EN 1186-3:2022

SLOVENSKI STANDARD
01-december-2022
Nadomešča:
SIST EN 1186-14:2003
SIST EN 1186-15:2003
SIST EN 1186-3:2002
SIST EN 1186-5:2002
SIST EN 1186-7:2002
SIST EN 1186-9:2002
Materiali in predmeti v stiku z živili - Plastika - 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
Matériaux et objets en contact avec les denrées alimentaires - Matière plastique - Partie
3 : Méthodes d’essai pour la migration globale dans les simulants évaporables
Ta slovenski standard je istoveten z: EN 1186-3:2022
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 1186-3
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 67.250 Supersedes EN 1186-14:2002, EN 1186-15:2002, EN
1186-3:2002, EN 1186-5:2002, EN 1186-7:2002, EN
1186-9:2002
English Version
Materials and articles in contact with foodstuffs - Plastics -
Part 3: Test methods for overall migration in evaporable
simulants
Matériaux et objets en contact avec les denrées Werkstoffe und Gegenstände in Kontakt mit
alimentaires - Matière plastique - Partie 3 : Méthodes Lebensmitteln - Kunststoffe - Teil 3: Prüfverfahren für
d'essai pour la migration globale dans les simulants die Gesamtmigration in verdampfbaren Simulanzien
évaporables
This European Standard was approved by CEN on 20 June 2022.

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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own 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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1186-3:2022 E
worldwide for CEN national Members.

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
4.2 Reagents . 6
4.3 Materials and apparatus . 7
4.4 Preparation of test specimens . 8
4.5 Exposure to food simulants . 11
4.6 Determination of migrating amount . 13
4.7 Expression of results . 15
5 Test report . 18
Annex A (normative) Requirements for alcohol dilution and contact time and temperature
tolerances. 19
Annex B (informative) Precision data. 22
Bibliography . 23

European foreword
This document (EN 1186-3:2022) has been prepared by Technical Committee CEN/TC 194 “Utensils in
contact with food”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2023, and conflicting national standards shall
be withdrawn at the latest by February 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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.
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; therefore, it is strongly recommended that users of
this document refer to the latest relevant published regulatory texts (to be found on the European
Commission website) before commencement of any of the tests described in this document.
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;
— combined in one document the 6 previous standards that use evaporable simulants and which are
based on the same principle of measuring.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Türkiye and the United
Kingdom.
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 shape of 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.
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:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
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
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 the 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
food simulant
test medium imitating food, in its behaviour food simulant mimics migration for food contact materials
3.10
evaporable simulants
alternative and screening simulants/solvents, e.g. 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 100 °C or to the reflux
temperature.
According to the type of sample, the tests are conducted based on one of the contacting methods given in
4.1.2 to 4.1.6.
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 100 °C or to reflux temperature.
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
...