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National Node of the BCH
Law, Regulation or Guideline
Record information and status
Record ID
753
Status
Published
Date of creation
2003-09-11 15:59 UTC (Ryan.Hill@biodiv.org/43)
Date of last update
2010-05-10 13:54 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of publication
2010-05-10 13:54 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)

General Information
Country
  • European Union
Jurisdiction
  • European Union
Title of document
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Legislative details
Type of document
  • National Law
Subject areas
  • Competent National Authorities and National Focal Points
  • Confidential Information
  • Handling, transport, packaging and identification
  • Human and/or Animal Health
  • Illegal transboundary movements
  • Intentional introduction into the environment (AIA)
  • Public awareness and participation
  • Risk assessment and management
  • Transit
  • Unintentional transboundary movements and emergency measures
Types of LMOs addressed
  • All types of organisms
Brief description of the document including objective and scope:
Directive 2001/18/EC on the "deliberate release of GMOs into the environment" regulates the releases of GMOs into the environment, be it for experimental purposes (field trials) or for commercial purposes (placing on the market).

Directive 2001/18/EC provides for the Community procedure for granting consent for deliberate release of GMOs into the environment. Its key provisions include:

- The EU definition of a GMO (see article 2): a genetically modified organism (GMO) means an organism, with the exception of human beings, in which the genetically material has been altered in a way that does not occur naturally by mating and/or natural recombination.

- Common methodology and principles for environmental risk assessment (see Annex II) before any GMO release into the environment

- Mandatory labelling and traceability of GMOs at all stages of the placing on the market

- Mandatory post-market monitoring requirements, including on long-term effects associated with the interaction with other GMOs and the environment

- Approvals for the release of GMOs to be limited to a maximum of ten years (renewable)

- Mandatory information to the public, including public registers for recording information on deliberate release of GMOs into the environment
Date of entry into force
2001-04-17
Document details
Document text
EN
directive 2001-18-ec.pdf (224 KB)
DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Regulatory contact information
Contact person
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Brussels
Belgium, 1040
Phone:+32 2 2962362
Fax:+32 2 2964736
Email:chantal.bruetschy@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Additional Information
Other relevant website address or attached documents