Regulatory review of the environmental risk assessment of veterinary medicinal products in the European Union, with particular focus on the centralised authorisation procedure

Environmental Sciences Europe

Table 1 Outcome of environmental risk assessments (ERA) for centralised veterinary medicinal products (VMPs) since 1995

	Number of VMPs^a	Reason for ending at phase I
Total pharmaceutical VMPs	108
Products with Phase I only (103 products)	16	Treatment of individual animals
	3	Naturally occurring substance (such as electrolytes, peptides, proteins and vitamins that do not alter the natural concentrations in the environment)
	15	PEC < 100 µg/kg
	69	Use in companion animals only
Products with phase I and II (5 products)	1	PEC > 100 µg/kg
	2	Potential PBT
	1	High PEC_{surface water} and risk to dung fauna
	1	Risk to plants
Total immunological/biological VMPs	101
Products with a higher tier environmental risk assessment	1	Risk of vaccine spillage to wild population

^aData obtained from published European Public Assessment Reports (EPARs) for veterinary medicinal products (centrally) authorised by the European Medicines Agency, from October 2019