Acceptable Intake (AI)

An intake level that poses negligble cancer risk, or for serious life threatening indications where risk and benefit are appropriately balanced

Acceptable Intake (AI) is defined in ICH M7 (R1) as, "An intake level that poses negligble cancer risk, or for serious life threatening indications where risk and benefit are appropriately balanced." An acceptable intake should be used when there is limited toxicological data available and is derived based on a threshold of toxicological concern (TTC). The AI is typically used when a health-based limit needs to be determined for a product but there is not enough data avaliable to create an acceptable daily exposure.