Tolcapone
Summary
Persistence. It cannot be excluded that tolcapone is persistent, due to lack of data.
Bioaccumulation. It cannot be excluded that tolcapone bioaccumulates, due to lack of data.
Toxicity. It cannot be excluded that tolcapone is toxic, due to lack of data.
Risk. Risk of environmental impact of tolcapone cannot be excluded, due to the lack of environmental toxicity data.
Environmental information is missing on fass.se for X (2026-01-16).
Detailed information
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
EMA’s scientific discussion
EMA’s scientific discussion for Tasmar (tolcapone), 2006‑01‑25.
"Although tolcapone is classified as harmful for the environment, the solubility of the compound would be sufficient to result in a rapid and high degree dilution yielding concentrations below levels that will cause adverse effects."
Author: Health and Medical Care Administration, Region Stockholm