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Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

Country/Territory
European Union
Document type
Legislation
Date
2001 (2018)
Source
FAO, FAOLEX
Original source
Official Journal L 106, 17 April 2001, pp. 1–39
Subject
Livestock, Environment gen., Cultivated plants
Keyword
Genetically modified organism (GMO) PIC-prior informed consent Data collection/reporting Access-to-information Precautionary principle Biotechnology
Geographical area
European Union Countries
Entry into force notes
This Directive came into force on 17 April 2001.
Abstract

In the light of the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when: (a) carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community; (b) placing on the market genetically modified organisms as or in products within the Community. With a view to precisely defining the application scope of the present provisions, article 2 lays down several definitions. In particular, "genetically modified organism" (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination. Moreover, "deliberate release" means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment. The Directive shall not apply neither to organisms obtained through the techniques of genetic modification listed in Annex I B nor to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air.

Full text
English
Website
europa.eu

References - Legislation

Repeals

Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms.

Legislation | European Union | 1990

Keyword: Genetically modified organism (GMO), Pollution control, Authorization/permit, Access-to-information, Inspection, Research

Source: FAO, FAOLEX

Implemented by

Environment and Genetic Engineering Act (No. 811 of 2007).

Legislation | Denmark | 2002

Keyword: GMO, Basic legislation, Protection of habitats, Internal trade, Authorization/permit, Research

Source: FAO, FAOLEX

Decree implementing the Act on biotechnologies and genetically modified organisms.

Legislation | Slovakia | 2005

Keyword: Genetically modified organism (GMO), Authorization/permit, Biotechnology, Access-to-information

Source: FAO, FAOLEX

Décret n° 2009-45 relatif à l'étiquetage des organismes génétiquement modifiés mis à disposition de tiers à l'occasion d'une utilisation confinée et modifiant le code de l'environnement (partie réglementaire).

Legislation | France | 2009

Keyword: Genetically modified organism (GMO), Packaging/labelling, Biotechnology

Source: FAO, FAOLEX

Act no. 78/2004 on genetically modified organisms and genetic products.

Legislation | Czechia | 2004

Keyword: Basic legislation, Genetically modified organism (GMO), PIC-prior informed consent, Biotechnology, Internal trade, Offences/penalties, International trade

Source: FAO, FAOLEX

Décret n° 2007-358 relatif à la dissémination volontaire à toute autre fin que la mise sur le marché de produits composés en tout ou partie d'organismes génétiquement modifiés.

Legislation | France | 2007

Keyword: Data collection/reporting, Access-to-information, Genetically modified organism (GMO), Animal feed/feedstuffs, Biotechnology

Source: FAO, FAOLEX

Decree on treatment of genetically modified organisms and genetic products.

Legislation | Czechia | 2004

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Internal trade, Early warning system

Source: FAO, FAOLEX

Decree on the cultivation of genetically modified varieties.

Legislation | Czechia | 2006

Keyword: Genetically modified organism (GMO), Crops/grasses, Data collection/reporting, Biotechnology

Source: FAO, FAOLEX

Ministerial Decree No. 88740/1883 establishing measures and terms for the deliberate release into the environment of genetically modified organisms.

Legislation | Greece | 1995

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle

Source: FAO, FAOLEX

Release into Environment of Genetically Modified Organisms Act (2004)

Legislation | Estonia | 2004 (2019)

Keyword: Genetically modified organism (GMO), Authorization/permit, Monitoring, Internal trade, International trade, Public health, Consumer protection, Biosecurity, Crops/grasses, Biotechnology

Source: FAO, FAOLEX

Decree amending and supplementing the Decree implementing the Act on biotechnologies and genetically modified organisms.

Legislation | Slovakia | 2008

Keyword: Genetically modified organism (GMO), Residues, Environmental standards, Registration, Standards, Protection of environment

Source: FAO, FAOLEX

Décret relatif à la coexistence des cultures génétiquement modifiées avec les cultures conventionnelles et les cultures biologiques (1).

