4 °C et jusqu’à 175 °C.
NOTE   Certaines huiles végétales ne conviennent pas à une utilisation en dessous de 20 °C.
La migration globale à partir d’un échantillon de matière plastique est déterminée comme étant la perte de masse de substances non volatiles. Elle est exprimée :
-   par unité de surface ; ou
-   par kg de simulant de denrées alimentaires ; ou
-   par objet ;
après contact avec un simulant de denrées alimentaires dans des conditions définies.
En fonction du type de matériau ou d’objet, le contact avec le simulant est réalisé sur une surface unique (méthode du sachet, de la cellule, du remplissage) ou par immersion.
Le présent document ne couvre pas l’interprétation des résultats qui est censée tenir compte des exigences réglementaires.

Materiali in predmeti v stiku z živili - Polimerni materiali - 2. del: Preskusne metode za celotno migracijo v olivno olje

General Information

• Status: Not Published
• ICS: 67.250 - Materials and articles in contact with foodstuffs
• Technical Committee: CEN/TC 194 - Utensils in contact with food
• Drafting Committee: CEN/TC 194/WG 8 - Overall migration
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 13-Dec-2021
• Completion Date: 13-Dec-2021
• Directive: 10/2011 - Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance
• Ref Project: oSIST prEN 1186-2:2020 - Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for overall migration in vegetable oils

RELATIONS

• Revised: EN 1186-10:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 10: Test methods for overall migration into olive oil (modified method for use in cases where incomplete extraction of olive oil occurs)
• Effective Date: 23-Oct-2019
• Revised: EN 1186-6:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 6: Test methods for overall migration into olive oil using a pouch
• Effective Date: 23-Oct-2019
• Revised: EN 1186-12:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 12: Test methods for overall migration at low temperatures
• Effective Date: 23-Oct-2019
• Revised: EN 1186-2:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for overall migration into olive oil by total immersion
• Effective Date: 23-Oct-2019
• Revised: EN 1186-4:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 4: Test methods for overall migration into olive oil by cell
• Effective Date: 23-Oct-2019
• Revised: EN 1186-8:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 8: Test methods for overall migration into olive oil by article filling
• Effective Date: 23-Oct-2019

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN 1186-2:2020
01-april-2020

Materiali in predmeti v stiku z živili - Polimerni materiali - 2. del: Preskusne metode

za celotno migracijo v olivno olje

Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for

overall migration in vegetable oils
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 2:
Prüfverfahren für die Gesamtmigration in Olivenöl

Matériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie

8: Méthodes d'essai pour la migration globale dans l'huile d'olive
Ta slovenski standard je istoveten z: prEN 1186-2
ICS:
67.250 Materiali in predmeti v stiku z Materials and articles in
živili contact with foodstuffs
83.080.01 Polimerni materiali na Plastics in general
splošno
oSIST prEN 1186-2:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 1186-2:2020
---------------------- Page: 2 ----------------------
oSIST prEN 1186-2:2020
DRAFT
EUROPEAN STANDARD
prEN 1186-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2020
ICS 67.250 Will supersede EN 1186-10:2002, EN 1186-12:2002,
EN 1186-2:2002, EN 1186-4:2002, EN 1186-6:2002,
EN 1186-8:2002
English Version
Materials and articles in contact with foodstuffs - Plastics -
Part 2: Test methods for overall migration in in vegetable
oils
Werkstoffe und Gegenstände in Kontakt mit
Lebensmitteln - Kunststoffe - Teil 2: Prüfverfahren für
die Gesamtmigration in verdampfbaren Simulanzien

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 CEN-CENELEC

Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1186-2:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

1 Scope .................................................................................................................................................................... 4

2 Normative references .................................................................................................................................... 4

3 Terms and definitions ................................................................................................................................... 4

4 Test methods .................................................................................................................................................... 5

4.1 Principle ............................................................................................................................................................. 5

4.2 Reagents ............................................................................................................................................................. 6

4.3 Materials and apparatus ............................................................................................................................... 7

4.4 Preparation of test specimens ................................................................................................................. 10

4.5 Procedure........................................................................................................................................................ 13

