PBT Criteria (PFAS Context)

PBT stands for Persistent, Bioaccumulative, and Toxic—three hazard properties that, when a substance meets all three criteria, trigger the highest level of regulatory concern. Under REACH Annex XIII, PBT criteria include specific half-life thresholds for persistence, bioconcentration factors, and toxicity endpoints. Many PFAS meet PBT or the related vPvB (very Persistent, very Bioaccumulative) criteria, which is the primary basis for their SVHC identification under REACH.

REACH Regulation (EC) No 1907/2006, Annex XIII; ECHA PBT/vPvB Assessment Guidance; TSCA PBT regulations.

PBT classification is significant because REACH treats PBT/vPvB substances as having no safe threshold of exposure. This justifies the most restrictive regulatory action: SVHC identification, authorization, or restriction. For PFAS, the persistence criterion is virtually automatic (C–F bonds do not break down). RAC’s March 2026 opinion confirmed group-wide concern based on persistence alone, supporting a group-wide approach rather than substance-by-substance PBT assessment.

A chemical registrant submits a REACH registration dossier for a novel PFAS surfactant. ECHA’s PBT assessment identifies: persistence (half-life >180 days in soil), bioconcentration (BCF >5,000 in fish), and chronic toxicity (NOEC <0.001 mg/L). The substance meets all PBT criteria and is fast-tracked for SVHC identification.