Objective Hazard assessment of gardenia yellow were performed based on the existing toxicological data. Hazard assessment of gardenia yellow were performed based on the existing toxicological data. Methods The systematic literature searches (SLS) was used to collect toxicological data. Then, the reference dose method was employed to calculate the key toxic effects according to the results of subchronic toxicity test. The systematic literature searches (SLS) was used to collect toxicological data. Then, the reference dose method was employed to calculate the key toxic effects according to the result of subchronic toxicity test.Results Crocin is the main components of gardenia yellow, and no special toxicity has been found, but its toxic target organs may be liver and kidney . Geniposide is the main toxic component and has obvious hepatorenal toxicity. The NOAEL of gardenia yellow is 0.5 g/kg BW. The BMDL₁₀ with nephrotoxicity as the key end point is calculated as 0.46 g/kg BW by reference dose method. Crocin are the main components of gardenia yellow, and no special toxicity has been found,but its toxic target organs may be liver and kidney. Geniposide is the main toxic component and has obvious hepatorenal toxicity. The NOAEL of gardenia yellow was 0.5 g/kg BW. The BMDL₁₀ with nephrotoxicity as the key end point was calculated as 0.46 g/kg BW by reference dose method . Conclusion Renal tubular epithelial cytopigmentation is the sensitive toxic effect of gardenia yellow. This study can provide a basis for further population intake risk assessment. Renal tubular epithelial cytopigmentation is the sensitive toxic effect of gardenia yellow. This study can provide a basis for further population intake risk assessment.