CEN/TS 14235:2002

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 - Revêtements polymères sur supports métalliques - Guide pour le choix des conditions et des méthodes d'essai en matière 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 revêtements polymères sur des substrats en métal destinés à 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 revêtues de polymères et des revêtements antiadhérents.
NOTE   Les revêtements polymères 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

• Status: Published
• Publication Date: 22-Oct-2002
• ICS: 67.250 - Materials and articles in contact with foodstuffs
• Technical Committee: CEN/TC 194 - Utensils in contact with food
• Drafting Committee: CEN/TC 194/SC 1/WG 1 - Overall migration
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 17-Jul-2007
• Completion Date: 17-Jul-2007
• Directive: 89/109/EEC - Materials and articles intended to come into contact with foodstuffs
• Mandate: M/052 - Standardization mandate to CEN concerning methods of analysis for materials and articles intended to come into contact with foodstuffs
• Ref Project: SIST-TS CEN/TS 14235:2003 - Materials and articles in contact with foodstuffs - Polymeric coatings on metal substrates - Guide to the selection of conditions and test methods for overall migration

Overview

CEN/TS 14235:2002 - Materials and articles in contact with foodstuffs: Polymeric coatings on metal substrates - provides guidance for selecting appropriate conditions and test methods to determine overall migration from polymeric coatings on metal substrates into food simulants and test media. The Technical Specification covers migration testing principles and includes a dedicated test method for overall migration into aqueous simulants by article filling (applicable to food and beverage cans and certain non‑stick coatings). Note: polymeric coatings on metal substrates were not yet included in an EU Directive when this CEN/TS was published; the document was prepared to assist in the development of such regulation.

Key Topics

• Scope and definitions: clear terms for “polymeric coating”, “final article”, “test specimen”, “overall migration”, and related concepts.
• Types of tests: migration tests, substitute tests and alternative tests, and criteria for their use.
• Food simulants and test media: selection of aqueous and fatty simulants and recommended reagents.
• Selection of test conditions: guidance on contact times, temperatures, and reduction factors to simulate real‑use scenarios.
• Sample geometry and apparatus: surface‑to‑volume ratios, single vs double surface testing, cells, pouches and filling procedures.
• Fatty simulant considerations: extraction solvents, incomplete extraction, GC‑related issues and sample conditioning.
• Precision and reporting: repeatability/reproducibility, validity checks and required elements for test reports.
• Normative annexes: characteristics of fatty simulants, allowable deviations for contact time/temperature, and recommended supports/cells.

Applications

• Quality control and compliance testing for coated metal food packaging (cans, beverage cans, aerosol liners).
• Laboratory method selection and validation for migration testing of polymeric coatings on metal substrates.
• Risk assessment and materials selection by coating formulators and packaging manufacturers seeking to minimize migration.
• Support for regulators, standards developers and conformity assessment bodies preparing or evaluating legislation and guidance on food contact materials.

Who should use this standard

• Packaging manufacturers and converters using polymeric coatings on metal substrates.
• Testing laboratories performing overall migration and related analyses.
• Regulatory authorities and compliance officers drafting or enforcing food contact material rules.
• Material scientists and QA/QC professionals responsible for product safety and shelf‑life considerations.

Related standards

CEN/TS 14235 is part of the broader body of European guidance on food contact materials and migration testing. It is intended to be used alongside other CEN/CEN/TC guidance and national standards addressing analytical methods, specific migration limits and overall compliance procedures.