4.6 Expression of results ................................................................................................................................... 22

5 Test report ...................................................................................................................................................... 24

Annex A (normative) Contact time and temperature tolerances............................................................. 26

Annex B (normative) Determination of the suitability of oil as the fatty food simulant and of

triheptadecanoin as the internal standard ......................................................................................... 28

Annex C (normative) Determination of the need for sample conditioning .......................................... 30

Annex D (normative) Determination of the need for sample conditioning and

determination of the mass of moisture sensitive test specimens, by cacuum drying ......... 31

Annex E (informative) Typical chromatograms and calibration graph ................................................ 33

Annex F (informative) Precision data ................................................................................................................ 36

Bibliography ................................................................................................................................................................. 37

---------------------- Page: 4 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)
European foreword

This document (prEN 1186-2:2020) has been prepared by Technical Committee CEN/TC 194 “Utensils

in contact with food”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.

This document implements European Commission Regulation on plastic materials and articles intended

to come into contact with food with regards to the determination of the overall migration in food

simulants. This regulatory text is subject to change it is therefore strongly recommended that users of

this document refer to the latest relevant published regulatory texts before commencement of any of the

test or tests described in this document, looking to the European Commission website.

This document will supersede EN 1186-2:2002, EN 1186-4:2002, EN 1186-6:2002, EN 1186-8:2002,

EN 1186-10:2002 and EN 1186-12:2002.
---------------------- Page: 5 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)
1 Scope

This document specifies methods for measuring overall migration of plastic materials and articles

intended to come into contact with foodstuffs by contacting test specimens with vegetable oils at

temperatures greater than or equal to 4 °C and up to 175 °C.
NOTE Some vegetable oils are not suitable for use below 20 °C.

The overall migration from a sample of the plastics is determined as the loss in mass of non-volatile

substances expressed:
— per unit surface area, or
— per kg of food simulant, or
— per article;
after contact with a food simulant under defined conditions.

According to the type of materials or articles, contact with the food simulant is carried out on a single

surface (pouch, cell, filling) or by immersion.

This document does not cover the interpretation of the results which is expected to account for regulatory

requirements.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN ISO 8442-2:1997, Materials and articles in contact with foodstuffs — Cutlery and table hollowware —

Part 2: Requirements for gold-plated cutlery (ISO 8442-2;1997)
ISO 648, Laboratory glassware — Single-volume pipettes
3 Terms and definitions
For the purposes of this document, the following terms and definitions.

Note 1 to entry: Only terms not included in European Commission regulation on plastic materials are defined

herein.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
ready-to-use article
article as sold that can be used with minimal if any preparation
3.2
sample
material or article under test
---------------------- Page: 6 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)
3.3
test specimen
part of the sample undergoing a measurement during the test
3.4
piece
portion of a test specimen
3.5
conventional oven

thermostatically controlled heat chamber where the air within is heated and this heat is then transferred

to the food through the plastic as opposed to a microwave oven where the food itself is heated directly

by microwave’s irradiation
3.6
fillable pouch

receptacle of a defined size, manufactured in the film under test and which, once filled with food simulant,

exposes the side of the film to be in contact with foodstuffs to such a food simulant or to a test medium

3.7
reverse pouch

pouch manufactured such that the surface to be in contact with foodstuffs is the outer surface

Note 1 to entry: All sides are sealed to prevent inner surfaces from coming into contact with the food simulant.

The reverse pouch is to be completely immersed in the food simulant or in the test medium.

3.8
cell

device in which the film under test can be mounted and which, when assembled and filled with food

simulant, exposes the side of the film to be in contact with foodstuffs to such a food simulant or to a test

medium
4 Test methods
4.1 Principle
4.1.1 General

The overall migration of a material or a ready-to-use article made of plastic in contact with fatty foods,

for which vegetable oils must be used, is determined by putting test specimens in contact with a vegetable

oil in test conditions chosen on the basis of the worst case scenario of use, by weighing test specimens

before and after contact with the vegetable oil, by dosing the oil absorbed by the material by gas

chromatography which is deduced from the obtained mass difference.

