Biotechnology-derived and novel foods: Safety approaches and regulations

INTRODUCTION \nIn the history of mankind, the attainment of quantities of food sufficient to ensure \na healthy and productive life has always been a major concern. Major milestones \nin society&s;s effort to ensure adequate food supplies have been the development of \nagricultural methods and the domestication of livestock in most parts of the \nworld. During the course of these developments, new food items have continuously been selected and introduced as part of the human diet, the assessment of \ntheir safety being a consequence of "trial and error." This holds true for edible \nplants (e.g. potatoes), food products of animal origin, and microorganisms (e.g. \nthose involved in the preparation of fermented foods). Seen in this context, the \ndietary inclusion of "novel" foods has been and still is a continuing process. The \naspect of novelty may easily be expanded to include biotechnology-derived food \nitems. Seen in a broader sense of selection and introduction of genetic variations, \nbiotechnology also has a long history of use in food production and processing. \nIn fact, traditional breeding and selection techniques have a long tradition in the \ndevelopment of new varieties of microbial, plant or animal origin for such uses. \nThe process of selective breeding, however, by crossing and selection, is slow \nand its possibilities are limited because of the limited genetic diversity of the parent organisms, and the results are often unpredictable. By way of contrast, the \n"novel" methods of biotechnology (genetic engineering; cell fusion) permit the \nintroduction of rapid and more precisely targeted genetic changes. The aspect of \nnovelty thus may apply to food items or ingredients that have not been used for \nhuman consumption before as well as to those that have been produced using \nnew breeding or processing methods (1). In fact, there is still a lack of consensus \non the definition of the term " novel food," although it generally covers both \nfoods made by new processing techniques, including those based on methods of molecular biology, and foods that have not been previously used for human consumption (which often is true only for a certain country or region) (1-4).