Materials, which are intended to come into contact with food are specifically regulated in many countries.
In Europe food contact materials (FCM) are regulated under a framework regulation of European community law. Specific migration limits exist for some compounds and a positive list compiles monomers and additives that are authorized for use in plastic packaging based on a toxicological evaluation. Also for other materials than plastics specific legislation exists. This is the case for ceramics (Directive 84/500/EEC) and specific epoxy resin derivatives (Regulation EC 1895/2005).
In the US, food contact substances are considered indirect food additives (21 C.F.R. Parts 174-186). Authorization for substances used in FCM can be acquired formally through petitions (21 CFR 174-178) and more recently a Food Contact Notification system, or be obtained through the publishing of studies showing a substance to be safe. As in Europe, authorities enforce regulations by limiting migration. Those limits are based on estimates of hazard and exposure of a certain chemical. While hazard is estimated using toxicological data in both Europe and the US, exposure is estimated differently. In Europe, authorities assume the worst case scenario being 1 kg of each food type packaged in 6 dm2 consumed per day. In the US exposure is modeled with actual data. Assumptions of how much of a certain food stuff is consumed daily (see Consumption Factor) and how it is packaged (i.e. aluminum, glass, PET, PP, PE, steel, etc.) determines the final exposure estimate. In Japan, formal regulation (Food Sanitation Act and food safety basic law) is complemented by voluntary industry programs. These voluntary industry programs also comprise a positive list including the European Union list for plastic packaging, the US additive list amongst others.
The legal situation regarding food contact materials in the three different regions is summarized in more detail in 3 separate articles:
- Food packaging regulation in Europe
- Food packaging regulation in the U.S.
- Food packaging regulation in Japan
Magnuson, B. et al. (2013) “Review of the regulation and safety assessment of food substances in various countries and jurisdictions.” Food Additives and Contaminants, Part A, 30(7):1147-1220.