SIST-TS CEN/TS 14235:2003
(Main)Materials and articles in contact with foodstuffs - Polymeric coatings on metal substrates - Guide to the selection of conditions and test methods for overall migration
Materials and articles in contact with foodstuffs - Polymeric coatings on metal substrates - Guide to the selection of conditions and test methods for overall migration
This Technical Specification gives guidelines for the selection of the appropriate conditions and test methods for the determination of overall migration into food simulants and test media from polymeric coatings on metal substrates which are intended to come into contact with foodstuffs and a test method for overall migration into aqueous simulants by article filling from polymeric coatings on food and beverage cans and non-stick coatings.
NOTE Polymeric coatings on metal substrates are not yet included in the scope of any European Union Directive. This Technical Specification has been prepared to assist in the development of such a Directive.
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Polymerebeschichtungen auf Substraten aus Metall - Leitfaden zur Auswahl der Bedingungen und Prüfverfahren zur Bestimmung der Gesamtmigration
Diese Technische Spezifikation ist ein Leitfaden zur Auswahl der geeigneten Bedingungen und Prüfverfahren für die Bestimmung der Gesamtmigration aus polymeren Beschichtungen auf Substraten aus Metall, die für den Kontakt mit Lebensmitteln vorgesehen sind, in Prüflebensmittel und Prüfmedien und beschreibt ein Verfahren zur Bestimmung der Gesamtmigration aus polymeren Beschichtungen auf Konserven- und Getränkedosen sowie nichtklebenden Beschichtungen in wässrige Lebensmittel durch Füllen eines Gegenstandes.
ANMERKUNG Polymere Beschichtungen auf Substraten aus Metall fallen noch nicht in den Anwendungsbereich von Richtlinien der Europäischen Union. Diese Technische Spezifikation wurde zur Unterstützung der Ausarbeitung einer derartigen Richtlinie erarbeitet.
Matériaux et objets en contact avec les denrées alimentaires - Revetements polymeres sur supports métalliques - Guide pour le choix des conditions et des méthodes d'essai en matiere de migration globale
La présente Spécification Technique indique des lignes directrices pour le choix des méthodes et des conditions d'essai adéquates de la migration globale dans les simulants et les milieux d'essai de revetements polymeres sur des substrats en métal destinés a entrer en contact avec les denrées alimentaires ; ainsi qu'une méthode d'essai de la migration globale dans les simulants aqueux par remplissage des boîtes de conserves et des canettes revetues de polymeres et des revetements antiadhérents.
NOTE Les revetements polymeres sur les substrats en métal ne sont pas couverts par le domaine d'application d'une directive de L'Union Européenne quelconque pour le moment. La présente Spécification Technique a été élaborée pour préparer l'élaboration d'une telle directive.
Materiali in predmeti v stiku z živili – Polimerne prevleke za kovinske podlage – Vodilo za izbiro pogojev in preskusnih metod za celotno migracijo
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN/TS 14235:2003
01-julij-2003
Materiali in predmeti v stiku z živili – Polimerne prevleke za kovinske podlage –
Vodilo za izbiro pogojev in preskusnih metod za celotno migracijo
Materials and articles in contact with foodstuffs - Polymeric coatings on metal substrates
- Guide to the selection of conditions and test methods for overall migration
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Polymerebeschichtungen
auf Substraten aus Metall - Leitfaden zur Auswahl der Bedingungen und Prüfverfahren
zur Bestimmung der Gesamtmigration
Matériaux et objets en contact avec les denrées alimentaires - Revetements polymeres
sur supports métalliques - Guide pour le choix des conditions et des méthodes d'essai
en matiere de migration globale
Ta slovenski standard je istoveten z: CEN/TS 14235:2002
ICS:
67.250 Materiali in predmeti v stiku z Materials and articles in
živili contact with foodstuffs
SIST-TS CEN/TS 14235:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN/TS 14235:2003
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SIST-TS CEN/TS 14235:2003
TECHNICAL SPECIFICATION
CEN/TS 14235
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
October 2002
ICS 67.250
English version
Materials and articles in contact with foodstuffs — Polymeric
coatings on metal substrates — Guide to the selection of
conditions and test methods for overall migration
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln
– Polymerebeschichtungen auf Substraten aus Metall –
Leitfaden zur Auswahl der Bedingungen und Prüfverfahren
zur Bestimmung der 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 14235:2002 E
worldwide for CEN national Members.
