Regorafenib
Summary
Risk. Regorafenib possesses particularly hazardous properties from an environmental perspective. According to EU established criteria, regorafenib is considered a PBT/vPvB substance. The toxicity of aquatic organisms is very high, the substance is capable of bioaccumulation and degradation is slowly in the environment.
This summary information comes from assessment report and fass.se.
Detailed information
Assessment report
Assessment report for Stivarga (regorafenib) 4 July 2017, EMA/467788/2017.
Hazard
Persistence: DT50water = <1 day, DT50system = >> 100 days at 22–24 degrees Celsius and DT50soil = 181 days at 20 +/- 2 degrees Celsius.
Bioaccumulation: BCF = 3 241 L/kg.
Chronic toxicity: There is NOEC for three trophic levels, lowest NOEC for fish 0.007 microg/L.
"PBT-statement: regorafenib is considered PBT, not vPvB."
Fass environmental information
Fass environmental information for Stivarga from Bayer (retrieved on 2026-07-07).
PEC/PNEC is based on sales data in Sweden in 2024. PEC/PNEC = 0.176.
Regorafenib meets the EU criteria for classification as a PBT/vPvB substance. The substance is persistent (half-life in freshwater sediment >120 days), bioaccumulative (BCF 2,211–3,418), and highly toxic to aquatic organisms (chronic NOEC 0.007 µg/L).
Author: Health and Medical Care Administration, Region Stockholm