Abstract:All substances that may migrate from food contact materials (FCM) into foods need to be evaluated, including intentionally added substance (IAS), such as monomers, starting materials and additives, as well as non-intentionally added substances (NIAS), such as impurities, by-products and degradants produced during production process. The safety assessment of FCM can be mainly divided into pre-market safety evaluation and post-market monitoring evaluation. At present, there are mainly two approaches to do the pre-market safety evaluation, that is, the United States approach and the European Union approach. The two method have their own advantages and disadvantages. China has no basic parameters to do pre-market safety evaluation of FCM. Establishment of China FCM safety assessment system is an important project determined by National Expert Committee on Food Safety Risk Assessment. This paper describes the frame of FCM safety assessment system, its expected goals and the challenges of FCM risk assessment.