PBT evaluation
Environmental assessment for
environmentally relevant compound(s)
Risk assessment
PBT assessment
PBT screening
NO FURTHER
PBT
ASSESSMENT
NO FURTHER
RISK
ASSESSMENT
Decision tree
including PEC
sw
action limit
Tailored
assessment
strategies
Determine physico-chemical properties, fate and
ecotoxicity
(including data search and evaluation)
Trigger values
for groundwater, soil and secondary poisoning assessment
Tier A
Surface Water, Sediments and
Sewage Treatment Plant
Tier A
Groundwater
Tier A
Soil
Tier A
Secondary
poisoning
Tier A
Definitive PBT
assessment
No
Risk
Risk
evaluation
Tier B
Refinement options
Risk
evaluation
No
Risk
Labeling and
Risk mitigation
Not
PBT
Phase I
Phase II
Fig. 2
Flow chart of the environmental risk-assessment process prescribed by the European Medicines Agency (EMA) to be used in the registration of new
medicines (adapted from EMA guideline, [23])
16
N. Montemurro et al.