Test specimens of known mass are placed in contact with oil for the exposure time, at temperatures above

4 °C and below 175 °C, then taken from the oil, drained and wiped to remove oil adhering to the surface,

and reweighed.

The specimens will usually retain absorbed oil that is extracted and determined quantitatively by means

of gas chromatography after conversion to methyl esters. Methylation is carried out by reacting a boron

trifluoride/methanol complex with fatty acids formed by hydrolyzing the oil with potassium hydroxide.

An internal standard, triheptadecanoin, is added prior to the extraction of the absorbed oil from the test

specimens. This ensures that any active or extractable components of the plastics react with the internal

standard, as well as with the extracted oil. The internal standard is also subjected to the hydrolysis and

---------------------- Page: 7 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)

methylation reactions, providing compensation for any inefficiencies in the hydrolysis and methylation

processes.

Migration into the oil is calculated by subtracting the mass of oil retained by the test specimen from the

mass of the test specimen after removing the oil, then subtracting this mass from the initial mass of the

specimen.

The total loss in mass is expressed in milligrams per square decimetre of surface area of the test specimen

or in milligrams per kg of oil or in milligrams per article and the overall migration is reported as the mean

of a minimum of three determinations on separate test specimens.

According to the type of sample, the tests are conducted based on one of the following contacting methods

at a temperature greater than or equal to 4 °C and less than or equal to 175 °C and for the specified

exposure time.

NOTE In some vegetable oils, this method is also suitable for temperatures above 175 °C. The suitability of

vegetable oils depends their physical properties.
4.1.2 Method 1: total immersion

Test specimens of known mass and surface are immersed in oil; this method is most suitable for plastics

in the form of films and sheets, but can also be applied to a wide range of articles or containers from which

test specimens of a suitable size can be cut.
4.1.3 Method 2: cell

Test specimens of known mass are placed in contact with oil in a cell; this method is most suitable for

plastics in the form of films or sheets in which only one surface is to be in contact with foodstuffs (printed,

multi-layer materials, etc.).
4.1.4 Method 3: fillable pouch

Test specimens of known mass and in the form of pouches are filled with oil; this method is suitable for

plastics in the form of films or sheets in which the surface to be in contact with foodstuffs (printed, multi-

layer materials) can be sealed by applying heat or pressure, to form a pouch.
4.1.5 Method 4: reverse pouch

Test specimens of known mass and in the form of reverse pouches are immersed in oil; this method is

suitable for plastics in the form of films or sheets in which both surfaces can be sealed by applying heat

or pressure to form reverse pouches. This method, whenever possible, shall be preferred over those using

fillable pouches when the oil temperature is above 70°C due to the pressure from the oil that may damage

the pouch seal at high temperatures.
4.1.6 Method 5: filling a container

Test specimens of known mass are filled with oil; this method is suitable for plastics in the form of

containers and articles that can be filled. Testing samples by this method enables testing of non-

homogeneous articles provided they are not too large. If the article is large, to avoid handling and

weighing problems or using excessive amounts of oil, it may be preferable to cut it

4.2 Reagents
4.2.1 General
All reagents should be of analytical quality, unless otherwise specified.
---------------------- Page: 8 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)

4.2.2 Oil: Vegetable oils used as simulant shall be rectified and contain less than 1 % of unsaponifiable

matter (waxes and essential oils)
4.2.3 Extraction solvents

4.2.3.1 Pentane is the solvent recommended for the first extraction for all type of plastic materials.

4.2.3.2 Diethylether

4.2.3.3 A 95/5 by volume azeotropic mixture of pentane 98 % and ethanol 96 % is the solvent

recommended for polar plastics such as polyamide and polyacetal

NOTE 1 Due to the low boiling points of these solvents, cooled condenser water can be required to prevent undue

loss of the solvent from the condenser.
NOTE 2 The solvent can be recycled by redistilling it and removing fats.

