Regulation of Food Packaging in Europe and the USABy Derek J Knight and Lesley A Creighton, SafePharm Laboratories Ltd.
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A wide variety of plastics are used in food-contact applications and it is important that such plastics do not affect the food with which they come into contact. Given the obvious importance of producing safe and wholesome food, with adequate shelf life, it is not surprising that the food industry is heavily regulated. There is considerable public concern about the safety of food packaging, and one issue is the potential migration of compounding ingredients, monomers or additives from plastics into food. In general, food diffuses into plastic packaging, enhancing the migration of unreacted monomers and potentially mobile additives from the plastic into the food.
The objective of food packaging legislation is to protect the consumer by controlling the contamination of food by chemicals transferred from the packaging. Standard migration tests are available based on prescribed food simulants; these tests include overall migration testing and specific migration tests (for individual chemical species). The gradual development of lower detection limits for analytical methods has shown that many substances previously not considered as indirect food additives do actually migrate into food.
Food packaging regulations are constantly under revision, and differ significantly between Europe and the USA - even between countries within the EU, although there is a strong harmonising influence from the Council of Europe and the European Commission. The regulation of food-contact materials in the EU is currently in a state of development, with various aspects still subject to national provisions until the European Commission has completed the harmonisation process. The US regulatory system is complex, with various approval and certification schemes.
This Rapra Review Report provides a clearly written summary of the current legislation surrounding the use of plastics in contact with food. It will be of interest to those working to formulate food-contact plastics, food processors and testing laboratories, packaging manufacturers and users, together with organisations working to ensure safe conditions for food production.
This review is accompanied by around 400 abstracts compiled from the Polymer Library, to facilitate further reading on this subject. A subject index and a company index are included.
About the author
Derek J Knight is the Director of Regulatory Affairs at Safepharm Laboratories Ltd., a leading UK contract research organisation, specialising in safety assessments of chemicals, biocides, and agrochemical pesticides. He heads a team of regulatory affairs professionals who deal with a wide range of registration projects covering many product types for regulatory compliance in all the key markets globally. As such he has gained an overall perspective into commercial issues associated with the regulation of the chemical industry. He is a Fellow of the RSC and a Fellow of TOPRA. His doctoral studies at the University of Oxford were in organosulphur chemistry.
Lesley A Creighton has worked within SafePharm Laboratories for 13 years providing regulatory support to the chemical industry for the notification of new chemical substances, food contact materials and cosmetic products. She has a combined science degree in chemistry and mathematics and is a member of both the RSC and TOPRA.
1. INTRODUCTION AND OVERVIEW
2.1 Characteristics of Plastics
2.2 Applications in Packaging
2.2.1 Polymer Types
2.2.2 Combination Products
2. PLASTICS FOR USE IN PACKAGING
3. SAFETY EVALUATION OF FOOD PACKAGING
3.1 Exposure Assessment
3.1.1 Migration Evaluation
3.1.2 Estimation of Dietary Exposure
3.2 Toxicology Testing
3.3 Risk Assessment
4. CONTROL OF FOOD PACKAGING IN THE EU
4.1 General Principles and the Framework Directive
4.2 Food-Contact Plastics
4.2.1 The Plastics Directive
4.2.2 EU Lists of Substances for Plastics
4.2.3 Safety Assessment of Additives and Starting Substances for Food-Contact Plastics
4.2.4 Safety Assessment of Polymer Substances
4.3 Future Developments for Food Plastics in the EU
4.3.2 Proposed Introduction of a Revised Regulation to Council Directive 89/109/EC
4.3.3 The Plastics Super Directive
4.3.4 Active and Intelligent Packaging
4.4 Other EU Food Packaging Measures
4.4.1 Regenerated Cellulose Film
4.4.2 Ceramic Articles
4.4.3 Control of Vinyl Chloride from PVC
4.4.4 Control of N-nitrosamines from Teats and Soothers
4.4.5 Restrictions on Certain Epoxy Derivatives
4.5 Disposal and Recycling of Plastics
4.6 Strategy for Food-Contact Plastic Approval in the EU
5. NATIONAL CONTROLS ON FOOD PACKAGING IN EU COUNTRIES
5.4 The Netherlands
6. COUNCIL OF EUROPE WORK ON FOOD PACKAGING
6.2 Completed Council of Europe Resolutions
6.2.1 Colorants in Plastic Materials
6.2.2 Polymerisation Aids
6.2.3 Surface Coatings
6.2.4 Ion Exchange and Absorbent Resins
6.3 Council of Europe Ongoing Work
6.3.1 Paper and Board
6.3.2 Packaging Inks
6.3.4 Other Draft Resolutions and Guidelines and Future Developments
7. FOOD PACKAGING IN THE USA
7.2 Development of US Food Packaging Legislation
7.3 The Petition
7.4 Threshold of Regulation Process
7.5 The Pre-Marketing Notification Scheme
Abstracts from the Polymer Library Database
- Vol. 15, No. 5, Report 173, 2004