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

This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more severe' test character, for the assessment of the overall migration into fatty food simulants.  
Method A is based on the determination of the extraction of migrateable substances from plastics which are intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar, ethanol, solvents depending on the polarity of the packaging material.  According to results obtained by this method (see [1],[2],[3],[4],[5],) and taking physio-chemical considerations into account, the obtained extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results obtained under the test conditions, 10 days at 40 °C, 2 h at 70 °C, 1 h at 100 °C, 30 min at 121 °C and 30 min at 130 °C.
To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of the sample by the extraction solvent is necessary.  For this purpose, iso-octane is used as an extraction solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins.  For test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 % (v/v) aqueous ethanol is used.  For polystyrenes, plasticized polyvinyl chloride and other polymers where the identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using both of the proposed extraction solvents and taking the higher value obtained as the relevant result.
NOTE 1   In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food contact layer determines the selection of the extraction solvent(s).

Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 15: Alternative Prüfverfahren zur Migration in fettige Prüflebensmittel durch Schnellextraktion in Iso-Octan und/oder 95%iges Ethanol

Matériaux et objets en contact avec les denrées alimentaires - Plastiques - Partie 15 : Méthodes de remplacement pour la vérification de la migration dans les simulants gras par extraction rapide dans l'iso-octane et/ou l'éthanol aqueux à 95 %

La présente partie de la Norme européenne spécifie deux méthodes dites « de remplacement » comportant un essai d’extraction de nature « plus sévère » pour vérifier la migration globale dans les simulants gras.
La méthode A repose sur la détermination de l’extraction des substances potentiellement migrantes provenant des matières plastiques destinées à entrer en contact avec les denrées alimentaires, après immersion totale dans des solvants non polaires (comme l’iso-octane) ou polaires (comme l’éthanol), selon la polarité du matériau de conditionnement. Compte tenu des résultats donnés par la méthode (voir [1], [2], [3], [4], [5]) et des caractéristiques physico-chimiques, il s’est avéré que les rendements d’extraction obtenus étaient généralement équivalents ou supérieurs à ceux donnés par les essais de migration globale obtenus dans les conditions d’essai suivantes : 10 jours à 40 °C, 2 h à 70 °C, 1 h à 100 °C, 30 min à 121 °C et 30 min à 130 °C.
Pour assurer une extraction aussi complète que possible des migrants potentiels, il est nécessaire d’avoir une forte interaction (par exemple gonflement) entre l’échantillon et le solvant d’extraction utilisé. C’est la raison pour laquelle on utilise de l’iso-octane comme solvant d’extraction pour les matériaux et objets en plastiques multicouches à couche de contact non polaire, tels les polyoléfines, et de l’éthanol en solution aqueuse à 95 % (v/v) pour les échantillons en plastiques à couche de contact polaire, tels le polyamide ou le polyéthylène téréphtalate. Pour les polystyrènes, le chlorure de polyvinyle plastifié ou d’autres polymères dont l’identification ou la polarité n’est pas claire, il convient de mener deux extractions en parallèle avec les deux solvants d’extraction proposés et de retenir comme résultat celui qui donne la valeur la plus élevée.

Materiali in predmeti v stiku z živili - Plastika - 15. del: Alternativne preskusne metode za migracijo v modelne raztopine za maščobna živila s hitro ekstrakcijo z izooktanom in/ali 95-odstotnim etanolom

General Information

Status
Not Published
Current Stage
4098 - Decision to abandon - Enquiry
Start Date
24-Jul-2008
Completion Date
24-Jul-2008

Relations

Effective Date
19-Jan-2023

Overview

The European standard prEN 1186-15, developed by CEN/TC 194, addresses the assessment of migration from plastics materials intended for food contact. Specifically, it defines alternative test methods for overall migration into fatty food simulants by using rapid extraction techniques with iso-octane and/or 95% ethanol. These test methods serve as accelerated extraction procedures to evaluate potential migrant substances efficiently and are tailored to the polarity characteristics of the packaging material.

This standard plays a critical role in ensuring compliance with European food safety regulations by verifying that plastics do not release harmful substances into foods, especially fatty foods which can extract more substances from packaging materials. It supersedes EN 1186-15:2002 and aligns with EU directives like Commission Directive 2002/72/EC.

