Control of food contact materials in the EU
The basic rule in the Community food legislation specifies that only safe food shall be placed on the market General Food Law14 Art. 14 . Consequently food contact materials shall not transfer their substance into the food in concentrations that can endanger human health Art. 3 Framework Regulation . The main players to ensure safety as regards food contact materials are the packaging industry, the food industry, competent authorities in the Member States, and the European Commission. 3.6.1 The...
Degradation products and impurities
Other substances may be present in food contact plastics that were not originally intended to be present in the finished material or article, but arise from reactions during polymerisation or processing. Or they may be present as Table 10.5 Substances commonly used in the manufacture of PET PEN Table 10.5 Substances commonly used in the manufacture of PET PEN T total migration of two or more moieties. T total migration of two or more moieties. impurities in one of the starting substances or...
Rubber materials and products used in contact with food
As part of a major MAFF-funded research project1 an extensive review of the food industry was carried out by consultants at Rapra Technology Ltd in order to obtain information on the types of rubber used in the food industry. The following sectors of the food industry were amongst those surveyed abattoir and meat processors confectionary producers and bakers food canning and the preserves industry breakfast cereal manufacturers A relatively large range of rubbers were found to be used in a wide...
Case study traceability of plastic materials for food contact
4.5.1 Types of food contact plastics and their components Plastics for food contact can be rather difficult to trace, owing to the large variety of components and the various processes used to obtain the final product. Considering the finished product that comes in contact with food, a first classification can be made as follows 1. Products composed of one type of plastic only. Examples are monolayer foils used, e.g., in packaging for bakery or in the form of bags for household application. It...
References and bibliography
barlow s, 2005 , Threshold of toxicological concern TTC a tool for assessing substances of unknown toxicity present in the diet, ILSI Monograph 2005. benfort d.j., tennant d.r., 1997 , Food chemical risk assessment. Tennant D.R., ed. Food Chemical Risk Analysis, Blackie Academic amp Professional Chapman amp Hall pp 21-56. bouma K., STAVENGA k., draaijer a., August 2003 , Domestic use of food packaging materials in the Netherlands. Report NDFCM 010 01. Available http www.vwa.nl castle l., 2004 ,...
Problems related to packaging inks
13.5.1 Unevaluated substances and degradation products Unfortunately, the inventory list included in the draft TD 1 to the CoE resolution on packaging inks is incomplete. It appears that many of the numerous substances used in inks for food packaging have not been properly evaluated as regards their toxicological properties. Industry should ensure that there is no detectable migration into food of these unevaluated substances. Very little is known about degradation of substances during...
Conventional experimental compliance testing
Conventional compliance testing of food contact materials simulates food contact by bringing food contact materials into contact with a food simulant using certain temperature and time conditions . It then determines what is migrating from the food contact material to the food by testing how much in total migrates overall migration . For some chemical components specific migration or residual content must be performed. Furthermore, additional experiments like sensory evaluation, purity of...
Special considerations of using metals as FCMs
As with all food packaging, the control of migration, regulatory compliance and safety of the finished product is a combination of the intrinsic properties of the packaging and its appropriate use. In some cases, the use of the wrong specification for a particular food product or process may render a potentially compliant package non-compliant. This potential issue is not restricted to the control of migration. As already discussed, the safety of the foodstuff as consumed must also take into...
Regulation and the use of rubber as a food contact material
At the moment there is no specific EU legislation for rubber food contact materials or articles other than nitrosamines in babies' dummies .3 All such materials or articles need to comply with the general Framework Directive 89 109 EEC so that in normal use they will not transfer their constituents to food in quantities that could endanger health or cause unacceptable changes in the composition of food or deterioration in its organoleptic properties i.e. taste, texture, aroma, or appearance ....
Administrative compliance evaluation
The principle of administrative evaluation is simple information is requested on how the food contact material is produced this information is compared with relevant legislation and relevant tests are selected. The reality is far from simple. As can be seen from Fig. 5.1 the person who brings the food contact material in contact with the food can be many steps remote from the person who knows the exact composition of the food contact material. In the example in Fig. 5.1 a common situation is...
Food contact notifications 241 Administrative overview
FDA has several options following receipt of an FCN, all linked to the internal review processes. The FDA uses a two-phase approach in the administrative and technical review of FCNs. Phase 1 review, conducted during the first three weeks of initial receipt of the FCN, consists of an administrative review to ensure that the basic data and informational elements are present and that the submission meets the requirements set forth in the applicable statute and regulations. During this process,...
Future trends and requirements for screening and analysis of migrants
Despite the limitations of the current analytical techniques and the scheme shown in Fig. 5.4, the field of analytical chemistry is improving day by day and some new promising techniques and approaches may result in a major improvement in the screening of migrants. However, the whole idea behind the screening of migrants, especially those unintentionally added and not Table 5.7 Overview of literature dealing with screening of migrants Table 5.7 Overview of literature dealing with screening of...
Possibilities and limitations of migration modelling
Migration modelling is already allowed to be used as an additional tool for verification of compliance with the specific migration limits, as shown in the European Commission Directive 2002 72 EC. Detailed instructions, together with limitations of the applicability, are given in the European Commission Practical Guide 2004 . For practical applications of modelling specifically tailored and user-friendly computer programs are available on the market MIGRATEST Lite FABES GmbH, Munich, Germany...
Quantitative SAR QSAR analysis in the safety assessment of constituents
If the available genetic toxicity data, or the qualitative SAR analysis, indicate potential concern for the carcinogenicity of a constituent, QSAR may be a feasible approach to safety assessment by estimating a worst-case LCR Bailey et al., 2005 . Analog identification is an empirical case-by-case process that uses overlapping approaches to identify structurally and physicochemically related groups of analogs. Historically, analogs have been identified by experience and searching of the...
