EN 13130-1:2004

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General
    4.1 Summary
    4.2 Precautions in handling and testing
    4.3 Analysis of a substance in a food simulant - migration
          test
    4.4 Analysis of substance in a foodstuff
    4.5 Analysis of a substance in a test medium - substitute
          fat tests
    4.6 Analysis of a substance in a 'volatile' test medium -
          alternative fat tests
    4.7 Analysis of a substance in a plastics material or article
    4.8 Multi-analyte analyses
    4.9 Multilayer materials and articles
5 Types of test
    5.1 Substitute tests
    5.2 Substitute tests
    5.3 Alternative fat tests
          5.3.1 General
          5.3.2 Alternative tests with volatile media
          5.3.3 Extraction tests
    5.4 Residual content determination
          5.4.1 "QM" test
          5.4.2 "QMA" test
6 Food simulants, test media and reagents
    6.1 Aqueous food simulants
    6.2 Fatty food simulants
    6.3 Test media
          6.3.1 Test media for substitute tests
          6.3.2 Test media for alternative tests
    6.4 Reagents
7 Selection of food simulants
    7.1 General
    7.2 Simulating contact with all food types
    7.3 Simulating contact with specific food types
    7.4 Simulating contact with dry foods and frozen food
    7.5 Testing for fatty contact
8 Migration test, substitute test and alternative test
    conditions and conditions of residual content determination
    8.1 Test conditions for migration tests
          8.1.1 General
          8.1.2 Introduction
          8.1.3 Contact conditions generally recognized as
                 'more severe'
          8.1.4 Contact for less than 15 min at temperatures
                 between 70 degree C and 100 degree C
          8.1.5 Contact in a microwave oven
          8.1.6 Contact conditions causing changes in physical
                 or other properties
          8.1.7 Contact not covered by the conventional condition
                 for migration tests
          8.1.8 Testing at low temperatures
          8.1.9 Testing at high temperature
          8.1.10 Caps, gaskets, stoppers or similar sealing
                 devices and lids
          8.1.11 Tubing, taps, valves, filters
    8.2 Test conditions for substitute fat tests
    8.3 Test conditions for alternative fat tests
          8.3.1 Alternative fat test with volatile media
          8.3.2 Extraction tests
9 Apparatus
    9.1 Specimen supports
    9.2 Tubes, glass rods and glass beads
    9.3 Cells
    9.4 Thermostatically controlled ovens or incubators
10 Samples and sample geometry
    10.1 Samples
    10.2 Surface-to-volume ratio
    10.3 Single surface versus double surface testing (by total
          immersion)
    10.4 Single surface testing using a cell type A Mark 2
    10.5 Single surface testing using a pouch
    10.6 Single surface testing using a reverse pouch
    10.7 Single surface testing by filling
    10.8 Articles intended for repeated use
    10.9 Caps, closures and other sealing devices
    10.10 Large containers
    10.11 Tubing, tabs, valves and filters
    10.12 Fibres and cloths
    10.13 Articles of irregular shape
11 Sampling
    11.1 Sampling of test articles
    11.2 Sampling of foodstuffs
12 Precision
13 Expression of results
    13.1 General - specific migration test results
          13.1.1 Introduction
          13.1.2 For unknown surface-to-volume ratios
          13.1.3 For known surface-to-volume ratios and tested
                 under these conditions
          13.1.4 For known surface-to-volume ratios and not tested
                 under these conditions
          13.1.5 Conversion recalculation
    13.2 Reduction factors with the fat simulant
    13.3 Calculation of QA for compliance with QMA
    13.4 Validity of results
    13.5 Confirmation of results
    13.6 Group limits
14 Test reports and statements of compliance
    14.1 Test reports
15 Exposure by total immersion in a thermostatically controlled
    oven, incubator or refrigerator
    15.1 Introduction
    15.2 Principle
    15.3 Reagents
          15.3.1 Distilled water or water of equivalent quality
                 (simulant A)
          15.3.2 Acetic acid 3 % (w/v) in aqueous solution
                 (simulant B)
          15.3.3 Ethanol 10% (v/v) in aqueous solution (simulant C)
          15.3.4 Alcoholic simulants for liquids or beverages
                 of an alcoholic strength exceeding 10% (v/v)
          15.3.5 Olive oil, simulant D as specified in clause 8
          15.3.6 Dewaxed sunflower oil for determinations at
                 low temperatures
          15.3.7 Test media for substitute tests
    15.4 Apparatus
    15.5 Preparation of test specimens
          15.5.1 Number of test specimens
          15.5.2 Thin films and sheet materials
          15.5.3 Containers and other articles
          15.5.4 Articles of irregular shape
          15.5.5 General
    15.6 Procedure
16 Exposure by total immersion at reflux temperatures
    16.1 Introduction
    16.2 Principle
    16.3 Reagents
    16.4 Apparatus
    16.5 Preparation of test specimens
    16.6 Procedure
17 Single-side exposure in a cell in a thermostatically controlled
    oven, incubator or refrigerator
    17.1 Introduction
    17.2 Principle
    17.3 Reagents
    17.4 Apparatus
    17.5 Preparation of test specimens
          17.5.1 Number of test specimens
          17.5.2 Cutting test specimens
    17.6 Procedure
18 Single-side exposure with a pouch in a thermostatically
    controlled oven, incubator or refrigerator
    18.1 Introduction
    18.2 Principle
    18.3 Reagents
    18.4 Apparatus
    18.5 Preparation of test specimens
          18.5.1 Number of test specimens
          18.5.2 Cutting and preparation of specimens
    18.6 Procedure
19 Single-side exposure by article fill a thermostatically
    oven, incubator or refrigerator
    19.1 Introduction
    19.2 Principle
    19.3 Reagents
    19.4 Apparatus
    19.5 Preparation of the test specimens
          19.5.1 Number of test specimens
          19.5.2 Articles with a capacity of less than 500 ml
                 or more than 10 l
    19.6 Procedure
Annex A (normative) Criteria for classification of non-volatility
    A.1 Volatile substances
    A.2 Criteria for conventional classification of non-volatility
Annex B (normative) Characteristics of fatty food simulants and
        test media
Characteristics of rectified olive oil, reference simulant D
Composition of the mixture of synthetic triglycerides, simulant D
Characteristics of sunflower oil, simulant D
Characteristics of corn oil, simulant D
Characteristics of modified polyphenylene oxide (MPPO)
Annex C (normative) Tolerances on contact times and contact
        temperatures applicable to all parts of this standard
Annex D (informative) Supports and cells
Annex E (informative) Relationship of this European Standard
        with Council Directive 89/109/EEC and Commission Directive
        2002/72/EC and associated Directives
Bibliography

This part of this European Standard provides a guide to the selection of the appropriate conditions of contact of food simulants with the test article before the determination of specific migration of those substances subject to a migration limit.NOTEAccording to Directive 90/128/EEC[2] the determination of the migration of specified components in foodstuffs instead of the use of simulants is permitted. However, in that situation there is no need to give guidance on the test conditions of time and temperature as contact conditions shall be equal to conditions applied in real.Also general guidance is given for the determination of the amount of the substance in the final plastics material or article.