Keywords: CEN/TS 14235, polymeric coatings on metal substrates, food contact materials, overall migration, migration testing, food simulants, cans, non‑stick coatings.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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
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
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.
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.
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
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
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.
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 tests involve the use of all of the substitute test media, 95 % ethanol in aqueous solution, iso-octane and
modified polyphenylene oxide under the test conditions corresponding to the test conditions for simulant D, see
Table 4. A new test specimen is used for each test. The reduction factors, 2 to 5, are applicable to these substitute
tests, see clause 5. To ascertain compliance with the overall migration limit the highest value obtained using all of
the test media is selected.
4.3 Alternative tests
4.3.1 "Alternative tests" with volatile media
The results of alternative tests, using volatile test media such as iso-octane and 95 % ethanol in aqueous solution
or other volatile solvents or mixtures of solvents may be used to demonstrate compliance with the legislative limit,
provided that:
a) the result obtained in a comparison test shows that the value is equal to or greater than those obtained in the
migration test with a fatty food simulant;
b) the migration in the alternative test does not exceed the overall migration limit, after application of appropriate
reduction factors.
If either or both conditions are not fulfilled, then the migration tests (3.1) have to be performed.
4.3.2 Extraction tests
Other tests are permitted which use other test media having very strong extractive power under severe test
conditions, if it is generally recognized, on the basis of scientific evidence, that the results obtained using these
extraction tests are equal to or higher than those obtained with simulant D.
4.4 Criteria for the use of substitute tests
The use of substitute tests is justified, when the migration test carried out with each of the possible simulants D is
found to be inapplicable due to technical reasons connected with the migration test, e.g. interferences, incomplete
extraction of oil, absence of stability of the weight of the polymeric coating, excessive absorption of fatty food
simulant, reaction of components with the fat.
5 Food simulants, test media and reagents
5.1 Aqueous food simulants
The aqueous food simulants shall be of the following quality:
- distilled water or water of equivalent quality, simulant A;
- 3 % acetic acid (w/v) in aqueous solution, simulant B;
- For the purposes of this Technical Specification this means a solution prepared by diluting 30 g of acetic acid
with distilled water to a volume of 1 l;
- 10 % ethanol (v/v) in aqueous solution, simulant C.
For liquids or beverages with an ethanol content greater than a volume fraction of 10 % the test is carried out with
aqueous solutions of ethanol of a similar strength.
Each of the above food simulants shall give a non-volatile residue of less than 5 mg/l, when evaporated to dryness
and dried to constant weight at 105 °C to 110 °C.
For overall migration testing of a coating material which is applied to substrates which are not resistant to acid, 3 %
acetic acid is an unsuitable simulant because of the interfering corrosion products. 10 % aqueous ethanol should
be used instead, since intensive studies have demonstrated that they provide sufficient information to evaluate
coating materials for the overall migration properties even under the condition of contact with acidic food.
Only in certain cases would it appear necessary to use 3 % acetic acid as simulant, e.g. for samples containing
inorganic constituents and testing specific migration of certain additive such as pigments, siccatives, amines and
similar. In these cases the finished product can be tested with acetic acid only if the corrosion products do not
interfere with the determination of the particular specific migrant. Otherwise it is recommended either to apply the
coating on to an inert substrate prior to testing, or to test the unsupported film in the case of laminated metal.
5.2 Fatty food simulants
The fatty food simulants are as follows:
- rectified olive oil, "reference simulant D".
This "reference simulant D" may be replaced by a synthetic mixture of triglycerides or sunflower oil or corn oil with
standardized specifications. These are known as "other fatty food simulants" and called "simulant D".
For the characteristics of olive oil, a synthetic mixture of triglycerides, sunflower oil and corn oil, see annex A.
NOTE When these fatty food simulants are used to simulate some classes of food, reduction factors may be used, see 5.3
