Table 2 Persistence testing requirements under the various European substance regulations
From: Proposal for a harmonised PBT identification across different regulatory frameworks
Test on ready biodegradability (OECD 301) | Laboratory degradation simulation test in soil (OECD 307) | Laboratory degradation simulation test in a water-sediment system (OECD 308) | Laboratory degradation simulation test in water (OECD 309) | Field degradation test | |
|---|---|---|---|---|---|
PPPs | Required | Required in four soils if not readily biodegradable | Required in two test systems if not readily biodegradable | Required if not readily biodegradable | Required if DegT50lab >60 days (20°C, pF2) |
Human medicinal products | Required | Required in four soils if not readily biodegradable and Koc > 10,000 L/kg | Required in two test systems if not readily biodegradable | Not required | Not required |
Veterinary medicinal products | Not required | Required in four soils | Required in two test systems for aquaculture or if risk is identified for aquatic organism | Not required | Not required |
Biocides | Required | Required in four soils if not readily biodegradable and/or depending on emission pathway | Required in two test systems if not readily biodegradable depending on substance properties and emission pathway | Required if not readily biodegradable depending on substance properties and emission pathway | Required if PEC/PNECsoils >1 and DegT50lab >60 days (20°C, pF2) or DegT90lab >200 days (20°C, pF2) |
Chemicals (REACH) | Required for all substances > 10 t/a | One simulation study in the ‘compartment of concern’ required for all substances >100 t/a if not readily biodegradable | Not required | ||