ABSTRACT

I n t ro d u c t i o n During the past 10 years, there has been a rapid expansion of the number of regulatory hurdles enacted, governing the ability to place new products on the market as foods and food ingredients. Previously, foods were grouped into categories of familiar foods commonly consumed and new food additives. Familiar foods were placed on the market after safety reviews; however, these reviews did not have as a basis the knowledge of nutritional biochemistry, physiology, and toxicology that we have today. In the United States, natural food components were evaluated as Generally Recognized As Safe (GRAS), and did not necessarily require premarket approval by the Food and Drug Administration (FDA), whereas chemical food additives required premarketing approval, often a lengthy and expensive process. With the development of globalized food markets and the use of modern biotechnology to produce foods, increasing regulatory controls have been introduced to evaluate the safety of new food materials not previously present in a nation’s food supply at the proposed use levels. The regulatory systems put in place have followed models enacted by the United States, Canada, The European Union, and Japan.