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GMO guidance document - New chapter on general surveillance of unanticipated adverse effects of the GM plant
Bruxelles, Belgium
December 20, 2005

Source: European Food Safety Authority

GMO guidance document: new chapter on general surveillance of unanticipated adverse effects of the GM plant

Adopted on 7 December 2005

New chapter 11.4 : General Surveillance of unanticipated adverse effects of the GM Plant

The EFSA Guidancedocument of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed has been updated with a new version of chapter 11.4 on General Surveillance as part of the post market environmental monitoring.

The new version of chapter 11.4 has been adopted by the GMO Panel on 7 December 2005 and provides further guidance to applicants on the preparation and presentation of general surveillance plans as part of the post market environmental monitoring plan.

The EFSA GMO Panel considers that:

  • General Surveillance is always required in the environmental monitoring plan,
  • General Surveillance should not be hypothesis driven,
  • General Surveillance should make use of existing monitoring systems, when possible, and complement them with more focused monitoring systems (e.g. farm questionnaires),
  • Comparison should be made with baseline data,
  • Data quality, management and statistically analysis are of high importance in the design of General Surveillance plans.

EFSA held 7 working meetings, 3 consultation workshops with experts from industry, environmental groups and Member States (see minutes meetings) and one written public consultation (from 15 July to 30 September 2005).

See also: EFSA Guidance document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed

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