Key Topics

  • Purpose and Scope
    The standard specifies two alternative methods (Method A and Method B) which simulate the migration of substances from plastics into fatty foods by rapid extraction. This provides a severe or more rigorous test compared to conventional migration testing methods.

  • Method A: Total Immersion Extraction

    • Uses iso-octane for non-polar plastics such as polyolefins.
    • Uses 95% aqueous ethanol for polar plastics such as polyamide and polyethylene terephthalate (PET).
    • For unclear polymer polarity (e.g., polystyrene or plasticized PVC), both solvents are used in parallel, and the higher migration value is considered.
    • Specimens are fully immersed for 24 hours at 40 °C or 50 °C.
    • Extraction efficiency under this method is typically equivalent or higher than conventional migration tests under various temperature/time regimes.
  • Method B: Single-Side Extraction Using a Cell

    • Designed for multilayer or co-extruded plastics where full immersion may not be suitable.
    • Emphasizes application to flexible packaging with thin food contact layers (<300 μm).
    • Acts as a supplementary or confirmatory test when Method A yields excessive migration values.
  • Test Material and Thickness
    Designed primarily for flexible packaging materials less than 300 μm thick. Not recommended for materials intended for use above 130 °C.

  • Solvent Selection
    The polarity of the packaging layer in contact with food dictates solvent choice. For complex multilayer structures, the food contact layer's chemistry determines solvent use.

  • Safety Notes
    The solvents iso-octane and ethanol are volatile and flammable, requiring careful handling to prevent explosion risks during testing.

  • Regulatory Compliance
    The migration results obtained are directly compared to the official overall migration limits set by EU legislation, such as Commission Directive 2002/72/EC and Council Directive 82/711/EEC.

Applications

  • Food Packaging Industry
    Ensures plastics used in packaging fatty foods comply with migration limits, protecting consumer safety.

  • Quality Control laboratories
    Provides rapid extraction test methods to evaluate migration without requiring lengthy conventional migration testing.

  • Material Development
    Assists material scientists and manufacturers in screening polymers and multilayer constructions for compatibility with fatty food contact.

  • Regulatory Testing and Compliance
    Supports manufacturers and regulatory agencies in verifying compliance with EU food contact material regulations.

  • Risk Assessment
    Offers severe test conditions that can simulate worst-case migration, helping identify potential safety concerns in new plastics.

Related Standards

  • EN 1186 Series

    • Part 1: Guide to selection of conditions and test methods for overall migration
    • Parts 2 to 14: Various test methods for migration into olive oil, aqueous simulants, using cells, pouches, or article filling methods.
    • Part 14: Substitute tests for overall migration from plastics intended for fatty food contact using iso-octane and 95% ethanol.
  • EU Regulations and Directives

    • Commission Directive 2002/72/EC on plastic materials and articles intended to come into contact with food.
    • Council Directive 82/711/EEC concerning testing methods for overall migration.
  • ISO Standards for Laboratory Equipment

    • ISO 648 for laboratory pipettes.
    • ISO 4788 for graduated measuring cylinders.

Keywords: prEN 1186-15, migration test plastics, fatty food simulants, iso-octane extraction, 95% ethanol extraction, food contact materials, overall migration limit, CEN standards, EU food packaging compliance, plastics food safety testing, multilayer plastics migration.


This standard is essential for manufacturers, testing laboratories, and regulatory bodies involved in ensuring the safety of plastic materials and articles in contact with fatty foodstuffs, offering reliable, rapid test methodologies aligned with European legal requirements.

Frequently Asked Questions

prEN 1186-15 is a draft published by the European Committee for Standardization (CEN). Its full title is "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". This standard covers: This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more severe' test character, for the assessment of the overall migration into fatty food simulants. Method A is based on the determination of the extraction of migrateable substances from plastics which are intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar, ethanol, solvents depending on the polarity of the packaging material. According to results obtained by this method (see [1],[2],[3],[4],[5],) and taking physio-chemical considerations into account, the obtained extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results obtained under the test conditions, 10 days at 40 °C, 2 h at 70 °C, 1 h at 100 °C, 30 min at 121 °C and 30 min at 130 °C. To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of the sample by the extraction solvent is necessary. For this purpose, iso-octane is used as an extraction solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins. For test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 % (v/v) aqueous ethanol is used. For polystyrenes, plasticized polyvinyl chloride and other polymers where the identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using both of the proposed extraction solvents and taking the higher value obtained as the relevant result. NOTE 1 In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food contact layer determines the selection of the extraction solvent(s).