Legislation | Belgium | 2008

Keyword: Genetically modified organism (GMO), Data collection/reporting, Access-to-information, Precautionary principle, Research, EIA, Pollution control, Offences/penalties

Source: FAO, FAOLEX

Ministerial Decree No. 38639/2017 establishing measures and terms for the deliberate release into the environment of genetically modified organisms, in compliance with Council Directive 2001/18/EC.

Legislation | Greece | 2005

Keyword: Genetically modified organism (GMO), Data collection/reporting, Access-to-information, Precautionary principle

Source: FAO, FAOLEX

Environment and Gene Technology Act (No. 9 of 2017).

Legislation | Denmark | 1991 (2017)

Keyword: Basic legislation, Genetically modified organism (GMO), Protection of habitats, Internal trade, Inspection, Research, Waste management, Pollution control

Source: FAO, FAOLEX

European Communities (Seed Potatoes) Regulations 2011 (S.I. No. 532 of 2011).

Legislation | Ireland | 2011

Keyword: Planting material/seeds, Certification, Internal trade, Plant production, Classification/declassification, Packaging/labelling, Vegetables/legumes, Genetically modified organism (GMO), Plant protection, Plant variety, Inspection, Biotechnology

Source: FAO, FAOLEX

Regional Act No. 5 on the use of Genetically Modified Organisms in agriculture.

Legislation | Italy | 2011

Keyword: Genetically modified organism (GMO), Offences/penalties

Source: FAO, FAOLEX

Decree No. 209 of 2004 to amend the Decree Genetically Modified Organisms Based on the Act Concerning Environmentally Harmful Substances containing rules relative to deliberate introduction of genetically modified organisms in the environment (Implementation Directive No. 2001/18).

Legislation | Netherlands | 2004

Keyword: Genetically modified organism (GMO), EIA, Authorization/permit, Monitoring, Hazardous substances, Packaging/labelling, International trade, Biodiversity

Source: FAO, FAOLEX

Decree-Law No. 72/2003 regulating the GMOs deliberate release into the environment.

Legislation | Portugal | 2003

Keyword: Genetically modified organism (GMO), Data collection/reporting, Access-to-information, Biotechnology, Internal trade

Source: FAO, FAOLEX

Regional Act No. 25 making provision on genetically modified organisms.

Legislation | Italy | 2004

Keyword: Genetically modified organism (GMO), Precautionary principle, Research, Offences/penalties, Biotechnology

Source: FAO, FAOLEX

Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (S.S.I. No. 541 of 2002).

Legislation | United Kingdom | 2002

Keyword: Ecosystem preservation, EIA, Pollution control, Genetically modified organism (GMO), Biotechnology, Plant production

Source: FAO, FAOLEX

Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 (S.I. No. 3188 (W.304)).

Legislation | United Kingdom | 2002

Keyword: Ecosystem preservation, EIA, Pollution control, Genetically modified organism (GMO), Biotechnology, Plant production, Biosafety, Biosecurity

Source: FAO, FAOLEX

Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. No. 2443 of 2002).

Legislation | United Kingdom | 2002

Keyword: Ecosystem preservation, EIA, Pollution control, Genetically modified organism (GMO), Biotechnology, Biosafety, Plant production

Source: FAO, FAOLEX

Genetically Modified Organisms (Deliberate Release) Regulations 2003 (S.I. No. 500 of 2003).

Legislation | Ireland | 2003

Keyword: Ecosystem preservation, EIA, Pollution control, Genetically modified organism (GMO), Institution, Biotechnology, Plant production, Biosafety

Source: FAO, FAOLEX

Commission Decision 2003/701/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market.

Legislation | European Union | 2003

Keyword: Genetically modified organism (GMO), Data collection/reporting

Source: FAO, FAOLEX

Commission Decision 2004/204/EC laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council.

Legislation | European Union | 2004

Keyword: Genetically modified organism (GMO), Data collection/reporting, Access-to-information

Source: FAO, FAOLEX

Decree-Law No. 72/2003 on the deliberate release of genetically modified organisms (GMOs).

