Contained use of genetically modified microorganisms
Directive 2009/41/EC on the contained use of genetically modified microorganisms.It applies from 10 June 2009.
It lays down rules for the contained use* of genetically modified microorganisms (GMMs) in order to protect human health and the environment in the EU.
Classifications and notifications
Users of GMMs must assess the contained uses regarding the risk to human health and the environment. The assessment results in one of the following classes.
Class 1: for activities with no or negligible risk.
Class 2: for activities with low risk.
Class 3: for activities with moderate risk.
Class 4: for activities with high risk.
When a contained use of a GMM is to be carried out for the first time, the user must submit a notification containing information (listed in Annex V of the directive) to the competent authority of their EU country. This is to satisfy them that the proposed installation is appropriate for the purposes of the activity so that there is no risk to human health and the environment.
Following the notification to the competent authorities, class 1 contained use may proceed without further notification.
Class 2 contained use can proceed immediately after notification provided the premises were the subject of previous notification to carry out class 2 or higher. However, if this is not the case and in the absence of a refusal from the competent authority, class 2 contained use may proceed 45 days after the submission of the notification (or earlier with the agreement of the authority).
A class 3 or 4 contained use may not proceed without the prior consent of the competent authority, which must communicate its decision in writing.
Before a contained use begins, EU countries must ensure that:
in order to react in the case of an accident, an emergency plan is drawn up for cases where failure of the containment measures could lead to serious danger; and
persons at risk of being affected by an accident are informed of all aspects related to their safety.
Should an accident occur, the respective EU country must ensure that the GMM user informs the competent authorities and communicates the information necessary for assessing the situation and taking action.
This directive repeals and consolidates Directive 90/219/EEC and its successive amendments into a single act.
It lays down minimal standards applicable to the contained use of GMMs. EU countries are permitted to take stronger measures.
Contained use: Any activity in which microorganisms are genetically modified, cultured, stored, transported, destroyed, disposed of or used in any other way and for which containment/safety measures are used to limit their contact with the general population and the environment.
GMMs: Micro-organisms, such as bacteria, viruses or fungi, that have had their genetic material altered in a way that does not occur naturally by mating and/or natural recombination.
Accidents: In the context of this directive, these refer to any incident involving a significant and unintended release of GMMs in the course of their contained use that could be hazardous to human health or the environment.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, pp. 75-97)
Genetically modified organisms — unique identifiers
Commission Regulation (EC) No 65/2004 on unique identifiers for genetically modified organisms
The regulation establishes a unique identifier*, similar to a barcode, specific to each genetically modified organism* (GMO) brought to market. This is a key element in the traceability* and labelling of food and animal feed derived from GMOs, aiming to improve consumer choice and provide safeguards to health and the environment.
For consistency with developments in international fora, a unique identifier format is used by the Organisation for Economic Cooperation and Development BioTrack database and by the Biosafety Clearing-House of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
For each new application for the authorisation of a GMO to be put on the market, the applicant must check in the databases to make sure that an identifier has not already been assigned before creating a unique identifier in the prescribed format.
Where authorisation is granted for a GMO to be put on the market, the unique identifier is then communicated to the Biosafety Clearing-House by the European Commission and recorded in the EU register of authorised GMOs.
All GMOs authorised before the regulation came into force have been assigned unique identifiers under the regulation.
The format of the unique identifier is defined in the annex to the regulation, and consists of nine alphanumeric digits. The first two or three digits represent the company or organisation name. The second component of five or six digits represents the transformation event* and the final component is a single verification digit, all separated by a dash, for example: MON-00603-1.
For more information, see ‘Traceability and labelling’ on the European Commission’s website.It applies from 16 January 2004.
* Unique identifier: a 9-digit alphanumeric code specific to a GMO enabling it to be readily identified on a product’s labelling.
* Genetically modified organisms: plants or animals bred to give higher yield or resist disease, through modification of their cellular and genetic make-up.
* Traceability: the ability to track GMOs, and products produced from GMOs, at all stages of the production and distribution chain, facilitating accurate labelling.
* Transformation event: a term used to differentiate genetically engineered (transformed) crop varieties and other organisms.
Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, pp. 5-10)
Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (OJ L 102, 7.4.2004, pp. 14-25).
Successive amendments to Commission Regulation (EC) No 641/2004 have been incorporated into the original text. This consolidated version is of documentary value only.
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.
EU country flexibility in genetically modified organism cultivation
Directive (EU) 2015/412 — on allowing EU countries to restrict or prohibit the cultivation of genetically modified organisms in their territory
It amends Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs)* so that individual EU countries can ban or restrict their cultivation in their territory. Under the old rules, this was possible where the EU country had new evidence that the GMO concerned posed a risk to human health or to the environment.It has applied since 2 April 2015.
The new directive adds wording to the 2001 directive. It is in line with the principle of subsidiarity, whereby it gives EU countries more flexibility on the cultivation of GMOs without affecting the environmental risk assessment, which is part of the EU’s GMO authorisation system in Regulation (EC) No 1829/2003 and in Directive 2001/18/EC. It allows individual countries to ban or restrict GMO cultivation under certain conditions:
as part of the authorisation procedure of a specific GMO a country can, within 45 days of the initial assessment, ask to amend the geographical scope of the authorisation to exclude all or part of its territory from cultivating the GMO;
after a GMO has been authorised, a country may ban or restrict its cultivation for reasons such as those related to:
environmental policy objectives,
agricultural policy objectives,
town- and country-planning and land-use issues,
avoiding GMO presence in other products, and
public policy (restrictions cannot normally be based solely on this factor, nor can this outweigh environmental risk assessments).
The action taken by EU countries must conform to EU law and be reasoned, proportional and non-discriminatory. EU countries can later review their decisions and become reintegrated into the geographical scope of a GMO authorisation.
EU countries in which GMOs are cultivated must take action in border areas to avoid possible contamination of neighbouring EU countries where the cultivation of those GMOs is prohibited.
By 3 April 2019, the European Commission will report on the use of the directive to the European Parliament and to the Council, including its use by EU countries to restrict or prohibit the cultivation of GMOs and any effect it has on the EU internal market. Further legislative proposals could be proposed in the report.
The Commission will also report on the actual remediation of environmental damages that might occur due to GMO cultivation.
Genetically modified organism (GMO): 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 and/or natural recombination. This can allow plants and animals, for example, to be bred to give a higher yield or to resist disease.
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 (OJ L 68, 13.3.2015, pp. 1-8)
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)
Successive amendments to Regulation (EC) No 1829/2003 have been incorporated into the original text. This consolidated version is of documentary value only
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).