4.2.4 Triheptadecanoin (glyceryl trimargarate) CAS No. 2438-40-6 solution, 2 mg/ml in cyclohexane

NOTE Other internal standards can be used, such methyl cinnamate (CAS: 103–26–4) or glyceryl

trinonadecanoate (CAS n°26536–13–0).
4.2.5 Potassium hydroxide solution, 11g/l in methanol.
4.2.6 Boron trifluoride, methanol complex, approximately 150 g/l of BF .
4.2.7 n-heptane
4.2.8 Sodium sulfate, saturated solution
4.3 Materials and apparatus
4.3.1 General

The constituent materials of the materials and apparatus used and the condition thereof shall make it

possible to prevent contamination of the samples, reagents and solutions under analysis.

The materials and apparatus shall be suitably cleaned.
4.3.2 Common materials and apparatus for all methods
4.3.2.1 Analytical balance having a precision of at least 0.1 mg.

4.3.2.2 Conventional oven (thermostatically controlled oven, incubator, refrigerator, etc.) capable of

maintaining the set temperature, within the tolerances specified in Annex A
4.3.2.3 Steam bath, hot plate, distillation apparatus or rotary evaporator
4.3.2.4 Desiccator with, for example, anhydrous calcium chloride or silica gel
4.3.2.5 Lint-free cloth or soft brush or pure compressed air generator

4.3.2.6 Conditioning containers, for conditioning test specimens at 50 % ± 5 % and 80 % ± 5 % relative

humidity at 20°C ± 5°C

NOTE For 50 % relative humidity, 43 % w/v sulphuric acid solution in water is suitable and for 80 % relative

humidity, 27 % w/v sulphuric acid solution is suitable.
---------------------- Page: 9 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)

The solutions should be freshly prepared by adding a weighed amount of acid to a suitable volume of

water, cooling to room temperature and making up to the required volume. It is recommended that

relative humidity and temperature be maintained during the conditioning period. Therefore, the

containers should be placed in a conventional oven, at a temperature of approximately 20°C, the set

temperature should not vary by more than ± 1°C.
4.3.2.7 Anti-bumping beads.

4.3.2.8 Soxhlet type extractors, capable of holding test specimens on the supports, with flasks of

appropriate size

NOTE Alternative extractors capable of satisfactorily extracting absorbed oil from the test specimens can be

used.
4.3.2.9 Water bath, capable of holding the flasks of soxhlet type extractors.

4.3.2.10 Rotary evaporator or distillation apparatus, for evaporation and collection of the extraction

solvent

NOTE Artificially cooled water can be necessary for efficient condensation of a low boiling point solvent.

4.3.2.11 Flasks, 50 ml, long neck with condensers to fit, for methyl ester preparations.

4.3.2.12 Gas chromatograph, with flame ionization detector or other suitable detector equipped with

an appropriate column

For olive oil: When using a polar column, the major peaks of the olive oil, such as C16:0, methyl

hexadecanoate (methyl palmitate), C16:1, methyl 9-hexadecenoate (methyl palmitoate), C18:0, methyl

octadecanoate (methyl stearate), C18:1, methyl 9-octadecenoate (methyl oleate), C18:2, methyl 9,12-

octadecadienoate (methyl linoleate) and the internal standard C17:0, methyl heptadecanoate (methyl

margarate) shall demonstrate baseline separation. Optionally, a non-polar column can be used which

shall give baseline separation of the methyl esters with 16 and 18 carbon numbers and the internal

standard with 17 carbon number.
The following columns have been found to be suitable:

— Column 1, polar column, WCOT fused silica column, length 50 m, internal diameter 0,25 mm, coated

with a 0,21 micron film of cyanopropyl silicone;

— Column 2, non polar column, BP1, length 25 m, internal diameter 0,32 mm, with a 1 micron film

thickness;

— Column 3, polar column, stainless steel column 2 mm to 3 mm internal diameter and 2 m to 3 m

length with a packing of 10 % to 20 % by mass of polyestersuccinate on a stationary phase of

diatomaceous earth 80 mesh to 100 mesh.

For other vegetable oils: The condition for separation of the main fatty acid esters should be checked.

4.3.2.13 Glass containers with stoppers, of a volume of approximately 10 ml, for storing the heptane

layer if necessary.

