Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater - Scientific guideline

Groundwater is a source of human drinking water and also provides a very unique ecosystem with vulnerable aquatic communities. This guideline provides a methodology for performing a risk assessment of residues of veterinary medicinal products (VMPs) in groundwater, serving both as a source of drinking water and as an ecosystem. It complements existing guidelines such as the Committee for Medicinal Products for Veterinary Use guideline on environmental impact assessment for veterinary medicines.

Keywords: Toxicology, groundwater communities

Current effective versionc

Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater

AdoptedReference Number: EMA/CVMP/ERA/103555/2015

Document history

Overview of comments on 'Guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater' (EMA/CVMP/ERA/103555/2015)

Reference Number: EMA/CVMP/ERA/609438/2017

Draft guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater

Consultation dates: 24/02/2017 to 31/08/2017Draft: consultation closedReference Number: EMA/CVMP/ERA/103555/2015Summary:

Groundwater is a source of human drinking water and also provides a very unique ecosystem with vulnerable aquatic communities. This guideline provides a methodology for performing a risk assessment of groundwater contamination by veterinary medicines for human health and aquatic ecosystems. It complements existing guidelines such as the Committee for Medicinal Products for Veterinary Use guideline on environmental impact assessment for veterinary medicines in support of the VICH guidelines 6 and 38.