CEN/TS 14234:2002
(Main)Materials and articles in contact with foodstuffs - Polymeric coatings on paper and board- Guide to the selection of conditions and test methods for overall migration
Materials and articles in contact with foodstuffs - Polymeric coatings on paper and board- Guide to the selection of conditions and test methods for overall migration
This Technical Specification specifies test methods for 'alternative tests' and 'substitute tests' performed with volatile test media, iso-octane and a volume fraction of 95 % aqueous ethanol, for the determination of overall migration from polymeric coatings on paper and board intended to come into contact with fatty foodstuffs.
NOTE 1 It also includes guidance for the application of Council Directive 82/711/EEC [1], as last amended by Commission Directives 93/8/EC and 97/48/EC [2] [3] as regards the determination of the specific and overall migration into fatty food simulants (fat test) and includes a glossary to clarify the terminology used, see annex B.
NOTE 2 The iso-octane and a volume fraction of 95 % aqueous ethanol volatile test media used in these test methods are those specified for 'substitute tests' in Council Directive 82/711/EEC and its subsequent amendments. In addition to the use of iso-octane and 95 % v/v aqueous ethanol as test media for 'substitute tests', Council Directive 82/711/EEC and its subsequent amendments specifies the use of modified polyphenylene oxide as a test medium for use at temperatures of 100 °C and above. A test method for overall migration from polymeric coatings intended to come into contact with fatty foodstuffs using modified polyphenylene oxide (MPPO) is in preparation.
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Polymere Beschichtungen auf Papier und Pappe - Leiftaden für die Auswahl von Prüfbedingungen und Prüfverfahren für die Gesamtmigration
Diese CEN Technische Spezifikation legt mit flüchtigen Prüfmedien, Isooctan und 95%igem (Volumenanteil) wässrigem Ethanol, durchgeführte Prüfverfahren für "alternative Prüfungen" und "Ersatzprüfungen" fest, zur Bestimmung der Gesamtmigration aus polymeren Beschichtungen auf Papier oder Pappe, die dafür vorgesehen sind, in Kontakt mit fetthaltigen Lebensmitteln zu kommen.
ANMERKUNG 1 Sie enthält auch eine Anleitung für die Anwendung der Richtlinie 82/711/EWG des Rates [1], zuletzt geändert durch die Richtlinien 93/8/EWG und 97/48/EU der Kommission [2], [3], was die Bestimmung der spezifischen und Gesamtmigration in fettige Prüflebensmittel (Fetttest) betrifft und enthält ein Wörterverzeichnis zur Erklärung der angewandten Terminologie, siehe Anhang B.
ANMERKUNG 2 Die in diesen Prüfverfahren verwendeten flüchtigen Prüfmedien Isooctan und 95%iges (Volumenanteil) wässriges Ethanol sind die in der Richtlinie 82/711/EWG des Rates und deren nachfolgenden Änderungsrichtlinien für "Ersatzprüfungen" festgelegten. Zusätzlich zu der Verwendung von Isooctan und 95%igem (Volumenanteil) wässrigem Ethanol als Prüfmedien für die "Ersatzprüfungen" wird in der Richtlinie 82/711/EWG des Rates und deren nachfolgenden Änderungsrichtlinien die Verwendung von modifiziertem Polyphenylenoxid als Prüfmedium bei Temperaturen von 100 °C und mehr festgelegt. Ein Prüfverfahren für die Gesamtmigration aus polymeren Beschichtungen, die für den Kontakt mit fettigen Lebensmitteln vorgesehen sind, unter Verwendung von modifiziertem Polyphenylenoxid (MPPO) wird derzeit ausgearbeitet.
Matériaux et objets en contact avec les denrées alimentaires - Revêtements polymères sur papier et carton - Guide pour le choix des conditions et des méthodes d'essai en matière de migration globale
La présente Spécification Technique spécifie des méthodes d'essai pour des " essais de remplacement " et des " essais de substitution " utilisant des milieux volatiles composés de l'iso-octane et de l'éthanol à 95 % en milieu aqueux, pour la détermination de la migration globale dans les revêtements polymères sur du papier et du carton destinés à entrer en contact avec des aliments gras.
NOTE 1 Elle comprend également des lignes directrices pour l'application de la Directive du Conseil 82/11/CEE [1], ainsi que les Directives 93/8/CE et 97/48/CE [2] et [3] récemment amendées par la Commission en matière de détermination de migration globale et spécifique dans les simulants gras (essai avec des simulants gras) et comprend un glossaire pour clarifier la terminologie utilisée, voir annexe B.