Legislation | Portugal | 2003

Keyword: Genetically modified organism (GMO), Precautionary principle, Protection of habitats

Source: FAO, FAOLEX

Forest Reproductive Material Regulations, 2004 (L.N. 273 of 2004).

Legislation | Malta | 2004

Keyword: Certification, Internal trade, Genetically modified organism (GMO), Biotechnology, Registration, Inspection, Genetic resources, Planting material/seeds

Source: FAO, FAOLEX

Commission Decision 2004/643/EC concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance.

Legislation | European Union | 2004

Keyword: Genetically modified organism (GMO)

Source: FAO, FAOLEX

Règlement grand-ducal déterminant les principes applicables à l’évaluation des effets néfastes potentiels sur la santé humaine et l’environnement lors des demandes d’autorisation de projets de dissémination volontaire et celles de projets de mise sur le marché d’organismes génétiquement modifiés.

Legislation | Luxembourg | 2004

Keyword: Pollution control, Hazardous substances, Authorization/permit, Internal trade, Genetically modified organism (GMO), Biotechnology

Source: FAO, FAOLEX

Règlement grand-ducal déterminant les lignes directrices pour l’établissement des rapports d’évaluation en matière de demandes de mise sur le marché d’organismes génétiquement modifiés.

Legislation | Luxembourg | 2004

Keyword: Genetically modified organism (GMO), Inspection, Internal trade, Biotechnology

Source: FAO, FAOLEX

Règlement grand-ducal déterminant les exigences en matière de surveillance des organismes génétiquement modifiés ayant fait l’objet d’une autorisation.

Legislation | Luxembourg | 2004

Keyword: Genetically modified organism (GMO), Authorization/permit, Inspection, Biotechnology

Source: FAO, FAOLEX

Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003 (S.R. No. 176 of 2003).

Legislation | United Kingdom | 2003

Keyword: Ecosystem preservation, EIA, Pollution control, Genetically modified organism (GMO), Biotechnology, Plant production

Source: FAO, FAOLEX

Arrêté royal réglementant la dissémination volontaire dans l'environnement ainsi que la mise sur le marché d'organismes génétiquement modifiés ou de produits en contenant.

Legislation | Belgium | 2005

Keyword: Pollution control, Genetically modified organism (GMO), Inspection, Research, Access-to-information, Animal feed/feedstuffs, Drugs, Animal health

Source: FAO, FAOLEX

Legislative Decree No. 224 implementing Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

Legislation | Italy | 2003

Keyword: EIA, Genetically modified organism (GMO), Data collection/reporting, Access-to-information, Institution, Public participation

Source: FAO, FAOLEX

Commission Decision 2009/770/EC establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council.

Legislation | European Union | 2009

Keyword: Genetically modified organism (GMO), Data collection/reporting, Precautionary principle

Source: FAO, FAOLEX

European Communities (Seed Potatoes) Regulations 2010 (S.I. No. 492 of 2010).

Legislation | Ireland | 2010

Keyword: Planting material/seeds, Certification, Internal trade, Plant production, Classification/declassification, Packaging/labelling, Vegetables/legumes, Genetically modified organism (GMO), Plant protection, Plant variety, Biotechnology

Source: FAO, FAOLEX

Order No. 226 on transport and notification in the marketing of approved genetically modified organisms in other EU countries.

Legislation | Denmark | 2009

Keyword: Genetically modified organism (GMO), Transport/storage, Authorization/permit, Data collection/reporting

Source: FAO, FAOLEX

Act on coexistence of genetically modified plants with other agricultural plants.

Legislation | Slovenia | 2009

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Basic legislation, Biotechnology

Source: FAO, FAOLEX

Regulation on risk assessment for placing on the market of product containing genetically modified organisms.

Legislation | Slovenia | 2005

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Precautionary principle

Source: FAO, FAOLEX

Regulation on risk assessment for deliberate release into the environment of genetically modified organisms.

Legislation | Slovenia | 2005

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Precautionary principle

Source: FAO, FAOLEX

Regulation on the register of genetically modified organisms.

