EN 1186-2:2022
(Main)Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for overall migration in vegetable oils
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 less than or equal 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 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.
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
bestimmt nach Kontakt mit einem Prüflebensmittel unter festgelegten Bedingungen.
Je nach der Art der Werkstoffe oder Form der 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 inférieures ou égales 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 de la forme de l’objet, le contact avec le simulant de denrées alimentaires 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 - Plastika - 2. del: Preskusne metode za celotno migracijo v olivno olje
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2022
Nadomešča:
SIST EN 1186-10:2003
SIST EN 1186-12:2002
SIST EN 1186-2:2002
SIST EN 1186-4:2002
SIST EN 1186-6:2002
SIST EN 1186-8:2002
Materiali in predmeti v stiku z živili - Plastika - 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: EN 1186-2:2022
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 1186-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 67.250 Supersedes EN 1186-2:2002, EN 1186-4:2002, EN
1186-6:2002, EN 1186-8:2002, EN 1186-10:2002, EN
1186-12:2002
English Version
Materials and articles in contact with foodstuffs - Plastics -
Part 2: Test methods for overall migration in vegetable oils
Matériaux et objets en contact avec les denrées Werkstoffe und Gegenstände in Kontakt mit
alimentaires - Matière plastique - Partie 2 : Méthodes Lebensmitteln - Kunststoffe - Teil 2: Prüfverfahren für
d'essai pour la migration globale dans les huiles die Gesamtmigration in Pflanzenölen
végétales
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, Turkey 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 1186-2:2022 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 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 . 23
5 Test report . 25
Annex A (normative) Contact time and temperature tolerances. 27
Annex B (normative) Determination of the suitability of oil as the fatty food simulant and of
triheptadecanoin as the internal standard . 29
Annex C (normative) Determination of the need for sample conditioning . 31
Annex D (normative) Determination of the need for sample conditioning and
determination of the mass of moisture sensitive and/or with presence of volatiles
specimens , by vacuum drying . 32
Annex E (informative) Typical chromatograms and calibration graph . 34
Annex F (informative) Precision data . 37
Bibliography . 38
European foreword
This document (EN 1186-2:2022) 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 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 1186-2:2002, EN 1186-4:2002, EN 1186-6:2002, EN 1186-8:2002,
EN 1186-10:2002 and EN 1186-12:2002.
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, 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.
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 6 previous standards that use vegetable oils as 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, Turkey 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 vegetable oils at
temperatures greater than or equal to 4 °C and less than or equal 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 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.
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 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
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
greater than or equal to 4 °C and below or equal to 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
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 on their physical propert
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