The European Medicines Agency sets out guidelines for assessing toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater. This means that, when used appropriately and in accordance with the manufacturers’ label and instructions, animal medicines do not pose a major risk to the environment.
The EU regulatory process for animal medicines licencing is designed to assess environmental safety prior to medicine approval. A marketing authorisation application for a veterinary medicine must include data addressing the safety for the user, the animal, the consumer and the environment. As a part of the safety dossier, a veterinary medicine needs an environmental risk assessment (ERA) before it can be approved. This requirement has been in the veterinary medicines legislation since 1992 .
For any animal medicines where the risks to the environment are higher than the benefits of the product, it will be denied an authorisation for use.