Carbon Black
- toluene extractable maximum 0.1 , determined according to ISO method 6209 - UV absorption of cyclohexane extract at 386 nm lt 0.02 AU for a 1 cm cell or lt 0.1 AU for a 5 cm cell, determined according to German BfR, BIII, Reinheitspr fung von Ru en, Stand 1.7.1972 - benzo a pyrene content max 0.25 mg kg Carbon Black. Compliance testing of the end product cannot be performed because the ingredients are not present. The company that uses a material with restrictions has to have data that the...
Properties and composition of plastic FCMs
Plastics can be placed into two main categories, thermoplastic and thermoset. Thermoset plastics are irreversibly formed into a permanent shape often by applying heat. Thermosets cannot be softened and remoulded on heating and have few applications in food packaging, except for the inner linings used for can coatings and many adhesives, as used, for example, in multilayer materials. A limited range of food contact materials is made from thermosets, predominantly melamine resins and unsaturated...
Regulation and use of metals as food contact materials
In general, the existing regulation of metal packaging covers the metallic and non-metallic components of the package separately. In the EU, where there is currently no harmonised specific regulation of metal foodstuff packaging, all components are covered primarily by the Framework Regulation 1935 2004 but it is expected that when harmonised legislation is extended to metal foodstuff packaging, metallic and non-metallic components will be treated separately. In the absence of harmonised EU...
Contributor contact details
Dr Karen Barnes and Mr Richard Sinclair Dr David Watson 14 Southview Road Southwick, Dr Michelle Twaroski , Dr Layla Batarseh and Dr Allan Bailey Office of Food Additive Safety HFS-275 Center for Food Safety and Applied Nutrition michelle.twaroski fda.hhs.gov Allan.Bailey fda.hhs.gov layla.batarshe fda.hhs.gov Dr Annette Sch fer European Commission Health and Consumer Protection Directorate E-mail annette.Schaefer ec.europa.eu The European Plastics Converters Association EuPC Avenue de...
Sources of further information and advice Bck
Regulation and safety assessment of FCM is a rapidly evolving area, particularly within the EU. This is even more the situation with metal foodstuff packaging as the need for harmonised comprehensive legislation intensifies. It seems probable that such harmonised legislation will be developed imminently with industry's support. The most effective way to maintain awareness both of the current legislative position and also likely future developments regarding metal foodstuff packaging is through...
Testing plastics materials for compliance with EU directives
EU legislation covering plastics food contact materials is well advanced with a positive list for monomers complete and a positive list for additives near completion. Decisions on how other substances used in plastics, such as aids to polymerisation and colourants are to be regulated, if at all, have yet to be made. Plastics used in contact with food must comply with the Framework Regulation,1 which lays down the basic rules Materials and articles in contact with food shall be manufactured in...
Carcinogenicity risk assessment for constituents of food additives
As discussed above, the Delaney clause applies to substances proposed for use as food additives, but does not apply to individual constituents of a food additive. Examples of constituents would include residual monomers or catalysts. The constituents policy, subjected to judicial review in Scott v. FDA, 728 F. 2d 322 6th cir. 1984 , states that FDA may consider the potential risks of constituent exposure under the general safety standards set forth in FFDCA. The notification process places the...
References Ggw
1. k. fritsch, f. welle Polyethylene terephthalate PET for packaging, Plast Europe, 2002, 92 10 , 40-41. 2. f. welle, Develop, a food grade HDPE recycling process, The Waste and Resources Action Programme WRAP , ISBN 1-84405-225-7, 2005, Internet http ww w. wrap. org. publication 2332. 3. l. incarnato, p. sarfato, d. acierno, m. r. milana, r. feliciani, Influence of recycling and contamination on structure and transport properties of polypropylene, Journal of Applied Polymer Science, 2003, 89,...
References and further reading
76 893 EEC O.J. n L340, of 09.12.1976 78 142 EEC O.J. n L44, of 15.02.1978, p. 15 80 590 EEC O.J. n L151, of 19.06.1980, p. 21 80 766 EEC O.J. n L213, of 16.08.1980, p. 42 81 432 EEC O.J. n L167, of 24.06.1981, p. 6 82 711 EEC O.J. n L297, of 23.10.1982, p. 26 83 229 EEC O.J. n L123, of 11.05.1983, p. 31 84 500 EEC O.J. n L277, of 20.10.1984, p. 12 85 572 EEC O.J. n L372, of 31.12.1985, p. 14 86 388 EEC O.J. n L228, of 14.08.1986, p. 32 89 109 EEC O.J. n L40, of 11.02.1989, p. 38 90 128 EEC...
Industrial guidelines for traceability of materials and articles for food
4.3.1 Objectives and contributors to the guidelines As already highlighted in the previous section, the associations representing the food contact materials and articles industries have been requested by the Commission to develop guidelines that would help the industry to harmonise the procedures adopted to achieve the objective set forth by Article 17 of Regulation 1935 2004 EC. These Guidelines have been prepared by a team representing virtually all the food contact materials industries the...
Key scientific advances achieved and needed
In outlining recent key scientific advances, it is in fact sobering to realise just how slow and hard-won some scientific advances have been. Looking back more than 25 years ago to a seminal meeting, the papers presented at the International Symposium on Migration held in Hamburg in 1980 are listed in Table 1.2. The chapters of this book reveal that many of the topics Table 1.2 Topics covered in the 1980 Hamburg symposium The diffusion mechanism of migration of low molecular weight Mathematical...