Division D ENVIRONMENTAL RISK ASSESSMENTF1

The purpose of the environmental risk assessment is to assess the potential harmful effects, which the use of the product may cause to the environment and to identify any precautionary measures, which may be necessary to reduce such risks.

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 established 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 the environmental system,

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

• the disposal of unused or waste product.

In the case of live vaccine strains which may be zoonotic, the risk to humans shall be assessed.

Where the conclusions of the first phase indicate potential exposure of the environment to the product, the applicant shall proceed to the second phase and evaluate the potential risk(s) that the veterinary medicinal product might pose to the environment. Where necessary, further investigations on the impact of the product (soil, water, air, aquatic systems, non-target organisms) shall be carried out.