Division 6.1 Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organismsF1

An environmental risk assessment shall be performed to assess the potential harmful effects, which the use of the veterinary medicinal product may cause to the environment and to identify the risk of such effects. The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.

This assessment shall normally be conducted in two phases. The first phase of the assessment shall always be performed. The details of the assessment shall be provided in accordance with accepted guidance. It shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:

• the target animal species, and the proposed pattern of use,

• the method of administration, in particular the likely extent to which the product will enter directly into environmental systems,

• the possible excretion of the product, its active substances or relevant metabolites into the environment by treated animals; persistence in such excreta,

• the disposal of unused veterinary medicinal product or other waste product.

In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites in case of an identified risk, which has been obtained during the conduct of the other tests and trials required by this Directive, shall be taken into consideration.