This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more severe' test character, for the assessment of the overall migration into fatty food simulants. Method A is based on the determination of the extraction of migrateable substances from plastics which are intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar, ethanol, solvents depending on the polarity of the packaging material. According to results obtained by this method (see [1],[2],[3],[4],[5],) and taking physio-chemical considerations into account, the obtained extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results obtained under the test conditions, 10 days at 40 °C, 2 h at 70 °C, 1 h at 100 °C, 30 min at 121 °C and 30 min at 130 °C. To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of the sample by the extraction solvent is necessary. For this purpose, iso-octane is used as an extraction solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins. For test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 % (v/v) aqueous ethanol is used. For polystyrenes, plasticized polyvinyl chloride and other polymers where the identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using both of the proposed extraction solvents and taking the higher value obtained as the relevant result. NOTE 1 In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food contact layer determines the selection of the extraction solvent(s).

prEN 1186-15 is classified under the following ICS (International Classification for Standards) categories: 67.250 - Materials and articles in contact with foodstuffs. The ICS classification helps identify the subject area and facilitates finding related standards.

prEN 1186-15 has the following relationships with other standards: It is inter standard links to EN 1186-15:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

prEN 1186-15 is associated with the following European legislation: EU Directives/Regulations: 89/109/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase prEN 1186-15 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-december-2006
0DWHULDOLLQSUHGPHWLYVWLNX]åLYLOL3ROLPHUQLPDWHULDOLGHO$OWHUQDWLYQH
SUHVNXVQHPHWRGH]DPLJUDFLMRYPRGHOQHUD]WRSLQH]DPDãþREQDåLYLODVKLWUR
HNVWUDNFLMR]L]RRNWDQRPLQDOLRGVWRWQLPHWDQRORP
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
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 15:
Alternative Prüfverfahren zur Migration in fettige Prüflebensmittel durch Schnellextraktion
in Iso-Octan und/oder 95%iges Ethanol
Matériaux et objets en contact avec les denrées alimentaires - Plastiques - Partie 15 :
Méthodes de remplacement pour la vérification de la migration dans les simulants gras
par extraction rapide dans l'iso-octane et/ou l'éthanol aqueux a 95 %
Ta slovenski standard je istoveten z: prEN 1186-15
ICS:
67.250 Materiali in predmeti v stiku z Materials and articles in
živili contact with foodstuffs
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
DRAFT
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 67.250 Will supersede EN 1186-15:2002
English Version
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
Matériaux et objets en contact avec les denrées Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln
alimentaires - Matière plastique - Partie 15 : Méthodes - Kunststoffe - Teil 15: Alternative Prüfverfahren zur
d'essai alternatives pour la migration dans les simulants Migration in fettige Prüflebensmittel durch Schnellextraktion
alimentaires gras par extraction rapide dans l'iso-octane in Iso-Octan und/oder 95%iges Ethanol
et/ou l'éthanol à 95 %
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 194.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1186-15:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
1 Scope.5
2 Normative references.5
3 Method A Alternative test method to migration into fatty food simulants by rapid
extraction into iso-octane and/or 95 % ethanol by total immersion.6
3.1 Principle.6
3.2 Reagents.6
3.3 Apparatus.7
3.4 Preparation of test specimens .7
3.5 Procedure.8
3.6 Expression of results.10
3.7 Test report.10
4 Method B Alternative test method to migration into fatty food simulants by rapid
extraction into iso-octane and/or 95 % ethanol in the single side mode by cell .11
4.1 Principle.11
4.2 Reagents.11
4.3 Apparatus.11
4.4 Preparation of test specimens .12
4.5 Procedure.12
4.6 Expression of results.15
4.7 Test report.15
Annex A (informative) Precision data.16
Annex ZA (informative)  Relationship of this European Standard with Regulation 1935/2004 and
Commission Directive 2002/72/EC and associated Directives .17
Bibliography .19

