Regulating the release of GMOs into the environment
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs)
WHAT IS THE AIM OF THE DIRECTIVE?
-Facilitating the functioning of the EU’s single market for the products concerned.
This directive provides for:
-a prior authorisation system for the deliberate release of GMOs, including a a case-by-case assessment of the risks to human health and to the environment associated with releasing GMOs;
-differentiated rules for the experimental release of GMOs (eg. field trials) and the placing on the market of GMOs;
-requirements concerning the labelling and monitoring of released GMOs; and
-an opt-out system for EU countries which refuse the cultivation of GMOs in their territory.
The authorisations for experimental releases of GMOs are given at national level.
The written consent for the placing on the market of a GMO in the EU is granted by the EU country which received the notification; this consent is either granted directly by that country or, in case of objections by other EU countries or the European Commission, after an arbitration procedure involving a Commission decision.
The first scientific assessment is done by the EU country which receives the notification and can be supplemented by a further assessment by the European Food Safety Authority.
GMO labelling is compulsory. Further rules on labelling and traceability are set out in Regulation (EC) No 1830/2003.
A monitoring plan must be implemented for GMOs placed on the market.
Regarding the cultivation of GMOs, which is a specific type of deliberate release, Directive (EU) 2015/412 amended the directive to allow EU countries to prohibit or restrict the cultivation of authorised GMOs on all or part of their territory (opt-out). However, this can only be done for reasons other than the protection of human health or of the environment, which are covered by the assessment that precedes authorisations. This opt-out can be done via 2 different procedures set out in the directive.
Co-existence* rules are not set at EU level but may be adopted at national level. However, since 3 April 2017, EU countries in which GMOs are cultivated have to introduce measures in border areas to avoid possible cross-border contamination into neighbouring EU countries in which the cultivation of those GMOs is prohibited — unless such measures are unnecessary in the light of particular geographical conditions.
FROM WHEN DOES THIS DIRECTIVE APPLY?
It applies from 17 April 2001. It had to become law in the EU countries by 17 October 2002.
This directive is only one of the several building blocks of the EU’s set of rules for GMOs. The other building blocks are directives and regulations (focusing on issues like genetically modified food or transboundary movements of GMOs) that work to:
-protect human and animal health and the environment;
-put in place harmonised procedures; and
-ensure the traceability of GMOs placed on the market.
For more information, see:
-Genetically modified organisms (European Commission).
Deliberate release: in the context of this legislation, any intentional introduction into the environment of GMOs without specific containment measures.
Coexistence: the existence of genetically modified, conventional and organic crops requires rules to ensure that that they can be kept segregated from one another during cultivation, harvest, transport, storage and processing.
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 — Commission Declaration (OJ L 106, 17.4.2001, pp. 1-39)
The successive amendments to Directive 2001/18/EC have been incorporated into the basic text. This consolidated version is of documentary value only.
Commission Decision 2004/204/EC of 23 February 2004 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 (OJ L 65, 3.3.2004, pp. 20-22)
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, pp. 1-23).
See consolidated version.
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 (OJ L 268, 18.10.2003, pp. 24-28).
See consolidated version.
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, pp. 1-10)
last update 01.02.2018
This summary has been adopted from EUR-Lex.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 - Commission Declaration