ISBN 978-92-871-7703-2 - EDQM

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Metals and alloys used in food contact materials and articles A practical guide for manufacturers and regulators Metals and alloys used in food contact
Metals and alloys

1 st Edition

PREMS29613

Metals and alloys used in food contact materials and ar ticles

used in food contact materials and articles

Committee of Experts on Packaging Materials for Food and Pharmaceutical Products  P-SC-EMB Metals and alloys used in food contac t materials and ar ticles

The EDQM is a directorate of the Council of Europe, an international organisation founded in 1949 that covers almost the entire continent of Europe. The Council of Europe aims to develop common democratic and legal principles based on the European Convention on Human Rights and other reference texts on the protection of individuals.

A practical guide for manufacturers and regulators

European Directorate for the Quality of Medicines & HealthCare

www.edqm.eu www.edqm.eu/store ISBN 978-92-871-7703-2

€ 30

EDQM

9 789287 177032

Committee of Experts on Packaging Materials for Food and Pharmaceutical Products  P-SC-EMB

2013

1st Edition

1st Edition

Metals and alloys used in food contact materials and articles A practical guide for manufacturers and regulators prepared by the Committee of Experts on Packaging Materials for Food and Pharmaceutical Products (P-SC-EMB)

European Directorate for the Quality of Medicines & HealthCare

Metals and alloys used in food contact materials and articles is published by the Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM). All rights conferred by virtue of the International Copyright Convention are specifically reserved to the Council of Europe and any reproduction or translation requires the written consent of the Publisher. Director of the publication: Dr S. Keitel Page layout and cover: EDQM European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe 7, allée Kastner CS 30026 F-67081 STRASBOURG FRANCE Website: www.edqm.eu For ordering: www.edqm.eu/store E-mail: [email protected]

ISBN: 978-92-871-7703-2 © Council of Europe, 2013 Printed on acid-free paper at the Council of Europe

Contents

Foreword........................................................................................................................6 Acknowledgements...................................................................................................8

Council of Europe Resolution CM/Res(2013)9 on metals and alloys used in food contact materials and articles......................................................9 Technical guide on metals and alloys used in food contact materials and articles................................................................................................................. 15 Abbreviations used in the Technical guide..................................................... 17

Chapter 1 – General provisions and specific release limits (SRLs) for metals..............................................................................................................................20 Introduction....................................................................................................................... 20 Objectives........................................................................................................................... 20 Elaboration procedure and stakeholders ................................................................ 21 Legal status of the resolution and link with the European Union...................22 General provisions............................................................................................................22

Chapter 2 – Safety review and recommendations...........................................31 Metals and alloy components...................................................................................... 31 Aluminium (Al)........................................................................................................................ 33 Antimony (Sb)..........................................................................................................................41 Chromium (Cr)........................................................................................................................ 45 Cobalt (Co)................................................................................................................................ 53 Copper (Cu).............................................................................................................................. 57

Iron (Fe)...................................................................................................................................... 63 Magnesium (Mg)....................................................................................................................69 Manganese (Mn).....................................................................................................................73 Molybdenum (Mo)................................................................................................................ 79 Nickel (Ni).................................................................................................................................. 83 Silver (Ag).................................................................................................................................. 91 Tin (Sn).......................................................................................................................................95 Titanium (Ti)........................................................................................................................... 103 Vanadium (V)......................................................................................................................... 107 Zinc (Zn)................................................................................................................................... 111

Metal contaminants and impurities..........................................................................117 Arsenic (As)..............................................................................................................................119 Barium (Ba)..............................................................................................................................125 Beryllium (Be)........................................................................................................................ 129 Cadmium (Cd)........................................................................................................................133 Lead (Pb)................................................................................................................................. 139 Lithium (Li)............................................................................................................................. 147 Mercury (Hg)...........................................................................................................................151 Thallium (Tl)............................................................................................................................157

Stainless steel and other alloys.................................................................................. 161 Stainless steels...................................................................................................................... 165

Chapter 3 – Analytical methods for release testing of food contact materials and articles made from metals and alloys.....................................173 Requirements established under the general provisions ............................... 173 Criteria for the choice of test procedure ..............................................................174 Sampling of materials and articles...........................................................................176 Pre-treatment of materials and articles.................................................................. 177 Release testing into foodstuffs..................................................................................178 Release testing into food simulants......................................................................... 181 Methods of analysis ..................................................................................................... 184 Measurements and reporting ................................................................................. 188

Calculation of specific release (SR).......................................................................... 189

Annex I (Informative): Experimental protocol of a national authority for the determination of aluminium in foodstuffs or food simulants .191 Annex II: Methods for measurement of articles that cannot be filled.203

Chapter 4 – Declaration of compliance for metals and alloys used in food contact materials and articles.................................................................... 213

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