Regulation of food contact materials in the USA

Twaroski, L. I. Batarseh and A. B. Bailey, United States Food and Drug Administration, USA 

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. 

The US Congress granted authority to the FDA to regulate food additives in the 1958 Food Additives Amendment to the FFDCA. A food additive is 

For the purpose of this chapter, the TD50 is the feeding dose that causes cancer in 50% of the test animals when corrected for tumors found in control animals. 

Bioassay herein describes a chronic feeding study for the assessment of the potential of a chemical to produce carcinogenic effects. 

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National agencies concerned with regulating the materials for contact with food and drugs plus para-medical uses have long recognised the basic suitability of silicone rubber for such applications. The permitted silicone polymer types, fillers and additives are listed, for example in F.D.A. 21 CFR 177.2600 (USA) and Bundesgesundheitsblatt XV.Ill (Germany). 

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