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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
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BCH-LAW-EU-115260-1   |   PDF   |   Print   |  
last updated: 08 Nov 2019
Amendment
No
General Information
Guidance on the environmental risk assessment of genetically modified animals
EN
Legislative details
Guidelines
Regional / Multilateral
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.
EN
23 May 2013
Regulatory contact information