This document provides guidance for the environmental risk
assessment (ERA) of living genetically modified (GM) animals,
namely fish, insects and mammals and birds, to be placed on the
European Union (EU) market in accordance with Regulation (EC) No
1829/2003 or Directive 2001/18/EC. It provides guidance for
assessing potential effects of GM animals on animal and human
health and the environment and the rationales for data requirements
for a comprehensive ERA.This document provides guidance also on the
ERA of any accidental or unintentional release of these GM animals
into the environment, after placing on the market.
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