Regulation Food contact materials

This powerpoint presentation reviews food-contact regulations worldwide with reference to current systems for regulating food-contact materials. These include general safety requirements, licensing/registration, mandatory and voluntary positive lists, no objection letters, and combinations of the above and their applicability to various countries. 

Establishing a threshold policy for regulating food contact materials... 

Additional regulations that provide specific requirements for color additives in foods are found in other parts of the CFR. Labeling of food products is found at 21 CFR 101.22(k). Color additives are sometimes called artificial colors or artificial colorings [21 CFR 101.22(a) (4)]. From a regulatory standpoint, a colorant is a dye or pigment used in a food contact material such as a polymer that does not migrate to food. Such materials are regulated as food additives [21 CFR 178.3297(a)], not as color additives. ... 

Where specific Regulations are in force then the methods associated with the Regulations shall be accredited if the control laboratory wishes to offer enforcement of the Regulations to customers. Examples of these are methods of analysis for aflatoxins and methods of analysis for specific and overall migration for food contact materials. 

The data required for the risk assessment in relation to human health can be categorized as data on the identity of the substance, its physico-chemical and toxicological properties, and on exposure. The minimum data set required for a risk assessment depends on the chemical use category (industrial chemical, pesticide, biocide, food additive, food contact material, etc.), the regulation involved, and the goal of the risk assessment. This chapter will focus on the data used in the hazard assessment. 

These procedures can be used as a powerful tool for solving complex interaction problems between plastic materials and foods, drugs, chemicals and other environments in protecting consumer health, one of the principal aims of food contact materials and articles regulations. The methods, results and their evaluation presented in this chapter encompasses all material developed in the book s previous chapters. 

FDA also concluded that establishing a 0.5 pg/kg dietary concentration as the threshold of regulation is appropriate because it corresponds to a migration level that is above the measurement limit for many of the analytical methods used to quantify migrants from food-contact materials. Thus, decisions are usually made based on dietary concentrations that result from measurable migration into food or food-simulating solvents rather than on worst-case estimates of dietary concentration based on the detection limits of the methods used in the analysis. 

One of the principal aims of regulations for food contact materials and articles is the protection of consumer health. World-wide investigations over the last 20 years have demonstrated that interactions between polymers and foodstuffs occur under foreseeable physical processes (Chapter 11). Standardization of migration measurements is based on this knowledge. However, with regard to consumer safety it has to be pointed out that it is not possible to carry out all desirable tests. The reasons for this are the variety of substances to control and the necessary time and cost requirements to carry out the analysis (Chapter 10). 

Two acts are pertinent to any discussion regarding the regulation of food contact materials in the US. These are the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) and the National Environmental Policy Act (NEPA) of 1969. A brief discussion of the authority granted the Pood and Drug Administration (PDA) under each follows. 

Table 2.2 Regulatory options relevant to food contact materials with regard to the food additive petition (petition), food contact notification (FCN) and threshold of regulation (TOR) exemption processes...

Table 2.9 Claims of categorical exclusions applicable to food-contact materials Title 21, Parts 25, Section 32 of the Code of Federal Regulations (denoted as 21 CFR 25.32)...

The Community legislation comprises general mles applicable to all materials and articles laid down in the Framework Regulation and specific rules only applying to certain materials or certain substances. The two general principles on which legislation on food contact materials is based are the principles of inermess and safety of the material. A general overview is presented in Fig. 3.1. 

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