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Law, Regulation or Guideline
Record information and status
Record ID
Date of creation
2019-11-08 15:14 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2019-11-08 15:14 UTC (chantal.bruetschy@ec.europa.eu)

General Information
  • European Union
  • European Union
Title of document
Guidance on the environmental risk assessment of genetically modified animals
Legislative details
Type of document
  • National Guideline
Subject areas
  • Risk assessment and management
Types of LMOs addressed
Brief description of the document including objective and scope:
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.
Date of entry into force
Document details
Document text
Guidance on the environmental risk assessment of genetically modified animals
Regulatory contact information
Contact person
European Food Safety Authority (EFSA) GMO Panel
Via Carlo Magno 1A
Italy, 43126
Phone:+39 0521 036 666
Url:European Food Safety Authority (EFSA)