The method specific certification of the overall migration into olive oil, of reference films a,b, and c intended for exposure to olive oil by total immersion, single sided cell and pouch- CRMs 537, 538 and 539

Directorate-General For Research And Innovation European Commission

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Agricultural and fisheries research

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• Sciences et techniques

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• Publié par: DIRECTORATE-GENERAL-FOR-RESEARCH-AND-INNOVATION-EUROPEAN-COMMISSION
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• Langue: English
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ISSN 1018-5593
European Commission
ber information
REFERENCE MATERIALS
THE METHOD SPECIFIC CERTIFICATION OF
THE OVERALL MIGRATION INTO OLIVE OIL, OF
REFERENCE FILMS A, B, AND C INTENDED FOR
EXPOSURE TO OLIVE OIL BY TOTAL IMMERSION,
SINGLE SIDED CELL AND POUCH
CRMs 537, 538 and 539 European Commission
ber information
REFERENCE MATERIALS
THE METHOD SPECIFIC CERTIFICATION OF
THE OVERALL MIGRATION INTO OLIVE OIL, OF
REFERENCE FILMS A, B, AND C INTENDED FOR
EXPOSURE TO OLIVE OIL BY TOTAL IMMERSION,
SINGLE SIDED CELL AND POUCH
CRMs 537, 538 and 539
A. L. LORD('), A. MAGGIOf) and A. BOENKEf)
(') PIRA International,
Randalls Road, Leatherhead, Surrey U.K.
(') Istituto Superiore di Sanità,
Viale Regina Elena, Roma, IT
(') European Commission, DG XII-C-5,
Standards, Measurement and Testing Programme, Brussels, BE
Directorate-General
Science, Research and Development
1998 EUR 18289 EN EUROPEAN COMMISSION
LEGAL NOTICE
Neither the European Commission nor any person acting on
behalf of the Commission is responsible for the use which might be made of the
following information
Cataloguing data can he found at the end of this publication
Luxembourg: Office for Official Publications of the European Communities, 1998
ISBN 92-828-3905-8
° ECSC-EC-EAEC, Brussels · Luxembourg, 1998.
Printed in Belgium EUROPEAN COMMISSION
Edith CRESSON, Member of the Commission responsible
for Research, Innovation, Education, Training
and Youth
DG XII-C-05 - SMT Programme ABSTRACT
This report describes the work carried out in the preparation, packaging and testing of
reference films intended for exposure to olive oil by total immersion (plastic film A, CRM
537), single sided cell (plastic film Β CRM 538), and pouch (plastic film C, CRM 539). The
reference materials are manufactured from an additive free Low Density Polyethylene of
nominal thickness 170 pm.
Data is presented to inform about the results of the homogeneity and the stability studies
during storage of the films. Two certification exercises were also carried out involving a
number of European laboratories, and the data obtained from the second exercise was
used to obtain the certified values for the overall migration value in olive oil on the basis of
three specific test methods in three RMs.
The method used to determine the overall migration into olive oil is the draft method
specified in ENV 1186 parts 1 (guide to the selection of conditions and test methods for
overall migration), 2 (test methods for the overall migration into olive oil by the total
immersion technique) 4 (test methods forln into olive oil by the single sided
cell technique), 6 (test methods for overall migration into olive oil by pouch) together with
additional instructions specified in this report.
The reference materials can only be used to check the performance of the overall migration
method including the additional instructions both used for certification, and for the quality
control of analytical measurements made to ensure compliance with current EC directives
on food contact plastics, by these specific methods including the additional instructions
specified in this report. CONTENTS
Page No
ABSTRACT i
CONTENTS
ABBREVIATIONS
1 INTRODUCTION 1
1.1 Background and need for CRM's 537, 538 and RM539 1
1.2 Choice of the materials for CRM's 537, 538 and CRM 539 2
1.3 Expression of results 4
2 PARTICIPANTS
2.1 Preparation of reference materials (RM's)
2.2 Homogeneity and stability studies
2.3 Analyses within the preliminary interlaboratory studies 4
2.4s within the certification exercises 5
2.5 Statistical analysis 6
3 PREPARATION OF THE MATERIALS
4 TESTING THE MATERIAL FOR HOMOGENEITY 7
4.1 Justification for the use of a rapid extraction procedure
4.2 Iso-octane versus olive oil cross correlation study 8
4.3 Two sided bulk homogeneity of RM's 537, 538 and 539 10
4.4 Homogeneity testing of the packaged materials RM 537 , 538 and 539 11
4.5 Influence of film thickness of RM's 537, 538 and 539 on homogeneity5
4.6 Overall conclusions 18
5 TESTING THE MATERIALS FOR STABILITY 1
5.1 Design of the stability studies
5.2 Results of theys9
5.3 Conclusion 22
6 PRELIMINARY INTERLABORATORY STUDIES 2
7 THE CERTIFICATION EXERCISE4
7.1 Design of the certification exercise
7.2 Technical evaluation of the results8
7.4 Statisticaln of results 38 THE CERTIFIED VALUES AND THEIR UNCERTAINTIES 42
8.1 Calculation of the certified values and their uncertainties
8.2 Summary of the certified values and theirs6
8.3 Traceability 47
9 INSTRUCTIONS FOR THE USE OF CRM's 537, 538 and CRM 539 4
9.1 Storage, handling and minimum test portion size 4
9.2 Specific instructions to be followed in conjunction with the draft ENV 1186 4
9.3 The use of the certified values for CRM's 537 538 and 5398
10 REFERENCES
APPENDIX 1 Description of the method to determine overall migration from
CRM 537, 538 and CRM 539 into iso-octane as used to study
the stability and homogeneity 50
APPENDIX 2 Homogeneity and stability data for RM 537, 538 and 539 6
APPENDIX 3 Draft method ENV 1186 parts 1 (guide to the selection of conditions
and test methods for overall migration), 2 (test methods for the overall
migration into olive oil by total immersion) 4 (tests for overall n into olive oil by cell), 6 (test methods for overall migration
into olive oil by pouch) and additional instructions 68