EMA: Guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine (Draft)

Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) are combinations of substance properties which give substances the potential to accumulate in remote environments which is difficult to reverse as cessation of emission will not immediately result in a reduction in chemical concentration due to long half-life. The aim of this guideline is to clarify an assessment strategy for identification of potential PBT veterinary medicines on the basis of the data available within a dossier.