prEN 1186-3

Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration in evaporable simulants

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 evaporable food simulants at temperatures greater than or equal to 4 °C and not exceeding the reflux temperature.
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, contacting 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 3: Prüfverfahren für die Gesamtmigration in verdampfbaren Simulanzien

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 verdampfbaren Prüflebensmitteln in Kontakt gebracht werden, die auf einer Temperatur von größer oder gleich 4 °C und nicht über der Rückflusstemperatur gehalten werden.
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 3 : Méthodes d’essai pour la migration globale dans les simulants évaporables

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 simulants évaporables à des températures supérieures ou égales à 4 °C et inférieures à la température de reflux.
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.

Materiali in predmeti v stiku z živili - Polimerni materiali - 3. del: Preskusne metode za celotno migracijo v modelno izparljivo raztopino

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 1186-3:2020 - Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration in evaporable simulants

RELATIONS

• Revised: EN 1186-14:2002 - 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
• Effective Date: 24-Jan-2018
• Revised: 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
• Effective Date: 24-Jan-2018
• Revised: EN 1186-13:2002 - Materials and articles in contact with foodstuffs - Plastics - Part 13: Test methods for overall migration at high temperatures
• Effective Date: 24-Jan-2018
• 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: 24-Jan-2018
• Revised: 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
• Effective Date: 24-Jan-2018
• 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: 24-Jan-2018
• Revised: 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
• Effective Date: 24-Jan-2018
• 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: 24-Jan-2018
• 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: 24-Jan-2018
• Revised: 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
• Effective Date: 24-Jan-2018
• Revised: EN 1186-15:2002 - 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
• Effective Date: 24-Jan-2018
• 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: 24-Jan-2018
• 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: 24-Jan-2018

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN 1186-3:2020
01-april-2020

Materiali in predmeti v stiku z živili - Polimerni materiali - 3. del: Preskusne metode

za celotno migracijo v modelno izparljivo raztopino

Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for

overall migration in evaporable simulants
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 3:
Prüfverfahren für die Gesamtmigration in verdampfbaren Simulanzien
Ta slovenski standard je istoveten z: prEN 1186-3
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 1186-3:2020 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN 1186-3:2020
---------------------- Page: 2 ----------------------
oSIST prEN 1186-3:2020
DRAFT
EUROPEAN STANDARD
prEN 1186-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 67.250 Will supersede EN 1186-3:2002, EN 1186-5:2002,
EN 1186-7:2002, EN 1186-9:2002, EN 1186-14:2002,
EN 1186-15:2002
English Version
Materials and articles in contact with foodstuffs - Plastics -
Part 3: Test methods for overall migration in evaporable
simulants
Werkstoffe und Gegenstände in Kontakt mit
Lebensmitteln - Kunststoffe - Teil 3: 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 NORMALISATIO N
E UR O P ÄISCHES KOMITEE FÜR NORMUN G
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 1186-3:2020 E

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

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

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

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

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

4 Test method ...................................................................................................................................................... 5

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

4.1.1 General ................................................................................................................................................................ 5

4.1.2 Method 1: total immersion (in conventional oven or at reflux) ..................................................... 6

4.1.3 Method 2: cell.................................................................................................................................................... 6

4.1.4 Method 3: fillable pouch ............................................................................................................................... 6

4.1.5 Method 4: reverse pouch .............................................................................................................................. 6

4.1.6 Method 5: filling a container ....................................................................................................................... 6

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

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

4.3.1 General ................................................................................................................................................................ 7

4.3.2 Common materials and apparatus for all methods ............................................................................ 7

4.3.3 Common materials for methods other than filling a container ...................................................... 7

4.3.4 Materials for method 1a (total immersion in conventional oven) ................................................ 7

4.3.5 Materials for method 1b (total immersion at reflux) ........................................................................ 8

4.3.6 Materials for method 2 (cell) ...................................................................................................................... 8

4.3.7 Materials for method 3 (fillable pouch) and method 4 (reverse pouch) .................................... 8

4.3.8 Materials for method 5 (filling a container) .......................................................................................... 8

4.4 Test specimens ................................................................................................................................................. 8

4.4.1 General ................................................................................................................................................................ 8

4.4.2 Preparation of test specimens and determination of the area in contact .................................. 9

4.5 Exposure to food simulants ...................................................................................................................... 11

4.5.1 Method 1a: total immersion in conventional oven .......................................................................... 11

4.5.2 Method 1b: total immersion at reflux ................................................................................................... 11

4.5.3 Method 2: cell................................................................................................................................................. 12

4.5.4 Method 3: fillable pouch ............................................................................................................................ 12

4.5.5 Method 4: reverse pouch ........................................................................................................................... 12

4.5.6 Method 5: filling a container .................................................................................................................... 12

4.5.7 Rinsing of test specimens and the containers of the blanks ......................................................... 13

4.5.8 Repeated exposure ...................................................................................................................................... 13

4.5.9 General recommendations ....................................................................................................................... 13