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Contents
page
Foreword.4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions.6
3.1 polymeric coating .6
3.2 final article .7
3.3 sample.7
3.4 test specimen .7
3.5 test piece.7
3.6 conventional oven .7
3.7 food simulant.7
3.8 migration test .7
3.9 substitute test.7
3.10 test media .7
3.11 alternative test.7
3.12 extraction tests.7
3.13 overall migration; global migration.7
3.14 reduction factor.8
3.15 pouch .8
3.16 reverse pouch.8
3.17 inert substrate .8
3.18 pressure retort or autoclave .8
3.19 cell .8
3.20 repeatability value 'r'.8
3.21 reproducibility value 'R' .8
3.22 repeatability conditions.8
3.23 reproducibility conditions.8
4 Types of test.9
4.1 Migration tests.9
4.2 Substitute tests .9
4.3 Alternative tests .9
4.4 Criteria for the use of substitute tests.9
5 Food simulants, test media and reagents .9
5.1 Aqueous food simulants .9
5.2 Fatty food simulants.10
5.3 Test media .11
5.4 Reagents.11
6 Selection of food simulants.11
6.1 General.11
6.2 Simulating contact with all food types .11
6.3 Simulating contact with specific food types.11
6.4 Simulating contact with dry foods .18
6.5 Testing for fatty contact .18
7 Migration tests, substitute tests and alternative test conditions .19
7.1 Test conditions for migration tests.19
7.2 Test conditions for substitute tests.22
7.3 Test conditions for alternative tests .24
8 Apparatus .24
8.1 Specimen supports.24
8.2 Tubes, glass rods and glass beads .24
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8.3 Cells.24
8.4 Thermostatically controlled ovens or incubators .24
9 Samples and sample geometry.25
9.1 Samples .25
9.2 Surface to volume ratio.25
9.3 Single surface versus double surface testing (by total immersion) .25
9.4 Single surface testing using a cell.26
9.5 Single surface testing by pouch .26
9.6 Single surface testing using a reverse pouch .27
9.7 Single surface testing by filling.27
9.8 Articles intended for repeated use.27
9.9 Caps, closures and other sealing devices .28
9.10 Food and beverage cans.28
9.11 Non-stick coatings.29
9.12 Flexible films .29
9.13 Large containers.29
9.14 Inert substrates.29
9.15 Tubing, taps, valves and filters .29
9.16 Articles of irregular shape .29
10 Overall migration test methods with fatty food simulants .30
10.1 Extraction solvents.30
10.2 Incomplete extraction of fat.30
10.3 Substances which interfere with gas chromatography.30
10.4 Loss of volatile substances.30
10.5 Gas chromatographic columns.31
10.6 Changes in the C18/C16 ratio .31
10.7 Initial mass of the test specimen .32
10.8 Final mass of the test specimen .33
10.9 Selection of the appropriate conditioning procedure.33
10.10 Loss of simulant due to permeation.34
11 Precision.34
12 Test reports .34
12.1 Surface to volume ratios in actual use.34
12.2 Reduction factors .35
12.3 Validity of results.36
12.4 Test report .36
12.5 Statements of compliance .36
13 Test method for overall migration into aqueous simulants by article filling from polymeric
coatings on food and beverage cans and non-stick coatings.37
13.1 Scope .37
13.2 Principle.37
13.3 Reagents.37
13.4 Apparatus .37
13.5 Preparation of test specimens .38
13.6 Procedure .39
13.7 Expression of results .40
13.8 Test report .43
Annex A (normative) Characteristics of fatty food simulants and test media.44
Annex B (normative) Limit deviations on contact times and contact temperatures applicable to all
clauses of this Technical Specification.46
Annex C (normative) Supports and cells.48
Bibliography .56
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Foreword
This document (CEN/TS 14235:2002) has been prepared by 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.
In this Technical Specification the annexes A, B and C are normative.
This Technical Specification includes a Bibliography.
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.
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Introduction
No single test method has been devised which can be used to determine overall migration, at all temperatures, in
all food simulants. Indeed, owing to the practical difficulties inherent in testing with involatile extractants such as
fats and the multitude of applications in which polymeric coatings on metal substrates come into contact with food,
there are many methods and permitted variations to methods in this Technical Specification.
This Technical Specification is intended to give advice on the selection of the most appropriate type of test, test
conditions and test method for a given application of a polymeric coating on a metal substrate and is intended to be
read in its entirety before testing protocols are finalized. A test method for overall migration into aqueous simulants
by article filling from polymeric coatings on food and beverage cans and non-stick coatings is given in clause 12.
For many polymeric coated articles methods in EN 1186-2 to EN 1186-9 are suitable, according to the form in
which the article is tested.
The general criteria for the operation and assessment of testing laboratories as well as the general criteria for
laboratory accreditation bodies are set out in EN 45001, EN 45002 and EN 45003. It is recommended that
laboratories using this Technical Specification validate their procedures by testing certified reference samples and
by taking part in a proficiency scheme. Suitable proficiency schemes are operated in Germany and in the United
Kingdom, for example the German Assessment Scheme for Food Testing (GAFT) and the Food Analysis
Performance Assessment Scheme (FAPAS) conducted by the Central Science Laboratory of the Ministry of
Agriculture, Fisheries and Food.
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1 Scope
This Technical Specification gives guidelines for the selection of the appropriate conditions and test methods for
the determination of overall migration into food simulants and test media from polymeric coatings on metal
substrates which are intended to come into contact with foodstuffs and a test method for overall migration into
aqueous simulants by article filling from polymeric coatings on food and beverage cans and non-stick coatings.
NOTE Polymeric coatings on metal substrates are not yet included in the scope of any European Union Directive. This
Technical Specification has been prepared to assist in the development of such a Directive.