Foreword
This document (prEN 1186-15:2006) has been prepared by Technical Committee CEN/TC 194 “Utensils in
contact with food”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
This document will supersede EN 1186-15:2002.
WARNING — Both iso-octane and ethanol are volatile flammable solvents. Take care to ensure that
the test specimens are well stoppered, closed and covered to prevent solvent volatilizing into the
interior of the oven, incubator or refrigerator and generating an explosive mixture. Care should be
taken at all times when handling these solvents to prevent contact with sources of ignition.
Read EN 1186-15 in conjunction with EN 1186-1.
Further Parts of this standard have been prepared concerned with the determination of overall migration from
plastics materials into food simulants. Their titles are as follows:
EN 1186 Materials and articles in contact with foodstuffs – Plastics –
Part 1 Guide to the selection of conditions and test methods for overall migration
Part 2 Test methods for overall migration into olive oil by total immersion
Part 3 Test methods for overall migration into aqueous food simulants by total immersion
Part 4 Test methods for overall migration into olive oil by cell
Part 5 Test methods for overall migration into aqueous food simulants by cell
Part 6 Test methods for overall migration into olive oil using a pouch
Part 7 Test methods for overall migration into aqueous food simulants using a pouch
Part 8 Test methods for overall migration into olive oil by article filling
Part 9 Test methods for overall migration into aqueous simulants by article filling
Part 10 Test methods for overall migration into olive oil (modified method for use in cases where
incomplete extraction of olive oil occurs)
Part 11 Test methods for overall migration into mixtures of C-labelled synthetic triglyceride
Part 12 Test methods for overall migration at low temperatures
Part 13 Test method for overall migration at high temperatures
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
1 Scope
This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more
severe' test character, for the assessment of the overall migration into fatty food simulants.
Method A is based on the determination of the extraction of migrateable substances from plastics which are
intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar,
ethanol, solvents depending on the polarity of the packaging material. According to results obtained by this
method (see [1], [2], [3], [4], [5]) and taking physio-chemical considerations into account, the obtained
extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results
obtained under the test conditions, 10 days at 40 °C, 2 h at 70 °C, 1 h at 100 °C, 30 min at 121 °C and 30 min
at 130 °C.
To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of
the sample by the extraction solvent is necessary. For this purpose, iso-octane is used as an extraction
solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins. For
test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 %
(v/v) aqueous ethanol is used. For polystyrenes, plasticized polyvinyl chloride and other polymers where the
identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using
both of the proposed extraction solvents and taking the higher value obtained as the relevant result.
NOTE 1 In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food
contact layer determines the selection of the extraction solvent(s).
This test method should only be applied to flexible packagings which are less than 300 µm in thickness. When
the result does not exceed the allowed overall migration limit then the material can be considered to be in
compliance with EC regulations. If the test result exceeds the allowed overall migration limit the following
options may be applied chronologically with respect to further migration testing:
1) single-sided extraction test using a cell, if technically feasible (see 15B of this standard);
2) conventional migration test using olive oil or other fatty food simulants;
NOTE 2 The overall migration limit is specified in Commission Directive 2002/72/EC [7] and the conditions of test in
Council Directive 82/711/EEC [8] and its subsequent amendments, [9], [10].
Method B is applicable in those cases where the total immersion test, EN 1186-15 Method 15A, yields total
extraction values that exceed the overall migration or may be technically unsuitable, i.e. in the case of
multilayer structures, such as plastics laminates and co-extruded films. This test method should primarily only
be applied to flexible packagings with a physical barrier layer (for instance of aluminium or other material to
prevent penetrative loss of extraction solvent) and which have a thinner food contact layer than 300 µm. If the
result does not exceed the allowed overall migration limit then the material can be considered to be in
compliance with EC regulations. If the test result exceeds the allowed overall migration limit then the following
option may be applied with respect to further migration testing:
- conventional migration test using olive oil or other fatty food simulants.
NOTE 3 Methods A and B are not applicable to test materials intended for applications over 130 °C.