4.5.10 General requirements ................................................................................................................................ 13

4.6 Determination of migrating amount ..................................................................................................... 13

4.6.1 Preparation of dishes ................................................................................................................................. 13

4.6.2 Evaporation method ................................................................................................................................... 14

4.6.3 Distillation method ...................................................................................................................................... 14

4.7 Expression of results ................................................................................................................................... 15

4.7.1 General ............................................................................................................................................................. 15

4.7.2 Calculation methods .................................................................................................................................... 15

4.7.3 Analytical tolerances and precision ...................................................................................................... 17

5 Test report ...................................................................................................................................................... 18

Annex A (normative) Alcohol dilution table...................................................................................................... 19

Annex B (informative) Precision data.................................................................................................................. 22

Bibliography ................................................................................................................................................................. 23

---------------------- Page: 4 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)
European foreword

This document (prEN 1186-3:2020) 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 supersedes EN 1186-3:2002, EN 1186-5:2002, EN 1186-7:2002, EN 1186-9:2002,

EN 1186-14:2002 and EN 1186-15:2002.

In comparison with the previous editions, the following technical modifications have been made:

— removed the regulatory provisions put in the document to avoid the document being obsolete after

an update of regulation;
— adapted the method of test to the new conditions defined in the regulation;

— gathered in one document the 8 previous standards that use evaporable simulants and which are

based on the same principle of measuring.
---------------------- Page: 5 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (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 evaporable food

simulants at temperatures greater than or equal to 4 °C and not exceeding the reflux temperature.

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, contacting 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 apply.

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

— IEC Electropedia: available at http://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
3.3
test specimen
part of the sample undergoing a measurement during the test
---------------------- Page: 6 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)
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
3.9
evaporable simulants

Alternative and screening simulants/solvents for example, isooctane and 95 % ethanol

Note 1 to entry: Aqueous food simulants defined in the regulation.
4 Test method
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 foods, is

determined by putting test specimens in contact with evaporable food simulants in test conditions chosen

on the basis of the worst case scenario of use and by weighing the dry residue of the evaporated food

simulant.

The conditions of exposure of the test specimens are between 4 °C up to the highest temperature given

by the regulation.

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

methods:
---------------------- Page: 7 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)
4.1.2 Method 1: total immersion (in conventional oven or at reflux)
4.1.2.1 General

Test specimens of known surface are immersed in the food simulant. This method is most suitable for

samples 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 suitable size can be cut.
4.1.2.2 Method 1a: total immersion in conventional oven

This method is suitable for tests between 4 °C up to the highest temperature given by the regulation.

4.1.2.3 Method 1b: total immersion at reflux

This method is only suitable for tests at the boiling point of the food simulant and generally for short

periods of time (for example, up to 4 h).
4.1.3 Method 2: cell

Test specimens of known surface are placed in contact with the food simulant in a cell. This method is

most suitable for plastics in the form of films or sheets in which only one side is to be in contact with

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

Test specimens of known surface and in the form of pouches are filled with the food simulant; 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 surface and in the form of reverse pouches are immersed in the food simulant;

this method is suitable for plastics in the form of films or sheets in which the surfaces can be sealed by

applying heat or pressure to form reverse pouches. If the sample material allows, the reverse pouches

shall be used instead of the fillable pouches when the temperature of the food simulant is greater than or

equal to 70 °C, because of the pressure of the food simulant that can break the sealing of the pouches at

high temperatures.
4.1.6 Method 5: filling a container

Test specimens of known surface are filled in with the food simulant; this method is most suitable for

plastics in the form of fillable containers and articles.
4.2 Reagents

The reagents specified hereinafter shall be evaporable at atmospheric pressure and at a temperature less

than or equal to 105 °C and shall produce a non-volatile residue of less than 5 mg/l when evaporated to

dryness and desiccated until a constant mass is obtained at a temperature between 105 °C and 110 °C.

The non-volatile residue of a food simulant shall be less than 5 mg/l when evaporate to dryness and

desiccated until a constant mass is obtained at a temperature between 105 °C and 110 °C.

— Purified water: Millipore Q quality water or equivalent;

— 3 % acetic acid (w/v) in aqueous solution: The solution is prepared, for example, by diluting 30 g of

glacial acetic acid in purified water to obtain one litre of solution;

— Hydroalcoholic solutions (10 %, 20 %, 50 % and 95 %) are prepared according to Annex A, Table A.1;

— Iso-octane.
---------------------- Page: 8 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)

NOTE Other kinds of evaporable liquids can be used as simulants of foods if permitted by the regulation.

4.3 Materials and apparatus
4.3.1 General

Equipment used for testing shall not have properties which interfere with the measurements. The total

mass transfers by the equipment shall be less than 5 mg/l of food simulant. The equipment shall be

suitably cleaned.
4.3.2 Common materials and apparatus for all methods
4.3.2.1 Analytical balance where it can be read at least 0,1 mg.

4.3.2.2 Thermostatically controlled oven, incubator or refrigerator, capable of maintaining the

temperature within the tolerance limits specified in A.2.