NOTE 2 Les milieux d'essai d'éthanol à 95 % en solution aqueuse et d'iso-octane à utiliser dans les présentes méthodes d'essai sont ceux indiqués pour les " essais de substitution " dans la Directive du Conseil 82/711/CEE et ses amendements ultérieurs. En plus de l'utilisation d'iso-octane et d'éthanol à 95 % en milieu aqueux en tant que milieux d'essai pour les " essais de substitution ", la Directive du Conseil 82/711/CEE et ses amendements ultérieurs spécifient l'utilisation d'oxyde de polyphénylène modifié en tant que milieu d'essai devant être utilisé à des températures supérieures ou égales à 100 °C. Une méthode d'essai pour la migration globale dans les revêtements polymères destinés à entrer en contact avec des aliments gras à l'aide d'oxyde de polyphénylène modifié est en cours d'élaboration.
NOTE 3 Ces méthodes d'essai peuvent également être utilisées pour les " essais de remplacement " décrits dans la Directive du Conseil 82/711/CEE et ses amendements ultérieurs lorsque les milieux d'essai volatiles choisis sont de l'iso-octane et de l'éthanol à 95 % en milieu aqueux, voir l'ENV 1186-1.
Une suggestion de protocole d'essai est donnée à la Figure A.1. Si les résultats d
Materiali in predmeti v stiku z živili – Polimerne prevleke na papirju in kartonu - Vodilo za izbiro pogojev in preskusnih metod za celotno migracijo
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2003
Materiali in predmeti v stiku z živili – Polimerne prevleke na papirju in kartonu -
Vodilo za izbiro pogojev in preskusnih metod za celotno migracijo
Materials and articles in contact with foodstuffs - Polymeric coatings on paper and board-
Guide to the selection of conditions and test methods for overall migration
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Polymere Beschichtungen
auf Papier und Pappe - Leiftaden für die Auswahl von Prüfbedingungen und
Prüfverfahren für die Gesamtmigration
Matériaux et objets en contact avec les denrées alimentaires - Revetements polymeres
sur papier et carton - Guide pour le choix des conditions et des méthodes d'essai en
matiere de migration globale
Ta slovenski standard je istoveten z: CEN/TS 14234:2002
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.
TECHNICAL SPECIFICATION
CEN/TS 14234
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
October 2002
ICS 67.250
English version
Materials and articles in contact with foodstuffs — Polymeric
coatings on paper and board — Guide to the selection of
conditions and test methods for overall migration
Matériaux et objets en contact avec les denrées Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln
alimentaires – Revêtements polymères sur papier et carton - Polymere Beschichtungen auf Papier und Pappe –
– Guide pour le choix des conditions et des méthodes Leiftaden für die Auswahl von Prüfbedingungen und
d’essai en matière de migration globale Prüfverfahren für die Gesamtmigration
This Technical Specification (CEN/TS) was approved by CEN on 28 July 2002 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available. It
is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible
conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 14234:2002 E
worldwide for CEN national Members.
Contents
Foreword.3
1 Scope .4
2 Normative references .5
3 Test conditions .5
4 Total immersion method .6
5 Cell method.9
6 Expression of results .12
7 Test report .13
Annex A (normative) Proposed test scheme for papers with polymeric coatings intended for fatty food
contact. .14
Annex B (informative) Guidance for migration testing of polymeric coatings on cellulosic substrates
(paper and board) .15
Annex ZA (informative) Relationship of this Technical Specification with Council Directive 89/109/EEC
and associated EU Directive(s) .23
Bibliography .25
Foreword
This document (CEN/TS 14234:2002) has been prepared by Technical Committee CEN/TC 194, "Utensils in
contact with food", the secretariat of which is held by BSI.
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.
In this standard the Annex A is normative and Annex B is informative.
Guidance for migration testing of polymeric coatings on cellulosic substrates (paper and board) is given in the
informative annex B.
At the time of preparation and publication of this Technical Specification the European Union legislation relating to
resinous and polymeric coatings on paper and board has not been formulated.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.
1 Scope
This Technical Specification specifies test methods for 'alternative tests' and 'substitute tests' performed with
volatile test media, iso-octane and a volume fraction of 95 % aqueous ethanol, for the determination of overall
migration from polymeric coatings on paper and board intended to come into contact with fatty foodstuffs.
NOTE 1 It also includes guidance for the application of Council Directive 82/711/EEC [1], as last amended by Commission
Directives 93/8/EC and 97/48/EC [2] [3] as regards the determination of the specific and overall migration into fatty food
simulants (fat test) and includes a glossary to clarify the terminology used, see annex B.