4.3.2.14 Conventional oven under vacuum or vacuum desiccator, capable of maintaining a temperature

of 60 °C ± 2 °C. The conventional oven or the desiccator shall be equipped with or connected to a

vacuum pump capable of achieving a vacuum of 1,3 kPa or less. The vacuum pump shall be provided

with a time controller to switch on the vacuum pump every hour for 15 min

NOTE If a conventional oven under vacuum is not available, a vacuum desiccator placed in an oven at 60°C can

be used.
---------------------- Page: 10 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)

4.3.2.15 Disposable plastic syringes with luer fitting, 1 ml or 10 ml and wide gauge luer needles

(80 mm ± 1,2 mm) or equivalent equipment (graduated cylinder, pipette, etc.)
4.3.2.16 Absorbent paper
4.3.3 Common materials for methods other than filling a container

4.3.3.1 Cutting slab, clean smooth glass, metal or plastic slab of sufficient area to prepare test

specimens.
4.3.3.2 Blunt-nosed tweezers, for example made of stainless steel

4.3.3.3 Cutting implement, scalpel, scissors, sharp knife or other suitable device

4.3.3.4 Cutting templates measuring (100 mm ± 0,2 mm) X (100 mm ± 0,2 mm)
4.3.3.5 Tool for measuring length, having a precision of 1 mm

4.3.3.6 Glass containers equipped with an inert sealing system (stopper, lid, etc.) for containing the oil

and test specimens, for example test tubes, ground neck, with an internal diameter of approximately

35 mm and length in the range of 100 mm to 200 mm, excluding the ground neck
4.3.3.7 Ground-necked flasks of suitable size

4.3.3.8 Pipettes, 50 ml and 100 ml, conforming to the requirements of ISO 648 Class B or automatic

pipettes of equivalent performances
4.3.4 Materials for method 1 (total immersion).

4.3.4.1 Specimen supports, for example made of stainless steel, capable of holding and keeping the test

pieces apart and at the same time ensuring complete contact with oil.

4.3.4.2 Gauze, for example, fine stainless steel gauze, mesh size 1 mm, approximately 25 mm x 100 mm

in size

4.3.4.3 Glass rods, for example 2 mm to 3 mm in diameter and approximately 100 mm long, for

insertion between the test pieces
4.3.4.4 Glass beads, for example 2 mm to 3 mm in diameter
4.3.5 Materials for method 2 (cell)
4.3.5.1 Migration cell
— Minimum of 0,5 dm of contact area for the test specimen
— Minimum of 1 dm / 50 ml of surface to volume ratio for the test specimen
— Blank value shall be less than 5 mg/l.

4.3.6 Materials for method 3 (fillable pouch) and for the method 4 (reverse pouch)

Heat or pressure sealing device, for use in forming pouches.
4.3.7 Materials for method 5 (filling a container)
Glass containers.
---------------------- Page: 11 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)
4.4 Preparation of test specimens
4.4.1 General

The test specimens shall be clean and free from surface contamination (many plastics can readily attract

dust due to static charges). Before preparing test specimens, remove any surface contamination from the

sample by gently wiping it with a lint-free cloth, or by brushing with a soft brush, or with a compressed

air stream.

As a general rule, do not wash the sample with water or solvent. However, if the articles are accompanied

by instructions for use intended for the user advising cleaning before use, these instructions should be

followed for the test, unless they advise rubbing the article with oil: in this case, the instructions should

not be followed insofar as the oil would be included in the overall migration
Minimize handling of the samples and where necessary, wear cotton gloves.

Seven test specimens are required for samples, in the form of thin films, sheets, cut sections from

containers or similar articles. Nine test specimens, similar dimensionally to one another, are required for

samples of articles of irregular shape.
These test specimens are utilized as follows:
a) four test specimens for the migration test;

b) one test specimen to determine the suitability of the oil as the fatty food simulant and

triheptadecanoin as the internal standard (see Annex B);

c) a minimum of one test specimens to check for possible loss of volatiles if the sample does not undergo

a stage in a vacuum oven;

d) two test specimens for determination of the surface area, in the case of samples of irregular shape.

If the conditioning test in Annex D is used, one additional test specimen is required.

If previous testing has established that interference in the gas chromatography procedure is unlikely and

Annex B is omitted, one fewer test specimen will be required.

