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...

Safety assessment of carcinogenic constituents of food additives

As stated above, identification of the best analog(s) is done on a case-by-case basis. From a pool of potential analogs with available data, the nearest analogs are generally considered the most appropriate. An exception might be to choose a less-near analog with high carcinogenic potency, to be more protective. For low proposed exposures when a rapid assessment would be adequate to demonstrate safety, FDA may summarily review the bioassay data for the analogs. In some cases, the CPDB is useful...

References

Framework Regulation EC 1935 2004, Official Journal of the European Union, Vol. 47, 13 November 2004 L338 4 . 2. Directive 2002 72 EC, Official Journal of the European Communities L220, 15 3. Plastics in Contact with Food - A Guide, British Plastics Federation, 2nd edition, June 1996. 4. Commission Directive 97 48 EC amending for the second time Council Directive 82 711 EEC laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended...

Use of functional barriers

Instead of using 'super-clean' recycling technologies which remove, or reduce substantially, the amount of post-consumer compounds and contaminants in the polymer down to similar levels to those in virgin polymers, so-called functional barrier packaging systems can also be efficiently applied to achieve the same effect. No or only negligibly low migration levels of any unwanted foreign compounds can be achieved. A functional barrier can be generally defined as a package construction that limits...

Sources of further information and advice

FDA webpage on indirect food additives at http vm.cfsan.fda.gov lrd foodadd.html Community Reference Laboratory for Food Contact Materials. Website at http crl-fcm.jrc.it Food Chemical Safety. Volume 1 Contaminants. D. H. Watson editor , Woodhead Publishing Ltd, Cambridge, UK and CRC Press, Boca Raton, USA, 2001. ISBN 1-85573-462-1. Migration from Food Contact Materials. L. L. Katan editor , Blackie Academic and Professional, Glasgow, UK, 1996. ISBN 0-7514-0237-0. Food Packaging Ensuring the...

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...

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...

Qualitative SAR analysis of food additives and constituents

Based on the available historical data, FDA considers carcinogenicity to be the pivotal endpoint of concern for consumer exposures below 150 mg p d, exposure levels typically encountered from food contact material uses. FDA's approach to qualitative SAR is to perform a preliminary 'first look' for structural alerts SAs and for close analogy to known carcinogens Bailey et al., 2005 . A useful tool for this type of analysis is the Ashby and Tennant 1991 classification scheme for SAs and a related...

Solutions of the diffusion equation

For interactions between packaging and product the above descriptions of both material transport processes by diffusion and convection as well as the simultaneous chemical reactions come into consideration. The general transport equation 8.6 is the starting point for solutions of all specific cases occurring in practice. Material loss through poorly sealed regions in the package can be considered as convection currents and or treated as diffusion in the gas phase. A solution of the general...

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...

Piringer And Baner 2000

Baner, A. l., 2000, Partition coefficients, in Piringer, O.-G. and Baner, A. L., Plastic Packaging Materials for Food, Wiley-VCH, Weinheim, New York. begley, t. h., 2000, Migration from food packaging Regulatory considerations for estimating exposure, in Piringer, O.-G. and Baner, A. L., Plastic Packaging Materials for Food, Wiley-VCH, Weinheim, New York. BEGLEY, T. H., CASTLE L., FEIGENBAUM A., FRANZ R., HINRICHS, K., LICKLY, T., MERCEA, P., MILANA, M., o'brian, a., rebre, s., rijk, r. and...