and Table 2.
When determining the overall migration from materials and articles the mixtures of fatty acid triglycerides
conventionally chosen to simulate fatty food have a number of shortcomings, as follows:
- they are not a single chemical compound and composition can vary even within the permitted specification.
The naturally occurring unsaturated fatty acid triglycerides can change upon storage. This allows the
possibility of inconsistent results;
- they cannot be evaporated to dryness without decomposition and therefore direct determination of the overall
migration by weighing the residue after evaporation is not feasible. An inherently less accurate and more time
consuming indirect determination is required;
- they are absorbed by the polymeric coating under test to a varying extent. If the absorption is excessive, this
leads to gross inaccuracies in the determination. If the olive oil is not readily extractable errors also can occur.
Errors can also occur if the different components of the fatty acid triglyceride are absorbed and extracted from
the polymeric coating to a varying degree. Furthermore, substances present in the polymeric coating can
interfere with the gas chromatographic determination of olive oil as described in EN 1186-2, EN 1186-4, EN
1186-6 and EN 1186-8;
- fatty acid triglycerides pose safety hazards when used at high temperatures both from the possibility of fire
and the dangers of handling hot liquids;
- testing of thin layer coatings, such as used as protective coatings in cans, collapsible tubes and similar
articles, does not give reliable results. The overall migration which could be expected under worst case
conditions if of about the same order of magnitude as the accuracy of the method (3 mg/dm ). The olive oil
procedure is difficult to apply to cans with double seamed or heat sealed ends, and it cannot be applied to
finished articles of greater dimension or weight.
For these reasons alternatives are desirable which should, as far as possible, avoid the deficiencies arising with
triglycerides while still giving levels of migration comparable with, but not less than, that obtained with fatty acid
triglycerides. Alternative fatty food simulants when compared with fatty food or existing fatty food simulants should
possess the following characteristics:
- they should penetrate polymeric coating to the same extent;
- they should be as good a solvent for ingredients of polymeric coatings;
- they should be single substances or clearly defined mixtures.
5.3 Test media
5.3.1 Test media for substitute tests
The test media to be used in substitute tests are iso-octane, 95 % ethanol in aqueous solution and a modified
polyphenylene oxide (MPPO). The characteristics of modified polyphenylene oxide are to be found in annex A.
5.3.2 Test media for alternative tests
These are volatile media such as iso-octane and 95 % ethanol in aqueous solution or other volatile solvents or
mixtures of solvents.
5.4 Reagents
Unless otherwise required, reagents shall be of analytical quality.
NOTE Specifications for solid reagents, used as such in discrete quantities, may not address suitability for use in methods
of analysis in this Technical Specification. Solid reagents may not be homogeneous with respect to contaminants not
addressed by specifications, therefore it may be necessary to demonstrate that such reagents are suitable for use.
6 Selection of food simulants
6.1 General
NOTE Commission Directive 85/572/EEC [6] specifies the use of a volume fraction of 15 % ethanol in aqueous solution as
simulant C. This has been superseded by Commission Directive 97/48/EC [5} the second amendment to Council Directive
82/711/EEC [3] that specifies a volume fraction of 10 % ethanol in aqueous solution.
6.2 Simulating contact with all food types
Where a polymeric coating on a metal article is intended for use in contact with all types of food it shall be tested
with a volume fraction of 3 % acetic acid in aqueous solution, simulant B, a volume fraction of 10 % ethanol in
aqueous solution, simulant C and a fatty food simulant, simulant D, without reduction factors, except when the
coating material is applied to a substrate which is not resistant to acid then testing with a volume fraction of 3 %
acetic acid is not required, see 4.1.
If, when using any of the other fatty food simulants, see 4.2, the migration limit is exceeded, for the judgement of
non compliance with the overall migration limit a confirmation of the result by using olive oil is obligatory, when
technically feasible. If this confirmation is not technically feasible and the migration from the material or article
exceeds the limit it shall be deemed not in compliance with the overall migration limit.
6.3 Simulating contact with specific food types
Provision for materials and articles intended to come into contact with specific food types has been made in the
following situations:
