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Food Contact Rubbers 2 - Products, Migration and Regulation
Product Code: 1-85957-522-6
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Food Contact Rubbers 2 - Products, Migration and Regulation
Rapra Review Report
Vol. 16, No. 2, Report 182, 2006 By Martin J. Forrest, Rapra Technology
The objective of this Rapra Review Report is to provide a comprehensive overview of the use of rubber as a food contact material, from an initial description of the types of rubber which are used in the industry, through the formulation of products, and the contact regulations and migration testing regimes, to the research that is on-going to improve its safety and the trends for the future. This report is a completely revised and updated version of Rapra Review Report 119 published in 2000. Since that time a number of important developments have taken place, notably the beginning of the harmonisation of the legislation within Europe with the issuing of the Council of Europe (CoE) Resolution on rubber in 2004, and the FSA has commissioned a number of fundamental studies at Rapra into the potential migrants that are present in rubber products (FSA contracts FS2248, A03038 and A03046).
Contents
1 Introduction 2 Rubber Materials and Products used in Contact with Food 2.1 Polymers Used in Food Contact Rubbers 2.1.1 Natural Rubber (i.e., cis-1,4-polyisoprene) 2.1.2 Nitrile Rubber 2.1.3 Ethylene-propylene Rubber 2.1.4 Fluorocarbon Rubber 2.1.5 Silicone Rubber 2.1.6 Thermoplastic Elastomers 2.1.7 Other Types of Rubbers 2.2 Additives Used in Food Contact Rubbers 2.2.1 Plasticisers/Process Oils and Fillers 2.2.2 Curatives and Antidegradants 2.2.3 Miscellaneous Additives 2.3 Rubber Products Used in the Food Industry and the Contact Conditions 2.3.1 Types of Rubber Product 2.3.2 Contact Areas 2.3.3 Contact Times 2.3.4 Contact Temperatures
3 Regulations Covering the Use of Rubber as a Food Contact Material 3.1 European Union Legislation 3.2 Council of Europe (CoE) Resolution on Rubber Products 3.2.1 Technical Documents 3.2.2 Product Categories 3.2.3 R Factors 3.2.4 Silicone Rubbers 3.3 Food and Drug Administration (FDA) in the USA 3.4 Bundesinstitut für Risikobewertung (BfR) German Regulations 3.4.1 Categories of Use 3.4.2 Silicone Rubbers 3.5 Other European legislation 3.5.1 Requirements in France 3.5.2 Requirements in the Netherlands 3.5.3 Requirements in Italy 3.5.4 Requirements in the United Kingdom
4 Assessing the Safety of Rubber as a Food Contact Material 4.1 Special Considerations When Using Rubber as a Food Contact Material 4.2 Migration Tests 4.2.1 Overall Migration Tests 4.2.1.1 FDA Regulations 4.2.1.2 BfR Regulations 4.2.1.3 CoE Resolution 4.2.2 Specific Migration Tests 4.3 Fingerprinting Potential Migrants from Rubber Compounds 4.3.1 Use of Gas Chromatography-Mass Spectrometry (GC-MS) to Fingerprint Food Contact Rubber Samples 4.3.1.1 Rubber Formulations 4.3.1.2 Experimental Conditions 4.3.2 Use of Liquid Chromatography-Mass Spectrometry (LC-MS) to Fingerprint Food Contact Rubber Samples 4.4 Determination of Specific Species in Rubbers and Migrants in Food Simulants and Food Products 4.4.1 Monomers 4.4.2 Plasticisers and Process Oils 4.4.3 Cure System Species, Accelerators and their Reaction Products 4.4.4 Antidegradants and their Reaction Products 4.4.5 Oligomers 4.5 Research Studies Carried out at Rapra for the FSA 4.5.1 FSA Project FS2219 – Migration Data on Food Contact Rubbers 4.5.1.1 Introduction 4.5.1.2 Standard Rubber Compounds 4.5.1.3 Migration Experiments Carried out on the Standard Rubber Compounds 4.5.1.4 Results of the Migration Experiments 4.5.2 FSA Project FS2248 – Further Migration Data on Food Contact Rubbers 4.5.2.1 Introduction 4.5.2.2 Standard Rubber Compounds 4.5.2.3 Tests Carried out on the Seven Rubber Compounds 4.5.2.4 Results Obtained During the Course of the Project 4.5.3 Project A03038 – Rubber Breakdown Products 4.5.3.1 Introduction 4.5.3.2 Listing of the Breakdown Products for the CoE Curatives and Antidegradants 4.5.3.3 Factors Affecting the Formation of the Breakdown Products 4.5.3.4 Fingerprinting of the Breakdown Products 4.5.3.5 Migration Behaviour of the Breakdown Products 4.5.3.6 Overall Summary of the Migration Data 4.5.3.7 Overall Conclusions 4.5.4 Project A03046 - Silicones 4.5.4.1 Introduction 4.5.4.2 Potential Migrants in Silicone Rubbers – Stage 1 of the Project 4.5.4.3 Data Obtained on Commercial Silicone Rubber Products – Stage 2 of the Project 4.5.4.4 Overall Summary of the Project Findings 4.6 Published Migration Data 4.6.1 Food Contact Products 4.6.1.1 Teats and Soothers 4.6.1.2 Meat Netting 4.6.1.3 Rubber Gloves for Handling Food 4.6.2 Specific Chemical Migrants from Rubber Compounds 4.6.2.1 Alkylphenol and Bisphenol A 4.6.2.2 Peroxide Breakdown Products 4.6.2.3 Dimethyl Siloxanes and Other Components from Silicone Rubbers 4.6.2.4 Accelerators and Antidegradants 4.6.3 General Surveys 4.6.4 Analytical Techniques
5 Improving the Safety of Rubber as a Food Contact Material 5.1 Nitrosamines 5.2 Amines 5.3 Polyaromatic Hydrocarbons 5.4 Use of Alternative Compounds
6 Future Trends in the Use of Rubber with Food 6.1 Increased Use of Thermoplastic Rubbers and High Performance Rubbers 6.2 Developments in Additives 6.3 Surface Coatings and Modifications 6.4 Developments in Analytical Techniques
7 Conclusion 7.1 Sources of Further Information and Advice 7.1.1 Professional, Research, Trade and Governmental Organisations 7.1.2 Commercial Abstract Databases 7.1.3 Key Reference Books and Journals 7.1.4 Food Standards Agency Research Projects
Appendix 1
References
Abbreviations and Acronyms
Abstracts from the Polymer Library Database Subject Index Company Index
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