NOTE 4 Test materials intended for applications over 70 °C should be checked for their physical suitability at the
intended time and temperature of use.
2 Normative references
This European Standard incorporates by dated and undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text, and the publications are listed
hereafter. For dated references, subsequent amendments to and revisions of any of these publications apply
to this European Standard only when incorporated in it by amendment or revision. For undated references the
latest edition of the publication referred to applies (including amendments).
EN 1186-1:2002, Materials and articles in contact with foodstuffs – Plastics – Part 1: Guide to the selection of
conditions and test methods for overall migration
ISO 648, Laboratory glassware - One mark pipettes
ISO 4788, Laboratory glassware - Graduated measuring cylinders
3 Method A
Alternative test method to migration into fatty food simulants by rapid extraction into
iso-octane and/or 95 % ethanol by total immersion
3.1 Principle
The migrateable substances extracted from a sample of the plastics is determined as the mass of non-volatile
residue after evaporation of the solvent following immersion. Test specimens of at least 1 dm² (single side
considered) are immersed in the extraction solvent for 24 h at 40 °C or 50 °C and then removed. The
extraction solvent is evaporated to dryness, the mass of the non-volatile residue is determined and expressed
as milligrams per square decimetre of surface area of the test specimen. The measured value is compared to
the EC-official overall migration limit and taking the analytical tolerance of this method (± 1 mg/dm²) into
account.
3.2 Reagents
NOTE For details of preparation and quality of these reagents, see clause 4 of EN 1186-1:2002.
3.2.1 Ethanol 95 % (v/v) in aqueous solution.
3.2.2 Iso-octane (2,2,4-trimethylpentane)
NOTE The extraction solvents given in 3.2.1 and 3.2.2 are selected according to the nature of the polymer test
sample as given by Table 1, see 3.5.1.
3.3 Apparatus
3.3.1 Cutting slab, clean smooth glass, metal or plastics slab of suitable area to prepare test specimens,
250 mm x 250 mm is suitable.
3.3.2 Tweezers, stainless steel, blunt nosed.
3.3.3 Cutting implement, scalpel, scissors or sharp knife or other suitable device.
3.3.4 Metal template, (100 mm ± 0,2 mm) x (100 mm ± 0,2 mm) (square).
3.3.5 Rule, graduated in mm, and with an accuracy of 0,1 mm.
3.3.6 Analytical balance capable of determining a change in mass of 0,1 mg.
3.3.7 Extraction containers; glass weighing jars with ground joints, tall form, of a capacity of approx. 60 ml.
3.3.8 Thermostatically controlled oven or incubator capable of maintaining a temperature within the
range of + 40 °C to + 50 °C and meeting temperature tolerance values within those specified for the test
temperature, see annex B of EN 1186-1:2002.
WARNING The interior / sample space of the oven or incubator should not have any exposed heating elements, to
minimise safety hazards arising from any loss of flammable test media during the test period.
3.3.9 Dishes, of stainless steel, nickel, platinum, platinum alloy or gold, 50 mm to 90 mm diameter and of
maximum mass 100 g, for evaporation of solvents and weighing of residues. Glass, glass ceramic, ceramic or
aluminium dishes may be used provided that their surface characteristics are such that the mass of the dishes
after evaporation of any specified solvent followed by conditioning in the desiccator used achieves a
constancy of
± 0,5 mg.
3.3.10 Steam bath, hot plate, distillation apparatus or rotary evaporator.
3.3.11 Desiccator with anhydrous calcium chloride or self indicating silica gel.
3.3.12 Measuring cylinder, 50 ml capacity, conforming to the minimum requirements of ISO 4788.
3.3.13 Round-bottom flask, 250 ml capacity [for distillation method (see 3.5.3.3) only].
3.4 Preparation of test specimens
3.4.1 General
It is essential that test specimens are 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. Under no circumstances
wash the sample with water or solvent. If it is specified in the instructions for use of the article that it should be
washed or cleaned before use see 8.1 of EN 1186-1:2002. Minimize handling of the samples and where
necessary, wear cotton gloves.
To ensure that test pieces are well separated and that the surfaces are freely exposed to the extractant during
the period of the test, insert a piece of fine stainless steel gauze between the cut test pieces.
3.4.2 Number of test specimens
Three replicate test specimens are required.
3.4.3 Cutting and preparation of specimen
Lay the sample on the cutting slab (3.3.1) and cut the test specimens of 1 dm² (see 8.3 of EN 1186-1:2002),
using the 100 mm x 100 mm template (3.3.4). Check, using the rule (3.3.5), that the dimensions of the
specimen are within the specified tolerance (1 mm). Fold the test specimens into a fan-like shape or cut into
strips approximately 2 cm wide and 5 cm long. Place in the extraction containers (3.3.7).
3.5 Procedure
3.5.1 Selection of extraction solvent
Select the appropriate extraction solvent(s) (see 3.2.1 and 3.2.2) according to the nature of the polymer test
sample as given in Table 1.
Table 1 — Use of extraction solvents and test conditions – Method A

