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National BCH > Record details
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)
Date of last update
2019-09-24 09:46 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2019-09-24 09:46 UTC (chantal.bruetschy@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
  • 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
Unofficial documents
EN
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1569318299361&uri=CELEX:02001L0018-20190726
Latest consolidated version of Directive 2001/18/EC This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
This record has been amended by the following record(s):
DIRECTIVE 2008/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission
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
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
Competent National Authorities and National Focal Points
Confidential Information
Handling, transport, packaging and identification
Human and/or Animal Health
Illegal transboundary movements
LMOs for direct use as feed
LMOs for direct use as food
LMOs for processing
Public awareness and participation
Risk assessment and management
Transboundary movement (import/export)
Unintentional transboundary movements and emergency measures
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
Handling, transport, packaging and identification
Illegal transboundary movements
Information Sharing
Intentional introduction into the environment (AIA)
LMOs for direct use as feed
LMOs for direct use as food
LMOs for processing
Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory
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
Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms
Competent National Authorities and National Focal Points
Handling, transport, packaging and identification
Human and/or Animal Health
Intentional introduction into the environment (AIA)
Risk assessment and management
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC
Competent National Authorities and National Focal Points
Confidential Information
Information Sharing
Public awareness and participation
Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union
Risk assessment and management
Regulatory contact information
Contact person
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Brussels
Belgium, 1040
Phone:+32 2 29 20485
Email:anastasia.pagida@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Additional Information
Other relevant website address or attached documents
Convention on Biological Diversity | Central Portal of the Biosafety Clearing-House