A minimum of three valid test results is required to calculate the mean. Testing in triplicate is allowed

but in this case if one test result is invalid repeat the entire procedure.
Determine the area of each test specimen to the nearest 0,01 dm and record.

If the result is to be expressed in mg/kg, determine the contact surface area and the volume of the article

and record.

To obtain three validated results and allow for inaccuracies which may arise during the procedure and

which may be difficult to detect, due for example to contamination or loss of oil during the sample

handling stages, four determinations should be carried out on the sample allowing for the result from one

specimen to be discarded.

NOTE The two test specimens, c), are used to check whether the sample loses mass from the evaporation of

volatiles, such as solvents, during the test period. If the vacuum drying procedure in Annex D is used, these test

specimens are not required as during the vacuum drying any volatiles will have been removed from the test

specimens.
4.4.2 Preparation of test specimens and determination of the area in contact
4.4.2.1 General

It is recommended to use surface of 1dm and a volume of 100 ml. Deviations should be recorded and

explained. If necessary, a test specimen could be cut in pieces.
---------------------- Page: 12 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)

The test specimens shall be clean and free from surface contamination (many plastics can readily attract

dust due to static charges).
4.4.2.2 Method 1: total immersion
4.4.2.2.1 General
2 2

Cut out test specimens measuring 1 dm ± 0,01 dm using using the tool of 4.3.3.4. If this is not possible,

cut out pieces suitable for obtaining test specimens having a surface area of approximately 1 dm .

Ensure that the test pieces are well separated and that their surfaces are freely exposed to the oil during

the test, using gauze, glass rods and/or specimen holders as required.

If the area of the edges of the test specimen exceeds 10 % of the area of the test specimen measured, this

is incorporated in the area calculation.
4.4.2.2.2 Films and sheets

Cut each test specimen into four pieces 25 mm x 100 mm using the tool of 4.3.3.5.

4.4.2.2.3 Containers and other articles

Cut sections from the walls of the container or article to give test specimens each of area approximately

2 2

1 dm . For articles with individual areas less than 1 dm , use a sufficient number of articles to provide

each test specimen. Measure the dimensions of each test specimen to the nearest 1 mm, using a suitable

measuring tool.

Calculate the area of each test specimen to the nearest 0,01 dm and record. If necessary, cut each test

specimen into smaller pieces to enable them to fit into the glass containers. The test specimens or pieces

are placed on the specimen supports or, if the test specimens or pieces are sufficiently rigid, they can be

tested unsupported.
The number of cuttings should be limited.
4.4.2.2.4 Articles of irregular shape

Select representative portions of the article, or multiples of the article for small articles, to give five

dimensionally identical test specimens, with a total surface area of at least 1 dm . Measure only the

surface area intended to come into contact with foodstuffs of two of these test specimens to the nearest

0,05 dm using the Schlegel Method, as described in EN ISO 8442-2:1997, Annex B, the method described

by Mieth and Hoekstra (JRC-2013) or any other suitable method. Record the surface area of each test

specimen.
4.4.2.3 Method 2: cell

Lay the sample on the cutting slab with the surface to be in contact with the oil uppermost.

Cut out the test specimen of suitable dimensions for the cell using the cutting implement.

4.4.2.4 Method 3: fillable pouch

Prepare a pouch suitable for obtaining an internal contact area of 2 dm and containing a suitable volume

of oil.

For example, fold over a sheet measuring 120 mm by 240 mm, with the surface under test facing inward,

and seal the 3 other sides such that the area inside the seals defines a square measuring 100 mm by

100 mm, then cut one corner of the pouch in order to be able to fill it with oil (after filling, the corner of

the pouch may be sealed).

An alternative method consists of only sealing 2 sides and sealing the final side after filling with oil.

---------------------- Page: 13 ----------------------
oSIST prEN 1186-2:2020
prEN 1186-2:2020 (E)

Another alternative method consists of using two sheets measuring 120 mm by 120 mm and creating 4

seals.

If required, remove any air bubbles liable to be present in the oil before sealing the filled pouch for the

final time.
Measure the internal dimensions of
...