2 Normative references
This Technical Specification incorporates by dated or 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 or 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).
EN 1186-2, Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for overall migration
into olive oil by total immersion.
EN 1186-3, Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration
into aqueous food simulants by total immersion.
EN 1186-4, Materials and articles in contact with foodstuffs - Plastics - Part 4: Test methods for overall migration
into olive oil by cell.
EN 1186-5, Materials and articles in contact with foodstuffs - Plastics - Part 5: Test methods for overall migration
into aqueous food simulants by cell.
EN 1186-6, Materials and articles in contact with foodstuffs - Plastics - Part 6: Test methods for overall migration
into olive oil using a pouch
EN 1186-7, Materials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration
into aqueous food simulants using a pouch.
EN 1186-8; Materials and articles in contact with foodstuffs - Plastics - Part 8: Test methods for overall migration
into olive oil by article filling.
EN 1186-12, Materials and articles in contact with foodstuffs - Plastics - Part 12: Test methods for overall migration
at low temperatures.
EN 1186-13, Materials and articles in contact with foodstuffs - Plastics - Part 13: Test methods for overall migration
at high temperatures.
ISO 648 Laboratory glassware - One-mark pipettes
3 Terms and definitions
For the purposes of this Technical Specification the following terms and definitions apply.
3.1
polymeric coating
organic material applied in the form of a continuous film on a substrate in such a way as to form a protective layer
and/or a functional barrier between food and substrate. They may be applied to the substrate in the form of
solution, dispersions, powders, or solvent free preparations.
NOTE This may be different to the definition which is expected to be included in Commission Directive 90/128/EEC when
its scope is extended to include polymeric coatings
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3.2
final article
article in its ready-for-use state or as sold
3.3
sample
material or article under investigation
3.4
test specimen
portion of the sample on which a test is performed
3.5
test piece
portion of the test specimen
3.6
conventional oven
oven where the air within the oven is heated and this heat is then transferred to the food through the final article as
opposed to a microwave oven where the food itself is heated directly by microwave irradiation
3.7
food simulant
medium intended to simulate a foodstuff (see clauses 3 and 4)
3.8
migration test
test for the determination of overall migration using food simulants under conventional test conditions
3.9
substitute test
test carried out which uses test media under conventional substitute test conditions when the use of a migration
test is not feasible
3.10
test media
substances used in "substitute tests", iso-octane, 95 % ethanol in aqueous solution and modified polyphenylene
oxide
3.11
alternative test
tests, with volatile media, that may be used instead of migration tests with fatty food simulants
3.12
extraction tests
tests in which media having strong extraction under very severe test conditions are used
3.13
overall migration; global migration
mass of material transferred to the food simulant or test media as determined by the relevant test method
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3.14
reduction factor
numbers, 2 to 5, which may be applied to the result of the migration tests relevant to certain types of fatty foodstuffs
and which is conventionally used to take account of the greater extractive capacity of the simulant for such
foodstuffs
3.15
pouch
receptacle of known dimensions manufactured from film to be tested, which when filled with food simulant exposes
the food contact side of the film to the food simulant or test medium
3.16
reverse pouch
pouch, which is fabricated such that the surface intended to come into contact with foodstuffs is the outer surface.
All of its sides are sealed to prevent the inner surfaces coming into contact with the food simulant. The reverse
pouch is intended to be totally immersed in food simulant or test medium
3.17
inert substrate
material (e.g. silver, platinum, stainless steel, tantalum) which is non-reactive in the food simulant and which can
simulate the intended metal substrate when coated with the test material. It is necessary that the inert substrate
does not interfere with the overall migration from the coating under the applied test conditions
3.18
pressure retort or autoclave
pressure vessel (complying with appropriate pressure vessel regulations) in which hermetically sealed containers
(e.g. metal plastics, glass) may be safely heated in a controlled manner, typically up to 122 C and above, and
which has suitable controlled cooling facilities
3.19
cell
device in which a film or flat sheet to be tested can be mounted which when assembled and filled with food
simulant, exposes the food contact side of the film to the food simulant or test medium
3.20
repeatability value 'r'
value below which the absolute difference between two single test results obtained under repeatability conditions
may be expected to lie with a probability of 95 %
3.21
reproducibility value 'R'
value below which the absolute difference between two single test results obtained under reproducibility conditions
may be expected to lie with a probability of 95%.
3.22
repeatability conditions
conditions where mutually independent test results are obtained with the same method on identical test material in
the same laboratory by the same operator using the same equipment within short intervals of time
3.23
reproducibility conditions
conditions where test results are obtained with the same method on identical material in different laboratories with
different operators using different equipment.
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4 Types of test
4.1 Migration tests
"Migration" tests for the determination of overall migration are carried out using the "food simulants" and
"conventional migration test conditions", see 4.1, 4.2 and Table 1.
4.2 Substitute tests
If the migration test using fatty food simulants is not feasible, for technical reasons connected with the test method,
"substitute tests" which use test media under the conventional substitute test conditions may be appropriate. The
substitute t
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