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Record information and status
Record ID
Date of creation
2011-01-11 08:56 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of last update
2011-12-06 20:08 UTC (manoela.miranda@cbd.int)
Date of publication
2011-12-06 20:08 UTC (manoela.miranda@cbd.int)

General Information
Guidance on the envrionmental risk assessment of genetically modified plants
EFSA Panel on Genetically Modified Organisms (GMO)
Organization(s) involved in the publication of this resource
European Food Safety Authority (EFSA)
Largo N. Palli 5/A
Italy, I-43100
Phone:+39 0521 036111
Fax:+39 0521 036110
Url:EFSA website
  • English
Publication date
Summary, abstract or table of contents
This document provides guidance for the environmental risk assessment(ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs).
This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with (1) problem formulation including hazard identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation.
The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA
(1) persistence and invasiveness of the GM plant , or its compatible relatives, including plant-to-plant gene transfer
(2) plant-to-micro-organism gene transfer
(3) interaction of the GM plant with target organisms
(4) interaction of the GM plant with non target organisms, including criteria for selection of appropriate species and relevant functional groups for risk assessment
(5) impact of the specific cultivation, management and harvesting techniques, including consideration of the production systems and the receiving environment(s)
(6) effects on biogeochemical processes
(7) effects on human and animal health.
Each specific area of concern is considered in a structured and systematic way following the above-mentioned steps (1 to 6). In addition, the guidance document is supplemented with several general cross-cutting considerations (e.g. choice of comparator, receiving environment(s), general statistical principles, long-term effects) that need to be considered in the ERA.
Thematic areas
  • LMO use and transboundary movement
    • LMOs for introduction into the environment (Environmental releases)
  • Scientific and technical issues
    • Risk assessment
Additional Information
Type of resource
  • Report / Review / Fact sheet / Notes
Publisher and its location
EFSA Panel on Genetically Modified Organisms (GMO); Guidance on the environmental risk assessment of genetically modified plants. EFSA Journal 2010;8(11):1879. [111 pp.]. doi:10.2903/j.efsa.2010.1879. Available online:
Keywords and any other relevant information
GM plant, GMO, guidance document, environmental risk assessment, environmental safety, import, processing, cultivation, Regulation (EC) No. 1829/2003, Directive 2001/18/EC.