Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the development of an approach for the environmental risk assessment of additives, products and substances used in animal feed
Directive 2001/79/EC highlighted the importance of assessing the environmental impact of feed additives since they are typically used over an extended period of time, potentially used for large numbers of animals and many additives are retained to a limited extent and hence released into the environment. Regulation (EC) No 1831/2003 establishes the requirement for an environmental risk assessment as part of the authorisation process. However, no methodology has been provided so far to calculate the predicted environmental concentrations in the different terrestrial and aquatic compartments (soil, groundwater, surface water and sediment). Exposure assessments conducted to date relied on the application of simple exposure models. EFSA has requested its FEEDAP Panel to develop a harmonised approach for environmental risk assessment of additives, products and substances used in animal feed reflecting in particular: (i) the common practice in which manure is stored and spread in Europe and the way feed additives leach to groundwater and drain or runoff from grassand arable land to surface water; (ii) the different European fish production systems including ponds, tanks and sea cages. This document provides an overview of the current agricultural and aquaculture practices in the EU and proposes how this information should be used in calculations to predict the concentrations of additives used in animal feed in terrestrial and aquatic target animals.