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    The application of modern biotechnology in food production presents new opportunities and challenges for human health and development. Use of advanced genetic engineering techniques in food crops production, and transferring genetic material from one species to another has developed the genetically modified (GM) food. The development of GM organisms (GMOs) offers the potential for increased field-crop production, reduced agricultural chemical usage, and improved crop sustainability and food security, particularly in developing countries. On the other hand, application of genetic engineering techniques could be lead to improve nutritional value and enhanced production of functional foods. Increasing global biotech crop area from 2 millionth hectares in 1996 to more than 100 millionth hectares in 2006 indicates the continuous development in the first decade of their cultivation. It is expected that stellar growth in biotech crops, witnessed in the first decade of commercialization, 1996 to 2005, will continue and probably be surpassed in the second decade 2006-2015. Despite the potential benefits of genetic engineering of foods, the technology is surrounded by controversy. Many concerns and risks of GMO related to human health and environment are allergy, extension of antibiotic resistance genes, horizontal gene transfer, and effect on biodiversity. During the two last decades, several international committees have instituted guidelines and legislations for risk assessment of GM foods. One of them is the Cartagena Protocol on Biosafety which covers environmental safety of GMOs. According to the regulations, safety assessment relies on establishing that the food is substantially equivalent to its non-GM counterpart and specific testing for allergenicity of proteins and toxicity of metabolites and the whole food. Regarding to significance of biotechnology in permanent development, Islamic republic of Iran approved the Cartagena Protocol in 2001 and officially has been obligated to accomplish it from the beginning of 2004. Therefore, government established the national biosafety council, but the related regulation has not been approved yet. As a result, there is not any legal control on the genetically modified food imports at the moment in our country. So, it is necessary to pass the related regulation as soon as possible. Otherwise, the country will encounter heavy losses.

Keywords: Key words: Genetically modified food, Safety, Assessment

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