Abstract
The world’s population has increased from 2.5 billion to 6.3 billion in the last 50 years and the population explosion threatens that another 3 billion people will inhabit the planet by 2100. Each night 800 million people go to bed hungry and about 842 million people suffer from malnutrition. It could be very difficult to improve nutritional deficiency exclusively by traditional breeding and better management of crops. Efforts are being made towards nutritional improvement of crops by using the tools of biotechnology by increasing the levels of essential nutrients .Adoption of biotechnology in agriculture has been the focus of controversy due to varied reasons, as questions have arisen regarding food and environmental safety. The food safety assessment requires the evaluation of safety of newly added DNA and the safety of their gene products and overall safety of balance of food. The concept of substantial equivalence has been accepted as the cornerstone of the health hazard assessment of genetically modified (GM) foods. The main safety issues for new varieties of crops include potential toxicity of the newly introduced protein(s), potential changes in allergencity, changes in nutrient composition, unintended effects giving rise to allergencity and toxicity besides the safety of antibiotic resistance marker encoded proteins associated with the trans-gene. Therefore evaluation of such interventions necessitates establishing “the reasonable likelihood of safety” and that new varieties are as safe as or safer than the crops produced through traditional methods.

Key words: Bio-fortification, Biotechnology, Food safety, Genetically modified, Substantial equivalence.