NOTE 2 The iso-octane and a volume fraction of 95 % aqueous ethanol volatile test media used in these test methods are
those specified for 'substitute tests' in Council Directive 82/711/EEC and its subsequent amendments. In addition to the use of
iso-octane and 95 % v/v aqueous ethanol as test media for 'substitute tests', Council Directive 82/711/EEC and its subsequent
amendments specifies the use of modified polyphenylene oxide as a test medium for use at temperatures of 100 C and above.
A test method for overall migration from polymeric coatings intended to come into contact with fatty foodstuffs using modified
polyphenylene oxide (MPPO) is in preparation.
NOTE 3 These test methods can also be used for the 'alternative tests' described in Council Directive 82/711/EEC and its
subsequent amendments, when the chosen volatile test media are iso-octane and a volume fraction of 95 % aqueous ethanol,
see ENV 1186-1.
A suggested test scheme is given in Figure A.1. If the test result obtained by the total immersion method, described
in clause 4 of this Technical Specification, exceeds the allowed overall migration limit the single-sided migration
test using a cell, see clause 5, if technically feasible; may be used. If it is not possible to use the single sided cell
method, e.g. because of pinholes, use adsorption by modified polyphenylene oxide, (MPPO).
Iso-octane is used as a test medium for test samples coated with non polar food contact layers, such as
polyolefins. For test samples coated with polar food contact polymers such as polyamide and polyethylene
terephthalate, a volume fraction of 95 % aqueous ethanol is used. For polystyrenes, plasticised polyvinyl chloride
and other polymers where the identification or polarity of the polymer is not clear, two parallel tests shall be
conducted using both of the proposed test media and taking the higher value obtained as the relevant result.
NOTE 4 The nature of the food contact layer determines the selection of the test medium(a).
NOTE 5 The overall migration limit for materials and articles of an all polymeric construction is specified in Commission
Directive 90/128/EEC [4] and the conditions of test in Council Directive 82/711/EEC [1] and its subsequent amendments, [2],[3].
There is an expectation that the scope of this directive will be extended to cover polymeric coatings on paper and board.
The 'substitute tests' described in this Technical Specification are by total immersion, see clause 4 and in a
migration cell, see clause 5.
NOTE 6 The test conditions are those described in Council Directive 82/711/EEC [1] and its subsequent amendments,
[2],[3].
The 'alternative test' methods described here specifies a rapid extraction test with a 'more severe' test character,
for the assessment of the overall migration into fatty food simulants. The method differs from the substitute test
methods only in the combination of test time and test temperature. The method is based on the determination of
the extraction of migrateable substances from polymeric coated paper or board, 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 polymeric coating. According to the results obtained by this method, see [5],[6],[7],[8],[9] 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 using fat simulant D,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.
NOTE 7 This method is not applicable to test materials intended for applications over 130 °C. Test materials intended for
applications over 70 °C have to be checked for their physical suitability at the intended time and temperature of use.
The test method should be applied to polymer coated packagings where the polymer layer is less than 300 μm in
thickness. However, if this extraction test is applied to materials with coatings with higher thickness than 300 μm
and the result does not exceed any allowed overall migration limit then the method is considered to be suitable for
those materials.
In those cases where the rapid extraction test by total immersion, yields total extraction values that exceed the
overall migration limit or may be technically unsuitable a cell test method using the same time and temperature
conditions is applicable. This cell test method should primarily only be applied to packagings with a physical barrier
layer (for instance of aluminium or other material to prevent penetrative loss of test medium) and which have a
thinner food contact layer than 300 μm. This test method can not be applied if the polymeric coating is shown to
have pinholes.
2 Normative references
This Technical Specification 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 Technical
Specification only when incorporated in it by amendment or revision. For undated references the latest edition of
the publication referred to applies (including amendments).
ENV 1186-1:1994 Materials and articles in contact with foodstuffs – Plastics - 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 Test conditions
3.1 ´Substitute test´ methods
For substitute tests, the conditions of test will be determined by the conditions of use, see clauses 4, 5 and 6 of
ENV 1186-1:1994.
3.2 ´Alternative test’ methods
For alternative tests, the test medium (a) and test conditions are to be selected according to the nature of the
polymeric coating as given by Table 1.
Table 1 — Use of test media and test conditions for alternative tests
Polymer type of food contact layer Test medium to be applied Test conditions to be applied
Polyolefins 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 (plasticised) iso-octane and 95 % ethanol 24 h at 40 °C
Polyvinyl chloride (rigid) 95 % ethanol 24 h at 50 °C
In case of doubt or unknown iso-octane and 95 % ethanol 24 h at 50 °C
4 Total immersion method
4.1 Principle
The migrateable substances extracted from a sample of the polymer coated paper or board 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 test medium for set periods of time
and at set temperatures and then removed. The test medium 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.
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