Legislation | Slovenia | 2006

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle

Source: FAO, FAOLEX

Regulation on the application for placing on the market of products containing genetically modified organisms.

Legislation | Slovenia | 2006

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Authorization/permit

Source: FAO, FAOLEX

Regulation on monitoring the effects of products containing genetically modified organisms and their use.

Legislation | Slovenia | 2006

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Precautionary principle, Inspection

Source: FAO, FAOLEX

Decree on the report on the adequacy of a product containing genetically modified organisms for its placing on the market.

Legislation | Slovenia | 2005

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting

Source: FAO, FAOLEX

Regulation on the report on results of deliberate release into the environment of genetically modified organisms.

Legislation | Slovenia | 2006

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting

Source: FAO, FAOLEX

Regulation on contents of the notification and technical documentation for the placing on the market of genetically modified organisms or products containing and/or consisting of or originating from genetically modified organisms and on conditions of labelling and packaging of genetically modified organisms or products containing and/or consisting of or originating from genetically modified organisms.

Legislation | Croatia | 2013

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle

Source: FAO, FAOLEX

Regulation on the content and method of implementation of measures aimed to eliminate the uncontrolled spread of genetically modified organisms into the environment.

Legislation | Croatia | 2006

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle

Source: FAO, FAOLEX

Genetic Participation Ordinance.

Legislation | Germany | 1995 (2006)

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle, Pollution control, Enforcement/compliance

Source: FAO, FAOLEX

Regulation on the scope and content of the assessment report on the adequacy of placing on the market GMOs or products containing and/or consisting of or originating from GMOs.

Legislation | Croatia | 2008

Keyword: Genetically modified organism (GMO), Data collection/reporting, Inspection, Internal trade, International trade, Food quality control/food safety

Source: FAO, FAOLEX

Regulation amending the Regulation on the content and scope of risk assessment in relation to placing on the market of genetically modified organisms or products which contain and/or consist of or derive from genetically modified organisms, methodology for the preparation of assessment.

Legislation | Croatia | 2013

Keyword: Genetically modified organism (GMO), Risk assessment/management, Legal proceedings/administrative proceedings, PIC-prior informed consent, Inspection, Food quality control/food safety

Source: FAO, FAOLEX

Act amending the Organisms Act.

Legislation | Liechtenstein | 2015

Keyword: Pollution control, Genetically modified organism (GMO), Authorization/permit, Registration

Source: FAO, FAOLEX

Order No. 37 approving release of genetically modified organisms into the environment.

Legislation | Denmark | 2012

Keyword: Genetically modified organism (GMO), Authorization/permit, Data collection/reporting, Pollution control, Drugs, Hazardous waste, Waste management

Source: FAO, FAOLEX

Regulation on the application form for permit for deliberate release into the environment of genetically modified organisms.

Legislation | Poland | 2015 (2022)

Keyword: Genetically modified organism (GMO), Authorization/permit, Precautionary principle

Source: FAO, FAOLEX

Law on Circulation of Genetically Modified Organisms (2007)

Legislation | Latvia | 2007 (2015)

Keyword: Basic legislation, Genetically modified organism (GMO), Public health, Sustainable development, Agricultural development, Biotechnology, Farming, Procedural matters, Public participation, Liability/compensation, Hazards, Access-to-information

Source: FAO, FAOLEX

Regulation on the model application for authorization of deliberate release of genetically modified organisms into the environment.

Legislation | Poland | 2021

Keyword: Genetically modified organism (GMO), Authorization/permit, Precautionary principle

Source: FAO, FAOLEX

Regulation on the method of assessing the risk to human health and the environment in case of deliberate release of GMOs into the environment or placing on the market.

Legislation | Poland | 2021

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle, Biotechnology

Source: FAO, FAOLEX

Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations 2019 (S.I. No. 506 of 2019).

Legislation | Ireland | 2019

Keyword: Ecosystem preservation, EIA, Pollution control, Genetically modified organism (GMO), Data collection/reporting

Source: FAO, FAOLEX

Law on genetically modified organisms.