a) when the material or article is already in contact with a known foodstuff;
b) when the material or article is accompanied, by a specific indication stating with which food types it may or may
not be used, for example "only for aqueous foods";
c) when the material or article is accompanied by a specific indication stating with which foodstuff(s) or group(s)
of foodstuffs they may or may not be used. This indication shall be expressed:
1) at the marketing stage other than retail stage, by using the " reference number" or "description of
foodstuffs" ;
2) at the retail stage using an indication which shall refer to only a few foods or groups of food, preferably
with examples which are easy to understand.
In situation b) the simulants to be used in the overall migration tests are specified in table 1.
Table 1 — Food simulants to be selected for testing food contact materials in special case
Contact foods Simulant
Only aqueous foods Simulant A
Only acidic foods Simulant B
Only alcoholic foods Simulant C
Only fatty foods Simulant D
All aqueous and acidic foods Simulant B
All alcoholic and aqueous foods Simulant C
All alcoholic and acidic foods Simulants C and B
All fatty and aqueous foods Simulants D and A
All fatty and acidic foods Simulants D and B
All fatty and alcoholic and aqueous foods Simulants D and C
All fatty foods and alcoholic and acidic foods Simulants D, C and B
In situation a) and c) the tests are carried out using the food simulants mentioned in Table 2.
In Table 2 for each foodstuff or group of foodstuffs, only the simulant(s) indicated by an 'X' is (are) to be used,
using for each simulant, a new sample of the materials and subject concerned. Where no 'X' appears, no migration
test is required for the heading or subheading concerned , see 5.4 on dry foods and frozen foods.
When 'X' is followed by an oblique stroke and a figure, the result of the migration tests should be divided by the
number indicated. In the case of certain types of fatty foodstuffs, this figure, known as the 'reduction factor', is
conventionally used to take account of the greater extractive capacity of the simulant for such foodstuffs.
Where a letter 'a' is shown in brackets after the 'X' only one of the two simulants given should be used:
- if the pH value is higher than 4,5, simulant A should be used;
- if the pH value is 4,5, or less, simulant B should be used.
Where a foodstuff is listed under both a specific heading and a general heading , only the simulant(s) indicated
under the specific heading is (are) to be used.
Where the foodstuff(s) or group(s) of foodstuffs are not included in the Table 2, select the item from the table of
food simulants to be selected for testing food contact materials in special cases, which corresponds most closely to
the foodstuff(s) or group of foodstuff(s) under examination.
Table 2 — List of simulants to be used in the migration test with a particular foodstuff or group of
foodstuffs
Reference Description of foodstuffs Simulants to be used
a
number
AB C D
Beverages
01.01 Non-alcoholic beverages or alcoholic beverages of an
alcoholic strength lower than a volume fraction of 5 % :
Waters, ciders, fruit or vegetable juices of normal
strength or concentrated, musts, fruit nectars,
lemonades and mineral waters, syrups, bitters,
infusions, coffee, tea, liquid chocolate, beers and others X(a) X(a)
01.02 Alcoholic beverages of an alcoholic strength equal to or
exceeding a volume fraction of 5 % :
Beverages shown under heading 01.01 but with an
alcoholic strength equal to or exceeding a volume
fraction of 5 % :
b c
X X
Wines, spirits and liqueurs
b c
01.03 X X
Miscellaneous: undenatured ethyl alcohol
Cereals, cereal products, pastry, biscuits, cakes and
other bakers' wares
02.01
Starches
02.02
Cereals, unprocessed, puffed in flakes, (including popcorn,
corn flakes and the like)
02.03
Cereal flour and meal
02.04
Macaroni, spaghetti and similar products
02.05
Pastry, biscuits, cakes, and, other bakers' wares, dry:
X/5
A. With fatty substances on the surface
B. Other
02.06
Pastry, cakes, and, other bakers' wares, fresh:
X/5
A. With fatty substances on the surface X
B. Other
Chocolate, sugar and products thereof Confectionery
products
03.01 X/5
Chocolate, chocolate-coated products, substitutes and
products coated with substitutes
03.02
Confectionery products:
X/5
A. In solid form:
I. With fatty substances on the surface
II. Other
Table 2 (continued)
Reference Description of foodstuffs Simulants to be used
a
number
AB C D
03.02 A. In paste form:
I. With fatty substances on the surface X/3
03.03 II. Moist X
Sugar and sugar products
A. In solid form
B. Honey and the like X
04 C. Molasses and sugar syrups X
04.01 Fruit, vegetables and products thereof
04.02 Whole fruit, fresh or chilled
Processed fruit:
A. Dried or dehydrated fruit, whole or in the form of flour or
powder X(a) X(a)
B. Fruit in the form of chunks, purée or paste
C. Fruit preserves (jams and similar products - whole fruit
or chunks or in
...