4.3.2.3 Glass, glass ceramic, ceramic, stainless steel, nickel, aluminium, platinum, platinum alloy, gold

dishes, 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 the dishes after evaporation of any specified food simulants

followed by conditioning in the desiccator used are stable within ± 0,5 mg.
NOTE Not all materials are suitable for all evaporable simulants

4.3.2.4 Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of food

simulant at the end of test period.
4.3.2.5 Desiccator with, for example, anhydrous calcium chloride or silica gel.
4.3.2.6 Lint-free cloth or soft brush or pure compressed air generator.
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 suitable 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 implement

4.3.3.4 Cutting templates measuring (100 mm ± 0,2 mm) × (100 mm ± 0,2 mm).
4.3.3.5 Tool for measuring length, when it can be read 1 mm.

4.3.3.6 Glass containers for containing the food simulant 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 or a ground-necked flasks of suitable size.

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

pipettes of equivalent performances or measuring cylinders.
4.3.4 Materials for method 1a (total immersion in conventional oven)

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 the food simulant.

---------------------- Page: 9 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)

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 1b (total immersion at reflux)
4.3.5.1 Ground-necked flasks of suitable size.
4.3.5.2 Condensers to fit the flasks.

4.3.5.3 Heating device for maintaining the food simulants at reflux temperature during exposure.

4.3.5.4 Glass filter, pore size 100 to 160 microns.

4.3.5.5 Device to prevent the test specimen to come in contact with the heated glass flask

4.3.6 Materials for method 2 (cell)
Appropriate cells have the following requirements:
— blank value shall be less than 5 mg/l;

— minimum of 0,5 dm of contact area for the test specimen using a number of cells to reach at least

0,5 dm .
4.3.7 Materials for method 3 (fillable pouch) and method 4 (reverse pouch)
4.3.7.1 Heat or pressure sealing device, for use in forming pouches.
4.3.7.2 Pouch holder.
4.3.8 Materials for method 5 (filling a container)
Glass containers of suitable size.
4.4 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 test specimens 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.
Use a sufficient number of test specimens to get a valid result.
---------------------- Page: 10 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)

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

surface area of 1 dm .

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

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

dust due to static charges).

NOTE Before preparing test specimens, any surface contamination can be removed by gently wiping it with a

lint-free cloth, or by brushing with a soft brush.
A surface area of 1 dm and volume of 100 ml is recommended.
4.4.2.2 Method 1: total immersion in conventional oven or at reflux
4.4.2.2.1 General
2 2

Cut out test specimens of 1 dm (±0,01 dm ) using a cutting template 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 food

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

4.4.2.2.2 Films and sheets

For the method in a conventional oven, cut each test specimen into four pieces measuring

25 mm × 100 mm by using the tool of 4.3.2.5.

For the method at reflux, if necessary, cut each test specimen into smaller pieces.

4.4.2.2.3 Containers and other articles

Cut pieces from the walls of the container or article to give test specimens each approximately 1 dm in

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

to provide to provide a surface of 1dm . Measure the dimensions of each test specimen to the nearest

1 mm, by using the tool of 4.3.2.5.

Calculate the surface 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 test tubes. The test specimens or

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

unsupported.
The number of cuttings should be as low as possible.
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 Surface area of each test specimen should be least 1 dm . Measure

only the surface area of the test specimens intended to come into contact with foodstuffs 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.
---------------------- Page: 11 ----------------------
oSIST prEN 1186-3:2020
prEN 1186-3:2020 (E)
4.4.2.3 Method 2: cell

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

Cut out a 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 volume of

approximately 100 ml of food simulant.

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 food simulant (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 food

simulant.

In any case, remove any air bubbles when sealing the filling pouch for the final time.

Measure and record the surface area of the pouch which will be in contact with the food simulant.

Remove excess film from the sealed area (to reduce the area of film not directly exposed to food simulant),

whilst leaving enough to withstand the test conditions without leaking.

For sealable films in which only one surface is to be tested, the reverse pouch method may be used.

Pouches of dimensions other than 100 mm × 100 mm can be used for this test. These pouches shall have,

wherever possible, a contact area greater than or equal to 1 dm .
4.4.2.5 Method 4: reverse pouch

Prepare pouches so that the surface area intended to come into contact with the food simulants is the

outer face. The pouches shall have a contact surface area of 2 dm , for example by folding over a sheet

measuring 120 mm by 240 mm, with the side under test facing inward and by sealing the 2 parallel edges

such that the inside area shall define a square measuring 100 mm by 100 mm. Then, reverse the pouch,

and seal the 4th side.

An alternative method consists of taking two sheets measuring 120 mm by 120 mm, creating 3 seals,

reversing the pouch and sealing the 4th side.

Measure the external dimensions of the pouches prepared and calculate the exposed areas to the nearest

0,01 dm .

To test for leaks, it is possible to put into the reverse pouches, a piece of filter paper of an adequate size.

If the pouches are leaking, the paper will absorb th
...