Legislation | Croatia | 2019

Keyword: Genetically modified organism (GMO), Biodiversity, Biosafety, Biosecurity, Offences/penalties, Food quality control/food safety, Inspection, Standards, Procedural matters, Processing/handling, Animal feed/feedstuffs, Biotechnology, Hazardous substances, Hazardous waste, Waste management

Source: FAO, FAOLEX

Regulation on the application form for the authorization to place a GMO product on the market.

Legislation | Poland | 2015

Keyword: Genetically modified organism (GMO), Authorization/permit, Precautionary principle

Source: FAO, FAOLEX

Cabinet Regulation No. 1078 of 2008 on Methodology for the Risk Assessment of Genetically Modified Organisms

Legislation | Latvia | 2008 (2015)

Keyword: Genetically modified organism (GMO), Risk assessment/management, Public health, Environmental standards, Standards, Protection of environment

Source: FAO, FAOLEX

Cabinet Regulation No. 457 of 2009 on Deliberate Release of Genetically Modified Organisms

Legislation | Latvia | 2009 (2015)

Keyword: Genetically modified organism (GMO), Procedural matters, Authorization/permit, Monitoring, Public participation, Access-to-information

Source: FAO, FAOLEX

Cabinet Regulation No. 78 of 2015 on Co-existence of Genetically Modified Crops

Legislation | Latvia | 2015

Keyword: Genetically modified organism (GMO), Registration, Crops/grasses, Monitoring, Inspection, Classification/declassification, Vegetables/legumes, Biotechnology

Source: FAO, FAOLEX

Real Decreto Nº 364/2017 - Modifica el Real Decreto Nº 178/2004, que reglamenta la Ley Nº 9/2003, sobre régimen jurídico de la utilización confinada, liberación voluntaria y comercialización de organismos modificados genéticamente.

Legislation | Spain | 2017

Keyword: Genetically modified organism (GMO), Biotechnology, Genetic resources, Standards, Internal trade, Toxicity/poisoning, Research, Legal proceedings/administrative proceedings, Registration, Institution, Biosafety, Plant protection, Biological control agents, Packaging/labelling

Source: FAO, FAOLEX

Decree implementing the Act on biotechnologies and genetically modified organisms.

Legislation | Slovakia | 2019

Keyword: Genetically modified organism (GMO), Authorization/permit, Biotechnology, Access-to-information

Source: FAO, FAOLEX

Amended by

Directive 2008/27/EC of the European Parliament and of the Council 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.

Legislation | European Union | 2008

Keyword: Genetically modified organism (GMO)

Source: FAO, FAOLEX

Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed.

Legislation | European Union | 2003

Keyword: Food quality control/food safety, Genetically modified organism (GMO), Authorization/permit, Packaging/labelling, Registration, Access-to-information, Animal feed/feedstuffs

Source: FAO, FAOLEX

Regulation (EC) No. 1830/2003 of the European Parliament and of the Council 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

Legislation | European Union | 2003

Keyword: Genetically modified organism (GMO), Inspection, Food quality control/food safety, Packaging/labelling, Traceability/product tracing, Animal feed/feedstuffs

Source: FAO, FAOLEX

Commission Decision 2002/623/EC establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

Legislation | European Union | 2002

Keyword: Genetically modified organism (GMO), Biotechnology

Source: FAO, FAOLEX

Council Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

Legislation | European Union | 2002

Keyword: Genetically modified organism (GMO)

Source: FAO, FAOLEX

Directive (EU) 2015/412 of the European Parliament and of the Council 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.

Legislation | European Union | 2015

Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Precautionary principle, Risk assessment/management

Source: FAO, FAOLEX

Regulation (EU) 2019/1381 of the European Parliament and of the Council 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.

Legislation | European Union | 2019

Keyword: Food quality control/food safety, Food additives, Genetically modified organism (GMO), Risk assessment/management, Fraud, Consumer protection, Access-to-information, Public participation, Business/industry/corporations, Animal feed/feedstuffs

Source: FAO, FAOLEX