Objective This paper reviewed the studies on hydrolyzed milk proteins used in infant formula food, and provides suggestions for research and development, supervision and clinical application of hydrolysate formulas. MethodsRequirements in laws and regulations, clinical trial studies and related researches for hydrolyzed milk proteins and hydrolysate formulas were collected and analyzed. Results Regulations and standards for hydrolyzed milk proteins used in formula food for special medical purposes had been released in China; Codex Alimentarius Commission (CAC) and European Union also had regulations and standards for hydrolyzed milk proteins used in infant formula; The US had a large number of literatures and studies for hypoallergenic infant formulas. The requirements of China Taiwan were in accordance with CAC. The relevant regulations of Australia, New Zealand, Japan and other countries and regions had not been found. Conclusion Scientific institutions should pay attention to the basic research of hydrolyzed milk proteins and hydrolysate formulas. Administration department should improve the standards and regulations.