Polymer type of food contact layer Extraction solvent to be Extraction conditions to be
applied applied
Polyolefines and copolymers iso-octane 24 h at 40 °C

Polyamides 95 % ethanol 24 h at 40 °C

Polystyrene iso-octane and 95 % ethanol 24 h at 40 °C

Polyethylene terephthalate 95 % ethanol 24 h at 50 °C

Polyvinyl chloride (plasticized) iso-octane and 95 % ethanol 24 h at 40 °C

Polyvinyl chloride (rigid) 95 % ethanol 24 h at 50 °C

3.5.2 Exposure to solvent
Take three extraction containers or jars (3.3.7), measure by measuring cylinder (3.3.12) 50 ml of the solvent
into each of these jars and immerse the test specimens in the solvent. Ensure that the test specimens are
totally immersed in the solvent. If the evaporation method is to be used (3.5.3.2) measure into a further two
jars by measuring cylinder the same amount of solvent, plus 10 ml ± 2 ml, to provide blanks. If the distillation
method (3.5.3.3) is to be used measure into those further two jars by measuring cylinder the same amount of
solvent in contact with the test specimens to provide blanks. Stopper the jars. Mark the jars for identification.
Mark the liquid level on the outside of each jar with a suitable marker.
The extraction conditions are to be selected from Table 1 according to the nature of the polymer test samples.
Place the five jars in the thermostatically controlled oven or incubator (3.3.8), set at the test temperature and
observe the temperature, leave the jars for the test period of 24 h after the air bath of the thermostatically
controlled oven or incubator has reached the set temperature and taking the permitted time and temperature
tolerances into account (see annex B of EN 1186-1:2002). Take the jars from the oven or incubator and allow
them to cool down to room temperature. Check the level of solvent in each. If this has fallen to more than 5
mm below the mark, or has exposed any part of the test pieces, repeat the test using fresh test specimens. If
the level of solvent in a jar is less than 5 mm below the mark, remove the test specimen from the jar, and
allow the solvent adhering to the test specimen and support to drain back into the jar. Recover at least 90 % of
the original volume of solvent, including the blanks, or repeat the test.
WARNING Both iso-octane and ethanol are volatile flammable solvents. Care should be taken to avoid any loss of
solvent into the interior of the thermostatting device. Place the jars, if possible, in a drip container serving as a possible
solvent reservoir in case of leakage. Do not allow the temperature to exceed 60 °C.
3.5.3 Determination of extracted substances
3.5.3.1 Preparation of dishes
Take five dishes (3.3.9), marked for identification, place the dishes in an oven maintained at 105 °C to 110 °C,
for a period of 30 min ± 5 min, to dry. Remove the dishes from the oven, place in a desiccator and allow to
cool to ambient temperature. Weigh and record the individual masses of each dish. Replace the dishes in the
oven and repeat the cycle of heating, cooling and weighing until individual consecutive masses differ by not
more than
0,5 mg. Record their final masses.
3.5.3.2 Evaporation method
For each jar, including the two blank jars, containing the solvent, pour 20 ml to 25 ml into a prepared dish. By
means of a steam bath, hot plate or other form of heating evaporate to a low volume (3.3.10), taking care to
avoid loss of residue, in particular, by sputtering or overheating.
NOTE 1 The evaporation should be carried out in a fume cupboard.
When most of the solvent has evaporated, pour the remaining solvent from each of the jars into the respective
dishes and continue the evaporation. Rinse each of the jars which had contained test specimens with two lots
of  5 ml ± 1 ml of fresh solvent and pour these washings into the respective dishes.  Continue the
evaporation.
NOTE 2 A stream of nitrogen may be used to facilitate evaporation.
When the solvent has almost completely evaporated, place the dish in an oven maintained at 105 °C to
110 °C, for a period of 30 min ± 5 min, to complete the evaporation and dry the residue. Remove the dishes
from the oven, place in a desiccator (3.3.11) and allow to cool to ambient temperature. Weigh and record the
individual masses of each dish and residue.
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